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Currently favored biomaterials in Total Joint Replacement
Dr Bhaskar Borgohain
MBBS (AMC), MS (Delhi Univ.), DNB (MAMS),
Joint Replacement Fellow (Computer Navigation), AO Fellow (Germany)
Professor and Head of Orthopaedics
NEIGRIHMS
North Eastern Indira Gandhi Regional Institute of Health and Medical
SciencesShillong, Meghalaya, India
www.neigrihms.gov.in
Proceedings of Annual Conference, Delhi Orthopedic Association at Safdarjung Hospital, New
Delhi . October 31ST, 2015
The Hip Joint is a Ball & Socket Joint
Clinical failure of Hip
Joint is common
The Solution is Hip Replacement Surgery:
To Re-create the ball & socket joint
What is done in the surgery
 Acetabular Cup: Hard/Soft
 Femural Stem: Hard
( Metal alloy)
 Head/ Ball: Hard
(Metal alloy)
 Cement: PMMA
 No cement: Screws
Hip joint is a ball and socket type of joint
Contemporary THR consist of three basic components:
 1) The Acetabular cup: Typically made of metal and a
liner made of polyethylene (PE), ceramic or metal.
 2) The Ball or Head: Replaces the head of the femur,
typically made of Co-Cr alloys, stainless steel or ceramic
materials (aluminium oxide or zirconium oxide).
 3) The Stem: Fits into the femur, typically made of Co-Cr,
titanium alloy (Ti6Al4V) or rarely 316L stainless steel.3, 4,
5
CUP FIXATION: 2 Types
Stem Fixation: 2 Types
Cemented Versus Uncemented
 Mechanical fit
 Mechanical interlocking
 Immediate fixation
 Immediate weight
bearing possible
 Easy to do
 Used in older people
 The Gold standard
 Press fit
 Geometric fit-size match
 Gradual fixation
 Osseo-integration: By
cellular growth
 Difficult to do
 Younger
 Futuristic
Indications for THR Today
 Osteoarthritis: 93%
 Fracture neck femur: 2%
 Rheumatoid arthritis group: 2%
 Congenital dislocation: 2%
 Pain is the main indication for surgical intervention
National Joint Registry , UK Data 2010
BIOMATERIALS: DEFINITION
Nonviable material used in a medical device, intended
to interact with biological system
 1st Biomaterials consensus
conference,1986,Chester UK
BIOMATERIALS
 Biocompatibility: No corrosion, allergy or rejection in
vivo
 Biomechanical behavior : Elastcity modulus/stiffness
closer to bone
 Primary Stability: Press fit geometry : Ractangular
cross section, tapered stem
 Secondary stability: osseointegration… biological
bonding
 Wettability
BIOMATERIALS USED IN THR
Metals Ceramics Polymers
316L stainless
steel*
Alumina
Ultra high
molecular
weight polyethylene
(UHMWPE)
Co-Cr Alloys
(Vitellium)
Zirconia *
Polyurethane
Titanium Carbon
(e.g. Pyrolytic
carbon)
Ti6Al4V Hydroxyapatite
Hip arthroplasty has a history spanning more
than 100 years.
National joint registries of various countries of the world
Country Established
in year
Joints included Other data
Included
Public vs.
private
hospitals
Participants/
surgeons/
Departments/% of
participation
Websites
Sweden 1979 THR Revision +/+ 80(100%) www.jru.orthop.gu.se/
Finland 1980 THR/TKR/Others Revision/
Complications
? 80(?) www.nam.fi/english/
Norway 1987 THR/TKR/UNI/
Others
Revision +/+ 70 (100%) www.haukeland.no/nr/
Denmark 1995 THR Revision/
Complications
+/+ 52(100%) www.dhr.dk
Australia 1998 THR/TKR/UNI Revision ++ 294(100%) www.dmac.adelaide.edu.au/aoanjr
r/index.jsp
Scotland 1999 THR/TKR/ Others Revision/
Complications
+/- 15(100%) www.show.
scot.nhs.uk/arthro/index. htm
New Zealand 1999 THR/TKR/ Others Revision +/+ 62(?) www.cdhb.g ovt.nz/NJR/
Canada 2001 THR/TKR Revision +/? 72% of all hip & knee
surgeons
http://secure.cihi.ca/cihiweb/disp
Page.jsp?cw_page=services_cjrr_e
Romania 2001 THR/TKR/Others Revision +/? 69(?) www.rne.ro/public/situatii_eng.ph
p
England &
Wales
2003 THR/TKR/ Others Revision ++ 384(94%) www.njrcentre.org.uk/
South
Africa
Because of low participation (20%) and lack of support from the Ministry of Health, South Africa has
suspended their joint registry (Wieting, 2011).
USA Since 2009 is in pilot stage
China NONE
India NONE
1938: M.o.M Cementless
Wiles
•SS femoral head
•Metallic components
•Screws
Mackee & Ring
Cast Co-Cr-Molybdenum
Mckee-farrar Model 1960
Ring’s M-o-M Design 1957
Ring MoM Mckee MoM
FUNCTIONS & FAILURES
-Short term : 2 years
-Intermediate : 5-7 yrs
-Long term : Over 10 yrs
-Very long term : >15 yrs
-Wear
-Aseptic osteolysis
-Loosening
Revision 1% per year
Today THR is a very successful operation
 Predictable
 Reproducible
 Benefitted millions of people with disabling hip
pain across the globe
 Long term failure: Biomaterial Wear …. Osteolysis
 1% failure rate every year……Revision surgery
State of the art THR
Operation of the century
Extremely successful in
restoring near normal
mobility without pain of
arthritis or damage
Cementless C-o-C
SWEDISH ARTHROPLASTY REGISTRY 2010 REPORT
SWEDISH ARTHROPLASTY REGISTRY 2010 REPORT
Frugality & practicality
 Close to 300,000 THAs
performed per year in the
United States.
 The calculated total cost of
250,000 THAs performed in
the United States during
1995 was five billion dollars.
