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Systematic Review Finds Cervical Disc Replacement Equal to Fusion
1. Ingrid Zechmeister • Roman Winkler •
Philipp Mad
A systematic review
Eur Spine J (2011)
2. Introduction
Spine disorders
are related to a
major burden
of d/s in
industrialised
world.
One of the
main causes of
pain &
neurological
symptoms in
the cervical
spine are DDD
Pain can also be caused by
other spinal structures
such as facet joints &
furthermore, degenerative
processes & protrusions
are very common & mostly
do not cause symptoms.
3. Usually, pain or neurological symptoms in
the cervical spine are treated with non-
surgical methods
-If this Rx fails, surgical interventions may be
considered.
ACDF - the gold std for Sx Rx of pts with
non-responsive symptoms in cervical spine,
although not for pure axial neck pain.
4. As an alternative to
arthrodesis
Cervical total disc
replacement (CTDR) is
increasingly applied
for surgical Rx.
5.
6. During the surgical procedure, the degenerated disc is removed
completely & replaced by an artificial device.
Different products from various manufacturers exist.
7. It has been
suggested that
CTDR maintains
anatomical disc
space ht,
normal segmental
lordosis &
physiological
motion patterns.
- It avoids adjacent disc degeneration (ADD) that has been
observed in pts after fusion
8. Cervical disc replacement
Indicated in pts with pain (radiculopathy &
myelopathy) or neurological symptoms related
to disc degeneration on one level b/w C3 & C7
after unsuccessful conservative Rx for at least 6
weeks unless in cases of severe or progressing
neurological deficits.
10. Literature search (Medline via Ovid, Embase, Cochrane Central Register of
Controlled Trials, NHS-CRD-HTA (INAHTA) – b/w 2000 & Jan 2010 & to pub’s in
English or German.
In Medline & Embase, search restricted to high-level evidence
Acc. to ‘evidence-based medicine stds’& RCTs selected only from ref’s identified.
Selection of ref’s & data extraction was done by 2 researchers independently.
For summarising the evidence, GRADE methodology was used that provides a tool
to grade the evidence according to pre-defined criteria for each outcome
parameter selected
METHOD
15. Efficacy of CTDR compared with fusion
After 2 years, studies consistently
demonstrated that in terms of the
combined endpoint ‘overall success’
artificial disc replacement (with the
products Pro-Disc C, Prestige St, Bryan
Cervical disc) is not inferior to fusion
Non-inferiority was statistically significant.
Additionally, two studies showed a slight &
statistically significant superiority of 4–11%
points
16. Bryan Total Cervical Disc®
single-piece prosthesis: metal and polyurethane
device
17. Prestige ST cervical disc
anatomic end-plate design with reduced
endplate thickness
Prestige I
20. Safety of CTDR compared with fusion
VS
- No procedure related deaths were reported.
-Frequency of complications was very similar b/w the two groups but
differed considerably between studies.
21. M/c compli. in both groups were ‘general
compli.’ (e.g. wound infection, dysphagia/
dysphonia, allergic reactions) seen in maximal
one-third of patients in both groups.
One study - a significantly higher rate of ADD
in fusion group , however, rate of secondary
Sx procedures was not statistically different
b/w groups
(up to 5% of prothesis- pts & up to 9% of
fusion pts had to undergo a re-operation).
23. • In two studies, Patients in the prothesis group
returned to work on average 15 days earlier
than patients in the fusion group. However, no
difference in the employment rate was found
after 2 years.
24.
25.
26. Discussion
• The review has shown that individual patient-related
outcomes (quality of life, pain reduction, disability)
were not better in the prosthesis group than in the
fusion group.
• Although marginal superiority could be demonstrated
for specific sub-parameters (e.g. return to work), the
benefit is relative in the general context.
• For eg, while some studies demonstrated that pts after
disc replacement return to work a few days earlier, the
overall employment rate after 2 years did not differ
between the groups.
• Complications are similar in both groups.
27. • Cervical total disc replacement has been
presented as a promising new technology to treat
patients with pain or neurological symptoms
secondary to degenerated discs that do not
respond to conservative treatment within 6
weeks.
• Evidence from randomised controlled clinical
studies has shown that after 2 years CTDR is
equal to fusion surgery in terms of outcomes and
complications.
Remove the anterior bone spurs then remove the disc & guide two drill holes for guide pin..distract the disc space..prepare the disc space ..remove posterior bone spurs..place trials to look for proper fitness ..make the trial to fit in perfectly..this device creates a saucer haped depresion
literature search was restricted
to the period between 2000 and January 2010 and to
publications in English or German. In Medline and Embase,
we restricted the search to high-level evidence
according to ‘evidence-based medicine standards’ and we
selected RCTs only from the references identified. Selection
of references and data extraction was done by two
researchers independently. For summarising the evidence,
we used the GRADE methodology that provides a tool to
grade the evidence according to pre-defined criteria for
each outcome parameter selected
- low friction, wear resistant elastic nucleus.
This nucleus is set b/w & articulates with two Ti plates covered with porous coating and screwed to the vertebral bodies.
-A flexible membrane surrounds the construct. Theoretically, it allows range of motion in all planes.
This device has been approved for use in Canada since Oct 2003
Bristol - Cummins - Frenchay cervical disc is the early predecessor of this series of Prestige discs I, II, ST and the most recent one STLP.
The Prestige disc is basically a ball & socket type metal on metal disc made from stainless steel.
Another disc replacement design using a metal-on-metal joint to imitate normal motion at the cervical disc space is the Cervicore prosthesis. The Cervicore is a metal-on-metal design having a saddle-shaped bearing surface. This surface permits the device to maintain a centre of rotation for flexion/extension in the vertebral body below and simultaneously maintaining a centre of rotation in the bone above for lateral bending.[10]
Till now there are no clinical data available at the time this review is written. So far this device is not yet in U.S. clinical trails.