Cervical disc replacement

Report
Disc Replacement vs. Fusion Surgery
Concepts, Rationale, and Results
February 22, 2013
Sanjay Jatana, MD
Disclosures
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Conflict of Interest: None
Paid Consultant: Zimmer
FDA IDE Study site : PCM disc replacement
Hospital Agreement: Rose Spine Institute
State of the Art
Disc Replacement vs. Fusion Surgery
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Cervical fusion indications & examples
Cervical fusion results and problems
 Ongoing research
Rationale for fusion vs. disc replacement
Cervical disc replacement results
Disc replacement positives/negatives
Fusion positives/negatives
Summary
Sanjay Jatana, MD
Cervical Fusion Indications
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SPINAL ISTABILITY due to
 Acute fracture with or without progressive neurological progression,
tumor, abscess, infection, deformity
SPINAL STENOSIS with Spondylolisthesis or documented instability
POSTERIOR APPROACH
PRIOR SPINAL SUGERY with
 Adjacent segment degeneration
 Recurrent Disc Herniation
 Spondylolisthesis
 Pseudoarthrosis (12 months)
DISC HERNIATION
SPINAL STENOSIS WITH TREATMENT FROM
ANTERIOR APPROACH
AR, 3 level Fusion
Pseudoarthrosis
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Fusion Rates
One Level ACDF 93-95%
 Two Level ACDF 70-75% (100%)
 Three Level ACDF 50-60%
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Two & Three Level Fusion Rates
UNACCEPTABLE
Anterior Cervical Pseudarthrosis
67% symptomatic
(28% asymptomatic for 2 years)
33% asymptomatic
Re-operation : fusion: 19 Excellent, 1 Good
Phillips, FM et al: Spine, 1997
Bohlman, HH., et. al: JBJS, 1993
Patient TT – C5 Stabilized
C5-6 Rotation = 1.1º; C4-5 Rotation = 5.0º
Anterior Cervical Fusion
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Overall success range from 70-90%
Historical standard of care
Surgery for disc herniation and one and two
level problem do better than surgery for 3 or
more levels, cord compression, deformity
Surgery for neck pain is less successful
As more levels get involved, problems exist that
have not been solved
Levels above and below breakdown over time
Prodisc-C for ALD
OPTIONS
Anterior Cervical Fusion & Non-union
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Pseudoarthrosis rates vary
Patients may be asymptomatic for a long time
No agreed upon radiographic criteria, probably underestimated
Treatment Options not perfect
 Revision anterior fusion
 Posterior spinal fusion
 BMP use in the neck is OFF-LABEL
 Not 100% successful
 Higher complications
Stand alone laminectomy / laminoplasty / foraminotomy, non
fusion options have limitations
AR – 3 - LEVEL PSF
“Improve the Environment”
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Don’t Fuse
Laminectomy
 Laminoplasty
 Multilevel arthroplasty
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Anterior Corpectomy/Discectomy
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Accept pseudoarthrsis rate and address as needed
Mechanical – Plate, Screw designs
Biological – Bone, Cells, BMP’s
EJ – 6mo, 1year
Spinal Fusion
Positive
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Stops motion at a vertebral
motion segment
Affords Stability
Long track record
Maintains vertebral alignment
Maintains central &
foraminal decompression
Negative
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Irreversible
Approach related
denervation and soft tissue
scarring
Long term effects on
adjacent levels
Non-union (pseudoarthrosis)
Hardware related problems
Rationale Differences
Cervical Disc Replacement
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Treat the neurologic problem
from anterior approach
Fill the VOID that is created by
the decompression.
Lumbar Disc Replacement
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Treat low back pain
Neurologic problem not
primary concern
Assuming DISC is the cause
Lumbar DR rationale not same as cervical DR rationale
Treatment of Low Back & Neck Pain
with Fusion or Disc Replacement
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Replacing a painful disc rather than fusion is ATTRACTIVE
Ability to diagnose a painful disc is IMPRECISE
 History & Physical Exam, X-rays: Low sensitivity &
specificity
 MRI: 19-28% false positive findings in younger patients
 Injections can help with facet joint pain
 Discogram is the only test to establish disc as the cause
Provocation Discography
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Long-standing topic of debate.