Healy WL. Clin Orthop. 1995; 102–108
NATIONAL JOINT REGISTRY,UK
 Data from 2010
 THR: 76,759
 6% increase than 2009
 Primary surgery: 68907
 Revision surgery: 7852
(11.4%)
 43% Cementless THR
 36% Cemented THR
 16% Hybrid THR
National Joint Registry , UK
(Since 2003)
The traditional bearing surfaces in THA: Metal
on Plastic &… beyond
 The first modern successful THR used a polished
metal ball and HMWPE cup
 M-o-Poly. became the standard for the first three
decades.
 Over the next decade manufacturing techniques have
improved, but metal on UHMWPE remains the
standard bearing surfaces
 Alternative bearings are those that are considered
highly wear-resistant and are an "alternative" to
conventional polyethylene.
Why alternatives?
 Reasons for long term failures are rather
Biomaterial related
 Wear
 Osteolysis
 Hypothesis :: better biomaterials Less wear Long
term results
Release of submicron PE debris
 Closely linked to the destructive-
wear scenario
 Release of submicron PE debris
 Phagocytosed by macrophages-
Activated macrophages release
cytokines (IL & PGs)
 Expansion of the effective joint space
 Osteoclastic bone resorption via local
cascading events
 Osteolysis with subsequent loosening
PE Wear: common postero-superiorly
 Sum of wear and creep.
PE Linear Wear rate
 Rare if rate is <0.1mm/yr
- 90 % Surv. at 25 years
 Linear wear rate >0.2mm/yr
is undesirable in THR:
- Only 30 % surviv. likely till
20 year
 0.05mm/yr
- Practically eliminates
Risk of Osteolysis
Sochart et at CORR1999;363:135-50
LIMITATIONS
 The average lifetime of a
hip prosthesis, for
example, is around 10 to
15 years
 Active and heavyweight
patients being
particularly prone to
premature failure.
 The cost of revision
surgery is 170-200% to
the one of the original
operation
Late 1990 :: Better PE: CROSSLINKING
 Gamma Irradiation
 High Vacuum
 Ethylene Oxide Gas
Sterilization
 Adding Vit E
 Reduce shelf degradation
 Reduce in vivo degradation
SWEDISH ARTHROPLASTY REGISTRY 2010 REPORT
Significantly lower PE wear
 > 5 years postoperatively, the steady-state femoral head
penetration rate associated with first-generation HXLPE
liner was significantly lower than a conventional PE
liner.
McCalden , MacDonald , Rorabeck et al 2009.
J Bone Joint Surg Am.2009;91(4):773-82
VOLUMETRIC WEAR (MM3/YR): BEARING SURFACES
COUPLE (FEMORAL HEAD-
ACETABULAR LINER)
 Metal-UHMWPE……………………..
 Ceramic-UHMWPE…………………
 Ceramic-Ceramic with
Microseparation…………………….
 Metal-Metal……………………………
 Metal-XLUHMWPE………………….
 Ceramic-Ceramic……………………
VOLUMETRIC WEAR (MM3/YR)
38-56
17
1.5
1
0.2-5
0.04-0.1
Ceramic-on-Ceramic.
 This combination was
FDA approved for
general use in the USA in
2003
 Alumina ceramics appear
to be most appropriate
for hard-on-hard
bearings.
 Since 1970 in Europe
 < 10% of all THAs done
in the USA
PROBLEMS WITH CERAMIC
 Noisy joint: squeaking
 Dislocations more
common
 Design flaws: Esp.
Earlier designs
 Technically perfection is
needed during surgery
 Breakage : tough but
brittle
CEMENTLESS THR : C o C
Biomaterial
Modulus
of
elasticity
( GPa )
Salient Features Demerits
Stainless Steel
(316-L)
200 • Compsoition: Iron- 60%, Chromium- 20%
(major corrosion protection), Nickel- 14%
(corrosion resistance), Molybdenum- 3%
(protects against pitting corrosion) Carbon-
0.03% (incr. strength) etc.
• Can undergo corrosion if carbon gets to the
surface.
• Relatively biocompatible
• Because Young’s
modulus high, need to
be inserted with a lower
modulus polymer
cement for fixation, to
prevent stress shielding
of the surrounding
bone.
• Nearly out from
cementless
designs/systems
• Now rarely used in
new hip designs except
Exeter Charnley hip
design
Biomaterial
Modulus
of
elasticity
( GPa )
Salient Features Demerits
Cobalt Chrome
(Co-Cr)
230 • 30-60% Cobalt, 20-30% Chromium, 7-
10% Molybdenum + Nickel.
• Stronger and more corrosion resistant
than stainless steel.
• Chromium and Molybdenum are
important for corrosion resistance.
• Oxidation Resistance: This property is
almost entirely dictated by the chromium
content.
• Currently, most hip/knee implants are
made from a cobalt-chrome alloy that
slides against polyethylene bearing.
• Young’s modulus
higher than stainless
steel (250 cf 200 GPa).
Stress shielding is a
risk. Usually fixed
with cement.
Biomaterial
Modulus
of
elasticity
( GPa )
Salient Features Demerits
Titanium Alloys
12
Most common
combination is
Ti-6Al-4V ELI12
100-120 • Strong and corrosion resistant 12
• Excellent biocompatibility
• Remakable Osseointregation potential
• Young’s modulus 110GPa (less than
cobalt chrome & stainless steel)
Often used for cementless joint
replacements.
• Ultimate Strength: Stainless Steel >
Titanium; Yield Strength (permanent
deformation): Titanium > Stainless Steel
• Ti13Zr13Nb is stronger and has lower
Young’s modulus.
• “The metal of choice in the implant
industry” 12
• Poorer wear
characteristics.
• Cost
Biomaterial
Modulus
of
elasticity
( GPa )
Salient Features Demerits
Polyethylene
UHMWPE
Ultra high
molecular weight
polyethylene.
• A polymer of ethylene.
• Molecular weight 2-6 million.
• 90% success rates at 15 years with metal on
polyethylene (therefore the gold standard).
• The weak link of any
THA
• Submicron particles
found in periprosthetic
tissues
• Osteolysis produced due
to wear debris
Ceramics
Alumina/
zirconia
200-230 for • Highly biocompatible.
• Strong ionic bonds between the metallic and
nonmetallic components.
