This document is a doctoral thesis that examines total wrist arthroplasty (TWA), patient-rated outcome measures related to TWA, and periprosthetic osteolysis following TWA. The thesis includes studies using a multicenter international registry of TWA patients, radiographical and histopathological evaluations, and validation of translated patient-rated outcome measures. The overall aim is to evaluate outcomes of TWA, assess patient-rated outcomes, and investigate periprosthetic osteolysis.

1. Total
Wrist
Arthroplasty:
outcomes,
patient
rated
outcome
measures
and
periprosthetic
osteolysis.
Michel
E.
H.
Boeckstyns
Doctoral
Thesis
University
of
Copenhagen
Gentofte
Hospital,
Clinic
for
Hand
Surgery

2. 2
Denne afhandling er af Det Sundhedsvidenskabelige Fakultet ved Københavns Universitet antaget til
offentligt at forsvares for den medicinske doktorgrad.
København, den 21/5 2015
Professor Ulla Wewer
dekan
Forsvaret finder sted fredag den 12. juni 2015, kl. 14 i Hannover Auditoriet, Panum, Blegdamsvej 2B,
2200 København N
Officielle opponenter:
Professor Leiv M. Hove, Bergen Universitet, Norge
Professor Torben Bæk Hansen, Aarhus Universitet.
Copyright © 2015 Michel E. H. Boeckstyns
All rights reserved
Printed in Denmark
Eget forlag
ISBN 978-87-998283-0-2
Address for correspondence:
mibo@dadlnet.dk

3. 3
Tak
til…
…
først
og
fremmest
min
gode
ven
og
kollega
Søren
Merser,
som
har
ydet
mig
en
utroligt
uselvisk
og
kvalificeret
hjælp
og
rådgivning,
ikke
mindst
i
det
statistiske
…
Iben,
som
har
udvist
stor
tålmodighed
…
Stig
Sonne-­‐Holm
for
hans
velvillige
og
kvalificerede
kommentarer
…
Gentofte
Hospital
for
at
give
mig
frihed
til
at
lave
arbejdet
…
Guillaume
Herzberg
for
det
værdifulde
samarbejde
…
de
øvrige
medarbejdere
i
mine
projekter,
uden
hvem
de
ikke
ville
være
blevet
fuldført:
Allan
Ibsen
Sørensen,
Alex
Herup,
Anders
Toxværd,
Karsten
Krøner,
Lars
Soelberg
Vadstrup,
Laurent
Obert,
Manjula
Bansal,
Peter
Axelsson,
Philippe
Liverneaux.
I
express
my
gratitude
to
Søren
Merser
for
his
invaluable
help
…
my
wife
Iben
for
being
so
patient
…
Stig
Sonne-­‐Holm
for
his
helpfulness
…
Gentofte
Hospital
for
giving
me
the
possibility
to
do
this
work
…
Guillaume
Herzberg
for
his
invaluable
contributions
…
all
my
other
co-­‐workers
in
this
project:
Allan
Ibsen
Sørensen,
Alex
Herup,
Anders
Toxværd,
Karsten
Krøner,
Lars
Soelberg
Vadstrup,
Laurent
Obert,
Manjula
Bansal,
Peter
Axelsson,
Philippe
Liverneaux.

4. 4
Contents
List
of
terms
and
definitions
5
Abbreviations
11
List
of
papers
13
Introduction
and
Background
14
1.
Historical
background
and
current
issues
concerning
Total
Wrist
Arthroplasty
(TWA).
14
2.
Patient-­‐rated
Outcome
measures
(PROMs)
and
TWA
16
Aims
of
the
Thesis
17
Initiatives
17
Methods
and
Methodological
Considerations
19
1.
The
PRISMA
statements
19
2.
The
multicenter
international
Re-­‐motion
registry
22
3.
The
cumulated
implant
survival
25
4.
Radiographical
measurements
26
5.
Histopathological
evaluations
27
6.
Translation
of
PROMs
28
7.
Validation
of
PROMs
28
Results
30
General
Discussion
and
Comparison
with
Other
Research
49
Review
of
the
literature
49
The
multicentre
international
Re-­‐motion
registry.
52
Periprosthetic
osteolysis
53
Validation
of
PROMs
61
Future
perspectives
63
Summary
and
Conclusions
of
the
Thesis
65
Dansk
resume
og
konklusioner
67
References
70
Paper
I
76
Paper
II
85
Paper
III
89
Paper
IV
95
Paper
V
100
Paper
VI
106
Paper
VII
115
Paper
VIII
119

5. 5
List
of
terms
and
definitions
Anchor
based
method:
method
that
uses
some
external
anchor,
such
as
patient
judgments
of
change,
which
is
then
used
to
compute
a
minimal
clinically
important
difference
(MCID).
Cohen’s
kappa:
Cohen's
kappa
coefficient
is
a
statistical
measure
of
inter-­‐rater
agreement
for
qualitative
(categorical)
items.
Condition-­‐specific
questionnaire:
addresses
specific
conditions,
like
carpal
tunnel
syndrome,
Dupuytren’s
disease,
distal
radius
fractures
etc.
Construct:
A
well-­‐defined
and
precisely
demarcated
subject
of
measurement
Construct
validity:
The
degree
to
which
the
scores
of
a
scale
are
consistent
with
a
priori
hypotheses
concerning
the
construct
to
be
measured.
Content
validity:
Content
validity
is
the
extent
to
which
an
outcome
measure
instrument
appears
to
measure
all
facets
of
what
it
was
intended
to
measure.
Criterion
validity:
Criterion
validation
assesses
how
a
person
who
scores
at
a
certain
level
on
a
scale
does
on
a
gold
standard
or
some
other
validated
criterion
measure.
Cronbach's
alpha:
a
coefficient
of
internal
consistency
that
indicates
the
intercorrelation
among
test
items.
Scales
are
considered
to
be
internally
consistent
if
Cronbach’s
alpha
is
between
0.7
and
0.9
1.
Cronbach’s
alpha
in
excess
of
0.9
suggests
possible
redundancy
in
the
questionnaire.
DASH:
Disabilities
of
Arm,
Shoulder
and
Hand
(Handicaps
i
Arm,
Skulder
og
Hånd).
Generic
patient
rated
outcome
measure
of
the
upper-­‐extremity
2.
Domain:
a
sub-­‐score
within
a
questionnaire
meant
to
cover
a
specific
condition
of
interest,

6. 6
e.g.
motion,
pain,
strength
etc.
Floor
and
ceiling
effect:
the
floor
and
ceiling
effects
show
the
proportion
of
individuals
who
achieve
the
highest
or
lowest
possible
numeric
value
of
a
score
and
are
considered
present
when
more
than
15%
of
the
individuals
achieve
these
values.
3
4
A
ceiling
or
floor
effect
indicates
that
the
measurement
instrument
cannot
be
used
for
the
entire
continuum
of
patients
seen.
General
outcome
assessment
(GOA):
assessment
of
outcome
made
by
an
observer
–
e.g.
a
surgeon
or
hand
therapist
–
on
the
basis
of
physical
tests,
like
measuring
motion,
stability
etc.
=
evaluation
from
the
clinician’s
perspective.
Generic
questionnaire:
questionnaire
addressing
more
general
health
concerns.
E.g.:
DASH
addresses
general
upper
limb
function.
Intraclass
correlation
(ICC):
The
ICC
is
used
to
assess
the
consistency,
or
conformity,
of
measurements
made
by
multiple
observers
measuring
the
same
quantity.
While
it
is
viewed
as
a
type
of
correlation,
unlike
most
other
correlation
measures
it
operates
on
data
structured
as
groups,
rather
than
data
structured
as
paired
observations
1.
ICC1:
Each
target
is
rated
by
a
different
judge
and
the
judges
are
selected
at
random.
It
is
sensitive
to
differences
in
means
between
raters
and
is
a
measure
of
absolute
agreement.
ICC2:
A
random
sample
of
k
judges
rate
each
target.
The
measure
is
one
of
absolute
agreement
in
the
ratings.
ICC3:
A
fixed
set
of
k
judges
rate
each
target.
There
is
no
generalization
to
a
larger
population
of
judges.
ICC2
and
ICC3
remove
mean
differences
between
judges,
but
are
sensitive
to
interactions
of
raters
by
judges.
The
difference
between
ICC2
and
ICC3
is
whether
raters
are
seen
as
fixed
or
random
effects

7. 7
Internal
consistency:
The
degree
of
the
interrelatedness
among
the
items.
The
degree
to
which
the
sum-­‐score
actually
reflects
the
trait
to
be
measured,
related
to
the
degree
of
unidimensionality
(see
also
Cronbach’s
alpha).
Item:
A
single
question
within
a
domain
or
questionnaire.
Items
with
dichotomous
response
options:
items
responded
by
whether
the
item
is
endorsed
or
not
(e.g.
yes/no
or
agree/disagree).
Items
with
polytomous
response
structure:
items
with
several
response
options.
The
structure
can
be
categorical,
ordinal,
intervallic.
Likert
scale:
A
rating
scale
in
which
raters
express
their
opinion
on
a
given
subject
by
marking
a
box
within
a
continuum
of
disagree-­‐agree
statements.
Minimal
clinically
important
difference
(MCID):
The
smallest
difference
that
patients
perceive
as
beneficial
(or
detrimental).
5.
There
are
several
methods
to
estimate
so-­‐called
minimal
clinically
important
differences
(MCIDs).
One
is
the
‘‘one
SEM’’
method,
which
defines
the
MCID
by
the
baseline
standard
deviation
multiplied
by
the
square
root
of
1
minus
the
reliability
coefficient
of
the
scale.
Another
is
the
anchor
based
method
(see
that
word).
Patient Rated Wrist Evaluation: the
Patient
Rated
Wrist
Evaluation
questionnaire
(PRWE)
6
was
originally
designed
as
a
specific
instrument
for
the
assessment
of
distal
radius
fractures
and
wrist
injuries.
Patient-­‐related
/
patient
reported
/
patient
rated
outcome
measures
(PROM):
evaluation
of
outcome
made
by
the
patient
without
interference
by
the
clinician
or
others
=
evaluation
from
the
patient’s
perspective.
A
questionnaire
used
in
a
clinical
trial
or
a
clinical
setting,
where
the
responses
are
collected
directly
from
the
patient.
Pearson’s
correlation
coefficient
(Pearson’s
r):
is
a
measure
of
the
linear
correlation
(dependence)
between
two
variables
X
and
Y,
giving
a
value
between
+1
and
−1
inclusive,
where
1
is
total
positive
correlation,
0
is
no
correlation,
and
−1
is
total
negative
correlation.
A

8. 8
correlation
value
between
0.8
and
1.0
or
-­‐0.8
and
-­‐1.0
is
considered
a
very
strong
relationship,
between
0.6
and
0.8
a
strong
relationship,
between
0.4
and
0.6
a
moderate
relationship,
between
0.2
and
0.4
a
weak
relationship
and
between
0
.0
and
0.2
a
very
weak
or
absent
relationship.
Periprosthetic
osteolysis
(PPO):
a
biological
process
of
bone
resorption
adjacent
to
prosthetic
joint
implants,
seen
as
radiolucent
lines
or
-­‐areas
on
radiographs.
QuickDASH:
Shortened
version
of
the
DASH-­‐questionnaire,
comprising
11
of
the
30
items
in
the
full
DASH7
Reproducibility:
The
extent
to
which
scores
for
patients,
whose
clinical
status
has
not
changed,
are
the
same
for
repeated
measurement
under
several
conditions:
over
time
(test-­‐
retest),
by
different
persons
on
the
same
occasion
(inter-­‐rater)
or
by
the
same
persons
on
different
occasions
(intra-­‐rater).
The
Pearson’s
and
Spearman’s
correlation
coefficients,
the
Intraclass
correlation
coefficient
and
the
Kappa
coefficient
are
commonly
used
statistic
to
evaluate
reliability.
Response
rate:
the
proportion
of
respondents
in
relation
to
all
patients
who
received
the
questionnaire.
Responsiveness:
the
extent
to
which
an
outcome
measure
instrument
is
able
to
detect
and
assess
how
a
patient
responds
to
treatment
or
a
meaningful
or
important
change
in
a
clinical
state
(the
ability
to
demonstrate
the
impact
of
treatment).
Responsiveness
can
be
assessed
by
the
standardized
effect
size
(SE)
or
the
standardized
response
mean
(SRM).
8
Sensitivity
of
a
measurement
instrument:
The
ability
of
an
instrument
to
measure
change
in
a
state
irrespective
of
whether
it
is
relevant
or
meaningful
to
the
decision
maker
9.

9. 9
Spearman’s
correlation
coefficient
(Spearman’s
rho):
is
a
nonparametric
measure
of
statistical
dependence
between
two
variables.
It
assesses
how
well
the
relationship
between
two
variables
can
be
described
using
a
monotonic
function.
If
there
are
no
repeated
data
values,
a
perfect
Spearman
correlation
of
+1
or
−1
occurs
when
each
of
the
variables
is
a
perfect
monotone
function
of
the
other.
Spearman's
coefficient
is
appropriate
for
both
continuous
and
discrete
variables,
including
ordinal
variables.
A
correlation
value
between
0.8
and
1.0
or
-­‐0.8
and
-­‐1.0
is
considered
a
very
strong
relationship,
between
0.6
and
0.8
a
strong
relationship,
between
0.4
and
0.6
a
moderate
relationship,
between
0.2
and
0.4
a
weak
relationship
and
between
0
.0
and
0.2
a
very
weak
or
absent
relationship.
Standard error of measurement (SEM): the
standard
deviation
of
repeated
test
Standardized
effect
size
(SE):
is
used
for
assessing
responsiveness
and
equal
to
the
mean
score
difference
(follow-­‐up
minus
baseline)
divided
by
the
score’s
standard
deviation
at
baseline.
An
ES
>0.80
is
considered
as
large,
0.50–0.79
as
moderate,
0.20–0.49
as
small,
and
0.00–0.19
as
very
small.
Standardized
response
mean
(SRM):
The
standardized
response
mean
is
one
of
several
available
and
widely
used
effect
size
indices,
used
to
gauge
the
responsiveness
of
scales
to
clinical
change.
The
SRM
is
computed
by
dividing
the
mean
score
change
(i.e.,
follow-­‐up
minus
baseline)
by
the
standard
deviation
of
the
change.
Cohen
has
advocated
thresholds
for
the
interpretation
of
effect
size
indices:
‘trivial’
(ES
<0.20),
‘small’
(ES
0.20-­‐0.50),
‘moderate’
(ES
0.50-­‐0.80),
or
‘large’
(ES
>0.80).
According
to
Middel
&
van
Sonderen
however,
this
may
lead
to
over-­‐
or
underestimation
of
the
magnitude
of
intervention-­‐related
change
over
time10.
Surrogate
measures:
measures
that
are
used
in
place
of
the
clinically
most
relevant
measures.
PROM’s
are
preferred
compared
to
surrogate
measures,
such
as
biomarkers
.

10. 10
Thurstone
scale:
is
made
up
of
statements
about
a
particular
issue,
and
each
statement
has
a
numerical
value
indicating
how
favourable
or
unfavourable
it
is
judged
to
be.
It
is
an
attempt
to
approximate
an
interval
scale.
E.g.
in
the
DASH-­‐questionnaire:
No
difficulty
(1),
Mild
difficulty
(2),
Moderate
difficulty
(3),
Severe
difficulty
(4),
Unable
(5).
Unidimensionality:
in
a
unidimensional
construct,
the
variable
is
identified
and
mapped
in
a
single
real
number
line.
A
questionnaire
that
measures
a
single
construct
is
described
as
unidimensional.
Items
(questions)
in
a
unidimensional
questionnaire
can
be
added
to
provide
a
single
scale
score.
Validity:
The
degree
to
which
a
PROM
measures
the
construct(s)
it
purports
to
measure.
Visual
Analogue
Scale
(VAS):
A
visual
analogue
scale
is
a
psychometric
response
scale,
which
can
be
used
in
questionnaires.
It
is
a
measurement
instrument
for
subjective
characteristics
or
attitudes
that
cannot
be
directly
measured.
When
responding
to
a
VAS
item,
respondents
specify
their
level
of
agreement
to
a
statement
by
indicating
a
position
along
a
continuous
line
between
two
end-­‐points.
This
continuous
(or
"analogue")
aspect
of
the
scale
differentiates
it
from
discrete
scales
such
as
the
Likert
scale.
There
is
evidence
showing
that
visual
analogue
scales
have
superior
metrical
characteristics
than
discrete
scales,
thus
a
wider
range
of
statistical
methods
can
be
applied
to
the
measurements.

11. 11
Abbreviations
CTS:
Carpal
Tunnel
Syndrome
DASH: Disabilities
of
Arm,
Shoulder
and
Hand
(Handicaps
i
Arm,
Skulder
og
Hånd):
Generic
patient
rated
outcome
measure
of
the
upper-­‐extremity
ICC:
Intraclass
Correlation
IWH:
Institute for Work & Health.
MCID:
Minimal
Clinically
Important
Difference
OA: Osteoarthritis
PPO: Periprosthetic Osteolysis
PRWE: Patient Rated Wrist Evaluation
PRISMA: Preferred Reporting Items for Systematic reviews and Meta-Analyses
PRO(M): Patient Related Outcome/ Patient Reported Outcome/ Patient Rated Outcome (Measure)
PT: Posttraumatic
PWA: Partial Wrist Arthroplasty
RA: Rheumatoid Arthritis
RSA:
Radiostereometric
Analysis
SEM: Standard Error of Measurement
SES:
Standardized
Effect
Size
SRM:
Standardized
Response
Mean
SLAC:
Scapholunate
Advanced
Collapse
SNAC:
Scaphoid
Nonunion
Advanced
Collapse
TAA: Total Ankle Arthroplasty
TEA: Total Elbow Arthroplasty
THA: Total Hip Arthroplasty

12. 12
TKA: Total Knee Arthroplasty
TSA: Total Shoulder Arthroplasty
TWA: Total Wrist Arthroplasty
TWF: Total Wrist Fusion
VAS: Visual Analogue Scale

13. 13
List
of
papers
I. Boeckstyns
MEH.
Wrist
arthroplasty
−
a
systematic
review.
Dan
Med
J
2014;61(5):A4834
11.
II. Herzberg
G,
Boeckstyns
M,
Sorensen
AI,
Axelsson
P,
Kroener
K,
Liverneaux
P,
et
al.
"Remotion"
total
wrist
arthroplasty:
preliminary
results
of
a
prospective
international
multicenter
study
of
215
cases.
J
Wrist
Surg.
2012
Aug;1(1):
17-­‐22.
12
III. Boeckstyns
ME,
Herzberg
G,
Sorensen
AI,
Axelsson
P,
Kroner
K,
Liverneaux
PA,
et
al.
Can
total
wrist
arthroplasty
be
an
option
in
the
treatment
of
the
severely
destroyed
posttraumatic
wrist?
J
Wrist
Surg.
2013
Nov;2(4):
324-­‐9.
13
IV. Boeckstyns
ME,
Herzberg
G,
Merser
S.
Favorable
results
after
total
wrist
arthroplasty:
65
wrists
in
60
patients
followed
for
5-­‐9
years.
Acta
orthopaedica.
2013
Aug;84(4):
415-­‐9.
14
V. Boeckstyns
MEH,
Herzberg
G:
Periprosthetic osteolysis after total wrist
arthroplasty. J Wrist Surg 2014;3:101–106 15
.
VI. Boeckstyns
MEH,
Toxværd
A,
Bansal
M,
Vadstrup
LS.
Wear
particles
and
osteolysis
in
patients
with
total
wrist
arthroplasty.
J
Hand
Surg
Am
2014;
39(12):2396-­‐2404
16
.
VII. Herup
A,
Merser
S,
Boeckstyns
M.
[Validation
of
questionnaire
for
conditions
of
the
upper
extremity].
Ugeskr
laeger
2010;172(48):
3333-­‐6.
17
VIII. Boeckstyns
MEH,
Merser
S:
Psychometric Properties of two Questionnaires in the
Context of Total Wrist Arthroplasty.
Dan
Med
J
2014;
61
(11):
A4939
18.

14. 14
Introduction
and
Background
1.
Historical
background
and
current
issues
concerning
Total
Wrist
Arthroplasty
(TWA).
Themistocles
Gluck
(1853-­‐1942)
is
said
to
have
performed
the
first
total
wrist
arthroplasty
(TWA)
19.
“A
19-­‐year-­‐old
male
patient,
named
Franz,
had
a
21-­‐month
history
of
tuberculosis
of
his
right
wrist,
presumably
due
to
a
trauma.
He
showed
progressive
loss
of
function
and
atrophy
of
the
hand.
On
9
June
1890
an
operation
was
performed.
A
dorsoradial
incision
in
the
manner
of
von
Langenbeck
was
used;
resection
of
the
joint
including
the
base
of
the
metacarpals,
the
two
carpal
rows
and
the
distal
part
of
radius
and
ulna
was
performed.
After
cleaning
the
wound
thoroughly
and
extirpation
of
the
capsule
a
device
made
of
ivory
was
placed,
a
ball
and
socket
articulation
with
forks
at
both
ends,
designed
so
that
one
fork
fitted
the
ulna
and
radius
and
the
other
in
the
medullary
canals
of
the
metacarpals.
Stable
fixation
was
achieved,
the
wound
was
closed
and
recovery
was
uneventful.
Today
the
device
is
fully
incorporated,
the
hand
is
not
shortened
and
no
pain
is
present.”
20.
At
a
follow-­‐up
of
more
than
one
year,
the
implant
was
still
in
place
with
a
good
range
of
motion,
but
a
chronic
fistula
was
present
due
to
the
nature
of
the
original
disease
process.
The
idea
of
wrist
arthroplasty
using
artificial
materials
was
then
abandoned
until
John
Niebauer
and
Alfred
Swanson
during
the
1960s
independently
introduced
the
concept
of
a
silicone
interpositional
spacer
for
joint
replacement
that
could
offer
immediate
stability
and
a
foundation
on
which
the
reparative
fibrous
tissue
could
grow
without
inhibiting
later
motion.
Swanson
started
using
these
silicone
implants
for
the
radiocarpal
joint
in
1967
and
reported
his
experience
in
1982
and
1984
21.
Lundkvist
&
Barfred
have
reported
on
a
Danish
experience
22.
The
results
have
been
generally
favourable
in
low
demand
rheumatoid
patients

15. 15
at
short
term
but
the
silicone
spacers
are
no
longer
in
use
for
wrist
replacement
due
to
problems
with
breakage,
subsidence
and
silicone
synovitis
23.
The
2nd
generation
of
implants,
introduced
in
the
1970s,
were
multicomponent
24
25-­‐28.
There
is
no
consensus
on
the
definition
of
second
generation.
In
this
thesis,
it
is
defined
as
an
implant
consisting
of
a
radial
component
and
a
carpal
component
that
is
fixated
in
one
or
more
of
the
metacarpal
bones.
Some
of
these
systems
have
been
developed
after
the
introduction
of
the
3rd
generation
27-­‐29.
The
3rd
generation
is
characterized
by
minimal
bone
resection
and
avoids
fixation
in
the
metacarpal
bones,
with
the
exception
of
an
optional
and
restricted
fixation
in
the
second
metacarpal.
They
attempt
to
mimic
the
natural
anatomy
and
biomechanics
of
the
wrist
and
are
largely
unconstrained
30-­‐32.
In
recent
years,
pyrocarbon
was
introduced
as
a
single
component
interposition
arthroplasty
33
or
hemiarthroplasty
34.
I
define
these
as
“4th
generation”.
Many
2nd
generation
implants
turned
out
to
have
deceiving
long
term
results
and
most
are
no
longer
available.
The
published
series
are
generally
rather
small
and
with
a
short
follow-­‐up.
The
most
well
documented
2nd
generation
implant,
the
Biax,
was
withdrawn
from
the
market
for
commercial
reasons.
Thus,
the
longevity
of
TWA
needs
to
be
investigated.
Reports
are
not
uniform.
Some
report
implant
survival
rates
at
8
years
at
a
level
of
80-­‐100%
25,35-­‐37,
whilst
others
report
markedly
lower
survival
38
39.
Problems
have
mainly
been
located
at
the
carpal
side.
Periprosthetic
osteolysis
has
also
been
a
problem.
It
may
be
associated
with
definite
implant
loosening
or
not
25
but
its
natural
history
and
clinical
consequences
have
not
been
well
described.
The
question
as
to
which
extent
and
on
what
indications
TWA
is
superior
to
total
wrist
fusion
(TWF)
also
needs
to
be
answered
definitely.
Although
many
patients
with
bilateral
procedures
-­‐TWA
on
one
side
and
TWF
on
the
other
–
would
have
preferred
arthroplasty
on

16. 16
both
sides,
this
is
not
always
the
case
36.
2.
Patient-­‐rated
Outcome
measures
(PROMs)
and
TWA
Patient-­‐rated
outcome
assessments
are
increasingly
emphasized
in
orthopaedic
surgery,
as
it
has
in
other
medical
specialties.
The
field
has
progressed
from
outcomes
defined
by
joint
motion
and
bony
union
to
standardized
assessments
of
function
and
disability
completed
by
the
patients.
It
is
essential
to
realize
that
the
choice
of
available
health
status
instruments
is
related
to
the
methodological
debate
on
the
psychometric
properties
of
instruments.
Generic
measures
allow
investigators
to
compare
health
status
across
different
diseases
and
interventions.
Condition-­‐specific
measures
focus
on
the
disease
being
studied,
allowing
greater
sensitivity
to
intervention
related
change
compared
to
generic
measures.
The
DASH
was
designed
as
a
measure
of
disability:
physical
function
(in
terms
of
disability)
and
symptoms
related
to
the
upper-­‐limb.
As
a
generic
upper-­‐limb
measure,
it
assesses
the
impact
of
disorders
on
the
whole
person
rather
than
on
a
specific
limb,
i.e.
the
whole
person’s
ability
to
function,
even
if
the
person
is
compensating
with
the
other
arm
or
using
devices.
The
DASH
and
the
shortened
version,
the
QuickDASH,
are
probably
the
most
widely
used
patient
rated
outcome
measure
instruments
(PROMs)
in
hand
surgery.
With
the
increased
international
focus
on-­‐
and
usage
of
PROMs
it
has
become
increasingly
important
that
they
are
properly
translated/culturally
adapted
and
well
validated
in
the
context
in
which
they
are
intended
to
be
used
40.

17. 17
Aims
of
the
Thesis
The
aims
of
this
thesis
were:
1. To
review
the
literature
in
order
to
update
and
summarize
the
current
knowledge
on
total
wrist
arthroplasty
(TWA).
2. To
analyse
the
clinical
and
radiographical
results,
and
the
longevity
obtained
with
one
3rd
generation
TWA,
the
Re-­‐motion
prosthesis
(SBI
Inc.,
Morrisville,
PA,
USA,
previously
the
Avanta
TWA,
AVANTA
Orthopaedics
San
Diego,
CA)
.
3. To
obtain
knowledge
on
the
prevalence,
location,
possible
causes
and
clinical
implications
of
periprosthetic
osteolysis
(PPO).
4. To
assess
and
validate
patient
rated
outcome
measures
(PROMs),
commonly
used
in
the
context
of
TWA
with
special
focus
on
the
QuickDASH
–
questionnaire
and
the
PRWE.
Initiatives
The
thesis
is
the
result
of
working
with
PROMs
and
TWA
during
15
years.
It
has
included
a
systematic
search
of
the
literature
and
the
construction
of
a
multicentric
international
registry
for
the
Re-­‐motion
TWA
in
view
of
collecting
data
on
a
larger
sample
and
with
a
longer
follow-­‐up
period
than
currently
available.
The
Re-­‐motion
TWA
is
an
elliptic
ball
and
socket
design
consisting
of
radial
and
carpal
Cr-­‐Co
components
that
are
titanium-­‐coated,
and
an
intercalated
polyethylene
component
that
mainly
articulates
with
the
radial
component
but
also
permits
a
rotational
articulation
of
20
degrees
with
the
carpal
plate
(Figure
1).
The
carpal
plate
is
fixated
to
the
carpus
by
its
stem
and
2
screws,
of
which
only
the
most
radial
may
penetrate
the
metacarpal
for
a
very
short
distance
even
though
many
advocate
not
doing
so.

18. 18
Thus,
fixation
is
mainly
aimed
to
be
to
the
carpus
and
minimally
in
the
metacarpals.
The
fixation
is
typically
done
without
cement.
Figure
1.
The
Re-­‐motion
TWA
with
the
metallic
radial
and
carpal
components
and
the
intercalated
polyethylene
ball
(Courtesy
Acta
Orthopaedica
2013,
paper
IV).
Both
initiatives
have
revealed
that
periprosthetic
osteolysis
(PPO),
showing
as
periprosthetic
radiolucency
on
plain
X-­‐rays,
with
or
without
total
loosening
of
the
implant
components
is
a
frequent
occurrence.
Further
investigations
were
conducted
-­‐
together
with
Guillaume
Herzberg,
Lyon
-­‐
in
order
to
obtain
more
precise
information
on
the
nature,
location,
prevalence
and
possible
clinical
consequences
of
PPO.
Finally
a
study
was
done,
aiming
at
finding
relations
between
implant
wear
and
PPO.
Concurrently
the
psychometric
properties
of
widely
used
PROMs
were
investigated
upon:
the
shortened
version
of
the
Disability
of
Arm
Shoulder
and
Hand-­‐questionnaire
(QuickDASH)

19. 19
and
the
Patient
Rated
Wrist
Evaluation
(PRWE).
An
essential
part
of
this
process
was
the
cross-­‐cultural
adaptations
of
the
DASH
and
QuickDASH
to
Danish.
Methods
and
Methodological
Considerations
1.
The
PRISMA
statements
Systematic
reviews
are
essential
tools
for
summarizing
evidence
accurately
and
reliably
in
an
effort
to
assess
the
benefits
and
harms
of
health
care
interventions.
They
attempt
to
collate
all
empirical
evidence
that
fits
pre-­‐specified
eligibility
criteria
to
answer
specific
research
questions
and
may
be
used
to
summarize
evidence
other
than
that
provided
by
randomized
trials.
The
review
of
the
literature
in
this
thesis
was
conducted
according
to
the
PRISMA
–
guidelines.
The
overall
aim
of
PRISMA
–
consisting
of
a
27-­‐item
checklist
and
a
four-­‐phase
flow
diagram
-­‐
is
to
help
ensure
the
clarity
and
transparency
of
reporting
of
systematic
reviews
and
meta-­‐analyses
41.
A
search
was
made
using
a
protocolled
strategy
and
well-­‐
defined
criteria
in
PubMed,
in
the
Cochrane
Library
and
by
screening
reference
lists
(Fig.
2).
I
made
a
primary
search
through
PubMed
with
the
Mesh
terms
“Wrist
Arthroplasty”
and
“Wrist
Replacement”
but
restricted
the
search
to
the
1994-­‐2013-­‐
period,
considering
earlier
material
to
have
historical
value
only.
A
second
search
was
done
in
the
Cochrane
Library
and
a
continuous
supplementary
search
by
scanning
the
reference
lists
of
the
papers
first
included.
The
inclusion
criteria
were:
papers
with
primary
clinical
data
on
second,
third
and
fourth
generation
implants.
Excluded
were:
cadaveric
studies;
biomechanical
studies;
studies
not
accessible
in
journals,
books
or
online;
reviews
without
primary
data.
Double
publications

20. 20
and
articles
with
overlap
of
cases
were
relative
exclusion
criteria.
Articles
not
written
in
English,
Danish,
Swedish,
Norwegian,
French,
Dutch
or
German
were
evaluated
on
the
basis
of
an
English
abstract,
if
available.
Papers
with
less
than
ten
cases
were
considered
to
be
less
useful
and
are
therefore
only
mentioned
very
briefly.
Implant
longevity
was
primarily
evaluated
on
the
basis
of
papers
reporting
a
cumulated
implant
survival
of
at
least
five
years;
secondarily,
papers
with
a
follow-­‐up
of
a
minimum
of
two
years
in
each
case.
Function
was
evaluated
if
reported
by
well-­‐validated
and
relevant
outcome
measurement
tools
like
the
DASH/QuickDASH,
the
PRWE
or
the
MHQ.