• Very strong.
• Very stiff.
• Very hard, therefore good wear characteristics.
• Bioinert e.g. Alumina, Zirconia, used for surface
replacement.
• Bioactive e.g. hydroxyapatite and glass used for
coating joint replacements for osseointegration
between bone and implant.
• But very brittle. Risk of
breakage or delamination.
• Difficult to process due to
very high melting points
therefore expensive.
Biomaterial
Modulus
of
elasticity
( GPa )
Salient Features Demerits
Bone cement
Polymethylmetha
crylate /PMMA
• Introduced over 30 years ago*
• No other fixation principle has given
better long term clinical results
• Stronger in compression than tension
• Antibiotic drug delivery capability
• Transfer of forces: Bone-to –implant
and from cement to implant-to bone is
primarily task of the cement optimally
distributing stresses and interface strain
energy like an elastic buffer
• Stress relaxation ability during non
weight bearing status reducing tensile
hoop stresses and fatigue failure
• Radiolucent
• Exothermic reaction
producing heat, Risk
of bone necrosis
• Weakest in shear
• Leakage of monomer
during polymerisation
can cause local and
sysytemic damage
• Controversy:
implant – cement
interface better in
roughened implant
surface or polished
surface
Bone cement: Polymethylmethacrylate
Biomaterial
Modulus
of
elasticity
( GPa )
Salient Features Demerits
Hydroxyapatite
coating of THR
It’s a ceramic
material
Ca10
(PO4)(OH)2
 Coated onto metal surface, usually onto
a porous surface
 Usually 50-150μm thick. Plasma spray
 Too thin can be resorbed, too thick can
flake off during insertion of implant
 Enhances osseointegration
 Good results at 5 years : 99% survival
• Some worry about
increased three body
wear on polyethylene
• Not known how
long it takes to resorb
and how stable the
implant is after
resorption
 The particles of HA
may also stimulate
osteolysis.
Hydroxyapatite coating of THR : a ceramic
material
( Data: Norwegian Arthroplasty register)
The failure scenarios in THR:
The six varieties
Type FAILURE
SCENARIO/TYPE
MECHANISM RELEVENT FOR POTENTIAL
PREVENTION
1 Accumulated-
Damage Scenario
 Mechanical damage
to the material from
repetitive loading
 It depends on the
stress and strength of
the material.
Cemented
(Fatigue failure)
+
Cementless
(Mechanical
debonding of
implant bone
interface)
Better &
advanced
cementing
Technique
Implans with
near equal
stiffness to
bone stiffness
2 Destructive-Wear
Scenario
 Mechanical wear of
the articulating
components
Cemented
+
Cementless
Nearly all bearing
surfaces in use
Avoiding THR
in young
active patients
Particulate reaction scenario:
Very important failure scenario
Type FAILURE
SCENARIO/TYPE
MECHANISM RELEVENT FOR POTENTIAL
PREVENTION
3 Particulate
Reaction
Scenario
 Closely linked to the
destructive-wear
scenario
 Release of submicron PE
debris
 Phagocytosed by
macrophages- Activated
macrophages release
cytokines (IL & PGs)
 Expansion of the
effective joint space
 Osteoclastic bone
resorption via local
cascading events
 Osteolysis with
subsequent loosening
Cemented OR
Cementless with
PE Cup
Avoiding PE surface
Thicker PE insert
Avoiding very large
head size
Using alternative
bearing
like C-o-C
Using
Highly XLHDPE
Type FAILURE SCENARIO/TYPE MECHANISM RELEVENT FOR POTENTIAL
PREVENTION
4 The Failed-
bonding scenario,
 It is impossible to rasp a bone
manually to the same shape as
the implant. Despite rasping,
minute gaps always left
undermining the implant
rigidity
Solely applicable to
cementless arthroplasties /
surgical press-fit technique.
Osteoinductive coating
helps to fill the gaps
and encourage
fixation.
BMP2
5 The stress-
shielding scenario
 Only involves the stem
 Load sharing depends on the
relative stiffness of the stem
(biomechanical feature of the
material.)
 When there is a difference in the
elasticity modulus with stiffer
implant will causes
Stress shielding of the bone (leads
to bone loss.)
 If the bone is stiffer than the
implant, failure of proximal
osseointegration might occur 24.
Cementless
+
Cemented
Avoid stainless steel
implant in cementless
system
Iso-elastic design
Failed-bonding & STRESS
SHIELDING
5 Stress-shielding
scenario
 Only involves the stem
 Load sharing depends on
the relative stiffness of
the stem (biomechanical
feature of the material.)
 When there is a
difference in the elasticity
modulus with stiffer
implant will causes
Stress shielding of the bone
(leads to bone loss.)
 If the bone is stiffer than
the implant, failure of
proximal osseointegration
might occur 24.
Cementless
+
Cemented
Avoid stainless
steel implant in
cementless system
Iso-elastic design
The stress-shielding scenario
Type FAILURE
SCENARIO/TYPE
MECHANISM RELEVENT FOR POTENTIAL
PREVENTION
6 Stress-bypass
scenario.
 It is related solely to the shape
of the Cementless femoral stem
that achieve their primary
stability by press-fit.
 In the proximal zones, the
press-fit is limited due to the
dissimilar elasticity modulus
diminishing proximal stress
transfer through the bone
forcing the prosthesis to subside
and find a new position of
stability. This progressive
secondary stability can only be
expected with a tapered femoral
stem 25. Radiologically, the
progressive stability can be seen
as calcar remodelling.
It is related solely to the
shape of the Cementless
femoral stem
The Disadvantage is raised
circumferential (hoop)
stress clinically manifests
itself as thigh pain.
To prevent this thigh
pain, various authors
have advocated
applying proximal
circumferential
porous coating to the
metaphyseal region.
Stress-bypass scenario.
Sl.N
o.