21. 21
Figure
2:
Flowdiagram
of
the
search
strategy
in
the
systematic
review
of
the
literature
on
TWA
(1994-­‐2013)
1
Search
for
“wrist
arthroplasty”
and
“wrist
replacement”:
800
articles
(by
April
2013)
Additional
search
by
scanning
reference
lists:
13
articles
Number
of
articles
after
exclusions
through
Mesh-­‐
words:
248
Number
of
eligible
articles
after
duplicated
removed:
44
Number
of
articles
after
screening:
36
Number
of
eligible
articles:
56
16
articles
for
qualitative
evaluation
of
longevity
(articles
with
follow-­‐up
in
every
case
≥2
years
or
with
documented
implant
survival
at
≥5
years)
Articles
with
N
<
10
excluded
from
analysis
but
briefly
mentioned:
7
21
16
37
articles
for
qualitative
evaluation
of
clinical
outcome
Duplicates
/
overlap
excluded:
12
articles
Supplementary
search
by
December
2013:
7
articles

22. 22
2.
The
multicenter
international
Re-­‐motion
registry
The
initiative
to
create
this
registry
was
taken
in
2009
in
collaboration
with
Guillaume
Herzberg
and
with
the
technical
assistance
of
Søren
Merser.
The
launching
has
partly
been
supported
by
SBI
Inc.,
Morrisville,
PA,
USA
and
has
since
been
administrated
by
the
two
initiators,
independently
from
any
industrial
or
commercial
interests.
The
input
of
data
in
the
registry
is
made
online,
directly
by
the
participants
and
is
overviewed
and
supported
by
the
two
initiators.
Data
sampled
before
the
creation
of
the
registry
could
be
also
be
entered,
provided
they
were
collected
prospectively
and
according
to
the
guidelines
of
the
registry.
On
demand
by
any
participant,
statistical
calculations
and
the
generation
of
extensive
updated
reports
are
performed
automatically
in
real
time.
The
registry
is
accessible
at
https://statcom.dk/irwa.
Ideally,
the
participant
centres
should
perform
follow-­‐up
examinations
of
their
cases
annually
after
operation.
Quality
control
in
the
registry
The
registry
offers
the
possibility
to
the
administrators
to
perform
data
quality
control.
Primarily,
this
consists
of
surveillance
of
the
completeness
of
data.
Lacking
follow-­‐up
data
are
reported
automatically
to
the
administrators,
in
which
case
they
may
choose
to
contact
the
participants
and
urge
them
to
complete
the
data,
an
action
that
has
been
taken
with
success
before
important
communications
and
publications
in
peer-­‐reviewed
journals.
Also,
the
administrators
may
choose
to
exclude
data
from
participants
that
do
not
have
included
a
sufficient
number
of
cases
or
follow-­‐up
examinations.
The
registration
of
general
outcome
measures,
like
motion
measured
with
goniometer,
grip-­‐strength
measured
with
the
JAMAR
Hydrolic
Hand
Dynamometer
(Sammons
Preston
Rolyan,
Bolingbrook,
IL,
USA)
and
pain
on
a
Visual
analogue
scale
(VAS)
may
be
considered
as
biased,
due
to
a
potential
inter-­‐rater

23. 23
variation,
but
“outliers”
can
be
spotted
by
the
administrators
and
action
taken
for
correction.
The
quality
of
data
on
function
or
disability
is
assured
by
the
use
of
approved
and
validated
versions
of
the
QuickDASH.
The
radiographical
data
are
considered
as
weak
and
merely
estimates,
because
it
is
left
to
the
judgment
of
the
surgeons
who
contributed
to
the
register,
how
to interpret
the
radiographs.
The degree of uniformity of data across centres is shown in table 1, showing data for each of the
seven centres that were selected to provide data in view of 3 publications 12-14
, recorded
preoperatively and at latest follow-up (minimum 1 year), revision cases excluded.

24. 24
Table 1.
Data recorded preoperatively and at latest follow-up after Re-motion TWA in 7 centres.
Centre (number of cases in brackets)
A (45) B (51) C (25) D (64) E (17) F (19) G (13)
Motion
Mean of Total
Extension-flexion in
degrees
(preop/postop)
75/61 72/65 47/48 64/65 77/72 69/73 75/70
Mean of total Ulnar-
radial flexion in
degrees
(preop/postop)
30/27 35/37 12/18 33/39 21/41 23/26 NA
Mean Grip strength
in kgF (preop/postop)
12/16 11/13 9/12 10/16 10/21 14/14 9/13
Median QuickDASH-
score (0-100)
(preop/postop)
47/30 61/45 67/42 55/25 50/20 92/72* 56/34
Median VAS-score
for Pain (0-100)
(preop/postop)
70/14 67/12 80/10 67/11 70/0 67/24 65/30
*: The QuickDASH was calculated in two cases only at this centre.

25. 25
3.
The
cumulated
implant
survival
We
consider
the
Kaplan-­‐Meier
method
for
the
analysis
of
implant
survival
as
a
powerful
tool
in
the
evaluation
of
the
durability
of
TWA
42.
The
method
makes
it
possible
to
analyse
data
from
patients
with
different
lengths
of
follow-­‐up,
taking
into
account
dropouts
for
any
reason.
A
disadvantage
is
the
fundamental
assumption
that
patients
who
are
lost
to
follow-­‐up
and
patients
who
have
died
have
the
same
failure
rate
as
those
who
comply
with
regular
follow-­‐
up
examinations,
which
is
not
necessarily
true.
The
most
widely
accepted
and
commonly
used
definition
of
failure
in
implant
survival
analysis
is
“revision”
(removal
of
implants).
This
endpoint
has
been
criticized
because
the
criteria
used
to
decide
the
need
for
removal
may
vary
between
patients
and
surgeons,
and
sometimes
it
is
argued
that
other
definitions
should
be
considered.
These
could
be
severe
pain
or
the
presence
of
radiolucency
or
subsidence
combined
with
moderate
or
severe
pain.
Still
other
definitions
can
be
considered,
but
it
will
remain
difficult
to
compare
survival
analyses
until
consensus
is
reached
about
which
other
outcome
measures
should
be
used
rather
than
revision.
In
the
studies
based
on
the
Re-­‐motion
registry,
the
decision
to
revise
implants
relies
on
the
judgment
of
several
surgeons
or
units
that
work
independently,
which
is
an
advantage
compared
with
studies
in
which
the
decision
is
made
by
a
single
surgeon
and
solely
dependent
on
this
person’s
views.
The
findings
must
be
interpreted
correctly:
The
survival
rate
at
the
“tail”
of
the
curve
is
less
reliable
because
of
the
relatively
small
number
of
patients
with
long
follow-­‐up,
and
it
must
be
expected
that
the
incidence
of
revision
will
increase
as
the
implants
inevitably
wear
out.

26. 26
4.
Radiographical
measurements
The
radiographical
data
in
the
Remotion
register
are
considered
as
weak
and
merely
estimates,
because
it
was
left
to
the
judgment
of
the
surgeons
who
contributed
to
the
register,
how
to
interpret
the
radiographs.
In
paper
V 15
, we (Guillaume Herzberg and myself) used the
measurement
software
provided
by
Sectra
(Sectra
AB,
Linköbing,
Sweden).
We
did
the
measurements
together
in
order
to
obtain
consensus
and
uniformity,
but
we
made
no
further
attempt
to
validate
the
measurements.
In
paper
VI
16
,
the
measurements
were
done
independently
with
the
Sectra
software
by
2
blinded
raters
(Lars
S.
Vadstrup
and
myself)
and
the
inter-­‐rater
reliability
assessed
on
a
total
of
820
measurements
of
the
width
of
radiolucent
zones.
It
can
be
argued
that
our
evaluation
of
the
osteolystic
area
may
not
reflect
the
volume
of
bone
resorption
correctly,
since
we
used
a
2-­‐dimensional
surrogate
for
a
3-­‐dimensional
space.
Nevertheless,
our
method
was
highly
reproducible
(Pearson’s
r
and
ICC
=
0.85)
and
corresponding
to
the
method
described
by
Cobb
et
al.
25
and
later
also
used
by
Takwale
et
al.
36,
although
these
do
not
operate
with
mean
values
of
2
zones.
We
considered
a
progressive
and
consistent
change
of
distances
indicating
the
position
of
the
implants
compared
to
the
bony
structures
form
the
first
postoperative
to
the
latest
radiograph,
of
≥
3mm
as
indicative
of
subsidence.
The
3
mm
threshold
was
considered
to
be
significant
because
any
error
due
to
obliquity
of
the
film
would
be
eliminated
and
because
it
has
been
used
in
other
studies
25
36.
Smaller
changes
that
were
consistent
and
progressive
on
the
serial
radiographs
could
theoretically
be
considered
as
possible
subsidence,
but
were
not
encountered.
Correspondingly,
change
of
angulation
of
≥
5
degrees
was
considered
as
indicative
of
tilting
of
the
implants.
The
inter-­‐rater
reliability
of
these
measurements
(4
x
78
measurements),
each

27. 27
performed
independently
by
the
two
blinded
investigators
was
also
very
high:
Pearson’s
r
and
ICC
were
between
0.87
and
0.98.
It
can
be
argued
that
other
methods
could
have
been
preferable
for
the
assessment
of
implant
loosening.
These
could
have
been
radiostereometric
analyses
(RSA)
or
CT-­‐based
methods.
CT-­‐based
methods
have
been
used
in
a
preclinical
cadaveric
trial
on
TWA,
but
have
not
been
validated
for
clinical
use
43.
RSA
has
been
applied
to
trapeziometacarpal
implants
44
but
to
date
not
to
TWA.
The
method
requires
standardization
and
validation,
which
is
beyond
the
scope
of
this
thesis.
Moreover,
traditional
marker-­‐based
RSA
requires
metal
markers
to
be
implanted
in
the
surrounding
bones
in
addition
to
the
polyethylene
component
of
the
implant
itself,
which
could
not
be
done
retrospectively.
Furthermore:
since
the
polyethylene
component
of
the
Re-­‐motion
is
mobile
compared
to
the
carpal
plate
and
hence
to
the
carpal
bones
(at
least
in
theory)
the
method
cannot
be
used
for
carpal
plate
assessment.
We
had
no
access
to
the
alternative
model-­‐based
RSA.
5.
Histopathological
evaluations
Histopathological
findings
may
be
subject
to
differences
of
interpretation
and
inter-­‐observer
variation
that
deserve
consideration
and
discussion.
For
this
reason,
in
paper
VI
16
two
blinded
pathologists
with
experience
in
examining
implant-­‐bone
interphases
reviewed
independently
the
biopsies
and,
after
a
general
common
discussion,
performed
an
independent
second
look
examination.
The
interobserver
agreement
between
the
two
investigators
concerning
different
findings
(“present”
or
“not
present”),
was
assessed
with
Cohen’s
kappa.
There
is
no
consensus
on
how
to
interpret
kappa
values
but
in
this
thesis,
I
adopted
values
<0.40
as
indicating
poor
agreement,
values
0.40-­‐0.75
fair
to
good
agreement

28. 28
and
>0.75
excellent
agreement
45.
Generally
the
inter-­‐observer
agreement
was
good
to
excellent
(Table
2)
.
Table
2:
The
reliability
of
histological
findings
(agreement
between
the
two
pathologists)
Findings
Kappa
Necrotic
tissue
0.68
Metal
particles
0.59
Polyethylene
debris
0.78
Preponderance
of
macrophages
compared
to
lymphocytes
1.00
Foreign
body
reaction
0.74
6.
Translation
of
PROMs
With
the
increased
international
focus
on-­‐
and
usage
of
PROMs
it
has
become
increasingly
important
that
they
are
properly
translated.
Translation
implies
a
cross-­‐cultural
adaptation
process.
Guillemin
et
al.
have
proposed
standardized
guidelines
for
this
process
46,
which
today
are
commonly
used.
The
process
of
cultural
adaptation
of
the
DASH
and
the
QuickDASH
included
forward
translation,
expert
panel
discussion,
back-­‐translation,
new
expert
panel
discussion,
pre-­‐testing
with
cognitive
interviewing
and
formulating
a
final
version
and
documentation
to
the
Institute
for
Work
&
Health
(IWH),
Toronto,
Canada.
The
cultural
adaptation
of
the
PRWE
has
been
performed
by
another
team
47.
7.
Validation
of
PROMs

29. 29
For
being
useful
PROMs
have
to
be
validated
in
the
specific
context,
in
which
they
are
intended
to
be
used.
This
can
be
done
by
classical
test
methods
or
by
item
response
methods
and
equivalents
45
,
chapter
12
40.
Sample
dependency
may
be
a
problem
connected
with
the
classical
test
theory
45
pp
299-­‐301,
which
emphasizes
the
need
of
validation
of
PROMs
in
the
specific
context
of
TWA.
At
this
stage
two
of
the
most
commonly
used
PROMs
in
wrist
surgery
–the
DASH/QuickDASH
and
the
PRWE
-­‐
were
validated
by
classical
test
methods
in
this
thesis.
The
validation
has
included
assessments
of
construct
validity,
reproducibility,
internal
consistency,
responsiveness
and
floor-­‐/ceiling
effect
17
18
.

30. 30
Results
In
the
systematic
review
of
the
literature
on
TWA
(paper
I)
11
,
37
publications
describing
a
total
of
18
implants
were
selected
for
analysis
12,25,27,28,30,32,33,35-­‐39,48-­‐72
(Fig.
1).
Sixteen
of
the
publications
were
useful
for
the
evaluation
of
implant
longevity
12,25-­‐27,30,35-­‐39,51-­‐53,62,71-­‐73.
Despite
methodological
shortcomings
in
many
of
the
source
documents,
some
summary
estimate
was
possible.
It
seems
that
wrist
arthroplasty
(TWA
or
PWA)
has
a
good
potential
to
improve
function
through
pain
reduction
and
preservation
of
mobility.
The
risk
of
severe
complications
–
deep
infection
and
instability
problems
–
is
small
with
the
available
implants.
A
cumulated
implant
survival
of
0.9
to
1.0
at
five
years
is
reported
in
most
series
–
if
not
all
–
on
newer
second
generation
implants
(the
Biax
TWA)
and
third
generation
implants
(the
Re-­‐
motion
and
the
Universal
2)
,
but
it
declined
between
five
and
eight
years.
Periprosthetic
osteolysis
(PPO)/radiolucency
is
frequently
reported:
In
13
of
the
37
series,
no
useful
information
could
be
retrieved,
whereas
20
papers
did
report
osteolysis,
ten
of
these
mentioning
radiolucency
without
frank
loosening
of
the
implant
components.
In
a
consecutive
series
of
Biaxial
TWA
with
a
follow-­‐up
time
of
5-­‐9
years,
there
was
progressive
radiolucency
at
the
carpal
component
in
12
out
of
46
wrists,
seven
of
which
were
revised.
Subsidence
of
the
carpal
component
was
present
in
seven
cases
after
one
year
and
in
20
cases
at
final
follow-­‐up.
The
causes
and
consequences
of
PPO
are
not
clarified
25.
In
the
clinical
studies
of
this
thesis
(paper
II-­‐IV)
12-­‐14
,
based
on
the
multicentre
international
Re-­‐motion
registry,
the
cases
of
seven
centres,
contributing
with
at
least
15
inclusions
in
the
multicentre
international
Re-­‐motion
registry
and
adequate
follow-­‐up
examinations,
were
considered
12.
A
total
of
215
wrists
were
included
in
paper
I.
In
the
rheumatoid
arthritis
group
(RA;
129
wrists)
and
the
non
rheumatoid
arthritis
group
(non-­‐RA;
86
wrists),
there
were
5

31. 31
and
6%
complications
respectively,
requiring
implant
revision,
with
a
survival
rate
of
0.96
and
0.92
respectively
at
4
years
(Figure
3a
and
b)
and
of
92
%
at
8
years.
Within
the
whole
series,
only
one
dislocation
was
observed
in
one
non-­‐RA
wrist.
A
total
of
112
wrists
(75
RA
and
37
non-­‐RA)
had
more
than
2
years
of
follow-­‐up
(average
4
years,
range
2-­‐8
years).
In
the
RA
and
non-­‐RA
group,
the
mean
VAS-­‐score
for
pain
improved
by
48
and
54
points,
respectively,
and
the
mean
QuickDASH
score
improved
by
20
and
21
points,
respectively,
with
no
statistically
significant
differences
between
the
two
diagnostic
groups.
Average
postoperative
arc
of
wrist
flexion–extension
was
58
degrees
in
RA
wrists
(loss
of
1
degree)
compared
with
63
degrees
in
non-­‐RA
wrists
(loss
of
9
degrees)
with
no
statistically
significant
differences
(Table
3).
Grip
strength
improved
respectively
by
40
and
19%
in
RA
and
non-­‐RA
groups
(p
=
0.033).
Implant
loosening
seen
at
follow-­‐up
was
reported
in
4%
of
the
RA
wrists
and
3%
of
the
non-­‐RA
wrists
with
no
statistically
significant
differences
between
the
two
diagnostic
groups.
Radiolucency
without
migration
of
the
implant
components
was
reported
in
8
%
of
the
RA
cases
and
in
15
%
of
the
non-­‐RA
cases,
still
without
differences
between
the
groups.
Essentially,
this
study
suggested
that
the
Re-­‐motion
TWA
was
feasible
in
the
midterm
in
RA
as
well
as
selected
non-­‐RA
patients.

32. 32
Table
3:
Outcomes
of
TWA
in
112
wrists
with
at
least
2
years
of
follow-­‐up
Rheumatoid
Non-­‐rheumatoid
Statistical
significance
of
the
differences
between
the
diagnostic
groups
VAS
Pain
improvement
(100
point
scale)
48
points
54
points
ns
Quick
DASH
improvement
20
points
21
points
ns
Wrist
Extension
29°
(+2°)
36°
(-­‐4°)
ns
Wrist
Flexion
29°
(-­‐3°)
37°
(-­‐5°)
ns
Ulnar
Deviation
24°
(+7°)
28°
(+2°)
ns
Radial
Deviation
5°
(-­‐1°)
10°
(64°)
P=0,015
Grip
Strength
improvement
(%
of
pre-­‐operative
value)
40%
19%
P=0,033

33. 33
Figure
3a:
Cumulated
Implant
survival
curve
for
non-­‐rheumatoid
patients
(Courtesy
Thieme/J
Wrist
Surg,
Paper
II).
Figure
3b:
Cumulated
Implant
survival
curve
for
rheumatoid
patients
(Courtesy
Thieme/J
Wrist
Surg,
Paper
II).

34. 34
We
made
a
specific
analysis
of
the
cases
in
which
the
Re-­‐motion
TWA
was
used
as
a
salvage
procedure
for
severe
arthritis
due
to
posttraumatic
causes
(paper
III)
13.
Thirty-­‐five
cases
had
a
minimum
follow-­‐up
time
of
2
years.
Average
follow-­‐up
was
39
(24–96)
months.
Pain
had
improved
significantly
at
follow-­‐up,
mobility
remained
unchanged.
The
total
revision
rate
was
3.7%,
and
the
implant
survival
was
92%
at
4–8
years
(Figure
4).
The
clinical
relevance
of
this
paper
was
that
although
painful
posttraumatic
wrists
with
severe
joint
destruction
can
be
salvaged
by
TWF
and
sometimes
by
partial
wrist
fusion,
TWA
can
be
an
alternative
procedure
and
yields
results
that
are
comparable
to
those
obtained
in
rheumatoid
cases,
at
least
evaluated
at
short
to
mid-­‐term.

35. 35
Figure
4:
Cumulated
implant
survival
curve
for
posttraumatic
patients
(Courtesy
Thieme/J
Wrist
Surg,
Paper
III).

36. 36
In
a
specific
analysis
of
the
cases
operated
between
2003
and
2007
–
performed
in
order
to
have
a
series
with
a
minimum
of
5
years
follow-­‐up
in
each
case
-­‐
60
patients
had
been
operated
(5
bilaterally),
5
wrists
had
been
revised,
and
52
with
the
original
implant
in
situ
were
available
for
follow-­‐up
(paper
IV)
14.
The
pain
scores,
grip
strength,
QuickDASH
scores,
ulnar
flexion,
and
supination
for
the
whole
group
were
statistically
significantly
better
at
follow-­‐up
(table
4
and
figure
5).
There
were
no
statistically
significant
differences
between
the
rheumatoid
and
the
non-­‐rheumatoid
patients
except
for
motion,
which
was
better
in
the
non-­‐rheumatoid
group.
The
motion
obtained
depended
on
the
preoperative
motion
(in
average
and
in
the
individual
patients).
The
implant
survival
was
0.9
at
9
years,
both
in
rheumatoid
and
non-­‐rheumatoid
cases
(figure
6).
In
six
cases,
there
were
radiographic
signs
of
implant
loosening
(subsidence
or
tilting):
five
carpal
plates
and
one
radial
component
(five
rheumatoid,
one
idiopathic
osteoarthrosis
(OA)).
In
11
other
cases,
PPO
without
any
loosening
of
implant
components
was
reported:
three
carpal
alone,
seven
radial
alone,
and
one
radial
and
carpal
(eight
rheumatoid,
three
posttraumatic).

37. 37
Table
4:
Clinical
results
at
the
latest
follow-­‐up
(“Post”)
compared
to
preoperative
values
(“Pre”).
Mean
values
(SD),
but
median
(range)
for
QuickDASH
Rheumatoid
cases
Non-­‐rheumatoid
cases
P-­‐value1
All
cases
P-­‐value2
Pre
Post
Pre
Post
Pre
Post
Pain
(
0-­‐
100
on
VAS)
66
(20)
29
(26)
72
(12)
23
(38)
P=0.6
67
(17)
27
(29)
P<0.001
Grip
strength
(KgF)
9
(8)
14
(8)
16
(14)
19
(13)
P=0.3
10
(10)
15
(10)
P=0.03
QDASH
(0-­‐100)
61
(41-­‐
89)
41
(8-­‐84)
41
(14-­‐
79)
50
(0-­‐61)
P=0.5
58
(14-­‐
89)
42
(0-­‐84)
P<0.001
Motion
(degrees)
Supination
71
(22)
81
(13)
72
(35)
89
(4)
P=0.003
71
(25)
83
(12)
P=0.005
Pronation
71
(16)
80
(10)
82
(12)
85
(13)
P=0.3
79
(15)
81
(11)
P=0.5
Extension
27
(16)
28
(15)
43
(18)
43
(22)
P=0.06
30
(17)
31
(18)
P=0.8
Flexion
25
(21)
25
(16)
50
(19)
44
(23)
P=0.003
31
(23)
29
(19)
P=0.7
Radial
7
(11)
6
(8)
14
(8)
7
(5)
P=0.6
8
(11)
6
(8)
P=0.3
Ulnar
14
(8)
20
(14)
23
(14)
28
(16)
P=0.2
16
(11)
22
(14)
P=0.02
1
Significance
of
differences
between
the
rheumatoid
cases
and
the
non-­‐rheumatoid
cases
at
follow-­‐up.
2
Signifcance
of
differences
between
preoperative
values
and
values
at
follow-­‐up
for
the
total
sample.

38. 38
Figure
5.
QuickDASH-­‐score
before
operation
and
at
follow-­‐up.
The
dotted
line
represents
equivalency.
(Courtesy
Acta
Orthopaedica
2013,
Paper
IV)

39. 39
Figure
6:
Cumulated
implant
survival
curve
for
patients
operated
between
2003
and
2007.
(Courtesy
Acta
Orthopaedica
2013,
Paper
IV).

40. 40
In
terms
of
radiography,
a
major
weakness
of
the
above
mentioned
analyses
in
paper
II-­‐IV
was
that
there
were
not
given
precise
guidelines
for
the
evaluation
of
radiolucency
or
precise
criteria
for
implant
loosening:
this
was
left
to
the
judgment
of
the
participating
surgeons.
For
this
reason,
we
made
a
specific
analysis
of
the
prevalence,
location
and
natural
history
of
PPO
following
TWA
with
precise
measurements
on
the
radiographs
of
consecutive
patients
operated
in
2
wrist
centres
(paper
V)
15.
We
excluded
patients
with
less
than
2
years
follow-­‐
up
and
cases
that
had
been
revised
with
removal
of
implant
components.
Thus
we
analysed
44
consecutive
cases.
The
X-­‐ray
examinations
were
done
preoperatively,
at
6
months
after
operation
and
thereafter
annually.
We
defined
radiological
spots
for
the
measurement
of
radiolucency
on
digitalized
posteroanterior
radiographs
(figure
7)
and
measured
the
maximal
width
of
the
radiolucent
zones
at
these
spots.
We
found
significant
periprosthetic
radiolucency
(more
than
2
mm
in
width)
at
the
radial
component
side
in
16
of
the
cases
and
at
the
carpal
component
side
in
seven.
It
developed
gradually
around
the
prosthetic
components
near
the
joint
regardless
of
the
primary
diagnosis,
and
seemed
to
stabilize
in
most
patients
after
1-­‐3
years
(figure
8a
and
b).
In
a
small
percentage
of
the
patients,
the
periprosthetic
area
of
bone
resorption
was
markedly
larger.
In
general,
radiolucency
was
not
related
to
evident
loosening
of
the
implant
components
and
only
five
carpal
components
and
one
radial
had
subsided
or
tilted.

41. 41
Figure
7
Spots
for
the
measurement
of
the
width
of
radiolucency
on
serial
postero-­‐anterior
radiographs.
(Courtesy
Thieme/J
Wrist
Surg,
Paper
V).

42. 42
Figure
8a
(Courtesy
Thieme/J
Wrist
Surg,
Paper
V)
Width
of
radiolucent
zones
at
spot
4-­‐5
in
function
of
time.
Each
line
represents
a
single
case.
X-­‐axis:
length
of
follow-­‐up
in
years.
Y-­‐axis:
Width
of
radiolucency
in
mm.

43. 43
Figure
8b
(Courtesy
Thieme/J
Wrist
Surg,
Paper
V).
Width
of
radiolucent
zones
at
spot
9-­‐10
in
function
of
time.
Each
line
represents
a
single
case.
X-­‐axis:
length
of
follow-­‐up
in
years.
Y-­‐axis:
Width
of
radiolucency
in
mm.
The
arrows
indicates
a
maximal
width
of
radiolucency
under
the
carpal
plate
at
2
years
after
operation
in
this
particular
case
(6.2
mm),
and
at
4
years,
where
the
radiolucent
zone
was
reduced
to
almost
0
mm,
as
the
carpal
plate
sunk
into
the
carpus.
In
a
following
study
(paper
VI)
16,
we
aimed
at
determining
whether
the
amount
of
polyethylene
and
metallic
debris
in
the
interphase
tissue
between
prosthesis
and
bone
in
patients
with
TWA
correlated
to
the
degree
of
periprosthetic
osteolysis
(PPO).
We
also
measured
the
level
of
Cr-­‐
and
Co-­‐
ions
in
the
blood,
and
assessed
the
possible
role
of
infectious
or
rheumatoid
activity
in
the
development
of
PPO.
Biopsies
were
taken
from
the
implant-­‐bone
interphase
in
13
consecutive
patients
with
Re-­‐motion
TWA
and
with
at
least
3
-­‐
years
follow-­‐up,
and
histological
as
well
as
bacteriological
examinations
were
done.
Serial

44. 44
annual
radiographs
were
obtained
prospectively
for
the
evaluation
of
PPO.
Blood
samples
were
collected
for
white
blood
cell
count,
C-­‐reactive
protein,
and
metallic
ion
level.
A
radiolucent
zone
of
>
2mm
was
observed
juxta-­‐articular
to
the
radial
component
in
four
cases
and
at
the
carpal
component
in
three
cases.
Its
magnitude
tended
to
level
out
over
time.
Subsidence
of
the
implant
was
observed
in
three
cases
on
the
carpal
side
and
in
no
case
on
the
radial
side.
The
amount
of
polyethylene
and
metallic
debris
was
generally
small
and
did
not
correlate
with
the
width
of
the
radiolucent
zone
(Figure
9
and
10).
The
blood
levels
of
Cr-­‐
and
Co-­‐
ions
were
normal.
There
was
no
evidence
of
infectious
or
rheumatoid
activity.
Figure
9:
scatterplot
showing
the
width
of
radiolucency
in
zone
4-­‐5
vs.
the
amount
of
polyethylene
fragments
in
the
samples
taken
from
the
periprosthetic
tissue
between
the
radial
component
and
the
radius.

45. 45
Figure
10:
Polarized
light
microscopy,
x
200
magnification).
Polyethylene
fragments
engulfed
by
multinucleated
foreign
body
giant
cells,
semi-­‐quantitatively
estimated
as
“intermediate”
on
a
4-­‐grade
scale
from
“none”
to
“high”
for
the
amount
of
foreign
body
particles.
In
paper
VII,
we
evaluated
the
reproducibility
of
the
Danish
version
of
the
DASH
in
a
total
of
83
patients,
72
of
these
having
hand-­‐related
conditions
and
ten
having
shoulder
problems.
This
investigation
was
a
supplement
to
the
cultural
adaptation
of
the
DASH.
The
patients
included
were
all
in
a
stable
stage
of
their
disease,
which
typically
was
chronic,
and
they
were
invited
to
answer
the
questionnaire
in
connection
with
a
medical
examination
preceding
surgery
or
at
the
final
ambulatory
visit
after
treatment.
After
one
week,
a
second
questionnaire
was
sent
to
the
patients
and
the
correlation
between
the
two
scores
was
calculated.
Fifty-­‐four
of
the
patients
completed
both
questionnaires
at
an
interval
of
maximum
30
days.
.
The
DASH
scores
of
the
first
and
second
test
were
numerically
close
with
an
intra-­‐class
coefficient
of
0.85.
Cronbach's
alpha
was
0.96,
indicating
that
the
subtests
were

46. 46
internally
consistent.
Spearman's
correlation
coefficient
was
overall
0.90
and,
thus,
there
was
a
strong
correlation
between
the
first
and
the
second
response
(figure
11).
The
scores
were
evenly
spread
across
the
scale,
suggesting
a
good
discriminative
property.
Ten
percent
of
the
responses
were
insufficient
for
the
calculation
of
a
score.