Surfaces Strength Risks
i Metal on
Polyethylene
UHMWPE
 Head size and neck length
options
 Toughness
 Long term clinical results: over
25 years 5,31
 Design effects well known
 In vivo degradation
 Wear: local and systemic toxicity
 More wear with large head sizes
 More failure with metal backed PE
insert in uncemented THR
 May be unsuitable for young patients
 Wear rate higher than HXLPE
ii Metal on
highly Cross-
linked
Polyethylene
HXLPE
 Head size and neck length
options
 Toughness
 Lesser wear
 Excellent resistance to
degradation
 Head scratches limit the benefits
 More wear with large head sizes
 Risk of fatigue crack propagation5
 Higher cost
 Shorter clinical history
Comparative merits and demerits of commonly
bearing surfaces used worldwide. 5, 28, 31
Sl.N
o.
Surfaces Strength Risks
iii Ceramic on Poly
 Reduced Wear
 Abrasion Resistance
 Low Friction
 Suitable for metal sensitive
patients
 Long term results good
 Ceramic Fracture Risk 5,28
 No Head Exchanges
 Limited head sizes
 Limited neck length options
 PE wear debris
 More osteysis with zirconia5
iv Metal on Metal
Co-Cr-
Molybdenum
alloys with finely
distributed
carbides 5,31
 Reduced volumetric Wear
 Head size options
 Large head size decreases
wear due to better fluid film
lubrication 5
 Toughness
 Self healing potential
 History of use over 30 years
 High ion Levels 5,31
 Metal allergy with
associated pain
 Less liner options
 Sensitive to Abrasion
 Osteolysis: acetabular >
femoral
 Same biological pathway for
osteolysis as PE 5
Sl.No. Surfaces Strength Risks
v Ceramic on
Ceramic
4th
generation
(delta)
Alumina on
Alumina
 Reduced Wear
 Abrasion Resistance
 Highly smooth surface
 Low Friction
 High resistance to third body wear
5
 Excellent biocompatibility
 High wettability: Reduces
adhesive wear 31
 Suitable for metal sensitive
patients
 History of use over 30 years in
Europe
 Ceramic Fracture Risk
 No Head Exchanges
 Limited Head sizes
(usually only 28mm-36 mm)
 Limited Neck Length Options
 Limited liner options
 Squeaky joint: 1.9%
 Results highly design dependent 5
 Older designs: Risk of dislocation
 Susceptible to slow crack growth
(SCG).
vi Oxidized
Zirconium*
( Oxinium )
on HXLPE
 Highly wettable,
 Abrasion resistant
 Toughness
 Low friction ceramic surface
 Zirconium alloy substrate is relatively
soft compared with co-cr
 alloy heads and may deform in contact
with acetabular shell in the case of
dislocation.
Property Unit Alumina Y-TZP ZTA ZPTA
Chemical
composition
Compression
strength
(MPa)
99.95 Al203
5000
ZrO2 + 3% Y2O3
2200
Al203 + ZrO2 + Y2O3
2900
Al203 + ZrO2+ Cr2O3+ SrO
4700
The recent introduction: clinical
use of alumina matrix
Alumina matrix composites represents the latest evolution that enhances
high hardness, toughness, and bending strength allowing manufacturing of new
design of ceramic components.86 Composites obtained introducing zirconia in
the alumina matrix, known as Zirconia ToughenedAlumina (ZTA)
Accelerated Biotechnological
Developments
 Significant advances to biomaterials used in hip joint
replacement
 But also several therapeutic risks that should not be
ignored
 M-o-M is going into disrepute again
 XLPE is in
 Alumina Ceramic is in
True biomechanical Failure in hip
replacement
 Defined as revision or potential revision due to aseptic
loosening as the end point.
 Failure usually do not occur after well performed
surgery for 10-15 years in most cases where implant
selection, implant orientation and patient selection is
right.
 Hip prostheses function well for up to 20 years in 80%
of patients, with failure rates of nearly 1% per year.
Losina, Barrett, Mahomed et al . Arthritis & rheumatism 50 (4),
2004: 1338–43
SURVIVORSHIP THR
COUNTRY JOINT
REGISTRY/STUDY
SURVIVORSHIP STUDY PERIOD
( YEARS)
NEW ZEALAND
(HYBRID)
92.97 % 10
UK
(HYBRID)
96.2 % 7
UK (M o M ) 86.4% 7
CEMENTLESS CUP 83-85% 17
FEMORAL CEMENTED 98% 17
Young Hoo Kim, Jun Shik Kim, Jang Won Park et al J Bone Joint
Surg. 2011 93: 1806-1810
J Bone Joint Surg. 2011 93: 1806-1810
Metal-on-metal THR failed at high rates.
 Failure was related to head size, with larger heads failing
earlier
 3·2% cumulative incidence of revision at 5 years for 28
mm and 5·1% for 52 mm head in men aged 60 years).
 5 year revision rates in younger women were 6·1% for 46
mm metal-on-metal compared with 1·6% for 28 mm
metal head-on-polyethylene.
 But for ceramic-on-ceramic articulations larger head sizes
were associated with improved survival (5 year revision
rate of 3·3% with 28 mm and 2% with 40 mm for men
aged 60 years).
National Joint Registry of England and Wales-The Lancet
379(9822):1199 - 1204, 2012
Interpretation
 Analysis of the National Joint Registry of England and
Wales for primary hip replacements (402 051, of which
31 171 were stemmed metal-on-metal THR) undertaken
between 2003 and 2011.
 Metal-on-metal stemmed articulations give poor implant
survival compared with other options and should not be
implanted.
 All patients with these bearings should be carefully
monitored, particularly young women implanted with
large diameter heads. Since large diameter ceramic-on-
ceramic bearings seem to do well support their continued
use.
A gist on the Limitations
 Primary stability of hip implant depends on the
geometry
 Secondary stability depends on geometry, surface
texture & coating
 Biocompatibility & biomechanical properties depends
on the biomaterials
 THR is thus a compromise between geometry, surface
texture, coating and the material properties
The exact "best" option is unknown
 The choice of bearing surface is controversial.
 The main reason for uncertainty: In vitro testing do not
always translate to similar clinical findings with new
biomaterials .
 Many contemporary "new" materials have been tried before
in their first generation forms in other countries
 The newest technologies do not have enough follow-up to
know which, if any, will be better than the current gold
standard.