47. 47
Figure
11:
correlation
between
DASH-­‐scores
in
a
test-­‐retest
trial
on
54
patients
with
a
stable
upper-­‐extremity
condition.
X-­‐axis
=
scores
at
first
test,
y-­‐axis
=
scores
at
retest
14-­‐30
days
later.
ICC
=
0.85,
Spearman’s
rho
=
0.90.
(figure
1
in
Herup
A,
Merser
S,
Boeckstyns
M.
[Validation
of
questionnaire
for
conditions
of
the
upper
extremity].
Ugeskr
laeger
2010;172(48):
3333-­‐6
(Paper
VII)).
As
the
DASH-­‐questionnaire
is
increasingly
replaced
by
the
QuickDASH,
we
decided
to
assess
the
psychometric
properties
of
the
Danish
QuickDASH
and
another
widely
used
PROM
for
wrist
conditions
–
the
PRWE
-­‐
in
patients
with
total
wrist
arthroplasty
(paper
VIII)
18.
In
a
prospective
cohort
of
102
cases,
we
evaluated
the
QuickDASH.
In
a
cross-­‐sectional
study
and
in
a
test-­‐retest
on
a
subgroup
of
the
patients
we
evaluated
both
the
QuickDASH
and
the
PRWE.
Internal
consistency
and
reproducibility
were
very
high
(Cronbach’s
alpha
0.96
/

48. 48
0.97;
Spearman’s
rho
0.90
/
0.91;
ICC
0.91
/
0.92)
and
there
were
no
floor-­‐
or
ceiling
effects.
The
responsiveness
of
the
QuickDASH
was
high
(SRM
1.06
and
ES
1.07).
The
construct
validity
of
both
scales
was
confirmed
by
three
a
priori
formulated
hypotheses:
a
moderate
negative
correlation
of
scores
with
grip-­‐strength,
a
moderate
positive
correlation
with
pain
and
a
very
weak
or
no
correlation
with
mobility.
Rheumatoid
patients
scored
significantly
higher
on
the
QuickDASH,
indicating
a
higher
degree
of
disability.
The
scores
of
both
questionnaires
were
very
closely
related
(figure
12,
Spearman’s
rho
=
0.90
)
.
Figure
12:
Scatter
plot
showing
the
QuickDASH-­‐
and
the
PRWE-­‐scores
in
patients
with
Total
Wrist
Arthroplasty.
The
curved
line
is
the
LOESS
(local
regression)
line,
the
thin
solid
line
is
the
regression
line
and
the
thick
solid
line
is
the
line
of
equivalency.
Dots
located
on
the
line
of
equivalency

49. 49
represent
patients
whose
QuickDASH
and
PRWE-­‐scores
are
equal.
Dots
below
this
line
indicate
a
QuickDASH-­‐score
that
is
lower
than
the
PRWE-­‐score
for
a
given
patient
and
vice-­‐
versa.
The
tendency
indicated
by
the
LOESS-­‐line
is
that
the
QuickDASH
scores
are
approximately
5
points
higher
than
the
PRWE-­‐scores
in
the
lower
end
of
the
scales,
while
they
are
approximately
10
points
lower
in
the
higher
end.
(figure
2
in
Boeckstyns
MEH,
Merser
S:
Psychometric
Properties
of
two
Questionnaires
in
the
Context
of
Total
Wrist
Arthroplasty.
Dan
Med
J
2014;
61
(11):
A4939
(Paper
VIII)).
General
Discussion
and
Comparison
with
Other
Research
Review
of
the
literature
According
to
the
systematic
review
of
the
literature
on
TWA
(paper
I),
no
more
than
17
publications
–
after
exclusion
of
one
paper
for
language
reasons,
one
paper
reporting
data
as
a
part
of
a
less
commonly
used
scoring
system
and
several
papers
because
of
an
important
overlap
of
the
materials
-­‐
were
prospective,
even
when
using
a
broad
definition:
data
collected
preoperatively
as
well
as
postoperatively.
Of
these
17
papers,
eight
used
a
validated
and
widely
used
outcome
measurement
system.
Weak
methodology
applied
mainly
to
studies
on
2nd
generation
implants.
In
at
least
16
of
the
37
papers
that
were
selected,
one
or
several
authors
were
involved
as
or
close
to
the
inventors,
developers
or
producers,
but
this
seemed
not
to
have
had
impact
on
the
reported
clinical
or
longevity
results.
The
majority
of
data
are
based
on
rheumatoid
cases,
although
other
diagnoses
are
increasingly
represented
in
recent
publications.
Previously,
the
general
opinion
has
been
that
better
longevity
must
be
expected
in
low-­‐
demand
patients,
typically
rheumatoid
patients.
It
is
not
possible,
throughout
the
different
series
in
the
literature
to
compare
outcomes
in
rheumatoid
and
non-­‐rheumatoid
patients,
except
that
the
series
of
Herzberg,
Boeckstyns
et
al.
(paper
I)
12
shows,
on
basis
of
prospective
data,
that
there
are
no
clinically
or
statistically
significant
differences
between
these

50. 50
diagnostic
groups.
This
is
consistent
with
a
growing
view
that
non-­‐rheumatoid
patients
may
do
better
because
of
a
better
bone
stock,
provided
that
their
level
of
activity
is
restricted
70.
In
general,
mean
values
for
motion
at
follow-­‐up
are
similar
for
most
implants
and
generally
within
the
functional
range
defined
by
Palmer
et
al.
74
although
somewhat
smaller
than
the
more
rigorous
range
defined
by
Ryu
&
Cooney
75.
An
exception
may
be
the
Maestro
that
showed
better
motion
in
the
single
series
with
this
implant
32.
On
the
other
hand,
there
is
less
consistency
concerning
the
change
in
motion
from
before
operation
to
follow-­‐up.
This
might
be
attributed
to
different
case
selections,
different
postoperative
protocols
or
factors
related
to
the
implant
itself
but
it
is
impossible
to
clarify
this
on
basis
of
the
published
data.
In
the
studies
based
on
the
Re-­‐motion
registry,
no
statistically
significant
change
in
motion
was
obtained
(see
below).
A
reasonable
appreciation
of
the
longevity
of
implants
was
possible
in
16
papers,
although
only
ten
provided
information
on
cumulated
implant
survival.
These
ten
papers
concerned
the
Biaxial,
Meuli,
Motec,
Re-­‐motion
and
Universal
prostheses.
Generally,
the
5-­‐year
implant
for
the
survival
rate
was
higher
than
90
%
but
declining
at
8
years
(0.81-­‐1.0
for
the
Biax
and
0.77
for
the
Meuli.).
One
exception
is
the
low
survival
of
the
Universal
1
reported
by
Ward
et
al.
38
(
0.75
at
5
years,
0.62
at
8
years).
This
series
contains
exclusively
rheumatoid
cases.
It
is
likely
that
the
lower
survival
rate
is
due
to
the
strategy
of
the
surgeon,
who
seemed
to
be
inclined
to
revise
implants
exhibiting
PPO
without
frank
loosening.
On
the
other
hand,
the
Universal
2
series
of
Ferreres
et
al.
report
a
100
%
survival
at
a
mean
follow-­‐up
of
5.5
years.
Another
notable
result
concerns
the
metal-­‐on-­‐metal
APH-­‐prosthesis:
36
of
37
implants
were
revised
during
a
follow-­‐up
time
of
2-­‐6.1
years.
.
Solitary
loosening
of
the
carpal
component
of
this
implant
was
predominant.
The
authors
believed
that
the
main
cause
of
loosening
was
bone
resorption
induced
by
titanium
debris
and
they
abandoned
the
use
of
this
implant
39.

51. 51
Krukhaug
et
al.
have
reported
on
the
survival
of
189
TWA
in
the
Norwegian
Arthroplasty
Register
76:
The
cumulated
survival
of
the
Biax
was
85
%
at
5
years
and
approximately
78
%
at
8
years.
The
survival
of
the
Gibbon/Motec
was
obviously
lower
than
published
by
Reigstad
et
al.
62,
which
possibly
can
be
attributed
to
underreporting
to
the
register
77.
Failed
TWA
can
successfully
be
revised
by
fusion
14,30,38,39,60,62,65,
by
total
or
partial
replacement
of
the
components
14,30,38,51,60,65
or
by
total
or
partial
removal
of
the
components
with
or
without
soft-­‐tissue
interposition,
typically
fascia
lata
25,38.
The
review
did
not
aim
to
make
a
comparison
between
TWA
and
TWF,
but
the
question
is
important
to
discuss.
Murphy
et
al
made
a
comparison
between
TWA
(Universal
1
in
24
rheumatoid
wrists)
and
TWF
(27
rheumatoid
wrists)
in
a
retrospective
design
78.
Treatment
groups
were
well
matched
by
patient
characteristics
and
radiographic
staging.
There
were
no
statistically
significant
differences
between
arthroplasty
and
arthrodesis
in
either
DASH
or
PRWE
scores.
Cavaliere
&
Chung
compared
TWA
with
TWF
in
a
systematic
review
of
the
literature
on
TWA
compared
with
TWF
for
rheumatoid
arthritis
79.
They
identified
18
total
wrist
arthroplasty
studies
representing
503
procedures
and
20
TWF
studies
representing
860
procedures
in
rheumatoid
patients.
They
concluded
that
the
outcomes
for
TWF
were
comparable
and
possibly
better
than
those
for
TWA.
One
major
limitation
in
that
study
was
that
the
methodology
in
the
source
publications
was
often
very
weak.
Furthermore,
the
TWA-­‐
implants
in
many
of
the
series
were
of
older
and
now
abandoned
designs,
as
well
as
the
techniques
for
TWF
varied
a
lot.
Nydick
et
al
compared
the
Maestro
TWA
(seven
wrists)
with
TWF
(15
wrists)
in
posttraumatic
arthritis
80.
The
PRWE
scores
were
significantly
better
in
the
arthroplasty
group,
but
there
were
no
differences
in
DASH
scores.
Besides
its
retrospective
design,
the
weakness
of
this
study
is
obviously
the
very
small
number
of
TWA
and
the
fact
that
all
cases
had
been
treated
at
the
same
clinic,
implying
that
there
had
been
a

52. 52
preoperative
decision
to
prefer
TWA
in
some
patients
and
TWF
in
others.
Thus,
the
question
as
to
which
extent
and
on
what
indications
TWA
is
superior
to
TWF
still
needs
to
be
answered
definitely.
The
multicentre
international
Re-­‐motion
registry.
The
multicentre
international
Re-­‐motion
registry
has
resulted
in
a
much
larger
material
than
ever
published
previously
on
TWA
and
permits
analysis
of
relatively
large
samples
with
an
observation
period
of
5-­‐10
years.
A
validated
PROM
–
the
QuickDASH
-­‐
is
used.
The
3
clinical
papers
(paper
II,
III
and
IV)
so
far
published
on
basis
of
the
multicentre
registry
can
be
summarized
as
follows:
1. In
general,
Re-­‐motion
TWA
in
patients
with
severely
destroyed
wrists
results
in
markedly
improved
function
2. The
tendency
is
that
motion
after
Re-­‐motion
TWA
remains
unchanged
compared
to
preoperatively.
3. The
cumulated
implant
survival
is
approximately
90
percent
at
9-­‐10
years.
This
applied
to
rheumatoid
cases
and
non-­‐rheumatoid
cases
as
well,
including
the
posttraumatic
cases.
4. Implant
survival
did
not
preclude
that
some
of
the
implants
could
be
loose
at
follow-­‐up
but
clinically
tolerated.
5. Periprosthetic
osteolysis
without
gross
loosening
of
the
implant
was
a
relatively
common
phenomenon
but
its
clinical
implications
are
not
clear.
Strenghts
and
limitations.
The
strength
of
the
multicentre
international
Re-­‐motion
registry
is
its
high
number
of
cases,
compared
to
any
other
TWA-­‐series
and
the
prospective
sampling
of
data.
The
number
of
cases

53. 53
is
continuously
growing,
as
is
the
follow-­‐up
period.
Also,
the
registry
reflects
the
activity
in
several
centres
with
expertise
in
wrist
surgery,
rather
than
the
results
of
a
single
surgeon
or
centre.
A
weakness
is
the
limited
control
with
the
sampling
and
input
of
data
across
centres.
However,
compared
to
very
large
arthroplasty
registries,
this
limitation
can
to
a
certain
extent
be
met
by
the
administrators
of
the
Re-­‐motion
registry.
This
has
so
far
resulted
in
selecting
data
from
seven
centers
only,
for
the
publications
that
underlie
this
thesis.
The
QuickDASH-­‐
scores
may
be
considered
as
relatively
strong
data,
the
cultural
adaptations
having
been
done
according
to
the
uniform
guidelines.
Also
grip
strength,
measured
with
the
JAMAR
Hydrolic
Hand
Dynamometer
(Sammons
Preston
Rolyan,
Bolingbrook,
IL,
USA)
is
generally
considered
as
reliable
data.
.
On
the
other
hand,
radiographic
assessments
must
be
considered
weak,
because
they
are
left
to
the
judgment
of
the
participating
observers,
without
precise
guidelines.
Periprosthetic
osteolysis
PPO
after
2nd
or
3rd
generation
TWA,
with
or
without
frank
loosening
of
the
implant
components
has
previously
been
reported
in
the
literature,
but
rarely
in
a
systematic
way
39
12,27,28,35,37,38,50,52-­‐55,58,62,66,71,72
.
Eight
articles
selected
in
the
systematic
review
of
the
literature
report
osteolysis
without
evident
loosening
of
the
implants
12,35,37,50,53,62,66,72.
Groot
et
al.
published
a
case
with
PPO
11
years
after
implantation
of
a
Biax
implant,
in
which
macrophages
containing
polyethylene
and
metallic
particles
were
found
at
the
histopathological
examination
81.
Ward
et
al.
have
followed
24
rheumatoid
wrists
with
a
cemented
Universal
I
TWA,
a
metal-­‐on-­‐polyethylene
prosthesis.
Amongst
the
19
cases
with
a
follow-­‐up
time
of
more
than
five
years,
nine
had
been
revised
due
to
loosening
of
the
carpal

54. 54
component.
The
authors
stated
that
there
was
polyethylene
wear
and
metallosis
in
all
these
cases
38.
Similar
osteolysis
has
been
reported
using
metal-­‐on-­‐metal
implants
as
well.
Radmer
et
al.
reviewed
APH-­‐implants
that
are
Titanium-­‐coated
at
the
articular
surfaces,
without
intercalated
polyethylene
39.
Reigstad
et
al.
reported
focal
osteolysis
in
the
radius
around
a
metal-­‐on-­‐metal
implant
in
three
patients
without
affecting
the
clinical
outcome,
the
largest
including
most
of
the
radial
styloid,
which
stabilized
after
one
year
62
(figure
13).
Figure
13:
PPO
3
years
after
Motec
metal-­‐on-­‐metal
TWA
(Reigstad
O,
Lütken
T,
Grimsgaard
C,
et
al.
Promising
one-­‐
to
six-­‐year
results
with
the
Motec
wrist
arthroplasty
in
patients
with
post-­‐traumatic
osteoarthritis.
J
Bone
Joint
Surg
[Br]
2012;94-­‐B:1540-­‐1545.
(Figure
4)62
,
reproduced
with
permission
and
copyright
©
of
the
British
Editorial
Society
of
Bone
and
Joint
Surgery
[citation].)
In
the
study
“Periprosthetic
osteolysis
after
total
wrist
arthroplasty”
(Paper
V),
juxta-­‐articular
radiolucency
larger
than
2
mm
was
seen
in
18
of
44
cases
(41
%),
in
11
at
the
radial
side
only,

55. 55
in
2
at
the
carpal
side
only
and
in
5
at
both
sides.
It
developed
gradually
around
the
edges
of
the
prosthetic
components
near
the
wrist
joint
during
the
first
years
after
operation,
regardless
of
the
primary
diagnosis,
and
seemed
to
stabilize
in
most
patients
after
1-­‐3
years
(figure
14a-­‐b).
Figure
14a:
4
years
after
TWA
(Courtesy
Thieme/J
Wrist
Surg,
Paper
V).
Figure
14b:
6
years
after
TWA,
no
change

56. 56
In
a
small
percentage
of
the
patients,
the
periprosthetic
area
of
bone
resorption
was
markedly
larger
and
without
clear
indication
of,
whether
it
stabilizes
after
2-­‐3
years
or
whether
it
is
continuously
progressing.
We
attempted
to
treat
one
of
the
cases
that
developed
radiolucency
without
loosening
of
the
implant,
by
bone
grafting,
when
this
rheumatoid
patient
presented
with
an
increasing
cystic
ganglion
at
the
dorsum
of
the
wrist.
Radiolucency
recurred
within
2
years
(Figure
15a-­‐d).

57. 57
Figure
15a:
one
year
after
TWA.
Figure
15b:
PPO
seven
years
after
TWA.
Figure
15c:
six
weeks
after
bone
grafting
of
the
osteolytic
area
under
the
carpal
plate
Figure
15d:
recurrence
of
osteolysis
under
the
carpal
plate,
2
years
after
bone
grafting.

58. 58
We
encountered
PPO
in
cemented
as
well
as
in
uncemented
cases
(figure
16)
Figure
16a-­‐b:
4
weeks
and
5
years
after
TWA.
Cemented
technique
was
used
because
of
the
osteoporotic
bone
structure.
PPO
also
occurs
frequently
after
arthroplasty
in
other
joints
of
the
upper-­‐extremity.
The
rate
of
PPO
after
total
shoulder
arthroplasty
(TSA)
in
clinical
series
has
been
reported
as
high
as
23%
82.
Kepler
et
al.
studied
52
patients
who
underwent
revision
total
shoulder
arthroplasty
at
a
mean
of
4.3
-­‐
4.7
years
after
the
index
surgery.
Ten
of
52
patients
(19%)
had
radiographic
evidence
of
osteolysis
surrounding
the
glenoid
component.
Histologic
specimens
taken
at
revision
surgery
demonstrated
no
significant
differences
between
patients
with
or
without
osteolysis
with
respect
to
the
presence
of
debris
particles
(60%
vs
67%).
Further
analysis
of
the
specimens
for
differences
with
regard
to
the
presence
of
specific
particles
from
polyethylene,
metal,
or
cement
also
yielded
no
significant
differences
between
groups
and
neither
did
cells
associated
with
inflammatory
states
(lymphocytes,
plasma
cells,
histiocytes
and
giant
cells).

59. 59
Bone
resorption
has
also
been
observed
frequently
after
ulnar
head
replacement,
in
which
no
artificial
components
articulate
with
each
other.
This
resorption
seems
to
stabilize
after
6
-­‐12
months
and
is
ascribed
to
stress
shielding
83,84
(figure
17).
Figure
17:
PPO
under
an
ulnar
head
implant,
attributed
to
stress
shielding
In
a
prospective
series,
Dalat
et
al.
revised
25
of
84
AES
total
ankle
arthroplasties
(TAA)
for
osteolysis.
Radiologically,
all
patients
showed
tibial
and
talar
osteolytic
lesions,
45%
showed
cortical
lysis
and
in
25%
the
implant
had
collapsed
into
the
cysts.
All
specimens
showed
macrophagic
granulomatous
inflammatory
reactions
in
contact
with
a
foreign
body;
the
cysts
showed
necrotic
remodelling.
Some
of
the
foreign
bodies
could
be
identified
on
optical
histologic
examination
with
polyethylene
in
95%
of
the
specimens
and
metal
in
60%
85.
Generally,
it
is
considered
that
phagocytosis
of
particulate
debris
from
component
abrasive
and
adhesive
wear
triggers
macrophage
activation
and
cytokine
release
that
in
turn
activates
osteoclasts
but
other
possible
mechanisms
have
been
proposed:
According
to
Skoglund
and

60. 60
Aspenberg,
the
much
less
studied
osteolytic
effects
of
pressure
could
be
far
more
important
than
particles
to
elicit
an
osteolytic
effect
86
.
The
hypothesis
to
be
tested
in
paper
VI
16
was
that
PPO
is
correlated
to
the
amount
of
polyethylene
and
metallic
debris,
which
turned
out
not
to
be
the
case.
Even
cases
without
detectable
polyethylene
particles
in
the
samples
could
develop
very
pronounced
osteolysis
and,
conversely,
very
modest
osteolysis
was
seen
in
cases
with
a
relatively
high
amount
of
wear
particles.
To
our
knowledge,
the
histology
of
the
bone-­‐implant
interphase
has
not
previously
been
investigated
in
a
consecutive
series,
including
asymptomatic
cases.
In
most
cases
PPO
was
associated
with
a
low
amount
of
debris
particles
and
the
metallic
wear
did
not
cause
elevated
levels
of
metallic
ions
in
the
blood
samples.
In
the
light
of
the
lack
of
correlation
between
particular
debris
and
PPO
and
the
absence
of
rheumatoid
or
infectious
activity,
we
hypothesize
that
the
PPO
we
have
described
can
be
at
least
partially
attributed
to
other
factors,
like
biocompatibility
or
biomechanics,
incl.
stress
shielding
of
the
bony
structures
by
the
implants.
There
is
a
need
for
further
investigation
however,
including
radiostereographical
methods
and
serial
focal
bone
mineral
density
measurements.
For
the
time
being
we
recommend
close
and
continued
observation
of
the
patients
with
marked
asymptomatic
PPO.
Bisphosphonates,
Denosumab,
strontium,
ranelate
and
parathyroid
hormone
have
been
reported
as
possible
treatment
agents
with
regard
to
maintaining
more
periprosthetic
bone
mineral
density
but
clinical
documentation
is
limited
87.
Since
the
amount
of
polyethylene
debris
was
modest
in
the
periprosthetic
tissue,
our
study
does
not
support
the
opinion
that
the
conventional
polyethylene
in
the
Re-­‐motion
implant
should
be
converted
to
the
more
resistant
highly
cross-­‐linked
polyethylene.
Strenghts
and
limitations

61. 61
A
strength
of
the
focused
studies
on
PPO
is
the
specific
and
uniform
radiographic
evaluations
in
paper
V
15.
In
paper
VI
16,
the
interobserver
reproducibility
was
secured.
A
limitation
was
that
we
had
no
access
on
RSA-­‐methods
for
the
evaluation
of
implant
loosening
and
made
this
evaluation
by
measuring
migration
(subsidence
and
tilting)
of
the
components
on
serial,
annual
radiographs.
As
far
as
the
histological
study
of
the
periprosthetic
tissue
is
concerned,
it
is
a
strength
that
the
study
involved
a
consecutive
series
of
cases,
including
cases
without
clinical
problems
or
radiographical
signs
of
prosthetic
loosening.
A
limitation
is
the
number
of
cases
in
this
study,
even
though
it
was
reasonable
according
to
the
preceding
sample
size
calculation.
Validation
of
PROMs
The
DASH
and
QuickDASH-­‐questionnaires
are
nowadays
commonly
used
for
the
assessment
of
function
after
TWA
14,32,35,38,48,61,62,64,65,68,69,88.
They
are
available
in
multiple
cultural
adaptations,
performed
according
to
the
Guillemin
guidelines
46
and
under
the
auspices
of
the
Institute for Work & Health (IWH), Toronto, Canada.
The
QuickDASH
has
increasingly
replaced
the
full
DASH
because
it
is
simpler
and
less
time
consuming
for
the
responders.
It
has
proven
equally
valid,
although
not
quite
numerically
equivalent
with
the
full
DASH
5,89-­‐91.
In the paper
“Psychometric
Properties
of
two
Questionnaires
in
the
Context
of
Total
Wrist
Arthroplasty”
its
psychometric
properties
in
the
field
of
TWA
has
been
assessed
and
found
adequate
according
to
classical
testing
methods
18. Sometimes
it
is
argued
that
a
more
region
specific
PROM,
like
the
PRWE
would
be
preferable.
This
problematic
is
important,
because
many
patients
with
TWA
suffer
conditions
involving
multiple
joints,
which
may
have
influence
on
their
general
disability.
However, the analyses we performed clearly show that there is no
advantage of using the PRWE rather than the QuickDASH 18
. Actually,
the
PRWE
may
not
be
as

62. 62
specific
as
usually
claimed:
four
of
the
ten
items
concerning
function
are
not
specifically
directed
towards
the
affected
wrist.
Moreover,
five
of
the
functional
items
are
very
similar
in
the
PRWE
and
the
QUICKDASH,
even
though
the
PRWE,
as
opposed
to
the
QUICKDASH,
specifies
that
four
of
them
relate
specifically
to
the
affected
hand.
The
scores
of
both
scales
correlated
equally
with
the
general
pain
level,
expressed
on
a
visual
analogue
scale.
This
is
interesting,
because
the
PRWE
contains
a
very
detailed
section
with
five
specific
pain
questions,
while
the
QUICKDASH
only
has
two
general
pain
questions.
This
finding
is
consistent
with
the
concept
that
pain
is
important
but
not
crucial
for
the
construct
measured
and
that
multiple
questions
regarding
pain
may
be
superfluous
and
may
contribute
to
item
redundancy.
Our
analysis
also
confirms,
that
motion
is
not
an
important
factor
in
the
construct
measured,
which
is
entirely
in
line
with
the
failure
of
disclosing
differences
between
TWA
and
wrist
fusion
by
means
of
the
DASH
or
PRWE
in
rheumatoid
patients
78,79.
For
the
sake
of
completeness,
we
must
mention,
that
in
another
comparative
study
a
difference
could
be
demonstrated
using
the
PRWE
in
posttraumatic
cases,
while
there
was
no
statistically
significant
difference
using
the
QUICKDASH
80.
This
may
be
so,
because
posttraumatic
are
not
as
complex
as
rheumatoid
cases.
The
study
however
is
flawed
for
two
reasons.
Firstly
the
number
of
cases
was
very
small
(15
fusions
and
seven
arthroplasties).
Secondly
there
is
a
potential
difference
in
patient
selection.
In
summary,
we
found
that
the
Danish
version
of
the
QUICKDASH
for
the
evaluation
of
TWA
was
valid,
reliable,
consistent
and
responsive.
The
PRWE
had
equivalent
psychometric
properties
and
offered
no
advantage
above
the
QuickDASH.
One
of
the
important
advantages
of
the
DASH
and
the
QUICKDASH
is
the
high
number
of
validated
translations
and,
due
to
its

63. 63
generic
upper-­‐extremity
related
nature,
and
because
it
is
widely
used
and
familiar
to
most
healthcare
professionals
working
with
upper-­‐extremity
related
conditions.
Strengths
and
limitations.
The
greatest
strength
of
the
validation
study
is
the
relatively
high
number
of
TWA-­‐cases
with
prospectively
sampled
data,
permitting
an
accurate
evaluation
of
the
psychometric
properties
of
the
PROMs
in
this
specific
context.
A
limitation
is
that
we
could
not
assess
the
responsiveness
of
the
PRWE
since
we
did
not
evaluate
the
patients
with
this
questionnaire
before
operation.
Another
limitation
is
that
we
only
used
classical
psychometric
methods
and
made
no
use
of
the
Rasch
model
or
equivalent
item
response
theory
methods
and
thus
we
were
not
able
to
verify
the
unidimensionality
of
the
scales
or
transform
the
scores
to
interval
level.
Future
perspectives
There
is
a
need
of
continuous
research
with
a
focus
on
indications
for
TWA
(rheumatoid
versus
non
rheumatoid,
age
groups,
level
of
activity
etc.)
and
on
long-­‐term
results
achieved
through
large
prospective
multicentre
studies,
national
registries
or
even
with
post-­‐market
surveillance
registries
of
implants
that
are
no
longer
available.
Furthermore,
the
question
as
to
which
extent
and
on
what
indications
TWA
is
superior
to
TWF
still
needs
to
be
answered
definitely.
The
causes
and
consequences
of
periprosthetic
osteolysis
and
prosthetic
loosening
also
need
further
investigation,
including
radiostereographical
methods
and
serial
focal
bone
mineral
density
measurements.
Bisphosphonates,
Denosumab,
strontium,
ranelate
and
parathyroid
hormone
have
been
reported
as
possible
treatment
agents
with
regard
to
maintaining
more

64. 64
periprosthetic
bone
mineral
density
but
clinical
documentation
is
limited
and
needs
to
be
investigated
upon.
Assessment
of
the
PROMs
by
means
of
the
Rasch
model
or
equivalent
item
response
theory
models
must
be
done
for
further
evaluation
in
terms
of
item
functioning,
unidimensionality,
differential
item
functioning,
and
interval-­‐level
scaling
.

65. 65
Summary
and
Conclusions
of
the
Thesis
Data
on
patients
with
a
Re-­‐motion
prosthesis
–
a
third
generation
polyethylene-­‐on-­‐metal
implant
for
TWA
–
have
been
collected
in
an
multicentre
international
database,
initiated
by
the
author
of
this
thesis
in
collaboration
with
Guillaume
Herzberg
from
Lyon,
France.
This
database
constitutes
a
material
on
TWA
that
is
far
larger
than
in
any
other
TWA-­‐series
ever
published.
The
database
is
continuously
updated
and
reanalysed
with
an
increasing
follow-­‐up
time.
The
analyses
published
in
paper
II-­‐IV,
show
that
Re-­‐motion
TWA
resulted
in
clinically
and
statistically
significantly
reduced
disability,
evaluated
with
a
validated
PROM
–
the
QuickDASH
questionnaire.
Likewise,
pain
and
grip
strength
improved
significantly.
This
was
the
case
in
rheumatoid
as
well
as
in
non-­‐rheumatoid
patients
with
severely
destroyed
wrists,
including
posttraumatic
cases.
Wrist
motion
however,
did
not
improve.
Nevertheless,
motion
after
Re-­‐motion
TWA
compared
well
with
other
currently
available
implants
with
the
exception
of
the
Maestro
TWA,
that
in
a
single
series
of
23
patients
yielded
better
motion.
The
question
as
to
which
extent
and
on
what
indications
TWA
is
superior
to
TWF
still
needs
to
be
answered.
The
cumulated
implant
survival
of
the
Re-­‐motion
was
approximately
90
per
cent
at
9
years
in
the
different
diagnostic
groups:
RA,
non-­‐RA
and
posttraumatic.
It
is
difficult
to
make
a
comparison
with
the
longevity
of
no
longer
available
implants
of
older
generations,
due
to
the
modest
information
in
the
literature,
with
the
exception
of
the
Biax
prosthesis,
that
had
a
comparable
or
somewhat
lower
implant
survival
(0.81
–
1.0
at
8
years).
One
implant,
the
APH,
had
a
disastrous
revision
rate
of
36/37
after
2
to
6.1
years.
Another,
the
Meuli,
declined
from
0.92
at
5
years
to
0.77
at
8
years.
Also
concerning
the
longevity
of
available
implants,
only
very
few
reports
have
been
published.
In
fact,
besides
our
reports
on
the
Re-­‐motion

66. 66
TWA,
information
concerning
the
cumulated
survival
of
currently
available
implants
at
8
years
or
more,
was
found
through
the
systematic
review
of
the
literature
only
for
the
Universal
prosthesis:
one
paper
dealing
with
24
Universal
1
cases
and
one
with
21
Universal
2
cases,
mostly
in
rheumatoid
patients.
For
the
Universal
1
the
cumulated
implant
survival
was
0.62
at
8
years
and
for
the
Universal
2
1.0.
This
discrepancy
may
be
due
to
differences
in
prosthetic
design,
patient
related
factors,
surgical
techniques
or
decision
making
concerning
revision:
closer
analysis
is
impossible
in
these
small
series.
PPO
after
TWA
was
frequently
reported
in
the
literature
with
varying
implants.
Its
precise
prevalence,
location,
natural
history
and
clinical
implications
have
not
previously
been
analysed
systematically.
According
to
our
systematic
measurements
on
serial
(annual)
radiographs
after
Re-­‐motion
TWA,
it
is
confined
at
the
edges
of
the
implant
components
close
to
the
wrist
joint
in
the
vast
majority
of
the
cases
and
the
radiolucent
zone
seems
to
stabilize
at
1-­‐2
mm
within
3
years.
More
rarely
it
increases
to
higher
levels,
especially
at
the
carpal
side,
but
this
seems
not
necessarily
to
cause
gross
loosening
of
the
components.
The
hypothesis
that
the
development
of
PPO
is
related
to
the
amount
of
polyethylene
or
metallic
wear
particles
in
the
periprosthetic
tissue
could
not
be
confirmed.
It
seems
that
other
factors
than
polyethylene
or
metallic
wear
may
cause
loosening
or
at
least
contribute
to
loosening
of
the
implants.
Other
factors
may
in
theory
be
related
to
biomechanics
or
biocompatibility.
For
the
time
being
we
recommend
close
and
continued
observation
of
the
patients
with
marked
asymptomatic
PPO
but
further
investigations
are
needed.
The
PROM
used
for
the
evaluation
of
disability/function
–
the
QuickDASH
–
in
paper
II-­‐IV,
has
been
culturally
adapted
from
US
English
to
Danish
according
to
the
Guillemin
guidelines
on
the
initiative
and
under
the
guidance
of
the
author
of
this
thesis.
In
our
analyses
it
has
proven
to
have
adequate
psychometric
properties
in
patients
with
TWA,
assessed
by
classical

67. 67
methods
and
was
of
equal
value
as
a
PROM
that
is
claimed
to
be
more
region
specific:
the
PRWE.
Dansk
resume
og
konklusioner
Data
vedrørende
patienter,
der
har
fået
indsat
en
total
håndledsalloplastik
(TWA)
af
Re-­‐
motion-­‐type
–
et
tredje
generations
metal-­‐polyætylen
implantat–
er
blevet
opsamlet
i
en
international
multicenterdatabase,
opbygget
af
forfatteren
i
samarbejde
med
Guillaume
Herzberg,
Lyon,
Frankrig.
De
indsamlede
data
udgør
et
markant
større
TWA-­‐materiale
end
nogensinde
før
publiceret.
Databasen
bliver
kontinuerligt
opdateret,
hvilket
gør
det
muligt
løbende
at
udføre
nye
analyser
med
stigende
observationstid.
Resultaterne,
præsenteret
i
artikel
II-­‐IV
viser,
at
Re-­‐motion
TWA
medfører
en
både
klinisk
og
statistisk
signifikant
handikapreduktion
hos
såvel
patienter
med
svære
reumatiske
håndledsdestruktioner,
som
hos
patienter
med
andre
diagnoser,
herunder
posttraumatiske,
evalueret
med
et
valideret
patientrapporteret
effektmål:
QuickDASH-­‐spørgeskemaet.
Smerteniveauet
og
håndtrykskraften
forbedres
ligeledes
signifikant.
På
den
anden
side,
ændres
bevægeligheden
i
håndleddet
stort
set
ikke
i
forhold
til
præoperativt.
I
analyserne
har
vi
kunnet
påvise,
at
dette
ikke
blot
gælder
gennemsnitsværdierne
i
materialerne,
men
også
bevægeligheden
for
den
enkelte
patient.
Bevægeligheden
efter
Re-­‐motion
TWA
er
på
højde
med
bevægeligheden
efter
anvendelse
af
andre
proteser
på
markedet,
vurderet
på
basis
af
publicerede
serier.
En
undtagelse
er
bevægeligheden
efter
anvendelse
af
Maestroprotesen,
som
i
en
enkelt
serie
på
23
patienter
gav
bedre
bevægelighed.
Spørgsmålet
hvorvidt
og
på
hvilke
indikationer
TWA
er
håndledsartrodese
overlegen,
er
stadig
ubesvaret.

68. 68
Den
kumulerede
overlevelse
af
Re-­‐motionprotesen
var
i
de
materialer,
der
indgår
i
denne
afhandling,
i
størrelsesorden
90
%
efter
9
år
for
de
forskellige
diagnosegrupper:
reumatiske
og
non-­‐reumatiske
tilfælde,
herunder
posttraumatiske.
Sammenligning
af
protesens
holdbarhed
med
proteser
af
ældre
generationer
er
vanskelig,
da
relevante
oplysninger
ofte
ikke
er
tilgængelige
i
litteraturen.
En
undtagelse
er
dog
Biaxprotesen,
en
af
de
sidste
anden
generationsproteser,
som
nu
ikke
findes
på
markedet
længere.
Den
kumulerede
overlevelse
af
Biaxprotesen
ser
ud
til
at
være
sammenlignelig
eller
noget
lavere.
En
protese
af
ældre
konstruktion,
APH-­‐protesen,
havde
en
katastrofal
revisionsrate
på
36/37
efter
2
til
6,1
år.
En
anden
protese,
Meuliprotesen,
faldt
i
proteseoverlevelse
fra
92
%
efter
5
år
til
77%
efter
8
år.
Hvad
angår
de
proteser
der
aktuelt
findes
på
markedet
er
der
heller
ikke
megen
dokumentation
for
langtidsholdbarheden.
Den
systematiske
litteraturgennemgang
fandt
kun
oplysninger
om
mindst
8-­‐års
implantatoverlevelse
for
en
enkelt
håndledsprotese,
Universal-­‐
protesen,
i
to
publikationer:
en
serie
på
24
patienter
med
Universal
1
og
en
serie
på
21
patienter
med
Universal
2.
For
Universal
1
var
overlevelsen
62
%
efter
8
år
og
for
Universal
2
100%.
De
allerfleste
patienter
i
disse
to
serier
havde
reumatoid
artrit.
Årsagen
til
den
betydelige
forskel
kan
muligvis
tilskrives
forskellen
i
proteseudformning,
kirurgisk
teknik
eller
holdningen
til
indikationen
for
revision.
En
nærmere
analyse
er
ikke
mulig
i
disse
små
materialer.
Periprostetisk
osteolyse
(PPO)
er
almindeligt
forekommende
efter
TWA.
Dens
prævalens,
lokalisation,
forløb
og
kliniske
betydning
er
ikke
tidligere
blevet
undersøgt
systematisk.
Vores
systematiske
målinger
på
de
årlige
røntgenundersøgelser
af
patienterne
har
vist,
at
PPO
oftest
er
lokaliseret
til
det
lednære
område
af
protesekomponenterne
og
den
radiologiske
opklaringszone
ser
ud
til
i
de
fleste
tilfælde
at
stabilisere
sig
til
en
bredde
på
1-­‐2
mm
indenfor
3
år.
Mere
sjældent
øges
opklaringszonen
yderligere,
især
på
karpalsiden,
men
dette
ser
ikke

69. 69
nødvendigvis
ud
til
at
medføre
destabilisering
af
protesedelene.
Hypotesen,
at
størrelsen
af
PPO
skulle
være
korreleret
til
mængden
af
polyætylen
eller
metalliske
slidpartikler
i
det
periprostetiske
væv,
kunne
ikke
bekræftes.
Det
ser
ud
til,
at
andre
faktorer
end
frigivelsen
af
slidpartikler
kunne
være
medvirkende:
faktorer
relateret
til
biokompatibilitet
eller
til
biomekaniske
forhold.
Foreløbig
anbefales
kontinuerlig
kontrol
af
patienterne
med
asymptomatisk
PPO
af
større
omfang,
men
mere
forskning
på
dette
område
er
nødvendig.
I
denne
afhandling
er
funktion
og
handikap
målt
ved
hjælp
af
QuickDASH-­‐spørgeskemaet,
et
generisk
patient-­‐rapporteret
effektmål
for
funktion
og
handikap
i
overekstremiteten.
Denne
er
oversat
til
dansk
på
initiativ
og
under
ledelse
af
forfatteren
i
henhold
til
de
såkaldte
Guillemin-­‐retningslinjer
(oversættelse,
tilbageoversættelse
og
sammenligning).
Vurderet
med
klassiske
psykometriske
metoder,
har
QuickDASH
vist
sig
at
have
tilfredsstillende
psykometriske
egenskaber
for
patienter
med
TWA
og
at
være
ligeværdig
med
et
mere
regionspecifikt
spørgeskema:
PRWE
(Patient
Rated
Wrist
Evaluation).

70. 70
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76. 76
Paper
I
DANISH MEDICAL JOURNAL
ABSTRACT
INTRODUCTION: Severely painful or dysfunctional destroyed
wrists can be reconstructed by fusion, interposition of soft-
tissue or by arthroplasty using artificial materials. Total and
partial wrist arthroplasty (T/PWA) has been used on a regu-
lar basis since the 1960’s. The objective of this study was to
review the literature on second, third and fourth generation
implants.
METHODS: The review was conducted according to the
PRISMA – guidelines. A search was made using a proto-
colled strategy and well-defined criteria in PubMed, in the
Cochrane Library and by screening reference lists.
RESULTS: 37 publications describing a total of 18 implants
were selected for analysis. 16 of the publications were use-
ful for the evaluation of implant longevity. Despite method-
ological shortcomings in many of the source documents, a
summary estimate was possible.
CONCLUSION: It seems that T/PWA has a good potential to
improve function through pain reduction and preservation
of mobility. The risk of severe complications – deep infec-
tion and instability problems – is small with the available
implants. Implant survival of 90-100% at five years are re-
ported in most series – if not all – using newer second gen-
eration and third generation implants, but declines from
five to eight years. Periprosthetic osteolysis/radiolucency is
frequently reported. Its causes and consequences are not
clarified.
Painful, dysfunctionally destroyed wrists can be recon-
structed by fusion, interposition of soft-tissue or arthro-
plasty using artificial materials. Total or partial wrist ar-
throplasty (T/PWA) was attempted in the beginning of
the twentieth century and has been used on a more
regular basis since the 1960s. Several generations of im-
plants exist, the first being interposition of single-com-
ponent silicone implants, a procedure that is hardly ever
used today [1].
The second generation of implants was multi-com-
ponent implants [2-6]. There is no consensus on the def-
inition of second generation. Herein, we define it as an
implant consisting of a radial component and a carpal
component, fixated in one or more of the metacarpal
bones. Some of these systems have been developed
after the introduction of the third generation [7].
The third generation of implants is characterised by
minimal bone resection to avoid fixation in the metacar-
pal bones, with the exception of an optional and re-
stricted fixation in the second metacarpal. These im-
plants attempt to mimic the natural anatomy and
biomechanics of the wrist and the implants are largely
unconstrained [8-10]. Pyrocarbon was recently intro-
duced as a single-component interposition arthroplasty
[11] or hemiarthroplasty [12]. We define these as
“fourth generation” implants.
The objective of this study was to review the litera-
ture concerning T/PWA using second, third and fourth
generation implants. The questions to be answered
were: What is the present knowledge on clinical results,
complications and implant longevity. An effort was
made to draw general conclusions rather than to de-
scribe the results obtained in individual series.
METHODS
The review was conducted according to the PRISMA
guidelines [13].
Search strategy
We made a primary search through PubMed with the
Mesh terms “Wrist Arthroplasty” and “Wrist Replace-
ment”. We restricted the search to the 1994-2013-
period, considering earlier material to have historical
value only. We made a second search in the Cochrane
Library and a continuous supplementary search by scan-
ning the reference lists of the papers first included.
The inclusion criteria were: papers with primary
clinical data on second, third and fourth generation im-
plants. Excluded were: cadaveric studies; biomechanical
studies; studies not accessible in journals, books or on-
line; reviews without primary data. Double publications
and articles with overlap of cases were relative exclusion
criteria. Articles not written in English, Danish, Swedish,
Norwegian, French, Dutch or German were evaluated on
the basis of an English abstract, if available.
Quality assessment and handling of data
We focused on the number of cases, the methodology
and the observation period. Papers with less than ten
cases were considered to be less useful and are there-
fore only mentioned very briefly. Implant longevity was
primarily evaluated on the basis of papers with a cumu-
lated implant survival of at least five years; secondarily,
papers with a follow-up of a minimum of two years in
each case. Function was evaluated by well-validated and
relevant outcome measurement tools like the Disabil-
Michel E. H. Boeckstyns
SYSTEMATIC
REVIEW
Clinic for Hand Surgery,
Gentofte Hospital
Dan Med J
2014;61(5):A4834

77. 77
DANISH MEDICAL JOURNAL
ities of Arm, Shoulder and Hand (DASH/QuickDASH), the
Patient-Rated Wrist Evaluation (PRWE) or the Michigan
Hand Questionnaire (MHQ). Series with clinical data col-
lected before operation and similarly at follow-up were
defined as prospective, even if there had been no men-
tion of a preoperative protocol. We made an effort to
clarify whether the authors were involved as inventors,
developers, or producers.
RESULTS
Selected publications
A total of 56 papers were eligible (Figure 1). Screening
for double publication or overlap of data led to the ex-
clusion of 12 papers [3, 7, 9-10, 14-21]. One paper [22]
was a retrospective review of TWA using three implants,
with a large overlap concerning the Biaxial implant with
two other included papers [4, 23], and there were data
on eight cases only concerning the second implant, the
Universal 2. Thus, only data concerning the Remotion
were used despite important methodological limitations
in this paper. Seven publications comprised less than ten
cases, which left 37 articles for final analysis of which 16
fulfilled the criteria for analysis of longevity. The eligible
studies represent a maximum of 1,127 cases, but the
precise number is probably somewhat smaller due to a
possible minor overlap between some of the series. 71%
were rheumatoid, 6% scapholunate advanced collapse
(SLAC) wrists, 4% scapho-nonunion advanced collapse
(SNAC) wrists, 4% other posttraumatic causes, 4% other
degenerative causes, 2% Kienboeck’s disease, and 9%
other or not well specified causes.
Implants
A total of 18 different implants were reported, including
certain modifications (Table 1). Of these, seven are no
longer available: the APH [19], Biaxial [4], CFV [24], Des-
tot [25], Meuli [3], Trispherical [26], Volz [27] and the
Rozing wrist system (RWS) [5]. Three have been rede-
signed: The Guepar [28], now marketed as Horus, the
Aphis [29] and Universal 1 [8]. The following are cur-
rently available: Amandys [11], Maestro [30], Motec [7],
Pech [31], RCPI [32], Remotion [9], Total Modular [6]
and Universal 2 [33]. The Amandys is an interposition
pyrocarbon implant, and the RCPI a pyrocarbon hemiar-
throplasty. All of the remaining devices have a carpal
and a radial component. The radial component of the
FIGURE 1
Flow diagram of search strategy.
Search for “wrist arthroplasty” and
“wrist replacement”:
Mesh-words:

78. 78
DANISH MEDICAL JOURNAL
TABLE 1
Implants, number of cases and methodology in 37 publications.
Reference Implant
Gener-
ation
Cases
(rheumatoid
cases), n
data permitting
comparison
Validated
outcome measures
instrument Change in scores
Pierrart et al, 2012 [68] Amandys IV 11 (0) Not reported QDASH
PRWE
–
Bellemère et al, 2012a
[11] Amandys IV 25 (1) Reported QDASH
PRWE
Improved 27 and 29
points (p < 0.05)
Radmer et al, 2003 [41] APH II 40 (40) Not reported – –
Isselin, 2003a
[29] APHIS III 13 (0) Reported – –
Lirette & Kinnard, 1995 [42] Biaxial II 15 (15) Not reported – –
Cobb & Beckenbaugh, 1996a
[4] Biaxial II 57 (57) Reported – –
Cobb & Beckenbaugh, 1996a
[67] Biaxial (long stem) II 10 (10) Not reported – –
Courtman et al, 1999 [44] Biaxial II 26 (26) Not reportedc
– –
Takwale et al, 2002 [47] Biaxial II 66 (66) Not reported – –
Rizzo & Beckenbaugh, 2003a
[23] Biaxial (long stem) II 17 (approx. 15) Reported – –
Stegeman et al, 2005 [43] Biaxial II 16 (16) Not reported – –
Kretschmer & Fansa, 2007 [46] Biaxial II 42 (3) Reported – –
Van Harlingen et al, 2011 [45] Biaxial II 32 (32) Reported – –
Ferlic & Clayton, 1995a
[24] CFV II 15 (13) Not reported – –
Levadoux & Legré, 2003a
[25] Destot II 27 (0) Not reported – –
Fourastier et al, 1996a
[28] Guepar II 72 (72) Not reported – –
Nydick et al, 2012 [30] Maestro III 23 (5) Reported DASH Not recorded
preoperatively
Meuli, 2000 [52] Meuli II 54 (approx. 45) Not reported – –
Vögelin & Nagy, 2003 [66] Meuli II 16 (13) Not reported – –
Strunk & Bracker, 2009 [48] Meuli, Biaxial, Universal 2 II, II, III 41 (38) Not reported DASH –
Reigstad et al, 2012a
[36] Motec (II) 30 (0) Reported DASH Improved 26 points
(p < 0.05)
Pech et al, 2008a
[31] Pech II 32 (32) –e
– –
Marcuzzi et al, 2013 [32] RCPI IV 35 (0) Reported DASH Improved 45 points
(p < 0.05)
Cooney et al, 2012a
[22] Remotion III 22 (?) Reported DASH -
Herzberg et al, 2012 [38] Remotion III 112 (75) Reported QDASH Improved 21 points
(NS)
Bidwai et al, 2013 [51] Remotion III 10 (10) Reported – –
Rahimtoola & Rozing, 2003a
[5] RWS II 29 (approx. 27) Reported – –
Rahimtoola & Hubach, 2004a
[6] Total Modular II 32 (29) Reported – –
Kraay & Figgie, 1995b
[26] Trispherical II 35 (35) Not reportedd
(HSS) (Improved, significance
not reported)
Menon, 1998a
[8] Universal 1 III 31 (23) Reported – –
Van Winterswijk & Bakx, 2010 [40] Universal 2 III 17 (16) Reported DASH Improved 24 points
(significance not
reported)
Ferreres et al, 2011 [50] Universal 1/2 III 21 (15) Not reported PRWE –
Ward et al, 2011a
[39] Universal 1 III 24 (24) Reported DASH Improved 22 points
(significance not
reported)
Morapudi et al, 2012 [37] Universal 2 III 21 (19) Reported DASH
PRWE
Improved 10 and
46 points (p < 0.05)
Adams, 2013a
[33] Universal 2
(hemiarthroplasty using
radial component)
(III) 26 (3) Not reported – –
Bosco et al, 1994 [27] Volz II 18 (14) Not reported – –
Gellman et al, 1997 [49] Volz II 14 (14) Not reported – –
Total
APH = anatomic-physiologic; APHIS = Arthroplastie Physiologique Isselin; CFV = Clayton Ferlic Volz; DASH = Disabilities of Arm, Shoulder and Hand; HSS = hospital for special surgery;
PRWE = Patient-Rated Wrist Evaluation; QDASH = QuickDASH; RCPI = Resurfacing Capitate Pyrocarbon Implant; RWS = Rozing Wrist System.
a) Some of the authors may be involved in the development or production of the implant; b) No clear available information on the authors’ affiliation to the production; c) Only sum
flexion – extension and of radial-ulnar reported, but without mention of statistical significance; d) HSS-score reported – this scoring system was not eligible according to the protocol
due to its restricted use and validation; e) Full text in Czech, only abstract available in English.

79. 79
DANISH MEDICAL JOURNAL
Universal, the Remotion and the Maestro have been
used as hemiarthroplasties [33-35]. The APH and the
Motec are metal-on-metal prostheses; all others are
metal-on-polyethylene. Only the Trispherical is fully con-
strained. For further details concerning all these im-
plants, we refer to the primary publications.
Clinical results
Six papers provided preoperative as well as post-opera-
tive data on function, all reporting improvement (Table
1): four reported statistical significance [11, 32, 36, 37],
one a statistically non-significant improvement [38] and
two papers did not report significance [39, 40]. In two of
the papers, a t-test was used to assess significance,
which is debatable since the scoring systems are based
on ordinal scales [36, 37].
The mean or median range of flexion-extension at
follow-up was reported in 32 papers and ranged from 15
to 89 degrees. The mean or median range of radial-ulnar
deviation was reported in 27 papers and ranged from
seven to 48 degrees (Table 2).
In all, 13 of 36 papers reported grip strength at fol-
low-up, but only ten compared grip strength with pre-
operative values, eight showing increased and two de-
creased values.
A total of 12 papers evaluated pain on a visual ana-
logue scale, 14 on a verbal Likert scale and one used the
pain section of the PRWE. Thirteen of these 26 papers
demonstrated improvement of mean values and nine re-
ported statistical significance. The other 14 had no pre-
operative values for comparison. Clear information con-
cerning pain was missing in ten papers.
Complications
Besides the important issue of prosthetic loosening, we
selected two major complications because we expected
these to be most consistently defined and reported.
Deep infection (early or late) was reported in a total of
16 cases (1.4%). The infection rate ranged from 0% (in
23 series) to 13% [24]. Instability problems were related
to certain implants. Radmer reported 32 cases of “loos-
ening with subsequent dislocation” out of 40 cases using
the APH prosthesis [41], the main reason for abandoning
the use of this implant. A total of 22 of 278 (8%) Biax im-
plants in seven series were reported to have dislocated
[4, 42-48], and four out of 32 (13%) Volz prostheses
were reported to have subluxed or dislocated in two ser-
ies [27, 49]. Menon [8] reported dislocation of five out
of 37 (14%) cases, and Ward [39] reported one persis-
tent instability and one dislocation out of 24 Universal 1
TABLE 2
Motion at follow-up in publications on currently available implants.
Total range of motion
Implant
post-oper
degrees
change compared
degrees
post-oper
degrees
change compared
degrees
post-oper
degrees
change compared
degrees
Amandys
Bellemere et al, 2012 [11] 68 1 NS 36 0 NS – – –
Pierrart et al, 2012 [68] 71 – – 36 – – – – –
Maestro
Nydick et al, 2012 [30] 90 5 NS 43 8 < 0.05 – – –
Motec
Reigstad et al, 2012 [36] 120 16 NS
Pech
Pech et al, 2008 [31] – – - - – – – – –
RCPI
Marcuzzi et al, 2013 [32] 67 17 < 0.05 24 17 < 0.05 – – –
Remotion
Herzberg et al, 2012 [38] 66 –4 NS 33 2 < 0.05
for radial
flexion
– – –
Cooney et al, 2012 [22] 67 –6 – 27 7 – – – –
Bidwai et al, 2013 [51] 61 38 < 0.05 22 – – – – –
Total Modular
Rahimtoola & Hubach,
2004 [6]
63 17 < 0.05 24 7 < 0.05
for ulnar
flexion
– – –
Universal 2
Morapudi et al, 2012 [37] 53 15 < 0.05 – – – – – –
NS = non-significant; RCPI = Resurfacing Capitate Pyrocarbon Implant.

80. 80
DANISH MEDICAL JOURNAL
cases (8%). Van Winterswijk [40] reported dislocation in
one out of 17 Universal cases. This instability problem
seems to have been solved with the modified version,
the Universal 2 [37, 50].
Dislocation has been only a very small problem with
the Remotion: one in 144 reported cases (< 1%) [22, 38,
51]. In the two Amandys series, problems were seen in
seven out of 36 cases (19%). One recurrent subluxation
was reported out of 13 Isselin [29] implants, and one in-
stability problem out 23 Maestro implants [30]. No dislo-
cations or other instability problems worth mentioning
have been reported following the Destot, GUEPAR,
Meuli, Motec, Pech, RWS, Trispherical or RCPI [5, 25, 26,
28, 31, 32, 36, 51].
Radiology
Osteolysis or radiolucency at follow-up, with or without
loosening of the prosthetic components, was assessed in
varying ways. In 13 of the 37 series, no useful informa-
tion could be retrieved, whereas 20 papers reported os-
teolysis, ten of these mentioning radiolucency without
frank loosening of the implant components [5, 23, 36,
38, 39, 42, 45, 49-51].
In a consecutive series of Biaxial TWA with a follow-
up time of 5-9 years, there was progressive radiolucency
at the carpal component in 12 out of 46 wrists, seven of
which were revised. Subsidence of the carpal compo-
nent was present in seven cases after one year and in 20
cases at final follow-up [4].
Ten papers provided data that permitted an evaluation
of the cumulated survival at five years or more (Table 3).
Eight reported a cumulated five-year survival of 90% or
more and one a cumulated five-year survival of 75%. The
last paper reported 0.83 at ten years.
Small series
Seven papers included less than ten cases. Boyer &
Adams used the radial component of a Universal 2 total
wrist arthroplasty system in two rheumatoid cases as a
hemiarthroplasty in combination with a proximal row
carpectomy [34]. Roux developed a hemiarthroplasty for
usage primarily in comminuted distal radius fractures
with irreparable joint surfaces [53]. Lorei et al used a
custom Trispherical implant for the revision of three
failed TWAs [54]. O’Flynn reported on a single case of
failure of the hinge mechanism in a Trispherical TWA
[55]. Talwalkar et al reported on five revision Biaxial re-
placements [56]. Lundborg et al published five cases us-
ing a titanium/polyethylene ball-and-socket articulation
fixated with osseointegrated Titanium screws [18] and
with a further follow-up [57]. Daruwalla presented a
series of six Amandys pyrocarbon implants [58].
DISCUSSION
Although this review used systematic search criteria and
protocol inclusion and exclusion criteria, it was limited
by the quality of the source reports. After exclusion of
TABLE 3
Cumulated survival rate and/or revision rate of implants in 16 publications.
rate, n mean (range), yrsReference Implant Diagnosis at 5 yrs at 8 yrs at 10 yrs
Radmer et al, 2003 [41] APH RA (PSA, OA)b
– – – 36/37 4.3 (2-6.1)
Courtman et al, 1999 [44] Biaxial RA/PSA 1.0 – – – 2.8 (2-5.2)
Van Harlingen et al, 2011 [45] Biaxial RA 0.90c
0.81 – – 6.0 (5-8)
Cobb & Beckenbaugh, 1996a
[4] Biaxial RA – – 0.83 – 6.5 (5-9.9)
Takwale et al, 2002 [47] Biaxial RA 0.90c
0.83 – – 4.3 (1-8.3)
Cobb & Beckenbaugh, 1996a
[67] Biaxial (used for revision) RA – – – 2/10 3.8 (3-4.8)
Rizzo & Beckenbaugh, 2003a
[23] Biaxial (long stem) RA (OA)b
1.0 1.0 – – 6.2 (4.1-8.6)
Meuli, 2000a
[52] Meuli RA/PT 0.92 0.77 – – –(0.5-13)
Reigstad et al, 2012 [36] Motec SLAC/SNAC 0.93 – – – 3.2 (1.1-6.1)
Herzberg et al, 2012 [38] Remotion RA/PT/OA 0.92 0.92 – – 4.0 (2-8)
Rahimtoola & Rozing, 2003a
[5] RWS RA (PSA, OA)b
– – – 1/29 4.0 (2-8)
Menon, 1998a
[8] Uni 1 RA/OA – – – 4/37 6.7 (4-10)
Ward et al, 2011a
[39] Uni 1 RA 0.75 0.62c
0.40c
– 7.3 (5-10.8)
Ferreres et al, 2011 [50] Uni 1 and 2 RA (PSA, OA, misc.)b
1.0 1.0 – – 5.5 (3.2-8.8)
Gellman et al, 1997 [49] Volz RA – – – 1/14 6.5 (3.5-11.5)
Bosco et al, 1994 [27] Volz RA (PT)b
– – – 1/18 8.6 (3.5-12.5)
APH = anatomic-physiologic; OA = degenerative osteoarthritis; PSA = psoriatic arthritis; PT = posttraumatic arthritis; RA = rheumatoid arthritis; SLAC = scapholunate advanced col-
lapse; SNAC = scaphoid non-union advanced collapse.
a) Some of the authors may be involved in the development or production of the implant.
b) Diagnosis in bracket because of small percentage.
c) Evaluated on an illustration showing the cumulated implant survival curve in the publication.

81. 81
DANISH MEDICAL JOURNAL
one paper for language reasons and one paper reporting
data as a part of a less commonly used scoring system,
no more than 17 publications were prospective, even
when using a broad definition: data collected preopera-
tively as well as post-operatively. Of these 17 papers,
eight used a validated and widely used outcome meas-
urement system. This weakness of methodology applies
mainly to second generation implants. In at least 16 of
the 37 papers, one or several authors were involved as
or close to the inventors, developers or producers, but
this seemed not to have had an impact on the reported
clinical or longevity results. Finally, due to the lack of
more detailed information, our analyses were limited to
calculation of mean or median values, whereas calcula-
tion of statistically significant differences was impos-
sible. Despite these weaknesses, we find that some sum-
mary estimate of the results after T/PWA and some
general conclusions are possible.
The majority of the data are based on rheumatoid
cases, although other diagnoses are increasingly repre-
sented in recent publications. The general opinion has
generally been that better longevity must be expected in
low-demand patients, typically rheumatoid patients. It is
not possible throughout the different series to compare
results in rheumatoid and non-rheumatoid patients, but
the series of Herzberg [38], which consists of 75 rheuma-
toid and 37 non-rheumatoid cases, draws on prospective
data and concludes that there are no clinically or statis-
tically significant differences. This is consistent with an
emerging consensus that non-rheumatoid patients may
do better because of a better bone stock, provided that
their level of activity is restricted [33].
In terms of complications, it appears that the risk of
deep infection is small. Likewise, it seems that the insta-
bility problems of earlier designs have been solved, ex-
cept for the Amandys implant. Time must show if this re-
quires modification of the implant or if the issue can be
solved by modified surgical techniques.
In general, mean values for motion at follow-up are
similar for most implants and within the functional
range defined by Palmer et al [59], although somewhat
smaller than the more rigorous range defined by Ryu &
Cooney [60] (Table 2). An exception may be the Maestro
that showed better motion in the single series with this
implant [30]. On the other hand, there is less consist-
ency concerning the change in motion from before oper-
ation to follow-up. This may be attributed to different
case selections, different post-operative protocols or
factors related to the implant itself, but it is impossible
to clarify this on basis of the published data. The general
tendency is that the mean level of function, as evaluated
with patient-rated outcome measures, increases, and
that pain is reduced. However, a general summary of the
extent of the pain reduction through the different re-
ports is impossible.
The main advantage of T/PWA over total wrist fu-
sion (TWF) is claimed to be a higher degree of function-
ality. Although many patients with bilateral procedures
– TWA on one side and TWF on the other – would have
preferred arthroplasty on both sides, this is not always
the case [47]. The present work did not aim to make a
comparison between these two solutions, but the ques-
tion is important. Murphy et al made a comparison be-
tween TWA (24 rheumatoid wrists) and TWF (27 rheu-
matoid wrists) in a retrospective design [20]. Treatment
groups were well matched by patient characteristics and
radiographic staging. There were no statistically signifi-
cant differences between arthroplasty and arthrodesis
in either DASH or PRWE scores.
Cavaliere & Chung compared TWA with TWF in a
systematic review of the literature [61]. They identified
18 total wrist arthroplasty studies representing 503 pro-
cedures and 20 TWF studies representing 860 proced-
ures in rheumatoid patients. They concluded that the
outcomes for TWF were comparable and possibly better
than those for TWA. One major limitation in that study
was that the methodology in the source publications
was often very weak.
In a subsequent study [62], TWA was associated
with the highest expected gain in quality-adjusted life-
years (QALY). This finding reflects the attitude of medical
specialists, but is, of course, not evidence of the super-
iority of TWA. In a third study, the authors compared
costs per QALY [63]. TWA turned out to have only a
small incremental cost over the traditional TWF proced-
ure. However, this study is limited by the uncertainty as-
sociated with utility values, life span and complication
rates. Especially, we question the assumption in the
model, that prostheses are durable enough to last the
duration of the patient’s life.
Nydick et al compared TWA (seven wrists) and TWF
(15 wrists) [10] in posttraumatic arthritis. The PRWE
scores were significantly better in the arthroplasty
group, but there were no differences in DASH scores.
FACT BOX
Several generations of total wrist arthroplasty have been used on a regular basis since the 1960s and
hemiarthroplasty has been introduced in recent years.
Many designs have been utilised and quite a few abandoned or modified. Currently, ten different im-
plants are available.
Wrist arthroplasty has a good potential for improvement of function through pain reduction and preser-
vation of mobility, but its superiority above total wrist fusion has not been proven in controlled ran-
domised trials.
The five-year implant survival is higher than 90% in most series using late second generation and third
generation implants. Implant survival seems to decline from five to eight years.

82. 82
DANISH MEDICAL JOURNAL
Besides its retrospective design, the weakness of this
study was the very small number of TWA and the fact
that all cases had been treated at the same clinic, imply-
ing that there had been a preoperative decision to pre-
fer TWA in some patients and TWF in others.
In our study, a reasonable appreciation of the lon-
gevity of the implants was possible in 16 papers, al-
though only ten provided information on cumulated im-
plant survival. The most widely accepted and commonly
used definition of failure in implant survival analysis is
“removal of implants”, but the decision to remove an
implant depends on the attitude of the surgeons: Some
might advise not to remove an implant, even in the pres-
ence of some (tolerable) pain; some might advise re-
moval of an implant with periprosthetic osteolysis, even
if the implant seems to be stable and in the absence of
pain. Thus, it is argued that other definitions should be
considered, but until another consensus is reached, re-
moval of implants remains the definition of choice.
Generally, the five-year implant survival rate was
higher than 90% (Table 3), but declining at eight years.
One exception is the low survival reported by Ward et al
[39]. This series contains exclusively rheumatoid cases,
but there were no statistically significant differences be-
tween the ten revised and ten non-revised wrists in
terms of age, Simmen classification, dominance or pre-
operative DASH score. Another notable result concerns
the metal-on-metal APH prosthesis. Solitary loosening of
the carpal component was predominant. The authors
believed that the main cause of loosening was bone re-
sorption induced by titanium debris, and they aban-
doned the use of this implant [41]. Krughaug et al re-
ported on the survival of 189 TWA in the Norwegian
Arthroplasty Register [64]: The cumulated survival of the
Biax was 85% at five years and approximately 78% at
eight years, which is somewhat lower than in the series
we have analysed. The survival of the Gibbon/Motec
was obviously lower than that published by Reigstad et
al [36], which can possibly be attributed to underreport-
ing to the register [65].
Six papers merely permitted a calculation of the re-
vision rate, which is much weaker information. Indeed,
a given revision rate in series with a long observation
period has a quite different value than the same revision
rate in a series with a short observation period. Failed
TWA can successfully be revised by fusion [8, 15, 22, 36,
39, 41, 66], by total or partial replacement of the com-
ponents [8, 15, 22, 39, 66, 67] or by total or partial re-
moval of the components with or without soft-tissue
interposition, typically fascia lata [4, 39].
Although reported in 20 articles, periprosthetic os-
teolysis/radiolucency, with or without gross loosening,
has been systematically investigated in two series only
[4, 47]. The remaining studies report on the phenom-
enon but use no standardised definitions or methods.
Osteolysis occurred frequently around both the radial
and carpal components, whereas frank loosening of the
component was more frequent on the carpal side.
Radiostereographic studies have not been published.
The cause of periprosthetic osteolysis is not clear,
but has been attributed to a local osteolytic reaction to
metallic or polyethylene debris. In this review, we can
confirm that it occurs in metal-on-polyethylene [4-6, 23,
27, 28, 39, 43-47, 49-51] as well as in metal-on-metal
prostheses [36, 41], but we are unable to clarify its
causes or consequences. To our knowledge, no system-
atic analyses of metallic ion levels in blood have been
published [36, 41].
CONCLUSION
Despite the methodological shortcomings in a consider-
able proportion of the published papers, some general
conclusions are possible. It seems that T/PWA has a
strong potential for improvement of function through
pain reduction and preservation of mobility. The risk of
severe complications – deep infection and instability
problems – is small with the available implants. An im-
plant survival of 90-100% at five years is reported in
most series – if not all – using newer second generation
and third generation implants, but implant survival de-
clines from five to eight years.
There is a need of continuous research with a focus
on indications (rheumatoid versus non rheumatoid, age-
groups, level of activity etc.) and on long-term results
achieved through large prospective multicentre studies,
national registries or even with post-market surveillance
registries of implants that are no longer available.
Furthermore, the question as to which extent and on
what indications TWA is superior to TWF still needs to
be answered definitely.
Finally, the possible causes and consequences of
the frequently reported periprosthetic loosening must
be exposed by radiostereographical methods, histo-
X-ray of the Remotion
total wrist arthroplasty.