 Clinical follow-up studies are ongoing: ceramics and
HXLPE
‘Fit and forget‘ biomaterial is an essential and
most desirable requirement today
 Ideally an implant should serve the lifetime of a
patient without need for a revision.
 However, implantation represents a potential assault
on the biochemical, physiological and biomechanical
structure of the human body. 3
 The compatible biomaterial in body fluids and tissue
forms stable organic complexes.
Till more evidence based results are
available
 High end revision operations will remain crucial to
salvage all failed arthroplasties
 Often in the background of poor health and in poor
bone stock in these group of patients.
 The cost of revision surgery is 170-200% more
References
1. Christian J.H. Veillette, Edward J. Harvey: The Information Age - Implications for Orthopaedic
Education. COA Bulletin. 2009 Avaiable at http://www.coa-aco.org/library/orthopaedic-
informatics/the-information-age-implications-for-orthopaedic-education.html.Accessed on Oct 2011.
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Thank you

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Currently favored Biomaterials in total hip replacements

  • 1. Currently favored biomaterials in Total Joint Replacement Dr Bhaskar Borgohain MBBS (AMC), MS (Delhi Univ.), DNB (MAMS), Joint Replacement Fellow (Computer Navigation), AO Fellow (Germany) Professor and Head of Orthopaedics NEIGRIHMS North Eastern Indira Gandhi Regional Institute of Health and Medical SciencesShillong, Meghalaya, India www.neigrihms.gov.in Proceedings of Annual Conference, Delhi Orthopedic Association at Safdarjung Hospital, New Delhi . October 31ST, 2015
  • 2. The Hip Joint is a Ball & Socket Joint
  • 3. Clinical failure of Hip Joint is common
  • 4. The Solution is Hip Replacement Surgery: To Re-create the ball & socket joint
  • 5. What is done in the surgery  Acetabular Cup: Hard/Soft  Femural Stem: Hard ( Metal alloy)  Head/ Ball: Hard (Metal alloy)  Cement: PMMA  No cement: Screws
  • 6. Hip joint is a ball and socket type of joint Contemporary THR consist of three basic components:  1) The Acetabular cup: Typically made of metal and a liner made of polyethylene (PE), ceramic or metal.  2) The Ball or Head: Replaces the head of the femur, typically made of Co-Cr alloys, stainless steel or ceramic materials (aluminium oxide or zirconium oxide).  3) The Stem: Fits into the femur, typically made of Co-Cr, titanium alloy (Ti6Al4V) or rarely 316L stainless steel.3, 4, 5
  • 7. CUP FIXATION: 2 Types Stem Fixation: 2 Types
  • 8. Cemented Versus Uncemented  Mechanical fit  Mechanical interlocking  Immediate fixation  Immediate weight bearing possible  Easy to do  Used in older people  The Gold standard  Press fit  Geometric fit-size match  Gradual fixation  Osseo-integration: By cellular growth  Difficult to do  Younger  Futuristic
  • 9. Indications for THR Today  Osteoarthritis: 93%  Fracture neck femur: 2%  Rheumatoid arthritis group: 2%  Congenital dislocation: 2%  Pain is the main indication for surgical intervention National Joint Registry , UK Data 2010
  • 10. BIOMATERIALS: DEFINITION Nonviable material used in a medical device, intended to interact with biological system  1st Biomaterials consensus conference,1986,Chester UK
  • 11. BIOMATERIALS  Biocompatibility: No corrosion, allergy or rejection in vivo  Biomechanical behavior : Elastcity modulus/stiffness closer to bone  Primary Stability: Press fit geometry : Ractangular cross section, tapered stem  Secondary stability: osseointegration… biological bonding  Wettability
  • 12. BIOMATERIALS USED IN THR Metals Ceramics Polymers 316L stainless steel* Alumina Ultra high molecular weight polyethylene (UHMWPE) Co-Cr Alloys (Vitellium) Zirconia * Polyurethane Titanium Carbon (e.g. Pyrolytic carbon) Ti6Al4V Hydroxyapatite
  • 13. Hip arthroplasty has a history spanning more than 100 years.
  • 14. National joint registries of various countries of the world Country Established in year Joints included Other data Included Public vs. private hospitals Participants/ surgeons/ Departments/% of participation Websites Sweden 1979 THR Revision +/+ 80(100%) www.jru.orthop.gu.se/ Finland 1980 THR/TKR/Others Revision/ Complications ? 80(?) www.nam.fi/english/ Norway 1987 THR/TKR/UNI/ Others Revision +/+ 70 (100%) www.haukeland.no/nr/ Denmark 1995 THR Revision/ Complications +/+ 52(100%) www.dhr.dk Australia 1998 THR/TKR/UNI Revision ++ 294(100%) www.dmac.adelaide.edu.au/aoanjr r/index.jsp Scotland 1999 THR/TKR/ Others Revision/ Complications +/- 15(100%) www.show. scot.nhs.uk/arthro/index. htm New Zealand 1999 THR/TKR/ Others Revision +/+ 62(?) www.cdhb.g ovt.nz/NJR/ Canada 2001 THR/TKR Revision +/? 72% of all hip & knee surgeons http://secure.cihi.ca/cihiweb/disp Page.jsp?cw_page=services_cjrr_e Romania 2001 THR/TKR/Others Revision +/? 69(?) www.rne.ro/public/situatii_eng.ph p England & Wales 2003 THR/TKR/ Others Revision ++ 384(94%) www.njrcentre.org.uk/
  • 15. South Africa Because of low participation (20%) and lack of support from the Ministry of Health, South Africa has suspended their joint registry (Wieting, 2011). USA Since 2009 is in pilot stage China NONE India NONE
  • 16. 1938: M.o.M Cementless Wiles •SS femoral head •Metallic components •Screws Mackee & Ring Cast Co-Cr-Molybdenum Mckee-farrar Model 1960
  • 17. Ring’s M-o-M Design 1957 Ring MoM Mckee MoM
  • 18. FUNCTIONS & FAILURES -Short term : 2 years -Intermediate : 5-7 yrs -Long term : Over 10 yrs -Very long term : >15 yrs -Wear -Aseptic osteolysis -Loosening Revision 1% per year
  • 19. Today THR is a very successful operation  Predictable  Reproducible  Benefitted millions of people with disabling hip pain across the globe  Long term failure: Biomaterial Wear …. Osteolysis  1% failure rate every year……Revision surgery
  • 20. State of the art THR Operation of the century Extremely successful in restoring near normal mobility without pain of arthritis or damage Cementless C-o-C
  • 21.