83. 83
DANISH MEDICAL JOURNAL
logical examinations, bone mineral content measure-
ments, metallic ion levels in blood, etc.
CORRESPONDENCE: Michel E. H. Boeckstyns, Håndkirurgisk Afdeling Z,
Gentofte Hospital, Niels Andersens Vej 65, 2900 Gentofte, Denmark.
E-mail: mibo@dadlnet.dk
ACCEPTED: 27 February 2014
CONFLICTS OF INTEREST: none. Disclosure forms provided by the authors
are available with the full text of this article at www.danmedj.dk.
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85. 85
Paper
II
“Remotion” Total Wrist Arthroplasty:
Preliminary Results of a Prospective
International Multicenter Study of 215 Cases
Guillaume Herzberg, M.D., Ph.D. 1 Michel Boeckstyns, M.D. 2 Allan Ibsen Sorensen, M.D. 3
Peter Axelsson, M.D. 3 Karsten Kroener, M.D. 4 Philippe Liverneaux, M.D., Ph.D. 5
Laurent Obert, M.D., Ph.D. 6 Soren Merser, M.D. 7
1 Wrist Surgery Unit, Department of Orthopaedics, Claude Bernard
Lyon University, Herriot Hospital, Lyon, France
2 Section of Hand Surgery, Gentofte Hospital, Hellerup, Denmark
3 Section of Hand Surgery, Sahlgrenska Hospital, Gothenburg, Sweden
4 Section of Hand Surgery, Aarhus University Hospital, Aarhus,
Denmark
5 Hand Surgery Unit, Orthopaedic Department, Strasbourg University,
Strasbourg, France
6 Hand Surgery Unit, Orthopaedic Department, Besancon University,
Besancon, France
7 Technical University of Denmark, Lyngby, Denmark
J Wrist Surg
Address for correspondence and reprint requests Guillaume
Herzberg, M.D., Ph.D., Wrist Surgery Unit, Orthopaedic Department,
Claude Bernard Lyon University, Herriot Hospital, 5 place Arsonval,
69437 Lyon, France (e-mail: guillaume.herzberg@chu-lyon.fr).
Keywords
► total wrist
arthroplasty
► multicenter study
► wrist arthrtitis
► wrist arthrosis
Abstract To report the current results of an international multicenter study of one last generation
total wrist arthroplasty (TWA) (“ReMotion,” Small Bone Innovation, Morristown, PA).
The two first authors (G.H. and M.B.) built a Web-based prospective database
including clinical and radiological preoperative and postoperative reports of “ReMotion”
TWA at regular intervals. The cases of 7 centers with more than 15 inclusions were
considered for this article.
A total of 215 wrists were included. In the rheumatoid arthritis (RA; 129 wrists) and
nonrheumatoid arthritis (non-RA; 86 wrists) groups, there were respectively 5 and 6%
complications requiring implant revision with a survival rate of 96 and 92%, respectively, at an
average follow-up of 4 years. Within the whole series, only one dislocation was observed in
one non-RA wrist. A total of 112 wrists (75 rheumatoid and 37 nonrheumatoid) had more
than 2 years of follow-up (minimum: 2 years, maximum: 8 years). In rheumatoid and non-RA
group, visual analog scale (VAS) pain score improved by 48 and 54 points, respectively, and
QuickDASH score improved by 20 and 21 points, respectively, with no statistical differences.
Average postoperative arc of wrist flexion–extension was 58 degrees in rheumatoid wrists
(loss of 1 degree) compared with 63 degrees in non-RA wrists (loss of 9 degrees) with no
statistical differences. Grip strength improved respectively by 40 and 19% in rheumatoid and
non-RA groups (p ¼ 0.033). Implant loosening was observed in 4% of the rheumatoid wrists
and 3% of the non-RA wrists with no statistical differences.
A Web-based TWA international registry was presented. Our results suggest that the use
of the “ReMotion” TWA is feasible in the midterm both for rheumatoid and non-RA
patients. This is a significant improvement compared with the previous generationTWA.
Level of evidence for the study is 4.
Copyright © 2012 by Thieme Medical
Publishers, Inc., 333 Seventh Avenue,
New York, NY 10001, USA.
Tel: +1(212) 584-4662.
DOI http://dx.doi.org/
10.1055/s-0032-1323642.
ISSN 2163-3916.
Special Focus

86. 86
The Kaplan–Meier survival graphs are shown in ►Figs. 2
and 3. At the average follow-up of this study, the survival rate
(with failure defined as implant revision) was 96% in the
rheumatoid group of wrists and 92% in the non-RA group.
Clinical and Radiological Results of 112 Wrists with
More Than 2 Years of Follow-Up
The clinical results (mean: 4 years; minimum: 2 years, maxi-
mum: 8 years) are reported in ►Table 1. Except for radial
deviation and grip strength improvement, we could not find
any statistically significant differences between rheumatoid
and non-RA wrists. Patient’s satisfaction was high both in the
rheumatoid (88% very satisfied or satisfied) and in the non-RA
groups (95% very satisfied or satisfied).
In terms of radiological results, implant positioning was
subjectively judged by the operating surgeon as optimal (86%)
or suboptimal (11%) in 97% of the rheumatoid wrists and 100%
of the non-RA wrists (optimal: 79% and suboptimal: 21%).
Loosening with implant migration was observed in 4% of the
rheumatoid wrists and 3% of the non-RA wrists (nonsignifi-
cant [ns], p ¼ 1.000). Loosening without implant migration
was observed in 8% of the rheumatoid wrists and 15% of the
non-RAwrists (ns, p ¼ 0.2520). Overall, the incidence of signs
of periprosthetic loosening was 12% in the rheumatoid group
compared with 18% in the non-RA group (the Fischer exact
test; level of significance 0.05).
Discussion
The use of TWA to treat end-stage rheumatoid and non-RA
arthritis is very controversial due to the high range of
complications reported in previous series.1
Historically, the
first total silicone wrist implants were abandoned because of
unacceptable revision rates.5
They were followed by a first
generation of metal-polyethylene total wrist arthroplasties
that still had high complications and revisions rates.9
Even
some newer metal-polyethylene prostheses designs showed
at first promising results followed by unacceptable longer
follow-up results.10,11
A recent systematic meta-analysis of a
large series of total wrist arthroplasties (most of the first
generation metal-polyethylene TWA) concluded that existing
data do not support widespread application of TWA for
rheumatoid arthritic wrists.5
This is why many surgeons prefer total wrist fusion to treat
end-stage rheumatoid or non-RA wrist arthritis. Indeed, total
wrist fusion will remain the only option for a destroyed RA
wrist with bony destruction and complete loss of the carpal
architecture.12
However, there are many debatable issues
Figure 3 Probability of implant survival in nonrheumatoid patients
(failure defined as revision).
Table 1 Clinical Results of TWA in 112 Wrists with At Least 2 Years of Follow-Up
Rheumatoid Nonrheumatoid Statistical Significance (p)
VAS pain improvement (100-point scale) 48 points 54 points ns
QuickDASH improvement 20 points 21 points ns
Wrist extension, degrees 29 (þ2) 36 (À4) ns
Wrist flexion, degrees 29 (À3) 37 (À5) ns
Ulnar deviation, degrees 24 (þ7) 28 (þ2) ns
Radial deviation, degrees 5 (À1) 10 (À4) 0.015
Grip strength improvement (% of preoperative value) 40 19 0.033
ns, not significant; TWA, total wrist arthroplasty; VAS, visual analog scale.
Figure 2 Probability of implant survival in rheumatoid patients
(failure defined as revision).
Journal of Wrist Surgery
TWA: Prospective Multicenter Study Herzberg et al.

87. 87
about total wrist fusion for end-stage arthritic wrist. It cannot
be considered as a panacea for several reasons, both in
rheumatoid and non-RA destroyed wrists. Wrist fusion may
not provide optimal results in terms of daily activities as
personal hygiene care, combing, dressing, or if multiple upper
extremity joints are involved, or if there is bilateral wrist
involvement.13
A wrist fusion implies the loss of the syner-
gistic motion of wrist extension and long fingers flexion,
which is very important to provide a good prehension. Wrist
fusion may be followed by complications as hardware prob-
lems, secondary tendon ruptures, or carpal tunnel syn-
drome.14–16
The optimal position of the fusion for
prehension, that is, slight extension and ulnar deviation is
not always obtained.17
In some series of first generation total
wrist arthroplasties where rheumatoid patients had a fusion
on one side and a TWA on the other side, they almost always
preferred arthroplasty.18
In osteoarthritic patients, total wrist
fusion for end-stage destruction may leave a high percentage
of residual pain or substantial dysfunction.19,20
Little has been written regarding the results of the newest
resurfacing metal-polyethylene implants characterized by a
smaller size allowing for minimal bone resection. The series
are small and the follow-ups are still short or medium term.6,7
The only series with long-term follow-up showed a high
percentage of revisions.8
Our current preliminary short-
term results suggest that one last generation TWA may
have better outcomes that those reported on more limited
numbers of patients or old generation TWA. The results in
terms of pain are good and active motion is consistent with
functional wrist motion (30-degree extension, 5-degree flex-
ion, 15-degree ulnar deviation, and 10-degree radial devia-
tion) according to Palmer et al.21
The percentage of
radiological loosening was relatively low and similar in
rheumatoid and non-RA wrists (3 and 4%, respectively). The
significance of periprosthetic osteolysis without loosening is
unclear and needs further investigation. The overall revision
rate is lower than those previously reported. The current
survival rate of our study exceeds 90% at an average of 4 years
of follow-up, both in rheumatoid and non-RA wrists.
In comparison with the first generation metal-polyeth-
ylene TWA, our current results suggest a significant im-
provement in terms of survival rate for revision (►Table 2).
In comparison with the few articles6–8
reporting the results
of new generation TWA, our results are based on much
larger groups of patients, which allowed analyzing rheu-
matoid and non-RA wrists, separately, for the first time.
Indeed, these are very different categories of patients with
very different lives, prognoses, and functional needs. The
survival rates of these two groups were surprisingly high
and similar (►Table 3).
This study has limitations. It is a multicenter study, and the
current follow-up is only a midterm follow-up. The radio-
graphs were not gathered electronically and the radiological
criteria were based on surgeon’s judgment. This may have led
to slightly different interpretations. The strengths of this
study are the homogeneous recording into the database,
the automatic update of statistics, and the large number of
patients, which allows for the first time to individualize a
consistent non-RA group of patients.
Our study suggests that the ReMotion TWA is feasible in
the midterm and may be used in selected non-RA patients.
Our results need to be confirmed at a longer follow-up.
Table 2 Comparisons of Survival Rates between First and Last Generation TWA
Name of TWA Survival Rate for Revision
at Maximal Follow-Up
Cobb and Beckenbaugh22
Biaxial 83% at 10 years
Meuli23
Meuli 77% at 10 years
Takwale et al9
Biaxial 83% at 8 years
Krukhaug et al2
Biaxial 77% at 10 years
Current study ReMotion (new generation) 92% at 8 years
TWA, total wrist arthroplasty.
Table 3 Comparisons of Survival Rates within New Generation TWA Series
Ratio Rheumatoid/
Nonrheumatoid Etiologies
Survival Rate for Revision
at Average Follow-Up
Ward et al8
UTW1 24/0 60% at 7 years
Ferreres et al6
UTW2 14/7 100% at 5.5 years
Herzberg7
ReMotion 13/6 100% at 2.8 years
Current series ReMotion 129/86 RA: 96% at 4 years
Non-RA: 92% at 4 years
TWA, total wrist arthroplasty; UTW, Universal Total Wrist; RA, rheumatoid arthritis.
Journal of Wrist Surgery
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88. 88
Disclaimer
There was no conflict of interests from any of the authors
of this article.
References
1 Trail IA, Stanley JK. Total wrist arthroplasty. In: Gelberman RH, ed.
The Wrist. 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins;
2010:457–471
2 Krukhaug Y, Lie SA, Havelin LI, Furnes O, Hove LM. Results of 189
wrist replacements. A report from the Norwegian Arthroplasty
Register. Acta Orthop 2011;82(4):405–409
3 Rizzo M, Ackerman DB, Rodrigues RL, Beckenbaugh RD. Wrist
arthrodesis as a salvage procedure for failed implant arthroplasty. J
Hand Surg Eur Vol 2011;36(1):29–33
4 Harlingen D, Heesterbeek PJC, J de Vos M. High rate of complica-
tions and radiographic loosening of the biaxial total wrist arthro-
plasty in rheumatoid arthritis: 32 wrists followed for 6 (5–8) years.
Acta Orthop 2011;82(6):721–726
5 Cavaliere CM, Chung KC. A systematic review of total wrist
arthroplasty compared with total wrist arthrodesis for rheuma-
toid arthritis. Plast Reconstr Surg 2008;122(3):813–825
6 Ferreres A, Lluch A, Del Valle M. Universal total wrist arthroplasty:
midterm follow-up study. J Hand Surg Am 2011;36(6):
967–973
7 Herzberg G. Prospective study of a new total wrist arthroplasty:
short term results. Chir Main 2011;30(1):20–25
8 Ward CM, Kuhl T, Adams BD. Five to ten-year outcomes of the
Universal wrist arthroplasty in patients with rheumatoid arthritis.
J Bone Joint Surg Am 2011;93(10):914–919
9 Takwale VJ, Trail IA, Stanley JK. Biaxial total wrist replacements in
patients with rheumatoid arthritis. J Bone Joint Surg Br 2002;84
(5):692–699
10 Radmer S, Andresen R, Sparmann M. Wrist arthroplasty with a
new generation of prostheses in patients with rheumatoid arthri-
tis. J Hand Surg Am 1999;24(5):935–943
11 Radmer S, Andresen R, Sparmann M. Total wrist arthroplasty in
patients with rheumatoid arthritis. J Hand Surg Am 2003;28
(5):789–794
12 Herren DB, Simmen BR. Limited and complete fusion of the
rheumatoid wrist. J Am Soc Surg Hand 2002;2:21–32
13 Herzberg G. Management of bilateral advanced rheumatoid wrist
destruction. J Hand Surg Am 2008;33(7):1192–1195
14 Adams BD, Grosland NM, Murphy DM, McCullough M. Impact of
impaired wrist motion on hand and upper-extremity performance
(1). J Hand Surg Am 2003;28(6):898–903
15 De Smet L, Truyen J. Arthrodesis of the wrist for osteoarthritis:
outcome with a minimum follow-up of 4 years. J Hand Surg [Br]
2003;28(6):575–577
16 Meads BM, Scougall PJ, Hargreaves IC. Wrist arthrodesis using a
Synthes wrist fusion plate. J Hand Surg [Br] 2003;28(6):571–574
17 Barbier O, Saels P, Rombouts JJ, Thonnard JL. Long-term functional
results of wrist arthrodesis in rheumatoid arthritis. J Hand Surg
[Br] 1999;24(1):27–31
18 Trieb K. Treatment of the wrist in rheumatoid arthritis. J Hand Surg
Am 2008;33(1):113–123
19 Adey L, Ring D, Jupiter JB. Health status after total wrist arthrodesis
for posttraumatic arthritis. J Hand Surg Am 2005;30(5):932–936
20 Sauerbier M, Kluge S, Bickert B, Germann G. Subjective and
objective outcomes after total wrist arthrodesis in patients with
radiocarpal arthrosis or Kienböck’s disease. Chir Main 2000;19
(4):223–231
21 Palmer AK, Werner FW, Murphy D, Glisson R. Functional wrist
motion: a biomechanical study. J Hand Surg Am 1985;10(1):39–46
22 Cobb TK, Beckenbaugh RD. Biaxial total wrist arthroplasty. J Hand
Surg Am 1996;21(6):1011–1021
23 Meuli HC. Total wrist arthroplasty. Experience with a nonce-
mented wrist prosthesis. Clin Orthop Relat Res 1997;(342):77–83
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Paper
III
Can Total Wrist Arthroplasty Be an Option in the
Treatment of the Severely Destroyed
Posttraumatic Wrist?
Michel E. H. Boeckstyns, MD1 Guillaume Herzberg, MD, PhD2 Allan Ibsen Sørensen, MD3,4
Peter Axelsson5 Karsten Krøner, MD6 Philippe A. Liverneaux, MD, PhD7 Laurent Obert, MD, PhD8
Søren Merser, MD9
1 Section of Hand Surgery, Gentofte Hospital/University of
Copenhagen, Denmark
2 Wrist Surgery Unit, Department of Orthopaedics, Claude Bernard
Lyon University, Herriot Hospital, Lyon, France
3 Section of Hand Surgery, Sahlgrenska Hospital, Gothenburg, Sweden
4 Section of Hand Surgery, Rigshospitalet, Copenhagen, Denmark
5 Section of Hand Surgery, Sahlgrenska Hospital, Gothenburg, Sweden
6 Section of Hand Surgery, Aarhus University Hospital, Aarhus, Denmark
7 Hand Surgery Unit, Orthopaedic Department, Strasbourg University,
Strasbourg, France
8 Hand Surgery Unit, Orthopaedic Department, Besançon University,
Besançon, France
9 Technical University of Denmark, Lyngby, Denmark
J Wrist Surg 2013;2:324–329.
Address for correspondence Michel E. H. Boeckstyns, Kløverbakken
11, 2830 Virum, Denmark (e-mail: mibo@dadlnet.dk).
Total wrist arthroplasty (TWA) still remains a controversial
procedure. Early types of implants have given disappoint-
ing results: The first generation were silicone implants
whose risks included implant breakage, subsidence, and
silicone synovitis.1–3
The next generation of implants re-
quired extensive bone resection, which had implications if
Keywords
► total wrist
arthroplasty
► posttraumatic
► wrist arthritis
► wrist arthrosis
► prospective
Abstract Background Severely destroyed posttraumatic wrists are usually treated by partial or
total wrist fusion or proximal row carpectomy. The indications for and longevity of total
wrist arthroplasty (TWA) are still unclear.
Case Description The aim of this study was to analyze a series in which one last-
generation total wrist arthroplasty was used as a salvage procedure for wrists with
severe arthritis due to traumatic causes. The data were prospectively recorded in a web-
based registry. Seven centers participated. Thirty-five cases had a minimum follow-up
time of 2 years. Average follow-up was 39 (24–96) months. Pain had improved
significantly at follow-up, mobility remained unchanged. The total revision rate was
3.7%, and the implant survival was 92% at 4–8 years.
Literature Review Very few studies have described specific results after TWA in
posttraumatic cases and almost none using classical “third-generation” implants. The
number of cases and the follow-up in the published series are small.
Clinical Relevance Although painful posttraumatic wrists with severe joint destruction
can be salvaged by partial or total fusion, we found that, evaluated at short- to midterm,
total wrist arthroplasty can be an alternative procedure and gives results that are
comparable to those obtained in rheumatoid cases.
Level IV Case series
Copyright © 2013 by Thieme Medical
Publishers, Inc., 333 Seventh Avenue,
New York, NY 10001, USA.
Tel: +1(212) 584-4662.
DOI http://dx.doi.org/
10.1055/s-0033-1357759.
ISSN 2163-3916.
Scientific Article324
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90. 90
conversion to fusion was necessary. Moreover, fixation of
the distal component in the metacarpals was another
severe problem with these designs, often leading to subsi-
dence through the dorsal metacarpal cortices.4–6
The last
generation requires less bone resection and avoids meta-
carpal fixation,1,7
which could imply better and more
durable results. However, clinical documentation remains
modest because of limited numbers of patients or short
follow up.8–10
This is especially true in the case of wrists
with severe posttraumatic joint destruction. Carpal desta-
bilization after longstanding scaphoid nonunion (scaphoid
nonunion advanced collapse [SNAC] wrists), scapholunate
dissociation (scapholunate advanced collapse [SLAC]
wrists), or sequel of intraarticular distal radius fractures
is usually treated with partial or total fusion, and the
possibility of treating the advanced stages of these con-
ditions with TWA have not been investigated on a larger
scale. One recent study has demonstrated that results after
TWA in nonrheumatoid cases are comparable to those
obtained in rheumatoid arthritis,11
but without specific
data on posttraumatic cases, and thus the potential of TWA
in posttraumatic cases remains to be evaluated.
The purpose of this study was to report the results of a
multicenter series using one last-generation TWA in post-
traumatic cases. The questions to be answered were primarily
how TWA performs in patients with severe posttraumatic
wrist problems in terms of (1) patient-related outcome
measures, (2) objective measures, (3) radiological findings,
and (4) longevity of the implants.
Methods
The Re-Motion Total Wrist implant (Small Bone Innovation,
Morristown, PA) has a ball-and-socket design with a radial
and a carpal chromium-cobalt component that are titanium
coated. There is an intercalated polyethylene component
that primarily articulates with the radial component
but also has some articulation with the carpal plate
(►Fig. 1). The carpal plate is fixated to the carpus by its
stem and two screws, of which only the most radial
normally may penetrate the metacarpal for a very short
distance (►Fig. 2). Typically the procedure is done without
using cement.
In 2009 we created a web-based registry in which sur-
geons using the Re-Motion Total Wrist could enter prospec-
tively collected data. Seven participating centers that
contributed with at least 15 consecutive cases and regular
follow-up examinations were selected, and the data they had
entered in the registry were analyzed: preoperative data on
the etiology of wrist destruction, pain (0–100 on a visual
analogue scale [VAS]), function (0–100 according to the
QuickDASH questionnaire), active wrist motion, forearm
rotation and grip strength (with the JAMAR Dynamometer),
data concerning the operative procedure and complications,
Fig. 1 The Re-motion Total Wrist.
Fig. 2 X-ray view of the Re-motion Total Wrist (frontal view).
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91. 91
and data from the clinical follow-up examinations, performed
at 6 weeks, 6 months, and 1 year after the arthroplasty and
thereafter yearly without upper limit. The evaluation of the
surgeons regarding the position of the implants and the
presence of osteolysis, with or without loosening, made at
the annual postoperative follow-up examinations was noted,
loosening being assessed in terms of angulation or subsidence
on serial radiographs (posteroanterior [PA] and lateral views).
In the present study, only cases with a posttraumatic diagno-
sis were included, and only cases with minimum 2 years of
follow-up. Revision cases were excluded.
Statistics
Kaplan-Meier survival analysis was used to estimate the
cumulative probability of remaining free of revision (i.e.,
reoperation with total or partial removal of the implants).
A nonparametric Wilcoxon signed-rank test was used for data
not normally distributed (QuickDASH scores), and the
parametric Student’s t-test was used for normally distributed
data (range of motion, grip strength, and VAS scores). Signifi-
cance was set at a P-value of less than 0.05.
Results
At the time, when this analysis was performed, the seven
participating centers had included 253 cases. Of these, 54
were posttraumatic cases, and 35 of them had a follow-up
period of minimum 2 years. Our follow-up analysis is based
on these 35 cases, the demographics of which are listed
in ►Table 1. In all cases, the extent of joint destruction was
considered to exclude the possibility of performing partial
wrist fusion. The revision rate and the implant survival curve,
however, were calculated on the basis of all 54 cases in order
not to exclude possible early revisions.
The following complications were encountered: one case
of reflex sympathetic dystrophy and one case of carpal tunnel
syndrome. Mean follow-up time was 39 (24–96) months.
In ►Table 2, the clinical data before operation and at the latest
performed follow-up are shown.
Patient-Related Outcome Measures
There was an improvement of 42 points in VAS score (highly
significant) and of 14 points in QuickDASH-score (not
significant).
Objective Outcome Measures
Grip strength improved slightly (not significant). Motion was
not different at follow-up, except for improved rotation (not
significant) (►Table 2). This was not only the case for the
mean values, but also for the individual patients, There was a
direct correlation between preoperative motion and motion
at follow-up.
Radiological Findings
At final follow-up no signs of loosening (angulation, subsi-
dence, or any other change in position of the implants) were
reported. Some degree of osteolysis without loosening of the
implants was reported in six cases.
Longevity of the Implants
Two cases were revised. The total revision rate was thus 3.7%,
calculated as the percentage of all the 54 posttraumatic
wrists. One case was revised two and a half years after
operation due to malposition of the implants, causing painful
impingement. At revision all components were found solidly
fixated. The components were exchanged, but the radius had
to be decorticated widely, and fixation of the new radial
component failed. Ultimately the wrist was fused successful-
ly. In the other case the carpal component loosened and was
Table 1 Demographics
Age (mean and range) 63 (33–81) years
Gender (men/women) 17/18
Side (dominant/nondominant) 18/16
1 NA
Follow-up (mean and range) 3 (2–8)
Diagnosis 22 SNAC/SLAC
11 malunited distal
radius fractures
2 carpal fracture-
dislocations
Table 2 Clinical results at latest follow-up compared with
preoperative values
Mean values
and range
Significance
Pain (VAS 0–100)
Preoperative
Postoperative
65 (35–100)
23 (0–82)
p ¼ 0.0000018
Function
(QuickDASH 0–100)
Preoperative
Postoperative
47 (12–79)
33 (0–77)
p ¼ 0.33
Grip strength (kg)
Preoperative
Postoperative
18 (2–42)
22 (2–43)
p ¼ 0.29
Motion (degrees)
Extension
Preoperative
Postoperative
Flexion
Preoperative
Postoperative
Radial flexion
Preoperative
Postoperative
Ulnar flexion
Preoperative
Postoperative
Pronation
Preoperative
Postoperative
Supination
Preoperative
Postoperative
37 (0–70)
34 (0–80)
36 (0–70)
33 (0–80)
12 (0–35)
9 (0–25)
19 (0–52)
22 (0–46)
77 (30–90)
82 (60–90)
74 (10–90)
79 (45–90)
p ¼ 0.43
p ¼ 0.56
p ¼ 0.37
p ¼ 0.33
p ¼ 0.21
p ¼ 0.15
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92. 92
exchanged after 10 months. The implant survival curve
according to the Kaplan-Meier method shows an implant
survival rate of 92% at 4–8 years (►Fig. 3).
Discussion
Many destroyed posttraumatic wrist joints often are salvaged
by partial fusions, such as the four-corner procedure or the
radiocarpal fusion, and even in panarthritic wrists efficient
pain relief can often be obtained with total fusion. Patients
may accommodate well for the loss of motion,12
and a recent
systematic review of a large series of TWAs concluded that
there were no sufficient data to support the preference for
TWA over wrist fusion,13
but in that study only rheumatoid
wrist were considered. Nevertheless, total wrist fusion is not
always unproblematic and does not give uniformly good
results,14,15
and motion-preserving solutions must also be
sought for in cases where partial fusion is impossible because
of extensive damage of the cartilage. Little is known about the
results of TWA in general for the salvage of severely destroyed
wrists in posttraumatic conditions. Only one study of a
second-generation wrist implant (the Biax TWA) had a some-
what larger number of posttraumatic cases and reported a
high dislocation rate and revision rate.16
Levadoux and Legré
reported on 28 posttraumatic cases treated with a last
generation TWA (the Destot TWA) with a follow-up time of
3.9 (1–6) years. Results were good in terms of pain relief and
especially in terms of motion: extension-flexion, 89 degrees,
and radial-ulnar, 34 degrees.17
This implant is, however, no
longer available. Nydick et al have published a series of 23
cases in which the Maestro TWA was used, 13 being post-
traumatic. The follow-up time (0.3 to 4.6 years) is too short to
be informative on longevity.18
Reigstad et al reported 30 SLAC
and SNAC cases treated with the Motec TWA with a follow-up
time of 3.2 (1.1–6.1) years.19
That implant is a metal-on-metal
implant with uncemented fixation in the radius and the third
metacarpal. Motion was not reported in detail, but total wrist
motion was not statistically significantly different at follow-
up. Pain and Disabilities of the Arm, Shoulder, and Hand
(DASH) scores improved significantly. Grip strength was
significantly better at some of the annual follow-up exami-
nations. Periprosthetic radiolucency without prosthetic loos-
ening was seen at follow-up in 10% at the proximal and 7% at
the distal component. A report from the Norwegian Arthro-
plasty register stated less favorable longevity of this implant,
0.77 at 4 years, but that figure was the subject of a later
discussion, in which it was claimed that wrist implants had
been underreported in the registry, thus skewing the fig-
ures.20
A different concept is the Amandys pyrocarbon inter-
position arthroplasty, which was described by Bellemère et
al21
and by Pierrart et al,22
reporting quitefavorable results. In
their series there are several posttraumatic cases, but the
reports do not differentiate the results according to the
diagnoses (rheumatoid arthritis, osteoarthritis, posttraumat-
ic, and other), and follow-up time was very short. Cooney et al
published a series of 39 cases operated with 3 different
implants: the Biaxial, the Universal, and the Re-Motion. Ten
cases were posttraumatic. Motion at follow-up was stated to
be better in posttraumatic arthritis than in rheumatoid
arthritis but no further details were given concerning the
results in posttraumatic conditions.23
The question concerning the durability of TWA is very
important. Generally, posttraumatic patients are more active
than rheumatoid patients. From that point of view, one might
fear a lower longevity of TWA in these patients. On the other
hand, the bone quality as well as the soft tissue quality is
usually better. In the present study we have retrieved data
from an international registry.11
The number of cases is
relatively small and the follow-up time relatively short, but
large enough to show clinical results at short term that are
comparable to those obtained in rheumatoid patients, in
terms of both pain relief and the ability to return to activities
of daily living. The revision rate is comparable with what has
been published in other communications reporting on last-
generation TWA for rheumatoid arthritis,7,9–11,24,25
and the
survival curve compares with total elbow arthroplasty and
may be better than that of total ankle arthroplasty.26,27
The
implication of osteolysis without migration of the implants
that has been reported in several of our cases (and in other
series as well) is not clear. So far, we have no certain indication
of its causes and, despite the serial annual radiological
examinations that we performed, there are no indication of
its consequences in terms of longevity of the implants.
The method we have used for this analysis combines
aspects of a registry report with aspects of a conventional
prospective multicenter study. Its strength, compared with
single-center study, is that we are able to produce a larger
cohort and reflect the diversity of several specialized wrist
units in different countries rather than the results of a single
unit, which might be dependent on the specific opinion and
strategy of a single surgeon. The weakness is that (as in other
registry reports) there is a limit to how far the analysis can go
into details, since this is dependent on the number of criteria
Fig. 3 Implant survival curves according to the Kaplan-Meier method
with 95% confidence interval (log-type). Failure was defined as “revi-
sion with removal of implants.”
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93. 93
chosen to conduct the registry. Nevertheless, we believe that a
sufficient range of criteria has been selected to permit valid
conclusions.
We consider the Kaplan-Meier method for the analysis
of implant survival as a powerful tool in the evaluation of
the durability of TWA. The method makes it possible to
analyze data from patients with different lengths of follow-
up, taking into account dropouts for any reason.28
It has
been used for evaluation of implants in the hand and wrist
for many years.6,8,17,29
A disadvantage is the fundamental
assumption that patients who are lost to follow-up and
patients who have died have the same failure rate as those
who comply with regular follow-up examinations, which is
not necessarily true. However, there were no dropouts in
our series.
The most widely accepted and commonly used defini-
tion of failure in implant survival analysis is revision
(removal of implants). This endpoint has been criticized
because the criteria used to decide the need for removal
may vary between patients and surgeons, and sometimes it
is argued that other definitions should be considered. These
could be severe pain or the presence of radiolucency or
subsidence combined with moderate or severe pain. Yet
other definitions can be considered, but as yet there exist
no clear indicators of early loosening of TWA (i.e., before
subsidence is evident on plain radiographs) that can be
used for routine purposes, and it will remain difficult to
compare survival analyses until consensus is reached about
which other outcome measures should be used rather than
revision. In our study the decision to revise implants is
based on the judgment of several surgeons or units that
work independently, which is an advantage compared with
studies in which the decision is made by a single surgeon
and solely dependent on this person’s views. We have
demonstrated a favorable survival rate for the Re-Motion
TWA in posttraumatic diagnoses at 4–8 years, with some
revisions during the early years. This finding must be
interpreted correctly: The survival rate at the “tail” of the
curve is less reliable because of the small number of
patients with long follow-up, and it must be expected
that the incidence of revision will increase as the implants
inevitably wear out, which also is indicated by the number
of implants with signs of loosening at follow-up in this
study. For this reason we prefer to conclude cautiously that
the implant survival was 90% at four years and not to
make any assumptions beyond that.
It is not the intention of this article to advocate for the
general use of TWA for painful posttraumatic wrist de-
struction but merely, for the sake of general scientific
information, to report on the results we have obtained. In
many cases, partial wrist fusion or selective denervation
certainly remains the first-choice solution; if those ap-
proaches are not feasible, total wrist fusion also remains
an option.
Conflict of Interest
None
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80(4):472–477
28 Murray DW, Carr AJ, Bulstrode C. Survival analysis of joint replace-
ments. J Bone Joint Surg Br 1993;75(5):697–704
29 Boeckstyns ME, Sinding A, Elholm KT, Rechnagel K. Replacement of
the trapeziometacarpal joint with a cemented (Caffinière) pros-
thesis. J Hand Surg Am 1989;14(1):83–89
Journal of Wrist Surgery Vol. 2 No. 4/2013
Can TWA Be an Option in the Treatment of a Destroyed Wrist? Boeckstyns et al. 329
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IV
Acta Orthopaedica 2013; 84 (4): 415–419 415
Favorable results after total wrist arthroplasty
65 wrists in 60 patients followed for 5–9 years
Michel E H Boeckstyns1, Guillaume Herzberg2, and Søren Merser3
1Section of Hand Surgery, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; 2Wrist Surgery Unit, Department of Orthopedics, Claude
Bernard Lyon University, Herriot Hospital, Lyon, France; 3Informatics Statistical Consulting Centre at the Technical University of Denmark, Lyngby,
Denmark.
Correspondence MEHB: mibo@dadlnet.dk
Submitted 13-01-03. Accepted 13-05-06
Open Access - This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use,
distribution, and reproduction in any medium, provided the source is credited.
DOI 10.3109/17453674.2013.823588
Background and purpose During the past 40 years, several
attempts have been made with total wrist arthroplasty to avoid
fusion in severely destroyed wrists. The results have often been
disappointing. There is only modest clinical documentation due
to the small number of patients (especially non-rheumatoid cases)
and short follow-up times. Here we report a multicenter series
using a third-generation implant with a minimum follow-up time
of 5 years.
Methods In 2012, data were retrieved from a registry of consec-
utive wrist operations at 7 centers with units specialized in hand
surgery, between 2003 and 2007. The wrists had been reviewed
annually and analysis was done on the latest follow-up data.
Results 60 patients had been operated (5 bilaterally), 5 wrists
had been revised, and 52 were available for follow-up (with the
revised cases excluded). The pain scores, QuickDASH scores,
ulnar flexion, and supination for the whole group were statisti-
cally significantly better at follow-up. There were no statistically
significant differences between the rheumatoid and the non-rheu-
matoid patients except for motion, which was better in the non-
rheumatoid group. The motion obtained depended on the preop-
erative motion. Implant survival was 0.9 at 5–9 years.
Interpretation The clinical results in terms of pain, motion,
strength, and function were similar to those in previous reports.
The implant survival was 0.9 at 9 years, both in rheumatoid and
non-rheumatoid cases, which is an important improvement com-
pared to the earlier generations of total wrist arthroplasty.
■
During the last 40 years, several attempts have been made to
avoid fusion in severely destroyed wrists, to preserve motion.
The flexible silicone spacers used in the 1970s were mainly
used for rheumatoid wrists and, although early reports indi-
cated favorable results, later reports indicated that the pro-
cedure should be reserved for low-demand patients with
good bone stock and restricted motion, because of frequent
implant breakage and subsidence or osteolysis (Jolly et al.
1992, Lundkvist and Barfred 1992, Schill et al. 2001, Kistler
et al. 2005). The next generations of total wrist arthroplasty
(TWA) combined metal and polyethylene and they were dis-
tally fixated with pegs, pins, or screws in the metacarpals
(Dennis et al. 1986, Meuli and Fernandez 1995, Rahimtoola
and Hubach 2004, van Harlingen et al. 2011). The results
were disappointing. The third generation of wrist replace-
ments requires less bone resection and avoids metacarpal
fixation (Menon 1998, Herzberg 2011). However, clinical
documentation has been modest due to the limited num-
bers of patients (especially non-rheumatoid cases) or short
follow-up time (Divelbiss et al. 2002, van Winterswijk and
Bakx 2010, Ferreres et al. 2011, Herzberg 2011, Ward et al.
2011). The main issues that still have to be answered are:
what can be expected in terms of the longevity and what
should the indications be—rheumatoid arthritis, degenera-
tive arthritis, posttraumatic arthritis, low-demand patients,
or high-demand patients? We report on a multicenter series
using a third-generation implant, the Re-motion Total Wrist,
with a follow-up time of at least 5 years.
Methods
The Re-motion TWA is an elliptic ball and socket design con-
sisting of radial and carpal Cr-Co components that are tita-
nium-coated, and an intercalated polyethylene component that
mainly articulates with the radial component but also permits
a rotational articulation of 20 degrees with the carpal plate
(Figure 1). The carpal plate is fixated to the carpus by its stem
and 2 screws, of which only the most radial may penetrate the
metacarpal for a very short distance even though many advo-
cate not doing so (Herzberg 2011). Thus, fixation is mainly
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416 Acta Orthopaedica 2013; 84 (4): 415–419
aimed to be to the carpus and minimally in the metacarpals.
The fixation is often done without cement (Figure 2).
In 2009, we created a web-based registry in which surgeons
using the Re-motion Total Wrist could enter prospectively col-
lected data. Data were recorded on the etiology of wrist destruc-
tion, pre- and postoperative pain (0–100 on a visual analog
scale, VAS), function (0–100 according to the QuickDASH
questionnaire), active wrist motion, forearm rotation, and grip
strength (measured with the JAMAR dynamometer). Surgical
details and data concerning complications were also recorded.
Clinical follow-up examinations were performed at 6 weeks,
6 months, and 1 year after the operation and annually thereaf-
ter without any upper limit. In real time, users can generate a
detailed and updated statistics report online at no charge.
Radiographic examinations were performed on each of
these occasions and the evaluation of the surgeons regarding
the position of the implants and the presence of osteolysis
with or without loosening (change in position of the implants)
was noted.
In 2012, we retrieved data on consecutive wrists operated
between 2003 and 2007 at 7 centers with units specialized
in hand surgery: Gentofte Hospital, Denmark; Lyon Univer-
sity Hospital, France; Rigshospitalet, Denmark; Sahlgrenska
Sjukhuset, Sweden; Aarhus University Hospital, Denmark;
Strasbourg University Hospital, France; and Besançon Uni-
versity Hospital, France. Revisions were excluded.
Statistics
A Kaplan-Meier survival analysis was used to estimate the
cumulative probability of remaining free of revision (i.e. reop-
eration with total or partial removal of the implants). A non-
parametric Wilcoxon signed-rank test was used for data that
were not normally distributed (Quick DASH scores) and the
parametric Student t-test was used for normally distributed
data (range of motion, grip strength, and VAS scores) when
comparing rheumatoid patients and non-rheumatoid patients.
For comparison of data collected at follow-up with preop-
erative data, the paired t-test was used. Bilaterally operated
patients were included in the calculations with the first-oper-
ated wrist only to avoid possible statistical dependency prob-
lems. When comparing postoperative values with preoperative
values, the tests were used for paired data. Significance was
set at a p-value of less than 0.05.
Results
65 consecutive wrists had been operated in the period consid-
ered; 5 were bilateral (Table 1). In 49, one or several simultane-
ous procedures had been performed: 38 ulnar head resections,
19 tendon procedures, 3 ulnar head replacements (2 SBI, 1
Eclypse), 1 fusion of the first metacarpophalangeal joint, and
1 Nalebuff procedure on the thumb. Perioperative complica-
tions occurred in 5 cases: 2 crack fractures of the radius that
healed uneventfully, 1 carpal fracture, 1 partial tendon lacera-
tion, and 1 total tendon laceration. 2 patients developed carpal
tunnel syndrome during the early postoperative period. Carpal
Figure 1. The Re-motion TWA with the metallic radial and carpal com-
ponents and the intercalated polyethylene ball.
Figure 2. Frontal radiograph of the Re-motion TWA in a 75-year old
woman with primary osteoarthrosis.
Table 1. Patient demographics
Median age at operation (range) 58 (30–78)
Sex, men/women a 17/48
Side, dominant/non-dominant b 33/32
Median follow-up time (range), years 6 (5–9)
Diagnosis
Rheumatoid arthritis 50
Idiopathic osteoarthrosis (OA) 6
Posttraumatic arthritis 8
Kienboeck’s disease 1
a Numbers of wrists
b 5 were operated bilaterally
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Acta Orthopaedica 2013; 84 (4): 415–419 417
tunnel release was successful. There were no infections, dislo-
cations, or reflex sympathetic dystrophy.
5 cases were revised: 3 were fused, in 1 a total exchange of
implant components was done, and in 1 the carpal plate and
polyethylene ball were revised. The causes of revision were
loosening in 4 patients, 3 of whom (aged 56, 58, and 62 years)
suffered from rheumatoid arthritis and the other (aged 55)
having a posttraumatic condition. In the fifth patient (aged 55
years) who also had rheumatoid arthritis and almost no motion
preoperatively, the TWA was not loose but had stiffened in an
awkward position. Thus, no specific demographic cause could
be identified as a confounding factor for failure.
7 patients (8 wrists) did not join the late follow-up: 2 had
died, 3 were untraceable, and 2 could not participate for per-
sonal reasons. The late follow-up examination of the remain-
ing 52 wrists (with revised patients excluded) was performed
at an average of 6.5 (5–9) years after operation. None of the
wrists operated between 2003 and 2007 were missed in the
registration, but the QuickDASH was not available in Danish
Table 2. Clinical results at the latest follow-up (“Post”) compared to preoperative values (“Pre”). Mean values (SD), but median (range) for
QuickDASH
Rheumatoid cases Non-rheumatoid cases p-value a All cases p-value b
Pre Post Pre Post Pre Post
Pain (0–100 on VAS) 66 (20) 29 (26) 72 (12) 23 (38) 0.6 67 (17) 27 (29) 0.001
Grip strength (KgF) 9 (8) 14 (8) 16 (14) 19 (13) 0.3 10 (10) 15 (10) 0.03
QuickDASH (0–100) 61 (41–89) 41 (8–84) 41 (14–79) 50 (0–61) 0.5 58 (14–89) 42 (0–84) 0.001
Motion (degrees)
Supination 71 (22) 81 (13) 72 (35) 89 (4) 0.003 71 (25) 83 (12) 0.005
Pronation 71 (16) 80 (10) 82 (12) 85 (13) 0.3 79 (15) 81 (11) 0.5
Extension 27 (16) 28 (15) 43 (18) 43 (22) 0.06 30 (17) 31 (18) 0.8
Flexion 25 (21) 25 (16) 50 (19) 44 (23) 0.003 31 (23) 29 (19) 0.7
Radial 7 (11) 6 (8) 14 (8) 7 (5) 0.6 8 (11) 6 (8) 0.3
Ulnar 14 (8) 20 (14) 23 (14) 28 (16) 0.2 16 (11) 22 (14) 0.02
a Significance of differences between the rheumatoid cases and the non-rheumatoid cases at follow-up.
b Signifcance of differences between preoperative values and values at follow-up for the total sample.
Figure 3. Pain on Visual analogue scale before operation and at fol-
low-up. The dotted line represents equivalency.
Figure 4. QuickDASH-score before operation and at follow-up. The
dotted line represents equivalency.
before 2005. Thus, the preoperative QuickDASH was miss-
ing in 24 cases. The pain scores on VAS, QuickDASH scores,
ulnar flexion, and supination for the whole group were statisti-
cally significantly better at follow-up. There were no statisti-
cally significant differences between the rheumatoid patients
and the non-rheumatoid patients except for motion: supination
and flexion were better in the non-rheumatoid group (Table 2).
Almost all patients had a statistically significantly lower pain
score and QuickDASH score at follow-up (Figures 3 and 4).
There was a positive correlation between motion before opera-
tion and motion at follow-up (Figure 5).
In 6 cases, there were radiographic signs of implant loosen-
ing (subsidence or tilting): 5 carpal plates and 1 radial com-
ponent (5 rheumatoid, 1 idiopathic osteoarthrosis (OA)). In
11 other cases, osteolysis without any loosening of implant
components was reported: 3 carpal alone, 7 radial alone, and 1
radial and carpal (8 rheumatoid, 3 posttraumatic).
Implant survival (no implant removal) based on all 65 wrists
was 0.9 at 9 years (Figure 6). According to the principles of
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418 Acta Orthopaedica 2013; 84 (4): 415–419
Kaplan-Meier survival calculations, the cases lost to follow-
up were censored, assuming that the survivorship in the group
lost to follow-up was the same as in the remaining group. The
survival curves were identical in the rheumatoid group and in
the non-rheumatoid group.
Discussion
The role of TWA is debated: efficient pain relief can be
obtained with total fusion and patients may accommodate
well for the loss of motion (Murphy et al. 2003). A recent sys-
tematic review of the literature, covering 503 TWAs and 860
The clinical results in terms of pain, motion, strength, and
function in our series are similar to those in previous reports.
Moreover, we found that the motion that could be obtained
depended on the preoperative motion and it did not change
significantly, either clinically or statistically, except for supi-
nation and ulnar flexion. The improvement in supination is
probably due to additional procedures performed on the ulnar
head. As in other series, most of our patients had rheuma-
toid arthritis; such patients were mainly operated in the early
years.
The strength of our series was the longer observation time,
minimum 5 years. The implant survival was 0.9 after 9 years,
in both rheumatoid and non-rheumatoid cases, which is an
important improvement over the earlier generations of metal-
polyethylene TWA (Cobb and Beckenbaugh 1996, van Har-
lingen et al. 2011). The most probable explanation for this
improvement in implant survival is that fixation of the carpal
component does not rely on stems inserted in the metacarpals.
Indeed, loosening of the carpal component was a major prob-
lem in the earlier implants. Of the 52 “surviving” implants in
our series, 6 showed signs of loosening on radiographs. The
treating surgeons had not considered that revision was indi-
cated, mainly because the patients did not suffer severe pain—
or any pain at all. Even so, implant survival would be expected
to decrease in the years to come. Even if the implant survival
curve would decline after 9 years, the implant survival in our
series is still comparable to the implant survival after total
elbow arthroplasty and total ankle arthroplasty, which are
more commonly used and less debatable procedures (Fevang
et al. 2007, 2009, Skytta et al. 2009, 2010).
Figure 5. Motion before operation and at follow-up. The dotted line represents equiva-
lency.
Figure 6. Implant survival curve with CI.
wrist fusions, concluded that there were insuffi-
cient data to support the preference of TWA over
wrist fusion in the severely destroyed rheumatoid
wrist (Cavaliere and Chung 2008). These data
were mainly based on older-generation metal-
polyethylene implants with metacarpal fixation
of the distal component (Biaxial-, Trispherical,
CVF, and RWS prostheses).
Some reports on the latest generation of TWA
have described favorable results using the Re-
motion Total Wrist (Herzberg 2011, 20 cases)
or the Universal Total Wrist (van Winterswijk
and Bakx 2010, 17 cases; Ferreres et al. 2011,
22 cases). On the other hand, the series pub-
lished by Ward et al. (2011) with 24 Universal
wrist implants had a survival rate of only 0.4 at
10 years. These small series include rheumatoid
patients almost exclusively. An analysis per-
formed on cases with a shorter observation period
(2–8 years) from the same registry as in our series
had a more substantial number of non-rheumatoid
cases (Herzberg et al. 2012) and showed similar
clinical results in rheumatoid and non-rheumatoid
cases.
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Acta Orthopaedica 2013; 84 (4): 415–419 419
As in other registry reports, the details of analysis depend
on the data included in the registry. Thus, a reliable analysis of
periprosthetic osteolysis, as seen in routine plain radiographs,
was not possible since no precise guidelines for evaluation of
osteolysis were given to the surgeons. In the literature, oste-
olysis or radiolucency with or without prosthetic loosening
has often been reported. In a series of 40 Biaxial TWAs, 32
of which joined a follow-up examination, 22 showed possible
radiographic signs of loosening. In 12 of these, a periprosthetic
radiolucent zone of at least 2 mm was present in frontal plain
radiographs (mean follow-up time 6 years) (van Harlingen et
al. 2011). Rizzo and Beckenbaugh (2003) analyzed a series
of 17 Biaxial TWAs with a modified (long) metacarpal stem.
There were radiolucent zones in 4 of 17 cases with a mean
follow-up time of 6 years, without other signs of implant loos-
ening. Takwale et al. (2002) re-examined 76 Biaxial TWAs
with a mean follow-up time of 4 years. Implant survival was
0.86 and 14 more cases showed radiographic signs of pros-
thetic loosening, but it was not reported whether osteolysis
was associated with subsidence or angulation of the implant
components. Ferreres et al. (2011) reported 2 cases of osteoly-
sis or prosthetic loosening in a series of 21 Universal TWAs
3–8 years after operation. Ward et al. (2011) published a series
of 24 cemented Universal I TWAs in rheumatoid patients. Of
the 19 patients with a follow-up time of more than 5 years,
9 had been revised because of loosening of the carpal com-
ponent. Polyethylene wear has been mentioned as a possible
cause of osteolysis, but in our opinion no definite proof has
been given for this assumption.
MB: planning of the study, interpretation of data analysis, and writing. SM:
planning of the study, computation of data, and constructive comments. GH:
planning of study and constructive comments.
We thank the following surgeons for contributing data: Dr. Allan Ibsen
Sørensen and Dr. Peter Axelsson, Gothenburg; Prof. Laurent Obert, Besan-
çon; Prof. Philippe Liverneaux, Strasbourg; and Dr. Karsten Krøner, Aarhus.
No competing interests declared.
Cavaliere C M, Chung K C. A systematic review of total wrist arthroplasty
compared with total wrist arthrodesis for rheumatoid arthritis. Plast Recon-
str Surg (Comparative Study Review). 2008; 122 (3): 813-25.
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1996; 21 (6): 1011-21.
Dennis D A, Ferlic D C, Clayton M L. Volz total wrist arthroplasty in rheuma-
toid arthritis: a long-term review. J Hand Surg 1986; 11 (4): 483-90.
Divelbiss B J, Sollerman C, Adams B D. Early results of the Universal total
wrist arthroplasty in rheumatoid arthritis. J Hand Surg 2002; 27 (2): 195-
204.
Ferreres A, Lluch A, Del Valle M. Universal total wrist arthroplasty: midterm
follow-up study. J Hand Surg 2011; 36 (6): 967-73.
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ankle arthroplasties performed in Norway between 1994 and 2005. Acta
Orthop 2007; 78 (5): 575-83.
Fevang B T, Lie S A, Havelin L I, Skredderstuen A, Furnes O. Results after
562 total elbow replacements: a report from the Norwegian Arthroplasty
Register. J Shoulder Elbow Surg 2009; 18 (3): 449-56.
Herzberg G. Prospective study of a new total wrist arthroplasty: short term
results. Chir Main 2011; 30 (1): 20-5.
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33 (3): 198-206.
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arthroplasty in rheumatoid arthritis: a population-based study from the
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ankle replacement: a population-based study of 515 cases from the Finnish
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100. 100
Paper
V
Periprosthetic Osteolysis after Total Wrist
Arthroplasty
Michel E. H. Boeckstyns, MD1 Guillaume Herzberg, MD, PhD2
1 Gentofte Hospital, University of Copenhagen, Copenhagen,
Denmark
2 Wrist Surgery Unit, Department of Orthopedics, Claude Bernard Lyon
University, Herriot Hospital, Lyon, France
J Wrist Surg 2014;3:101–106.
Address for correspondence Michel E.H. Boeckstyns, MD, Hand
Surgery Clinic, Gentofte Hospital, Niels Andersens Vej 65, DK 2900,
Denmark (e-mail: mibo@dadlnet.dk).
Periprosthetic osteolysis (PPO) is a biologic process of bone
resorption, seen as radiolucent lines or areas on radio-
graphs. It has been well described after total joint replace-
ment, mostly in the hip. Its causes are multifactorial, and it
is supposed that the occurrence of debris, especially poly-
ethylene, may play an important role.1,2
A correlation
between polyethylene wear and implant loosening has
been found in several clinical studies,3
and it is documented
that polyethylene wear is diminished by the use of highly
cross-linked polyethylene.4,5
Furthermore, it is well known
that some patients develop focal PPO without implant
loosening.6
In a recent study, based on data retrieved from the
International RE-MOTION Register, it was brought to light
that PPO may occur frequently after total wrist arthroplasty
(TWA): signs of implant loosening were reported in 6 of 52
cases (11%) seen at follow-up 5–9 years after operation and
PPO without implant loosening in another 11 cases (21%),7
but these figures were only estimates, because it was left to
the judgment of the surgeons who contributed to the register
Keywords
► wrist
► arthroplasty
► osteolysis
► radiolucency
Abstract Background and Literature Review Periprosthetic osteolysis (PPO) after second- or
third-generation total wrist arthroplasty (TWA), with or without evident loosening of the
implant components, has previously been reported in the literature, but rarely in a
systematic way.
Purpose The purpose of this study was to analyze the prevalence, location, and natural
history of PPO following a TWA and to determine whether this was associated with
prosthetic loosening.
Patients and Methods We analyzed 44 consecutive cases in which a RE-MOTION TWA
(Small Bone Innovations Inc., Morrisville, PA, USA) had been done.
Results We found significant periprosthetic radiolucency (more than 2 mm in width)
at the radial component side in 16 of the cases and at the carpal component side in 7. It
developed gradually juxta-articularly around the prosthetic components regardless of
the primary diagnosis, and seemed to stabilize in most patients after 1–3 years. In a
small percentage of the patients, the periprosthetic area of bone resorption was
markedly larger. In general, radiolucency was not related to evident loosening of the
implant components, and only five carpal components and one radial had subsided or
tilted.
Conclusion Periprosthetic loosening is frequent following a TWA. In our series it was
not necessarily associated with implant loosening and seemed to stabilize within 3 years.
Close and continued observation is, however, recommended.
Level of Evidence Therapeutic IV
Copyright © 2014 by Thieme Medical
Publishers, Inc., 333 Seventh Avenue,
New York, NY 10001, USA.
Tel: +1(212) 584-4662.
DOI http://dx.doi.org/
10.1055/s-0034-1372532.
ISSN 2163-3916.
Scientific Article 101
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101. 101
whether PPO was considered present or not. Moreover, no
attempt was made to quantify the magnitude of PPO.
The purpose of this study was to analyze the prevalence,
location, and natural history of PPO following a TWA and to
determine whether this was associated with prosthetic
loosening.
Materials and Methods
We included radiographs of consecutive patients operated in
two wrist centers performing a TWA using the RE-MOTION
prosthesis (Small Bone Innovations Inc., Morrisville, PA, USA)
on a regular basis. In these centers, we routinely followed the
patients with annual clinical and radiographic examinations,
including standard posteroanterior and lateral views of
the wrist after a TWA. The mean follow up was 3.7 years
(2–6 years). We excluded patients with less than 2 years
follow-up and cases that had been revised with removal of
implant components for other reasons than loosening. De-
mographics are shown in ►Table 1.
We defined radiological spots for the measurement of
radiolucency on digitalized posteroanterior (PA) radiographs
(►Fig. 1) and measured the maximal width of the radiolucent
zones at these spots, perpendicular to the surface of the
implant components, using Sectra measurement software
(Sectra AB, Linköping, Sweden). Both authors performed
the measurements together, one measurement for each
spot. We calculated the average of the measurements at
zones 1–3, 4–5, 6–8, and 9–10. For example, if the maximal
width at location 4 was 3 mm and it was 4 mm at location 5,
this would be recorded as an average width of 3.5 mm at zone
4–5. For each patient, we plotted these figures as a function of
time.
Furthermore, we measured the angle between the radial
component and the long axis of the radius, as well as the angle
between the carpal peg and the axis of the third metacarpal.
Finally, we measured the distance between the tip of the
radial implant and the tip of the radial styloid, as well as the
distance between the tip of the carpal peg and the third
carpometacarpal (CMC) joint space. We defined frank loos-
ening of the components as increasing angulation or subsi-
dence over time, based on these measurements.
Results
Forty-four cases fulfilled the inclusion and exclusion criteria.
The width of radiolucency in zone 1 averaged 0.05 mm
(range 0–1), and 0.17 mm in zone 6 (range 0–3.4) respectively,
indicating minimal radiolucency at the extremities of the
Table 1 Demographics of 44 patients
Mean age and range at operation 59.7 (34–84)
Sex 12 male, 32 female
Mean follow-up time and range 3.7 (2–6) years
Diagnosis
• Rheumatoid arthritis 21
• Idiopathic osteoarthritis 10
• Posttraumatic arthritis after
distal radius fracture
4
• SLAC wrist (scapholunate
advanced collapse)
3
• Miscellaneous (Kienböck,
Madelung)
2
• Revision of failed TWA 4
Fig. 1 Spots for the measurement of the width of radiolucency on
serial PA radiographs.
Fig. 2 Radiolucency 5 years after TWA: There is pronounced radio-
lucency near the joint but no radiolucent zones at the extremities of
the components. Neither was there subsidence or progressive angu-
lation of the implant.
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102. 102
components. By contrast, the width averaged 2.0 (range
0–9) mm at zone 4–5 and 1.0 (range 0–7) mm at zone 9–10,
indicating that radiolucency mainly developed juxta-articu-
larly (►Fig. 2).
A total of 26 of the 44 patients (59%) had radiolucency of
2 mm or less in zones 4–5, while 37 of 44 patients had
radiolucency of less than 2 mm in zones 9–10 (84%). In 15
patients (34%) the radiolucency was between 2 and 4 mm at
zone 4–5 and in four patients at zones 9–10 (9%).
►Fig. 3a, b shows the development of radiolucency at the
juxta-articular spots in function of time for each
patient: ►Fig. 3a shows zones 4–5 and ►Fig. 3b shows zones
9–10. In the cases in which the radiolucency was 2 mm or less
(mean of zones 4–5, ►Fig. 3a) this seemed to remain stable
over time. In 14 cases radiolucency at zones 4–5 increased
slowly to 2–3 mm and stabilized after 3–4 years. In two cases
radiolucency at zones 4–5 developed more dramatically dur-
ing the first 2 years, although not causing angulation or
subsidence of the radial implant. ►Fig. 4a–c shows an example
of this phenomenon. At zones 9–10, a total of seven patients
(16%) had a radiolucency of more than 2 mm at some time
during the observation period (►Fig. 3b). In two cases the
width of radiolucency increased at first but later decreased, as
the carpal plate sank into the osteolytic area. The radiographs
of the other five patients did not show any subsidence.
Conversely, there were three other patients with subsidence
who did not develop a radiolucency of 2 mm or more. In these
cases no radiolucent line appeared because the zone of bone
resorption collapsed gradually, as the carpal component sank
in the osteolytic area (►Fig. 5a, b). The number of patients was
too small to draw any conclusions between rheumatoid and
nonrheumatoid cases (►Table 2).
Fig. 3 (a) Width of radiolucent zones at zone 4–5 in function of time. Each line represents a single case. X-axis: length of follow-up in years. Y-axis:
Width of radiolucency in mm. (b) Width of radiolucent zones at zone 9–10 in function of time. Each line represents a single case. X-axis: length of
follow-up in years. Y-axis: Width of radiolucency in mm. The arrows indicates a maximal width of radiolucency under the carpal plate at 2 years
after operation in this particular case (6.2 mm), and at 4 years, where the radiolucent zone was reduced to almost 0 mm, as the carpal plate sank
into the carpus
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103. 103
Evident loosening of implant components, defined as pro-
gressive angulation or subsidence, was seen in 6 out of 44 cases
(14%): five carpal components, one radial. Subsidence was seen
in six cases: Radial subsidence started to be visible at 2 years in
one patient, carpal subsidence at 2 years in three patients, at
3 years in one patient, and at 4 years in one patient.
Discussion
PPO after second- or third-generation total wrist arthroplasty
(TWA), with or without frank loosening of the implant
components, has previously been reported in the literature,
but rarely in a systematic way.8–24
Eight studies reported
osteolysis without evident loosening of the implants.
Cobb and Beckenbaugh analyzed a consecutive series of 64
Biaxial TWAs systematically, with a follow-up time of 5–9
years (average 6.5).25
In 12 out of 46 wrists (26%), there was
progressing radiolucency at the carpal component, seven of
which were revised (15%). Subsidence of the carpal compo-
nent was present in seven cases after 1 year and in 20 (43%)
cases at final follow-up.
Groot et al published a case with PPO 11 years after
implantation of a Biax implant, in which macrophages con-
taining polyethylene and metallic particles were found at the
histopathological examination.26
Ward et al have followed 24 rheumatoid wrists with a
cemented Universal I TWA. Among the 19 cases with a follow-
up time of more than 5 years, nine had been revised due to
loosening of the carpal component. The authors stated that
there was polyethylene wear and metallosis in all these
cases.21
Similar osteolysis has been reported using metal-on-metal
implants as well. Radmer et al reviewed APH implants, which
are titanium-coated at the articular surfaces, without inter-
calated polyethylene.8
Follow-up period was 52 months
(range, 24–73). Radiolucent lines larger than 2 mm were
present in 30 of 36 patients (83%), including 30 on the
metacarpal side and 5 on the radial side. Reigstad et al
reported focal osteolysis in the radius around a metal-on-
metal implant in three patients without affecting the clinical
outcome, the largest including most of the radial styloid,
which stabilized after one year.16
Bone resorption has also been observed frequently after
ulnar head replacement, in which no artificial components
Fig. 4 (a) 6 weeks after TWA. Bone grafting was performed ulnarly under the radial component. Because of considerable resection of the carpal
bones, the ulnar screw and the central carpal peg cross the CMC joint. No periprosthetic osteolysis. (b) The patient had gradually developed a
growing radiolucency in zones 4 and 5, here shown at 4 years after operation. The annual radiographs did not reveal any angulation or subsidence
of the radial component. Radiolucency is also present around the carpal component, including the peg and the screws. (c) A computed
tomography (CT) scan 4.5 years after operation confirms periprosthetic osteolysis distally around the radial component but no loosening of this
component more proximally. Seemingly, there is a narrow radiolucent line around the extremity of the radial component away from the wrist joint,
but this is an artifact created by the O-MAR software. On the other hand, there seems to be a radiolucent area around the screws.
Fig. 5 (a) 6 weeks after operation. The carpal peg does not penetrate
the third CMC joint. (b) Same case as in a, 2 years after operation. The
carpal plate has sunk in the carpal bones and the carpal peg penetrates
the third metacarpal.
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104. 104
articulate with each other. This resorption seems to stabilize
after 6–12 months and is ascribed to stress shielding.27,28
In our series, juxta-articular radiolucency larger than
2 mm was seen in 18 of 44 cases (41%), in 11 at the radial
side only, in two at the carpal side only, and in five at both
sides: In some patients it was visible already 1 year after
operation, while in other patients it did not appear at all, even
6 years after operation (►Figs. 3a, b). We attempted to treat
one of the cases that developed radiolucency without loos-
ening of the implant, by bone grafting, because this rheuma-
toid patient presented with an increasing cystic ganglion at
the dorsum of the wrist. Radiolucency recurred within 2 years
(►Fig. 6a–c). No samples were collected for histopathological
examination in this case. The main strength of our study is
that we have followed a consecutive group of patients with
annual radiographical examinations,. We were able to answer
the questions formulated in the introduction of this paper
with reasonable validity. We found significant periprosthetic
radiolucency, more than 2 mm in width, relatively frequent-
ly: at the radial component side in 36% of the cases and at the
carpal component side in 16%. It developed gradually juxta-
articularly around the prosthetic components during the first
years after operation, regardless of the primary diagnosis, and
seemed to stabilize in most patients after 1–3 years at a level
of a few mm. In a small percentage of the patients, the
periprosthetic area of bone resorption was markedly larger.
This number of patients is too small to indicate clearly
whether it stabilizes after 2–3 years or is continuously
progressing. On the other hand, radiolucency did not at all
develop at the extremities of the components to the same
extent as near the joint and in general was not clearly related
to evident loosening (angulation or subsidence over time):
only one radial component was loose at latest follow-up, and
only two of the carpal implants with major periprosthetic
bone resorption had subsided. Weaknesses of this study
include the fact that the examiners were not blinded and
there was no calculation of intraobserver agreement. We did
not perform histology to rule out osteolysis possibly due to
polyethylene wear particles.
Our data, based on a single metal-on-polyethylene im-
plant, do not allow us to draw any conclusion on the possible
causes of bone resorption without implant loosening. From
the literature cited above, several possible mechanisms could
play a role: metallic or polyethylene-induced osteolysis or
stress-shielding. The mere simultaneous occurrence of debris
and radiolucency is not in itself a proof of a causal relationship
between these two phenomena. Further investigations are
necessary to elucidate the question. It is difficult to infer any
practical consequence of our findings for the time being. So
far, we have adopted the policy of not revising implants with
PPO in patients who did not have pain. Our single case that
was bone-grafted and in which the PPO recurred rapidly does
not prompt us to recommend this procedure. We are inclined
to recommend close observation of these cases, at least until
it is clear whether they stabilize or continue to progress,
which increases the chances of implant loosening.
Table 2 Width of radiolucent zone at zones 4–5 and zones 9–10 in different diagnostic groups
Width of radiolucency
at zone 4–5
(mean of zones 4 and 5)
Width of radiolucency
at zone 9-10 (mean of
zones 9 and 10)
Rheumatoid 2.1 mm 0.8 mm
Nonrheumatoid 1.7 mm 0.8 mm
Fig. 6 (a) Periprosthetic radiolucency, confined to the juxta-articular periprosthetic areas, 6 years after TWA. (b) Same case as in a, after bone
grafting under the carpal plate. (c) Recurrent radiolucency under the carpal plate 2 years after bone grafting. No subsidence.
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105. 105
Acknowledgment
We would like to acknowledge Dr. Marion Burnier, Lyon,
for her assistance with the radiologic evaluation.
Conflict of Interest
None
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Paper
VI
SCIENTIFIC ARTICLE
Wear Particles and Osteolysis in Patients With
Total Wrist Arthroplasty
Michel E. H. Boeckstyns, MD, Anders Toxvaerd, MD, Manjula Bansal, MD, Lars Soelberg Vadstrup, MD
Purpose To determine whether the amount of polyethylene debris in the interphase tissue
between prosthesis and bone in patients with total wrist arthroplasty correlated with the degree
of periprosthetic osteolysis (PPO); and to investigate the occurrence of metal particles in the
periprosthetic tissue, the level of chrome and cobalt ions in the blood, and the possible role of
infectious or rheumatoid activity in the development of PPO.
Methods Biopsies were taken from the implantebone interphase in 13 consecutive patients
with total wrist arthroplasty and with at least 3 years’ follow-up. Serial annual radiographs
were performed prospectively for the evaluation of PPO. We collected blood samples for
white blood cell count, C-reactive protein, and metallic ion level.
Results A radiolucent zone of greater than 2 mm was observed juxta-articular to the radial
component in 4 patients and at the carpal component in 3. The magnitude of the radiolucent
zone tended to level out over time. We observed subsidence of the implant in 3 patients on the
carpal side and in none on the radial side. The amount of polyethylene and metallic debris was
generally small and did not correlate with the width of the radiolucent zone. The blood levels of
chrome and cobalt ions were normal. There was no evidence of infectious or rheumatoid activity.
Conclusions Polyethylene wear has been accepted as a major cause of osteolysis in total hip
arthroplasty, and metallic debris has also been cited to be an underlying cause. However,
our hypothesis that polyethylene debris correlated with the degree of PPO could not be
confirmed. Also, metallic debris and infectious or rheumatoid activity did not correlate
with PPO. (J Hand Surg Am. 2014;39(12):2396e2404. Copyright Ó 2014 by the American
Society for Surgery of the Hand. All rights reserved.)
Type of study/level of evidence Prognostic I.
Key words Wrist arthroplasty, osteolysis, histopathology, interphase.
P
ERIPROSTHETIC OSTEOLYSIS (PPO) is a biological
process of bone resorption seen as radiolucent
lines or areas on radiographs. Polyethylene wear
has been accepted as a major cause of osteolysis in
total hip arthroplasty. Particles, which occur because of
abrasive wear, are considered to stimulate a foreign
body response resulting in bone loss mainly mediated
by macrophages that lead through complex cellular
interactions to the recruitment and activation of
osteoclasts.1e3
Metallic debris has also been cited as an
underlying cause, and abnormal chrome (Cr) and cobalt
(Co) levels in blood can be found in patients with metal-
on-metal total hip arthroplasty.4e7
Osteolysis may be
silent, and loosening of the implants may be incomplete
From the Clinic of Hand Surgery, Gentofte Hospital, and the Department of Pathology, Herlev
Hospital, University of Copenhagen, Denmark; and the Department of Pathology, Hospital for
Special Surgery, New York, NY.
Received for publication May 14, 2014; accepted in revised form July 23, 2014.
M.E.H.B. received support from Gentofte Hospital, Clinic for Hand Surgery.
No benefits in any form have been received or will be received related directly or indirectly
to the subject of this article.
Corresponding author: Michel E. H. Boeckstyns, MD, Clinic of Hand Surgery, Gentofte
Hospital, University of Copenhagen, Niels Andersens Vej 65, 2900 Hellerup, Denmark;
e-mail: mibo@dadlnet.dk.
0363-5023/14/3912-0007$36.00/0
http://dx.doi.org/10.1016/j.jhsa.2014.07.046
2396 r Ó 2014 ASSH r Published by Elsevier, Inc. All rights reserved.