  • 24.
  • 25. Frugality & practicality  Close to 300,000 THAs performed per year in the United States.  The calculated total cost of 250,000 THAs performed in the United States during 1995 was five billion dollars. Healy WL. Clin Orthop. 1995; 102–108
  • 26. NATIONAL JOINT REGISTRY,UK  Data from 2010  THR: 76,759  6% increase than 2009  Primary surgery: 68907  Revision surgery: 7852 (11.4%)  43% Cementless THR  36% Cemented THR  16% Hybrid THR National Joint Registry , UK (Since 2003)
  • 27. The traditional bearing surfaces in THA: Metal on Plastic &… beyond  The first modern successful THR used a polished metal ball and HMWPE cup  M-o-Poly. became the standard for the first three decades.  Over the next decade manufacturing techniques have improved, but metal on UHMWPE remains the standard bearing surfaces  Alternative bearings are those that are considered highly wear-resistant and are an "alternative" to conventional polyethylene.
  • 28. Why alternatives?  Reasons for long term failures are rather Biomaterial related  Wear  Osteolysis  Hypothesis :: better biomaterials Less wear Long term results
  • 29. Release of submicron PE debris  Closely linked to the destructive- wear scenario  Release of submicron PE debris  Phagocytosed by macrophages- Activated macrophages release cytokines (IL & PGs)  Expansion of the effective joint space  Osteoclastic bone resorption via local cascading events  Osteolysis with subsequent loosening
  • 30. PE Wear: common postero-superiorly  Sum of wear and creep.
  • 31. PE Linear Wear rate  Rare if rate is <0.1mm/yr - 90 % Surv. at 25 years  Linear wear rate >0.2mm/yr is undesirable in THR: - Only 30 % surviv. likely till 20 year  0.05mm/yr - Practically eliminates Risk of Osteolysis Sochart et at CORR1999;363:135-50
  • 32. LIMITATIONS  The average lifetime of a hip prosthesis, for example, is around 10 to 15 years  Active and heavyweight patients being particularly prone to premature failure.  The cost of revision surgery is 170-200% to the one of the original operation
  • 33. Late 1990 :: Better PE: CROSSLINKING  Gamma Irradiation  High Vacuum  Ethylene Oxide Gas Sterilization  Adding Vit E  Reduce shelf degradation  Reduce in vivo degradation
  • 35. Significantly lower PE wear  > 5 years postoperatively, the steady-state femoral head penetration rate associated with first-generation HXLPE liner was significantly lower than a conventional PE liner. McCalden , MacDonald , Rorabeck et al 2009. J Bone Joint Surg Am.2009;91(4):773-82
  • 36. VOLUMETRIC WEAR (MM3/YR): BEARING SURFACES COUPLE (FEMORAL HEAD- ACETABULAR LINER)  Metal-UHMWPE……………………..  Ceramic-UHMWPE…………………  Ceramic-Ceramic with Microseparation…………………….  Metal-Metal……………………………  Metal-XLUHMWPE………………….  Ceramic-Ceramic…………………… VOLUMETRIC WEAR (MM3/YR) 38-56 17 1.5 1 0.2-5 0.04-0.1
  • 37. Ceramic-on-Ceramic.  This combination was FDA approved for general use in the USA in 2003  Alumina ceramics appear to be most appropriate for hard-on-hard bearings.  Since 1970 in Europe  < 10% of all THAs done in the USA
  • 38. PROBLEMS WITH CERAMIC  Noisy joint: squeaking  Dislocations more common  Design flaws: Esp. Earlier designs  Technically perfection is needed during surgery  Breakage : tough but brittle
  • 40. Biomaterial Modulus of elasticity ( GPa ) Salient Features Demerits Stainless Steel (316-L) 200 • Compsoition: Iron- 60%, Chromium- 20% (major corrosion protection), Nickel- 14% (corrosion resistance), Molybdenum- 3% (protects against pitting corrosion) Carbon- 0.03% (incr. strength) etc. • Can undergo corrosion if carbon gets to the surface. • Relatively biocompatible • Because Young’s modulus high, need to be inserted with a lower modulus polymer cement for fixation, to prevent stress shielding of the surrounding bone. • Nearly out from cementless designs/systems • Now rarely used in new hip designs except Exeter Charnley hip design
  • 41. Biomaterial Modulus of elasticity ( GPa ) Salient Features Demerits Cobalt Chrome (Co-Cr) 230 • 30-60% Cobalt, 20-30% Chromium, 7- 10% Molybdenum + Nickel. • Stronger and more corrosion resistant than stainless steel. • Chromium and Molybdenum are important for corrosion resistance. • Oxidation Resistance: This property is almost entirely dictated by the chromium content. • Currently, most hip/knee implants are made from a cobalt-chrome alloy that slides against polyethylene bearing. • Young’s modulus higher than stainless steel (250 cf 200 GPa). Stress shielding is a risk. Usually fixed with cement.
  • 42. Biomaterial Modulus of elasticity ( GPa ) Salient Features Demerits Titanium Alloys 12 Most common combination is Ti-6Al-4V ELI12 100-120 • Strong and corrosion resistant 12 • Excellent biocompatibility • Remakable Osseointregation potential • Young’s modulus 110GPa (less than cobalt chrome & stainless steel) Often used for cementless joint replacements. • Ultimate Strength: Stainless Steel > Titanium; Yield Strength (permanent deformation): Titanium > Stainless Steel • Ti13Zr13Nb is stronger and has lower Young’s modulus. • “The metal of choice in the implant industry” 12 • Poorer wear characteristics. • Cost
  • 43. Biomaterial Modulus of elasticity ( GPa ) Salient Features Demerits Polyethylene UHMWPE Ultra high molecular weight polyethylene. • A polymer of ethylene. • Molecular weight 2-6 million. • 90% success rates at 15 years with metal on polyethylene (therefore the gold standard). • The weak link of any THA • Submicron particles found in periprosthetic tissues • Osteolysis produced due to wear debris Ceramics Alumina/ zirconia 200-230 for • Highly biocompatible. • Strong ionic bonds between the metallic and nonmetallic components. • Very strong. • Very stiff. • Very hard, therefore good wear characteristics. • Bioinert e.g. Alumina, Zirconia, used for surface replacement. • Bioactive e.g. hydroxyapatite and glass used for coating joint replacements for osseointegration between bone and implant. • But very brittle. Risk of breakage or delamination. • Difficult to process due to very high melting points therefore expensive.