107. 107
with the implant remaining steadily anchored in the
bone.3
Periprosthetic osteolysis with or without complete
loosening occurs in other joints as well and has been
frequently reported after total wrist arthroplasty
(TWA).8e13
Since 2003, we have been using the
Re-motion TWA (SBI, Inc, Morrisville, PA) as an
alternative to total wrist arthrodesis for the recon-
struction of severely destroyed and painful wrists.
This implant contains an articular component made of
conventional polyethylene that articulates with a
metallic CreCo component.
Our hypothesis was that the occurrence of poly-
ethylene debris in the interphase tissue between
prosthesis or cement and bone was correlated with
the degree of PPO. A secondary aim of the study was
to investigate the occurrence of metal particles in the
periprosthetic tissue, the level of Cr and Co ions in
the blood of patients, and the possible role of infec-
tious or rheumatoid activity in the development of
PPO.
MATERIALS AND METHODS
Ethics
The study conformed to the ethical guidelines of the
1975 Helsinki Declaration. The Scientific Ethical
Committee for the Capital Region in Denmark
approved the study (Study H-2-2013-032). We ob-
tained written informed consent from all patients.
Selection of patients
Re-motion TWA is an elliptical ball and socket
design consisting of radial and carpal CreCo com-
ponents that are titanium coated and an intercalated
polyethylene ball. It mainly articulates with the radial
component in an unconstrained link but also permits
a rotational articulation of 20
with the carpal plate. It
requires minimal bone resection and is designed to
act much like a surface replacement. The carpal plate
is fixated to the carpus by its stem and 2 screws. The
polyethylene in the carpal ball is of a conventional,
not highly cross-linked type. All patients in whom a
Re-motion TWA was implanted at Gentofte Hospital,
Denmark, between September 2003 and April 2010
(21 patients) were eligible for this study.
We excluded wrists that had been revised to a new
TWA or arthrodesis (3 patients), those who were
unable to participate for geographical reasons (2 pa-
tients), those who had not given informed consent
(1 patient), those with conditions that contraindicated
the surgical procedure (one patient: recent ipsilateral
shoulder fracture), and those who were already
included with the contralateral wrist (one patient).
Thus, 13 patients were included. Table 1 shows the
demographics. We obtained tissue samples from the
implantebone or implantecementebone interphase,
collected blood samples, obtained plain x-ray exam-
inations, and updated the clinical status in June 2013.
Surgical procedure
We used Bier block for anesthesia, made a 2- to 3-cm
straight incision in the existing dorsal surgical scar,
and approached the dorsal wrist capsule between the
third and fourth extensor compartments. Through
windows in the capsule we collected samples from the
soft tissue surrounding the implant for bacteriological
cultures. From the dorsal interphase area between the
radial component and the radius and from the inter-
phase area between the carpal plate and the carpus, we
collected tissue samples for histopathological exami-
nation. In one patient we also collected tissue under an
ulnar head component; but to avoid a potential con-
founding influence, we did not include this in the an-
alyses aimed at testing our hypothesis. We closed the
wound with resorbable sutures in the capsule and
nonresorbable sutures in the skin. Patients were
allowed to mobilize the wrist without delay.
Histopathological examination
After fixation in 10% buffered formaldehyde all tissue
samples were sectioned and embedded in paraffin.
Sections cut at 2 mm thickness were prepared, stained
with hematoxylineeosin, and examined by light and
polarized microscopy. The amount of foreign body
particles was graded semi-quantitatively from 0 to 3, in
which 0 represented no particles; 1, particles present
but hard to find; 2, no problem in identifying particles;
and 3, a marked amount of particles as seen on
TABLE 1. Demographics of the 13 Patients
Included
Age, y (mean [range]) 68 (53e87)
Sex 2 male, 11 female
Mean follow-up, y
(mean [range])
6 (3e10)
Diagnosis
Rheumatoid arthritis 6
Idiopathic osteoarthritis 4
Posttraumatic arthritis 3
Fixation technique 2 cemented, 11 not cemented*
*Cemented fixation was used when the bone was considered too
fragile to support uncemented implant components.
WEAR PARTICLES AND OSTEOLYSIS AFTER TOTAL WRIST ARTHROPLASTY 2397
J Hand Surg Am. r Vol. 39, December 2014

108. 108
high-field magnification. Two pathologists (AT and
MBa) blinded to the study protocol, who had experi-
ence in examining implantebone interphases,
reviewed the biopsies independently; after a general
common discussion, they performed an independent
second look examination. The reliability (ie, agree-
ment between the 2 investigators) was assessed.
Radiology
According to our protocol for TWA, plain radio-
graphs were obtained within 6 weeks after the index
operation, then 6 months later, and annually there-
after. If the last of these radiographs were older than
3 months, new radiographs were obtained in view of
the present study. Two senior hand surgeons (MBo
and LSV), who were blinded with respect to the
clinical and the histological findings, examined the
radiographs independently. On all serial poster-
oanterior radiographs, we measured the width of the
radiolucent area (if present) at selected spots (Fig. 1)
and calculated the mean of the width at spots 1/2/3,
4/5, 6/7/8, and 9/10 (expressed in millimeters). We
correlated these mean values with the histopatho-
logical, clinical, and serological findings. Further-
more, we established the evolution of radiolucency in
function of time in the individual patients. To eval-
uate angulation and subsidence, we measured the
angle between the radial component and the radial
diaphysis and the angle between the carpal compo-
nent and the third metacarpal. We also measured the
distance from the tip of the radial component to the
tip of the radial styloid and the distance from the tip
of the central carpal peg to the third carpometacarpal
joint on all radiographs. The digitalized measurement
systems were provided by Sectra’s IDS5/web (Sectra
AB, Linköbing, Sweden). We considered a progres-
sive and consistent change of distances from the first
postoperative to the latest radiograph of 3 mm or
greater as indicating subsidence and a corresponding
change of angulation of 5
or greater as indicating
tilting of the implants.14
The inter-observer reliability
of the measurements was also calculated.
Bacteriology
Bacteriological examination of the samples included
direct microscopy and aerobic as well as anaerobic
cultures.
Blood analyses
We determined C-reactive protein values and
white blood cell count to evaluate possible ongoing
infection. We also measured the concentration of
Cr and Co in whole blood according to the EPA
200.7þ8-ICP/AES/SFMS method (Swedish Board
for Accreditation and Conformity Assessment, Borås,
Sweden), expressed as micrograms per liter.
Clinical examination
Patients expressed the general level of wrist pain on a
visual analog scale (0e100) with 0 indicating no
pain and 100 indicating maximal pain. We recorded
grip strength in kilograms and used the Quicke
Disabilities of the Arm, Shoulder, and Hand ques-
tionnaire as a validated outcomes measure.
Statistics
For correlations of values on interval scales, we used
Pearson correlation coefficient and for values on
ordinal scales, Spearman rho correlation coefficient.
To evaluate the reliability of the radiological mea-
surements, we used Pearson correlation coefficient and
the intra-class coefficient (ICC3, single, fixed raters).15
We considered correlation coefficients between 0.8
and 1.0 to indicate a very strong correlation, between
0.6 and 0.79 a strong correlation, between 0.4 and 0.59
a moderate correlation, between 0.2 and 0.39 a weak
correlation, and between 0.0 and 0.19 a very weak or
absent correlation. To evaluate the histopathological
findings, we used Cohen kappa, in which values less
than 0.40 indicated poor agreement, 0.40 to 0.75 fair
FIGURE 1: Spots for measurement of the width of radiolucency
on serial posteroanterior radiographs. In this example, a small
radiolucent area is visible at spot 4 (maximal width, 1.4 mm).
2398 WEAR PARTICLES AND OSTEOLYSIS AFTER TOTAL WRIST ARTHROPLASTY
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109. 109
to good agreement, and greater than 0.75 excellent
agreement.
We calculated that the required sample size to
reveal strong correlations (r ¼ 0.7) was 11 with a
power of 0.8 and a ¼ .05.
RESULTS
Complications
There were no complications related to harvesting of
biopsies in terms of infection, pain, or deterioration of
function. Surgical wounds healed uneventfully within
2 weeks in all patients.
Radiology
Reliability of the measurements was very strong
(Table 2), and we used the measurements of the se-
nior author (MBo) for further analyses. Radiolucency
was not seen in zones 1 to 3 and only in 2 patients
in zones 6 to 8 (0.3 and 0.4 mm, respectively). Some
degree of radiolucency was seen in 10 patients in
TABLE 2. Interobserver Reliability of Measurements on Serial Radiographs
Measurements per
Observer, n
Pearson Correlation
Coefficient
Intra-class
Coefficient
Width of radiolucent zone at all spots (IeX) 820 0.85 0.85
Width of radiolucent zone at spots 4 and 5 164 0.81 0.81
Width of radiolucent zone at spots 9 and 10 164 0.81 0.80
Tilt of radial component 78 0.96 0.96
Subsidence of radial component 78 0.90 0.89
Tilt of carpal component 78 0.87 0.87
Subsidence of carpal component 78 0.98 0.98
FIGURE 2: Evolution of radiolucency. Each graph represents an individual patient. A Mean width at zones 4 and 5. B Mean of width at
zones 9 and 10.
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110. 110
zone 4 to 5 (Fig. 2). In 6 of these, the width remained
less than 2 mm throughout the observation period.
In 3 patients it increased initially to between 3 and
4 mm and then stabilized. In one patient it increased
rapidly but seemed to stabilize between 8 and 9 mm
after 4 years (Fig. 3). In zones 9 to 10 radiolucency
was seen in 7 patients (Fig. 2). In 4 of these the width
remained less than 1 mm. In 3 patients it increased to
between 3 and 4 mm. There was no evidence of
radial component loosening in any patient. In 3 pa-
tients subsidence of the carpal component was
evident. None of the cemented components had
subsided.
Histopathology
We harvested 13 samples at the radial component, 10 at
the carpal component, and 1 at a metallic ulnar head
implant. Table 3 shows the interobserver agreement
of the histological findings. Foreign body giant cell
reaction was a common finding, encountered by at least
one of the pathologists in 15 of the 24 specimens.
Macrophages were predominant compared with lym-
phocytesin22specimens.Necrotictissue wasseenin 17.
Polyethylene debris was detected in 17 specimens
by both investigators and in another 2 specimens
by at least one investigator (Fig. 4). In 11 of these,
the polyethylene particles were sparse and small
or minute. No marked amount of particles was
encountered in any case. In 5 cases no polyethylene
was identified by either of the investigators (Fig. 4).
The amount of polyethylene at the radial component
correlated very weakly or not at all with the width
of radiolucency according to both pathologists
(Spearman r, e0.16 and 0.18, respectively) (Fig. 5).
On the carpal side, the correlation was negative
(Spearman r, e0.55 and -0.69 respectively) (Fig. 6).
The same applied to the metallic particles (Fig. 4):
Spearman r ¼ e0.26 and 0.12, respectively, on the
radial side and e0.18 and e0.26, respectively, on the
carpal side.
Blood analyses
Mean blood level of Cr was 0.264 mg/L (SD, 0.384)
and of Co 0.253 mg/L (SD, 0.275). There was no
correlation between the blood level of Cr and the
width of the radiolucent zones 4 to 5 and 9 to 10 and
a reversed weak or moderate correlation for the blood
level of Co.
White blood cell count was normal in all patients,
and the C-reactive protein level was normal in all but
one patient.
FIGURE 3: Radiographs in a patient undergoing total wrist arthroplasty. A Two weeks after surgery. The peg penetrates the third
metacarpal, which does not comply with usual recommendations but resulted from an unusually large carpal resection. B Four years after
the operation. A large area of periprosthetic osteolysis has developed under the radial component. The mean width of radiolucency was
8.5 mm at spots 4 and 5. No radiolucency at spots 1, 2, or 3. Osteolysis is also present under the carpal plate and around the screws and
central peg. The carpal component has not subsided since surgery. C Computed tomography scan. The radiolucent lines seen at zone 2
and 3are artifacts caused by the imaging software. Bone condensation is present at the tip of the radial component where load is
transmitted maximally from implant to bone.
TABLE 3. Reliability of Histological Findings
(Agreement Between 2 Pathologists)
Findings k
Necrotic tissue 0.68
Metal particles 0.59
Polyethylene debris 0.78
Preponderance of macrophages
compared with lymphocytes
1.00
Foreign body reaction 0.74
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111. 111
Bacteriology
All samples were negative with respect to direct mi-
croscopy and culture for bacteria.
Clinical findings
QuickeDisabilities of the Arm, Shoulder, and Hand
and the visual analog scale scores and grip strength
did not correlate with radiolucency (all correlation
coefficients lower than 0.10).
DISCUSSION
Periprosthetic osteolysis has been reported frequently
after TWA.16
In a series of Biaxial implants (DePuy
Orthopedics, Inc., Warsaw, IN), a periprosthetic
radiolucent zone of at least 2 mm was found in 12 of
32 cases (mean follow-up, 6 y).8
In a Re-motion se-
ries, periprosthetic radiolucency more than 2 mm in
width was found in 16 of 44 cases on the radial side
and in 7 on the carpal side.17
In a series of cemented
Universal I TWA (KMI Inc., San Diego, CA) in
rheumatoid patients, 9 of 19 patients seen at follow-
up of more than 5 years after the operation had received
revisions because of loosening of the carpal compo-
nent.12
Among the remaining ten, 3 had radiographic
subsidence and/or osteolysis. The Biaxial, Re-motion,
and Universal TWA are metal-on-polyethylene im-
plants but similar PPO has also been demonstrated in
metal-on-metal TWA18
and even in metallic single
component implants such as ulnar head replacement
devices.19
The histology of PPO has been investigated in
other joints. Kepler et al20
studied 52 patients who
underwent revision total shoulder arthroplasty at a
mean of 4.5 years after the index surgery. Ten pa-
tients (19%) had radiographic evidence of osteolysis
at the glenoid component. Histological specimens
taken at the time of revision surgery demonstrated no
significant differences between patients with or
without osteolysis with respect to the presence of
metallic, polyethylene, or cement debris particles or
with the presence of inflammatory reactions. Dalat
et al21
revised 25 total ankle arthroplasties. Radio-
graphically, all patients showed tibial and talar
osteolytic lesions, and in 25% the implant had
collapsed into the osteolytic cysts. Histological ex-
amination of the biopsies showed granulomatous
response associated with a foreign body giant cell
reaction in all cases. The cysts contained necrotic
material. Implant material, primarily polyethylene,
was identified in 95% of the specimens and metallic
debris in 60% of patients.
Generally, it has been hypothesized that the
macrophage phagocytosis of particulate debris from
component abrasive and adhesive wear activates
the macrophages and other inflammatory cells with
FIGURE 4: Examples of histology. A Polarized light microscopy (x200 magnification). Polyethylene fragments engulfed by multi-
nucleated foreign body giant cells (arrows), semi-quantitatively estimated as 2 on a scale of 0 to 3 for the amount of foreign body
particles. B Polarized light microscopy (Â 100 magnification). No polyethylene fragments or particles could be demonstrated in this
specimen. C Hematoxylineeosin staining (Â 200 magnification). Only sparse metal particles were demonstrable (arrows).
WEAR PARTICLES AND OSTEOLYSIS AFTER TOTAL WRIST ARTHROPLASTY 2401
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112. 112
cytokine release that in turn activate the osteoclasts, but
other possible mechanisms have been proposed. Ac-
cording to Skoglund and Aspenberg,22
the much less
studied osteolytic effects of pressure could be far more
important, and stress shielding is also considered a
potent stimulator of bone resorption.19,23,24
The main strength of our study is that it investi-
gated a consecutive group of patients with TWA,
regardless of their clinical or radiological status,
and that we followed these patients prospectively
with annual clinical and radiographical examina-
tions. Another strength of this study was that 2
pathologists investigated all specimens indepen-
dently and in a blinded manner. Our results confirm
that the histopathological findings may be subject to
differences of interpretation and interobserver vari-
ation that deserve consideration and discussion.
Thus, the relative disagreement between the 2 pa-
thologists concerning the presence of metallic par-
ticles may be because in several cases the metallic
particles were minute and sparse and on occasion
could be confused with corrosion products. Gener-
ally, however, interobserver agreement was good to
excellent.
FIGURE 5: Scatterplot showing the width of radiolucency in
zones 4 and 5 versus the amount of polyethylene fragments in the
samples taken at the interphase between the radial component and
the radius: A According to pathologist AT. B According to
pathologist MBa.
FIGURE 6: Scatterplot showing the width of radiolucency in
zones 9 and 10 versus the amount of polyethylene fragments in
the samples taken at the interphase between the carpal component
and the carpal: A According to pathologist AT. B According to
pathologist MBa.
2402 WEAR PARTICLES AND OSTEOLYSIS AFTER TOTAL WRIST ARTHROPLASTY
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113. 113
The hypothesis in the current study was that the
presence and severity of PPO correlated with the
presence and degree of polyethylene and metallic
debris. We showed that this was not the case.
Moreover, foreign body giant cell reaction was seen
as frequently in patients with no or minimal PPO as
in those with pronounced PPO. The patient with the
most marked osteolytic lesion at the radial component
(Fig. 3) had no detectable polyethylene debris in the
collected specimen at all according to one pathologist
and only minimal amounts according to the other.
Only one of the pathologists considered a foreign
body giant cell reaction to be present in this spec-
imen, whereas both pathologists considered the
presence of metallic particles minimal or very small.
In most cases PPO was associated with a low
amount of metallic debris. Also, metallic wear did not
cause elevated levels of metallic ions in the blood
samples. The values were far below the proposed
acceptable upper limits of 2.56 mg/L for Cr and 2.02
mg/L for Co in whole blood, based on the studies by
Hart et al.25
According to Trace Elements Labo-
ratoryeLondon Health Sciences Centre, the reference
values for Cr in whole blood is 0.40 to 1.60 mg/L and
for Co, 0.032 to 0.290 mg/L . The only patient with a
Co value exceeding this reference had a bilateral
TWA and a bilateral total knee arthroplasty. In a
systematic study of the literature concerning Cr and
Co ion concentrations in blood and serum after
various types of metal-on-metal hip arthroplasties,
Jantzen et al26
found that the average Cr concentra-
tion ranged between 0.5 and 2.5 mg/L in blood. For
Co, the range was 0.7 to 3.4 mg/L.
Our series was underpowered because of the small
number of cases; conversely, however, it represents a
broad spectrum of histopathological findings
(amounts of debris) as well as radiological findings
(width of radiolucency) and the lack of correlations
was unequivocal. Moreover, the sample size was
reasonable according to our calculations. Our evalu-
ation of the osteolytic areas may not represent the
volume of bone resorption correctly because we used
a 2-dimensional surrogate for a 3-dimensional space.
Nevertheless, our method was highly reproducible
and corresponded to the method described by Cobb
et al14
and Takwale et al.10
None of the radial com-
ponents collapsed into the osteolytic area, which
consequently was intact for evaluation.
The PPO tended to level out in time and rarely
caused gross loosening of the components. In light of
the lack of correlation between particulate debris and
PPO and the absence of rheumatoid or infectious
activity, we suggest that the PPO we describe can be
at least partially attributed to stress shielding of the
bony structures by the implants. The fact that bone
resorption occurred at the edges of the components
nearest to the joint, where load is transmitted through
the implant components, is consistent with this hy-
pothesis. There is a need for further investigation,
however, including radiostereographical methods and
serial focal bone mineral density measurements. For
the time being, we recommend close and continued
observation of patients with marked asymptomatic
PPO. Bisphosphonates, denosumab, strontium, rane-
late, and parathyroid hormone have been reported as
possible treatment agents with regard to maintaining
more periprosthetic bone mineral density, but clinical
documentation is limited.27
We find that there is currently no need to change
conventional polyethylene in the Re-motion implant
to the more resistant highly cross-linked polyethylene
because the occurrence of polyethylene debris was
low.
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Paper
VII
VIDENSKAB 3333Ugeskr Læger 172/48 29. november 2010
ORIGINALARTIKEL
Håndkirurgisk Afsnit,
Ortopædkirurgisk
Afdeling,
Gentofte Hospital
Validering af spørgeskema
ved lidelser i overekstremiteten
Alex Herup, Søren Merser Michel Boeckstyns
RESUME
INTRODUKTION: Disability of the arm, shoulder and hand
(DASH) er et amerikansk udviklet spørgeskema, der kan an-
vendes på patienter med lidelser i overekstremiteten. Ud fra
besvarelsen af spørgeskemaet kan der udregnes en numerisk
DASH-score. Scoren kan anvendes som et udtryk for patientens
opfattelse af invalideringsgraden. DASH kan anvendes på pa-
tienter med alle former for lidelser i overekstremiteten og er
anvendelig både ved akutte og kroniske tilstande, hvad enten
de er opstået på traumatisk vis eller ej. I denne undersøgelse er
DASH anvendt på en gruppe danske patienter med forskellige
overekstremitetslidelser. Formålet var at vurdere reproducer-
barheden af de danske patienters DASH-scorer for at belyse,
om spørgeskemaet er anvendeligt i det kliniske arbejde med
danske patienter.
MATERIALE OG METODER: Der deltog i alt 83 patienter, hvoraf
73 havde håndrelaterede lidelser, og ti havde skuldergener. De
inkluderede patienter var alle i stabil sygdomsfase, typisk med
kronisk lidelse, og de blev spurgt, om de ville udfylde DASH-
spørgeskemaet i forbindelse med forundersøgelse inden op-
skrivning til operation eller ved afslutning af et behandlings-
forløb i ambulatoriet.
RESULTATER: Der var i alt 54 patienter, der opfyldte alle krav
vedrørende aflevering og besvarelse af DASH. DASH-scorene lå
numerisk tæt på hinanden med en Intra Class Coefficient på
0,85. Cronbachs alfa blev udregnet til 0,96, hvilket er udtryk for,
at de indgående deltest måler det samme. Spearmankoefficien-
ten var samlet 0,9, og første og anden besvarelse var stærkt
korrelerede.
KONKLUSION: Undersøgelsen viser god reproducerbarhed af
DASH, og scoringen er stabil og pålidelig og kan anvendes på
danske patienter.
DASH står for disability of the arm, shoulder and hand.
Spørgeskemaet er udviklet af The Insitute of Work and
Health, Toronto, Ontario, Canada og The American
Academy of Orthopaedic Surgeons [1]. Det indeholder
30 spørgsmål: 21 vedrørende evnen til at udføre
praktiske aktiviteter, seks vedrørende symptomer i
overekstremiteterne og tre vedrørende psykosociale
forhold. Endvidere er der inkluderet to valgfrie mo-
duler med fire spørgsmål i hver. Det ene modul hen-
vender sig til sportsfolk og udøvende kunstnere,
mens det andet er et arbejdsmodul for patienter på
arbejdsmarkedet. Disse valgfri moduler er ikke an-
vendt i denne undersøgelse. Der foreligger endvidere
en kort version af spørgeskemaet, Quick DASH.
Transkulturel adaptation (dvs. valideret oversæt-
telse) af DASH er udført til talrige sprog og kulturer:
I skrivende stund er 35 adapterede versioner god-
kendt, og seks er under udarbejdelse. Der er fastlagt
strenge krav til oversættelsesprocessen og godken-
delse af skemaet på nye sprog, hvilket varetages af
the Institute of Work and Health i Canada [1], som har
udviklet DASH og ejer rettighederne til spørgeske-
maet. I korthed omfatter processen først oversættel-
sen fra originalsproget til målsproget, og herefter
tilbageoversættelse til originalsproget og sammenlig-
ning af tilbageoversættelsen med den originale ver-
sion. I forløbet deltager forskellige grupper af både
medicinsk faglige personer og sprogfaglige personer.
Den danske oversættelse af DASH er blevet godkendt
i 2004. Den danske oversættelse er den eneste autori-
serede version, og modifikationer er ikke tilladt hver-
ken i indhold eller udformning, da selv små ændrin-
ger kan påvirke måleegenskaberne.
Spørgsmålene i spørgeskemaet skal besvares
med en værdi fra 1 til 5 (fra »ingen gene« til »værst
mulig gene«). Den samlede score beregnes som
[(summen af n svar/n)-1] × 25. En DASH-score må
ikke udregnes, hvis der er mere end tre ubesvarede
spørgsmål. Den højest mulige score (værste gene) er
således 100 og den laveste 0 (ingen gener).
Scoring af de valgfrie moduler gøres efter samme
formel, dog med det forbehold, at scoren ikke må ud-
regnes, hvis der mangler besvarelser.
DASH har vist sig at være velegnet til vurdering
af patienter med lidelser og symptomer fra overeks-
tremiteterne inden for ortopædkirurgien. Specielt an-
vendes DASH meget i håndkirurgien, og det bruges
internationalt på en bred og varieret patientgruppe.
Eksempelvis patienter med karpaltunnelsyndrom [2],
reumatoid artritis [3], distal radius-fraktur [4], flek-
sorseneskade [5], discus triangularis-skade [6],
osteoartrose i hånden [7], amputationsskader [8]
m.m. DASH anvendes i et mere begrænset omfang
inden for skulderkirurgi [9].
Der er ved tidligere undersøgelser fundet god
reproducerbarhed af scoringerne i originalsproget
[10, 11].

116. 116
3334 VIDENSKAB Ugeskr Læger 172/48 29. november 2010
Formålet med denne undersøgelse var primært
at undersøge reproducerbarheden af DASH-spørge-
skemaet som et led i den transkulturelle adaptation
og sammenligne denne reproducerbarhed med origi-
nalversionen, sekundært at undersøge spørgeskema-
ets interne konsistens.
MATERIALE OG METODER
Indgangskriterierne var håndrelaterede eller skulder-
relaterede gener i stabil fase hos patienter, der var
henvist til forundersøgelse på Ortopædkirurgisk Af-
deling, Gentofte Hospital. Vi tilstræbte et materiale
af en størrelse og en fordeling af diagnosegrupperne,
der svarede til den originale amerikanske reproducer-
barhedsundersøgelse [10].
Ved forundersøgelsen blev patienterne bedt om
at udfylde spørgeskemaet uden nærmere information
om reproducerbarhedsundersøgelsen for at undgå,
at denne viden skulle påvirke deres senere besva-
relse. En uge efter forundersøgelsen fik patienterne
tilsendt et nyt spørgeskema, der nu indeholdt skriftlig
information om den pågående reproducerbarheds-
undersøgelse og anmodning om at indsende deres
besvarelse inden for en uge i en vedlagt frankeret
returkuvert. Besvarelserne blev indsamlet og data be-
arbejdet i et sekretariat, hvis medarbejdere ikke
havde direkte kontakt med patienterne.
Patienter som ikke ønskede at udfylde skema-
erne, udfyldte skemaerne mangelfuldt (dvs. mere
end tre ubesvarede spørgsmål) eller indsendte deres
svar mere end 31 dage efter forundersøgelsen, blev
ekskluderet.
STATISTIK
Da formålet med undersøgelsen ikke blot var at vur-
dere reproducerbarheden af DASH, men særligt at
undersøge om reproducerbarheden af den danske
version svarede til den originale version og andre
oversættelser, har vi valgt de samme statistiske test,
som blev anvendt i tidligere publikationer.
Beaton anvendte i sin originalpublikation Intra
Class Coefficient (ICC) model 2.1 [12], mens andre
har anvendt ICC model 1.1 [13]. Begge er korrela-
tionskoefficienter for kategoriske data, henholdsvis i
en tovejs- og en envejs ANOVA-analyse. Korrelations-
koefficienterne Pearson og Spearman er udtryk for
sammenhængen mellem første og anden DASH-
score. De indikerer således, om der er en høj første
score og en høj anden score, men er ikke nødvendig-
vis et udtryk for, om scorene rent numerisk er iden-
tiske. Vi mener, at Spearmanmodellen til test af data
på en rangordenskala er mest relevant i dette test/
retest studie, men vi har supplerende udregnet
Pearsons koefficient til sammenligning med andre
arbejder, hvor den anvendes [10].
Udregning af kappakoefficient fravalgte vi, da
den egentlige kappakoefficient er beregnet til nomi-
nelle skalaer og i øvrigt ikke er anvendt i de materia-
ler, vi ønskede at sammenligne os med.
Til evaluering af spørgeskemaets interne kon-
sistens har vi i lighed med andre [13-17] anvendt
Cronbachs alfa [18].
Alle statistiske beregninger og grafik er lavet
med open source-programmet R version 2.07, (R
Development Core Team (2008)). Der er anvendt
følgende R-packages:
Dataimport fra Microsoft Access-database med
RODBC (oprindeligt Michael Lapsley og fra oktober
2002 Brian D. Ripley (2008)). R til LATEX2e kode
med Hmisc (Harrell, Jr. (2007)) .Cronbachs alfa med
irr (Matthias Gamer samt Jim Lemon og Ian Fellows
(2007)).
RESULTATER
I alt indgik 83 patienter, hvoraf 73 patienter havde
håndrelateret gener og ti skulderrelaterede gener.
I alt 29 patienter blev sekundært ekskluderet: I otte
tilfælde var besvarelsen mangelfuld, 18 skemaer var
udfyldt senere end efter 31 dage, og tre angav ikke
datoen. Således omfattede korrelationsanalyserne
54 tilfælde.
Diagnosekategorier i undersøgelsen fremgår af
Tabel 1.
For så vidt angår de 54 patienter, hvor en score
kunne udregnes for begge besvarelser, var kun 30 ud
af 3.240 mulige spørgsmål (1%) ubesvarede. Det
hyppigst ubesvarede spørgsmål angik patienternes
Håndtrykskraft an-
vendes indimellem
som samlet mål for
håndfunktion.

117. 117
VIDENSKAB 3335Ugeskr Læger 172/48 29. november 2010
sexliv og udgjorde 20% af de ubesvarede spørgsmål.
De øvrige manglende svar var jævnt fordelt på de
øvrige spørgsmål.
Figur 1 viser den lineære korrelation mellem
DASH-scorene for skema 1 og skema 2.
For de 54 patienter, der indgik i de statistiske
beregninger, var ICC-værdierne 0,85, både ved an-
vendelse af envejs- og af tovejsanalysemodellen.
Pearson- og Spearmankoefficienterne var henholds-
vis på 0,89 og 0,90. Cronbachs alfa var på 0,96.
DISKUSSION
Reproducerbarheden af DASH-scoringerne i vores
undersøgelse havde en ICC-værdi på 0,85, både ved
anvendelse af en envejs- og en tovejsmodel.
Reproducerbarhed bedømmes som værende
»moderat god«, hvis ICC-værdierne er mellem 0,4 og
0,75 og »meget god« ved værdier over 0,75 [19].
Vores undersøgelsesresultat viser således »meget
god« overensstemmelse. Næsten identiske værdier er
fundet i andre arbejder [15, 16].
Nogle materialer angiver ICC-værdier, der ligger
noget højere end vores [14, 20]. Dette gælder også
originalmaterialet [10] med en værdi på 0,96. For-
skellen er dog ikke større, end at reproducerbarheden
i vores materiale må anses for at være af samme stør-
relsesorden som i den oprindelige DASH.
Den stærke korrelation bekræftes af Spearman-
og Pearsonkoefficienterne, som var næsten identiske
på 0,89 og 0,90, og de bekræfter således begge den
stærke korrelation. Cronbachs alfa angiver en meget
høj intern konsistens, der svarer til andre undersøgel-
ser [13-17]. Den jævne spredning af scorene, som
fremgår af Figur 1, viser endvidere, at spørgeskemaet
for det første har en god diskriminativ evne (evne til
at skelne patienter med få symptomer fra patienter
med flere symptomer) og for det andet, at reprodu-
cerbarheden ikke er afhængig af værdien af selve
scoren: Besvarelserne fra såvel patienter med lav
score som fra patienter med høj score var korrele-
rede. Endelig viser spredningen af scorene, at vores
materiale havde en bred fordeling og således repræ-
senterede et bredt symptomsværhedsspektrum.
Antallet af frafaldne respondenter i denne under-
søgelse er højt, men skal imidlertid vurderes på bag-
grund af undersøgelsens design, hvor der ikke forelå
en forhåndsaccept fra patienternes side, og hvor der
ingen direkte patientkontakt var ved anden besva-
relse. Det var således op til patienterne selv, om de
fandt det vigtigt at deltage og overholde tidsfristen.
Disse forhold var uundgåelige for at mindske biaspå-
virkningen mellem første og anden besvarelse, og vi
vurderer, at størrelsen af materialet – trods eksklusio-
nerne – er acceptabelt til vurdering af reproducerbar-
heden og sammenligningen med andre materialer.
Især finder vi det vigtigt, at kun 10% måtte eksklude-
res på grund af mangelfuld besvarelse. Det er tidli-
gere blevet diskuteret, hvorvidt spørgsmålet vedrø-
rende patienternes evne til at dyrke sex burde udgå,
men man har valgt at beholde spørgsmålet og dette
må respekteres for ikke at påvirke spørgeskemaets
validitet i forhold til udenlandske versioner, således
at sammenlignelighed er mulig. Set ud fra et repro-
ducerbarhedssynspunkt mener vi, at den danske
oversættelse af DASH er korrekt, idet reproducerbar-
heden af den danske oversættelse er god ved sam-
menligning med den oprindelige version.
Hvad angår intervallets længde mellem første og
anden besvarelse har vi på forhånd valgt 31 dage som
maksimum for at mindske risikoen for variationer,
der kan tilskrives reelle ændringer i selve sygdom-
mens forløb. Tidligere er det dog påvist, at det ikke er
af afgørende betydning, om der er et kort eller langt
tidsinterval mellem test/retest-tidspunkterne for
DASH [14], og dette kan vores undersøgelse be-
Diagnose Antal
Dupuytrens kontraktur 22
Artrose i 1. fingers rodled 17
Andre håndrelaterede sygdomme 34
Skulderlidelser 10
Diagnoseliste
TABEL 1
80
60
40
20
0
0 20 40 60
DASH-score, skema 1
80
Patienter, der opfyldte alle kriterier.
Øvrige patienter.
DASH-score, skema 2Den lineære korrelation
mellem DASH-scorerne
for skema 1 og skema 2.
DASH = disability of the
arm, shoulder and hand.
FIGUR 1

118. 118
3336 VIDENSKAB Ugeskr Læger 172/48 29. november 2010
kræfte, idet vi fandt ICC-værdier på 0,85 for den en-
delige gruppe på 54 patienter og en ICC-værdi på
0,87, når også de tilfælde inkluderes, hvor tidsfristen
blev overskredet.
KONKLUSION
Vores udregninger bekræfter, at der er god overens-
stemmelse mellem patienternes scoring ved første og
anden besvarelse af DASH-spørgeskemaet, og at
overensstemmelsen er af samme størrelsesorden, som
den der blev opnået i den originale version, hvilket
bekræfter den transkulturelle adaptations validitet.
Desuden påvises en god intern konsistens i spør-
geskemaet.
Overordnet viser DASH-scoren sig derfor som
stabil, valid og derfor velegnet til evaluering både i
klinikken og i videnskabelige undersøgelser.
KORRESPONDANCE: Alex Herup, Hvedevej 6, 2765 Smørum.
E-mail: al.herup@sport.dk
ANTAGET: 23. januar 2010
FØRST PÅ NETTET: 14. juni 2010
INTERESSEKONFLIKTER: Ingen
LITTERATUR
1. Solay S, Beaton DE, McConnell S et al. DASH outcome measure user’s manual.
2. ed. Toronto: Institute for Work Health, 2002.
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3. Chiari-Grisar C, Koller U, Stamm TA et al. Performance of the disabilities of the
arm, shoulder and hand outcome questionnaire and the Moberg picking up
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multicenter, randomized, blinded, clinical trial. J Bone Joint Surg Am
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gular fibrocartilage complex tears: factors affecting outcome. Arthroscopy
2005;21:1126-30.
7. De Smet L. Responsiveness of the DASH score in surgically treated basal joint
arthritis of the thumb: preliminary results. Clin Rheumatol 2004;23:223-4.
8. Davidson J. A comparison of upper limb amputees and patients with upper
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Rehabil 2004;26:917-23.
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10. Beaton DE, Katz JN, Fossel AH et al. Measuring the whole or the parts? Validity,
reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand
outcome measure in different regions of the upper extremity. J Hand Ther
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11. Turchin DC, Beaton DE, Richards RR. Validity of observer-based aggregate sco-
ring systems as descriptors of elbow pain, function, and disability. J Bone Joint
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12. Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability.
Psychol Bull 1979;86:420-8.
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ability of the Arm, Shoulder and Hand (DASH-HKPWH): cross-cultural adapta-
tion process, internal consistency and reliability study. J Hand Ther
2004;17:417-23.
14. Atroshi I, Gummesson C, Andersson B et al. The disabilities of the arm, shoulder
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naire. J Orthop Sci 2005;10:353-9.
16. Padua R, Padua L, Ceccarelli E et al. Italian version of the Disability of the Arm,
Shoulder and Hand (DASH) questionnaire. Cross-cultural adaptation and valid-
ation. J Hand Surg (Br) 2003;28:179-86.
17. Themistocleous GS, Goudelis G, Kyrou I et al. Translation into Greek, cross-
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1951;16:297-334.
19. Rankin G, Stokes M. Reliability of assessment tools in rehabilitation: an illustra-
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302.

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Paper
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ABSTRACT
INTRODUCTION: Patient-rated outcome measures are fre-
quently used to assess the results of total wrist arthro-
plasty, but their psychometric properties have not yet been
evaluated in this group of patients. The purpose of our
study was to assess the psychometric properties of the Dan-
ish Quick Disabilites of Arm Shoulder and Hand (QuickDASH)
and Patient-rated Wrist Evaluation questionnaires in pa-
tients with total wrist arthroplasty.
MATERIAL AND METHODS: In a prospective cohort of 102
cases, we evaluated the QuickDASH. Furthermore, in a
cross-sectional study and a test-retest on a subgroup of the
patients, we evaluated the Patient-rated Wrist Evaluation.
RESULTS: Internal consistency and reproducibility were very
high (Cronbach’s alpha 0.96/0.97; Spearman’s rho 0.90/
0.91; intraclass coefficient 0.91/0.92), and there were no
floor or ceiling effects. The responsiveness of the Quick-
DASH was high (standardised response mean 1.06 and ef-
fect size 1.07). The construct validity of both scales was
confirmed by three a priori formulated hypotheses: a mod-
erate, negative correlation of scores with grip-strength;
a moderate, positive correlation with pain and a very weak
or no correlation with mobility. Rheumatoid patients scored
significantly higher on the QuickDASH than other patients
did. The scores of both questionnaires were very closely
related.
CONCLUSION: Both questionnaires are valid and equivalent
for use in patients with total wrist arthroplasty.
FUNDING: This research received no specific grant from any
funding agency in the public, commercial, or not-for-profit
sectors.
TRIAL REGISTRATION: not relevant.
The QuickDASH questionnaire was developed by extract-
ing 11 of 30 items from the original DASH questionnaire.
It aims at measuring function, disability and symptoms
in persons with disorders of the upper limb with a short
patient-rated outcome instrument [1]. In a systematic
review, Kennedy et al identified studies validating the
original English version and cultural adaptations [2]. The
diagnostic groups in these studies vary widely. In one
study only, patients with upper limb arthroplasties were
included, but none of them had wrist arthroplasties [3].
The Patient-rated Wrist Evaluation questionnaire
(PRWE) [4] was originally designed as a specific instru-
ment for the assessment of distal radius fractures and
wrist injuries, but this questionnaire has not been vali-
dated in the specific context of wrist arthoplasty.
The purpose of our study was to assess and
compare the psychometric properties of the Danish
QuickDASH and PRWE in a group of patients with total
wrist arthroplasty (TWA) with regard to construct valid-
ity, reproducibility, internal consistency, responsiveness
and floor/ceiling effects.
MATERIAL AND METHODS
Study populations
In Group 1, we included consecutive patients operated
with a third generation TWA at Gentofte Hospital or at
Rigshospitalet, Denmark, during the 1999-2013 period.
We evaluated the patients with the DASH or QuickDASH
questionnaires: eight Universal (Integra Life Sciences
Corp., Plainsboro, NJ, USA) and 96 Remotion (SBI Inc.,
Morrisville, PA, USA). Two patients were excluded be-
cause they did not attend the 12-month follow-up exam-
ination. This group (102 patients) was used for the as-
sessment of the construct validity, internal consistency,
floor/ceiling effects and responsiveness of the Quick-
DASH (Figure 1).
Group 2 consisted of a subset of Group 1: we in-
cluded only the patients from Gentofte Hospital. This
group was used for the general assessment of the PRWE
and of the reproducibility of the QuickDASH (Figure 1).
There were 69 females and 33 males in Group 1,
and 41 females and 22 males in Group 2. The mean age
was 59.5 (29-83) years in Group 1 and 58.8 (31-83) in
Group 2. There were 57 rheumatoid patients versus 45
non-rheumatoid patients in Group 1 and 29 rheumatoid
versus 34 non-rheumatoid patients in Group 2.
Clinical design
In Group 1, we used data collected at the 12-month fol-
low-up after TWA to evaluate construct validity, internal
consistency, and floor/ceiling effects in a cross-sectional
study. The responsiveness of the QuickDASH was calcu-
lated in a prospective cohort study using data collected
preoperatively and at a 1-year follow-up.
Group 2 were entered into a cross-sectional study
to evaluate the PRWE and into a test-retest trial to
evaluate the reproducibility of both questionnaires. The
Psychometric properties of two questionnaires
in the context of total wrist arthroplasty
Michel E.H. Boeckstyns1
Søren Merser2
ORIGINAL
ARTICLE
1) Clinic for Hand
Surgery
2) Informatics
Statistical Consulting
Dan Med J
2014;61(11):A4939

120. 120
DANISH MEDICAL JOURNAL
questionnaires were sent to the patients’ private ad-
dresses by surface mail with a request to return it within
a week and without informing them about the intention
to retest. Six days after reception of the answer, a sec-
ond questionnaire was sent in which we explained our
wish to assess its reproducibility. A total of 53 returned
the first questionnaire. One of these had insufficient an-
swers to calculate a QuickDASH score, and we did not
send her a second questionnaire. Four other patients did
not return the second questionnaire. Thus, we had 48
sets of responses for the test-retest. The mean interval
between the responses was 14.1 days (range: 6-29 days).
Instruments and measurements
The QuickDASH consists of six items concerning the abil-
ity to perform activities of daily living (ADL), two con-
cerning social and work ability, one concerning pain and
two concerning other symptoms. Each item has five re-
sponse options (scored 1-5) which are used to create a
summative score ranging from 0 (no disability or symp-
toms) to 100 (maximal disability or symptoms). If more
than one item is missing in the QuickDASH, a score can-
not be calculated
The PRWE consists of eight items concerning ADL,
two concerning social and work ability and five concern-
ing pain. They are grouped into two sections: pain and
function. Each item is rated on a Likert scale from 0 to
10 producing a summative score for each section. The
total wrist score is calculated by adding the function
score divided by two plus the pain score, and ranges
from zero (no disability or symptoms) to 100 (maximal
disability or symptoms). If an item is missing, it is re-
placed with the mean score of the subscale. Both ques-
tionnaires were translated into Danish according to the
Guillemin guidelines [5-7].
Reproducibility expresses to which extent scores
can be reproduced in a test-retest.
Construct validity indicates the correlation between
the measurements and theoretical considerations. To
assess construct validity, we formulated three hypoth-
eses a priori. Firstly, there should be a moderate, nega-
tive correlation between the scores and grip strength –
the latter being a good indicator of hand function – but
not a high correlation, considering the individual vari-
ance across patients related to their age, sex and body
size. Secondly, we postulated a moderate, positive cor-
relation with pain, because good function implies a low
degree of pain. However, we did not expect a very high
correlation since the questionnaire is not intended to
simply measure pain. Thirdly, we postulated a weak or
no correlation of the scales with wrist motion, knowing
that even fused wrists are consistent with acceptable
hand function.
For the testing of our hypotheses, we measured
grip strength with the JAMAR (Sammon Preston Inc.,
Bolingbrook, IL, USA). We used a visual analogue scale
(VAS) for evaluation of “general level of pain throughout
the day”. To express motion, we used the total dorsal/
palmar wrist motion which was measured with a
goniometer.
Floor and ceiling effects show the proportion of in-
dividuals who achieve the highest or lowest possible nu-
meric value of a score and are considered present when
more than 15% of the individuals achieve these values
[8]. A ceiling or floor effect indicates that the measure-
ment instrument cannot be used for the entire con-
tinuum of patients.
FIGURE 1
Flow chart illustrating how the two patient groups, treated at Rigshos-
pitalet and Gentofte Hospital were selected. In Group 1, two patients
had been excluded due to lack of response at the one-year follow-up.
In Group 2, the number of patients was reduced from 53 to 48 in the
test-retest trial due to lack of second response.
Rigshospitalet Gentofte Hospital
Assessment of PREW:
– Construct validity
– Internal consistency
– Floor-/ceiling effect
(n = 53)
Assessment of QuickDASH:
– Construct validity
– Internal consistency
– Floor-/ceiling effect
– Responsiveness
(n = 102)
Reproducibility of
PREW and QuickDash
(n = 48)
PRWE = Patient-rated Wrist Evaluation questionnaire.
QuickDASH = Quick Disabilities of Arm Shoulder and Hand questionnaire.
Cemented remotion
total wrist arthro-
plasty.

121. 121
DANISH MEDICAL JOURNAL
Internal consistency measures to which extent the
different items that propose to measure the same gen-
eral construct tend to produce similar scores, i.e.
whether there is general internal agreement between
the items.
Responsiveness is the ability of a scale to measure a
meaningful or important change in a clinical state, e.g.
how it responds to treatment.
Statistical analysis
Correlations for construct validity were evaluated with
Spearman’s rho, values ± 0.8 to ± 1.0 indicating a very
strong relationship, ± 0.6 to ± 0.8 a strong relationship,
± 0.4 to ± 0.6 a moderate relationship, ± 0.2 to ± 0.4 a
weak relationship,and ± 0.0 to ± 0.2 a very weak or no
relationship [9].
Internal consistency was assessed with Cronbach’s
alpha. Scales are considered to be internally consistent if
Cronbach’s alpha is between 0.7 and 0.9 [10]. Values
higher than 0.9 might indicate item redundancy.
Responsiveness was expressed with the standard-
ised response mean (SRM) and the effect size (ES) [11].
We considered values between 0 and 0.2 as “trivial”, be-
tween 0.2 and 0.5 as “small”, between 0.5 and 0.8 as
“moderate” and higher than 0.8 as “large”.
Reproducibility was expressed with Spearman’s rho
and the intraclass coefficient (ICC3) with the same inter-
val definitions as mentioned.
Rheumatoid patients typically have multiple joint
involvement to a higher extent than non-rheumatoid pa-
tients. We made separate analyses for these diagnostic
subgroups in order to evaluate any bias. To compare the
scores between rheumatoid and non-rheumatoid cases,
we used the Wilcoxon rank-sum test.
The level of significance was set at p 0.05.
Trial registration: not relevant.
RESULTS
For 17 of 308 testings (5.5%), the QuickDASH score could
not be calculated, whereas all of the 100 PRWE scores
could be calculated. Rheumatoid patients scored signifi-
cantly higher according to the QuickDASH in Group 1,
but not in Group 2. Table 1 shows the result of the test-
ing of the hypotheses for construct validity. Reprodu-
cibility, internal consistency and responsiveness are
listed in Table 2. There were no statistically significant
differences between the psychometric properties of the
questionnaires in rheumatoid and non-rheumatoid
cases. There was a very high correlation between the
QDASH and the PRWE scores (Spearman’s rho = 0.90).
The scatter plot in Figure 2 demonstrates that the scores
are very similar, but not exactly numerically equivalent.
The QuickDASH scores are approximately five points
higher in the lower end of the scales (low disability),
while they are approximately ten points lower in the
higher end (high disability).
DISCUSSION
Earlier reports have demonstrated the validity of the
QuickDASH for assessment of patients with shoulder, el-
bow and basal thumb joint arthroplasty [3] and the va-
lidity of the PRWE for assessment of basal thumb joint
arthroplasty [12]. Our study indicates excellent psycho-
metric properties of the questionnaires when applied to
patients with TWA. The a priori formulated hypotheses
concerning construct validity were confirmed. Repro-
ducibility was very high. Cronbach’s alpha indicated a
strong internal consistency and possibly redundancy of
items. There were no floor/ceiling effects. Responsive-
TABLE 1
Construct validity of QuickDASH and PRWE according to three a priori
formulated hypotheses concerning the correla-tion of the scores with
grip strength, pain and wrist motion.
Spearman’s rho QuickDASH (p-value) PRWE (p-value)
Versus grip strength –0.56 ( 0.001) –0.50 ( 0.001)
Versus pain 0.54 ( 0.001) 0.59 ( 0.001)
Versus motion –0.10 (0.13) 0.22 (0.14)
PRWE = Patient-rated Wrist Evaluation questionnaire.
QuickDASH = Quick Disabilities of Arm Shoulder and Hand question-
naire.
TABLE 2
Reproducibility, responsiveness, internal consistency and floor-ceiling ef-
fect of the questionnaires.
QDASH PRWE
Reproducibility, Group 2
Spearman’s rho (p-value)
ICC, mean (range)
0.90 ( 0.001)
0.91 (0.85-0.95)
0.91 ( 0.001)
0.92 (0.87-0.96)
Responsiveness, Group 1
SRMa
ES
1.06
1.07
NA
NA
Internal consistency,
Cronbach’s alpha
Group 1
Group 2
0.96
NA
NA
0.97
Floor-ceiling effect, % of total
Group 1:
Floor
Ceiling
Group 2:
Floor
Ceiling
4
0
NA
NA
NA
NA
4
0
ES = effect size; ICC = intraclass coefficient; NA = not applicable; PRWE =
Patient-rated Wrist Evaluation question-naire; QuickDASH = Quick Dis-
abilities of Arm Shoulder and Hand questionnaire; SD = standard devi-
ation; SRM = standardised response mean.
a) Mean score (± SD) was 55.2 (± 18.3) preoperatively and 35.4 (± 23.7)
post-operatively. Difference in score was 19.6 (± 18.5).

122. 122
DANISH MEDICAL JOURNAL
ness to treatment was high according to the QuickDASH.
It may be argued that we could have chosen to measure
internal consistency, construct validity and floor/ceiling
effects of the QuickDASHin in Group 2, as we did for the
PRWE, but we chose to take advantage of a larger avail-
able sample. In the systematic review of the measure-
ment properties of the QuickDASH and its cross cultural
adaptations performed by Kennedy et al [2], the studies
were assessed with a recently described method: con-
sensus-based standards for the selection of health
measurement instruments (COSMIN). The studies with
the best methodological quality showed high Cronbach’s
alpha values for internal consistency (0.92-0.94) and ICC
values that ranged from 0.90 to 0.94. Hypothesis testing
was evaluated in nine studies with a range of overall
methodological quality: one excellent, six fair and two
poor. Correlations were in the expected magnitude and
direction: high for target construct (pain, function),
moderate for work disability measures and low for men-
tal health measures. Coefficients for the correlation with
pain were 0.64 to 0.73. Several studies found acceptable
SRM/ES after treatment of known efficacy (0.58-1.77),
which indicates that the Quick DASH is sensitive to vary-
ing amounts of change. Thus, the reported psychometric
properties were generally in agreement with our find-
ings, although they were not investigated in patients
with TWA.
At present, no systematic review of the psychomet-
ric properties of the PRWE is available, and it is far be-
yond the scope of this study to do so with the COSMIN
method, but we have identified a number of relevant
papers. Table 3 shows a summary of the internal con-
sistency, reproducibility and responsiveness in these
studies. A weak correlation with wrist motion and a
moderate correlation with grip strength were found in
patients with tendon interposition arthroplasty [12, 16,
18]. Correlations with VAS scores were moderate [14,
16, 17]. Fairplay et al found a high internal consistency
(Cronbach’s alpha = 0.96) and reproducibility (Spear-
man’s rho = 0.93) in 63 patients with chronic wrist or
hand pain [15]. These figures also are consistent with
our findings in TWA patients.
One weakness of our study is that we were unable
to assess the responsiveness of the PRWE since the Dan-
ish questionnaire was not available when we started
sampling data in 2003. The surgical procedure itself is in-
frequent to an extent that it is necessary to collect data
throughout several years in order to obtain sufficiently
large numbers. Apart from this flaw, our analysis shows
very similar psychometric properties for the two ques-
tionnaires. The fact that the scores produced by the
scales were numerically very close is unexpected, be-
cause the QuickDASH is generally considered a generic
upper limb instrument, whereas the PRWE is considered
a specific wrist evaluation instrument. Notwithstanding
the important fact that the psychometric properties of
the two questionnaires did not differ between rheuma-
toid and non-rheumatoid patients, the scores of the
rheumatoid patients in Group 1 were higher than the
scores of the non-rheumatoid patients, which means
that they had a higher grade of disability.
This must be interpreted in the light of the fact that
the rheumatoid patients generally have multiple joint in-
volvement. The difference was not significant in Group
2, which might be attributed to a smaller and hence an
underpowered sample. It is also interesting and unex-
pected that the scores of both scales correlated equally
with the general pain level, expressed on a visual ana-
logue scale, because the PRWE contains a very detailed
section with five specific pain questions, whereas the
QDASH only has two general pain questions. This con-
firms that the level of pain is important, but not crucial
for the construct measured and that multiple questions
regarding pain may be superfluous and may contribute
to item redundancy. The lack of correlation of the scores
with mobility is in agreement with the study of Murphy
et al 2003 [19] that failed to demonstrate any difference
in DASH or PRWE scores between TWA and total wrist
FIGURE 2
Scatter plot showing the QuickDASH- and the PRWE-scores in patients
with total wrist arthro-plasty. The curved line is the LOESS (local regres-
sion) line, the thin solid line is the regression line and the thick solid line
is the line of equivalency. Dots located on the line of equivalency repre-
sent patients whose QuickDASH and PRWE-scores are equal. Dots below
this line indicate a QuickDASH-score that is lower than the PRWE-score
for a given patient and vice-versa. The trend indicated by the LOESS-line
is that the QuickDASH scores are approximately five points higher than
the PRWE-scores in the lower end of the scales, whereas they are ap-
proximately ten points lower in the higher end.
20
20 40 60 80 PRWE0
0
40
60
80
QuickDASH
PRWE = Patient-rated Wrist Evaluation questionnaire.
QuickDASH = Quick Disabilities of Arm Shoulder and Hand questionnaire.

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DANISH MEDICAL JOURNAL
fusion (TWF) in a group of patients with generalised
arthritis.
In our study, we were unable to assess the criterion
validity of the scales. Criterion-related validity is based
on evidence that shows the extent to which the scores
of the instrument are related to a criterion measure or
gold standard. The challenge is that there is no readily
available gold standard: The authors and the institutions
that developed the QuickDASH state that its criterion va-
lidity has not been tested because of the absence of a
gold standard measure for the concept of upper-limb
disability and hand function [20]. Nor could we make a
direct assessment of the respondent burden, defined as
the time, energy, and other demands placed on the pa-
tients to whom the instruments are administered be-
cause our patients answered the questionnaires unat-
tended. However, the low number of missing items and
the number of responses in the test-retest indicate an
acceptable respondent burden and feasibility.
Future research must include other methods for
evaluating scaling properties, like the Rasch analysis, not
the least to assess unidimensionality and possible item
redundancy suggested by the very high Cronbach’s
alpha.
CORRESPONDENCE: Michel E.H. Boeckstyns, Kløverbakken 11, 2830 Virum,
Denmark. E-mail mibo@dadlnet.dk
ACCEPTED: 20 August 2014
CONFLICTS OF INTEREST: none. Disclosure forms provided by the authors
are available with the full text of this article at www.danmedj.dk
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TABLE 3
Psychometric properties of different versions of the PRWE in published studies.
Reference Version Diagnosis Cases, n
Internal consistency,
Cronbach’s alpha Reproducibility Responsiveness
MacDermid et al, 1998 [13] English Wrist fractures 101 – ICC 0.90 –
MacDermid et al, 2000b
English Wrist fractures 59 – – SRM = 2.27
Kim Kang, 2013 [14] Korean Wrist fractures 63 0.94 ICC = 0.96 ES = 0.94
SRM = 0.98
Wilcke et al, 2009b
Swedish Wrist fractures 99/49a
0.94-0.97 Spearman’s
rho = 0.99
ES = 1.3
SRM = 1.4-1.7
Mellstrand et al, 2011b
Swedish Wrist injuries 124 0.97 ICC = 0.93 SRM = 1.29
Fairplay et al, 2012 [15] Italian Chronic wrist pain 63 0.96 Spearman’s
rho = 0.93
–
Imaeda et al, 2010b
Japanese Various wrist conditions 117/50a
0.95 ICC = 0.92 ES = 1.9
SRM = 1.6
John et al, 2008 [12] German CMC1-arthritis after interposition 103/51a
0.97 ICC = 0.86 –
Hemelaers et al, 2008 [16] German Wrist fractures 44 0.98 ICC = 0.94 –
Wong et al, 2007b
Chinese (Hong Kong) Wrist injuries 47 0.78-0.93 – –
Schonnemann et al, 2013 [17] Danish Wrist fractures 60 0.94 ICC = 0.88 ES= 0.62
Present study Danish Total wrist arthroplasty 52/48a
0.97 ICC = 0.92
Spearman’s
rho = 0.91
ES = 1.07
SRM = 1.06
ES = effect size; CMC = carpometacarpal; ICC = intraclass coefficient; PRWE = Patient-rated Wrist Eval-uation questionnaire; SD = standard deviation; SRM = standardised response
mean.
a) The second figure refers to a subset of cases used in a test-retest.
b) Reference available from corresponding author.

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DANISH MEDICAL JOURNAL
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