  • 44. Biomaterial Modulus of elasticity ( GPa ) Salient Features Demerits Bone cement Polymethylmetha crylate /PMMA • Introduced over 30 years ago* • No other fixation principle has given better long term clinical results • Stronger in compression than tension • Antibiotic drug delivery capability • Transfer of forces: Bone-to –implant and from cement to implant-to bone is primarily task of the cement optimally distributing stresses and interface strain energy like an elastic buffer • Stress relaxation ability during non weight bearing status reducing tensile hoop stresses and fatigue failure • Radiolucent • Exothermic reaction producing heat, Risk of bone necrosis • Weakest in shear • Leakage of monomer during polymerisation can cause local and sysytemic damage • Controversy: implant – cement interface better in roughened implant surface or polished surface Bone cement: Polymethylmethacrylate
  • 45. Biomaterial Modulus of elasticity ( GPa ) Salient Features Demerits Hydroxyapatite coating of THR It’s a ceramic material Ca10 (PO4)(OH)2  Coated onto metal surface, usually onto a porous surface  Usually 50-150μm thick. Plasma spray  Too thin can be resorbed, too thick can flake off during insertion of implant  Enhances osseointegration  Good results at 5 years : 99% survival • Some worry about increased three body wear on polyethylene • Not known how long it takes to resorb and how stable the implant is after resorption  The particles of HA may also stimulate osteolysis. Hydroxyapatite coating of THR : a ceramic material ( Data: Norwegian Arthroplasty register)
  • 46. The failure scenarios in THR: The six varieties Type FAILURE SCENARIO/TYPE MECHANISM RELEVENT FOR POTENTIAL PREVENTION 1 Accumulated- Damage Scenario  Mechanical damage to the material from repetitive loading  It depends on the stress and strength of the material. Cemented (Fatigue failure) + Cementless (Mechanical debonding of implant bone interface) Better & advanced cementing Technique Implans with near equal stiffness to bone stiffness 2 Destructive-Wear Scenario  Mechanical wear of the articulating components Cemented + Cementless Nearly all bearing surfaces in use Avoiding THR in young active patients
  • 47. Particulate reaction scenario: Very important failure scenario Type FAILURE SCENARIO/TYPE MECHANISM RELEVENT FOR POTENTIAL PREVENTION 3 Particulate Reaction Scenario  Closely linked to the destructive-wear scenario  Release of submicron PE debris  Phagocytosed by macrophages- Activated macrophages release cytokines (IL & PGs)  Expansion of the effective joint space  Osteoclastic bone resorption via local cascading events  Osteolysis with subsequent loosening Cemented OR Cementless with PE Cup Avoiding PE surface Thicker PE insert Avoiding very large head size Using alternative bearing like C-o-C Using Highly XLHDPE
  • 48. Type FAILURE SCENARIO/TYPE MECHANISM RELEVENT FOR POTENTIAL PREVENTION 4 The Failed- bonding scenario,  It is impossible to rasp a bone manually to the same shape as the implant. Despite rasping, minute gaps always left undermining the implant rigidity Solely applicable to cementless arthroplasties / surgical press-fit technique. Osteoinductive coating helps to fill the gaps and encourage fixation. BMP2 5 The stress- shielding scenario  Only involves the stem  Load sharing depends on the relative stiffness of the stem (biomechanical feature of the material.)  When there is a difference in the elasticity modulus with stiffer implant will causes Stress shielding of the bone (leads to bone loss.)  If the bone is stiffer than the implant, failure of proximal osseointegration might occur 24. Cementless + Cemented Avoid stainless steel implant in cementless system Iso-elastic design Failed-bonding & STRESS SHIELDING
  • 49. 5 Stress-shielding scenario  Only involves the stem  Load sharing depends on the relative stiffness of the stem (biomechanical feature of the material.)  When there is a difference in the elasticity modulus with stiffer implant will causes Stress shielding of the bone (leads to bone loss.)  If the bone is stiffer than the implant, failure of proximal osseointegration might occur 24. Cementless + Cemented Avoid stainless steel implant in cementless system Iso-elastic design The stress-shielding scenario
  • 50. Type FAILURE SCENARIO/TYPE MECHANISM RELEVENT FOR POTENTIAL PREVENTION 6 Stress-bypass scenario.  It is related solely to the shape of the Cementless femoral stem that achieve their primary stability by press-fit.  In the proximal zones, the press-fit is limited due to the dissimilar elasticity modulus diminishing proximal stress transfer through the bone forcing the prosthesis to subside and find a new position of stability. This progressive secondary stability can only be expected with a tapered femoral stem 25. Radiologically, the progressive stability can be seen as calcar remodelling. It is related solely to the shape of the Cementless femoral stem The Disadvantage is raised circumferential (hoop) stress clinically manifests itself as thigh pain. To prevent this thigh pain, various authors have advocated applying proximal circumferential porous coating to the metaphyseal region. Stress-bypass scenario.
  • 51. Sl.N o. Surfaces Strength Risks i Metal on Polyethylene UHMWPE  Head size and neck length options  Toughness  Long term clinical results: over 25 years 5,31  Design effects well known  In vivo degradation  Wear: local and systemic toxicity  More wear with large head sizes  More failure with metal backed PE insert in uncemented THR  May be unsuitable for young patients  Wear rate higher than HXLPE ii Metal on highly Cross- linked Polyethylene HXLPE  Head size and neck length options  Toughness  Lesser wear  Excellent resistance to degradation  Head scratches limit the benefits  More wear with large head sizes  Risk of fatigue crack propagation5  Higher cost  Shorter clinical history Comparative merits and demerits of commonly bearing surfaces used worldwide. 5, 28, 31
  • 52. Sl.N o. Surfaces Strength Risks iii Ceramic on Poly  Reduced Wear  Abrasion Resistance  Low Friction  Suitable for metal sensitive patients  Long term results good  Ceramic Fracture Risk 5,28  No Head Exchanges  Limited head sizes  Limited neck length options  PE wear debris  More osteysis with zirconia5 iv Metal on Metal Co-Cr- Molybdenum alloys with finely distributed carbides 5,31  Reduced volumetric Wear  Head size options  Large head size decreases wear due to better fluid film lubrication 5  Toughness  Self healing potential  History of use over 30 years  High ion Levels 5,31  Metal allergy with associated pain  Less liner options  Sensitive to Abrasion  Osteolysis: acetabular > femoral  Same biological pathway for osteolysis as PE 5
  • 53. Sl.No. Surfaces Strength Risks v Ceramic on Ceramic 4th generation (delta) Alumina on Alumina  Reduced Wear  Abrasion Resistance  Highly smooth surface  Low Friction  High resistance to third body wear 5  Excellent biocompatibility  High wettability: Reduces adhesive wear 31  Suitable for metal sensitive patients  History of use over 30 years in Europe  Ceramic Fracture Risk  No Head Exchanges  Limited Head sizes (usually only 28mm-36 mm)  Limited Neck Length Options  Limited liner options  Squeaky joint: 1.9%  Results highly design dependent 5  Older designs: Risk of dislocation  Susceptible to slow crack growth (SCG). vi Oxidized Zirconium* ( Oxinium ) on HXLPE  Highly wettable,  Abrasion resistant  Toughness  Low friction ceramic surface  Zirconium alloy substrate is relatively soft compared with co-cr  alloy heads and may deform in contact with acetabular shell in the case of dislocation.
  • 54. Property Unit Alumina Y-TZP ZTA ZPTA Chemical composition Compression strength (MPa) 99.95 Al203 5000 ZrO2 + 3% Y2O3 2200 Al203 + ZrO2 + Y2O3 2900 Al203 + ZrO2+ Cr2O3+ SrO 4700 The recent introduction: clinical use of alumina matrix Alumina matrix composites represents the latest evolution that enhances high hardness, toughness, and bending strength allowing manufacturing of new design of ceramic components.86 Composites obtained introducing zirconia in the alumina matrix, known as Zirconia ToughenedAlumina (ZTA)
  • 55. Accelerated Biotechnological Developments  Significant advances to biomaterials used in hip joint replacement  But also several therapeutic risks that should not be ignored  M-o-M is going into disrepute again  XLPE is in  Alumina Ceramic is in
  • 56.
  • 57. True biomechanical Failure in hip replacement  Defined as revision or potential revision due to aseptic loosening as the end point.  Failure usually do not occur after well performed surgery for 10-15 years in most cases where implant selection, implant orientation and patient selection is right.  Hip prostheses function well for up to 20 years in 80% of patients, with failure rates of nearly 1% per year. Losina, Barrett, Mahomed et al . Arthritis & rheumatism 50 (4), 2004: 1338–43
  • 58. SURVIVORSHIP THR COUNTRY JOINT REGISTRY/STUDY SURVIVORSHIP STUDY PERIOD ( YEARS) NEW ZEALAND (HYBRID) 92.97 % 10 UK (HYBRID) 96.2 % 7 UK (M o M ) 86.4% 7 CEMENTLESS CUP 83-85% 17 FEMORAL CEMENTED 98% 17 Young Hoo Kim, Jun Shik Kim, Jang Won Park et al J Bone Joint Surg. 2011 93: 1806-1810 J Bone Joint Surg. 2011 93: 1806-1810
  • 59. Metal-on-metal THR failed at high rates.  Failure was related to head size, with larger heads failing earlier  3·2% cumulative incidence of revision at 5 years for 28 mm and 5·1% for 52 mm head in men aged 60 years).  5 year revision rates in younger women were 6·1% for 46 mm metal-on-metal compared with 1·6% for 28 mm metal head-on-polyethylene.  But for ceramic-on-ceramic articulations larger head sizes were associated with improved survival (5 year revision rate of 3·3% with 28 mm and 2% with 40 mm for men aged 60 years). National Joint Registry of England and Wales-The Lancet 379(9822):1199 - 1204, 2012
  • 60. Interpretation  Analysis of the National Joint Registry of England and Wales for primary hip replacements (402 051, of which 31 171 were stemmed metal-on-metal THR) undertaken between 2003 and 2011.  Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted.  All patients with these bearings should be carefully monitored, particularly young women implanted with large diameter heads. Since large diameter ceramic-on- ceramic bearings seem to do well support their continued use.
  • 61. A gist on the Limitations  Primary stability of hip implant depends on the geometry  Secondary stability depends on geometry, surface texture & coating  Biocompatibility & biomechanical properties depends on the biomaterials  THR is thus a compromise between geometry, surface texture, coating and the material properties
  • 62. The exact "best" option is unknown  The choice of bearing surface is controversial.  The main reason for uncertainty: In vitro testing do not always translate to similar clinical findings with new biomaterials .  Many contemporary "new" materials have been tried before in their first generation forms in other countries  The newest technologies do not have enough follow-up to know which, if any, will be better than the current gold standard.  Clinical follow-up studies are ongoing: ceramics and HXLPE
  • 63. ‘Fit and forget‘ biomaterial is an essential and most desirable requirement today  Ideally an implant should serve the lifetime of a patient without need for a revision.  However, implantation represents a potential assault on the biochemical, physiological and biomechanical structure of the human body. 3  The compatible biomaterial in body fluids and tissue forms stable organic complexes.
  • 64. Till more evidence based results are available  High end revision operations will remain crucial to salvage all failed arthroplasties  Often in the background of poor health and in poor bone stock in these group of patients.  The cost of revision surgery is 170-200% more
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