Strict operational criteria, ISIS
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VAS, pressure difference at pain from opening pressure, anesthetic
response, control levels, CT scan to evaluate grade of annular tear.
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False positive Rate is 10%
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Systematic analysis with strict operational criteria False positive rate is
6% and specificity of 94%.**
Re-analysis 38 months after discography led to 1.3% new pathology#
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**Wolfer LR, Derby R, Lee JE, Lee SH, Pain Physician, 11: 4, 513-38 2008
#Johnson RG, Spine, 14:4, 424-26, 1989.
BRYAN Disc Replacement
Prodisc-C and ACDF FDA Study Results
5 year
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Randomized controlled trial, 103 Prodisc-C, 106 ACDF
NDI, VAS, SF-36 SINGLE LEVEL PROBLEM
2 year, 5 year all clinically significant IMPROVEMENT from
baseline
5 year: Prodisc-C had less NECK PAIN intensity and
frequency
Secondary surgery: Prodisc-C 2.9%, ACDF 11.3%
NDI: 50 to 23 range, VAS Neck pain 7 to 2 range
Zigler, JE., Delamarter, RB., et al., SPINE in publication 2012
Prodisc-C C5-6 Primary
PCM 2005 PG
PCM 2005 CB
Prodisc-C 7 year Results
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81.8% available for follow up
NDI, VAS similar in both fusion and CDR
Secondary procedures showed difference
5.8% CDR, 16% fusion
 7.2% CDR developed bridging bone
 3.8% Fusion developed Non-union
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CDR 100% would have it again (91.7%
fusion) One – level problem
Murrey, DB., Zigler, JE. et al., NASS Annual Mtg, 2012.
Bryan CDR
Eight-Year Clinical and Radiological Follow-Up
of the Bryan Cervical Disc Arthroplasty, Gerald M. Y. Quan, MBBS, FRACS, PhD,
Jean-Marc Vital, MD, PhD, Steve Hansen, MD, and Vincent Pointillart, MD, PhD,
SPINE Volume 36, Number 8, pp 639–646,2011. FRANCE
Randomized, Controlled, Multicenter, Clinical Trial Comparing BRYAN Cervical
Disc Arthroplasty With Anterior Cervical Decompression and Fusion in CHINA
Xuesong Zhang , MD , Xuelian Zhang , PhD , Chao Chen , PhD , Yonggang Zhang ,
MD , Zheng Wang , MD , Bin Wang , MD , * Wangjun Yan , MD , Ming Li , MD , Wen
Yuan , MD , and Yan Wang , MD SPINE Volume 37, Number 6, pp 433–438 2012.
Comparison of BRYAN Cervical Disc Arthroplasty With Anterior Cervical
Decompression and Fusion Clinical and Radiographic Results of a Randomized,
Controlled, Clinical Trial John G. Heller, MD,Rick C. Sasso, MD,Stephen M.
Papadopoulos, MD,Paul A. Anderson, MD, Richard G. Fessler, MD, PhD, Robert J.
Hacker, MD, Domagoj Coric, MD, Joseph C. Cauthen, MD, and Daniel K. Riew, MD
SPINE Volume 34, Number 2, pp 101–107 2009. USA
REOPERATION
CDR
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5/84 (6%)
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Mean follow-up 49.7 mo.
(1) Decompression same level
(1) Decompression same level and
adjacent level
(2) Adjacent level (HNP)
(1) SCS for pain mgmt
Longer time to re-op (55.9 mo)
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FUSION
9/51 (17.6%)
Mean follow-up 49.7 mo.
(4) Pseudoarthrosis
(5) Adjacent level (DD, HNP)
Shorter time to re-op (27.5 mo)
Reoperation rate less and survival longer for CDR group
Blumenthal, SL., et al., NASS Annual Mtg, 2012.
Adjacent Level Radiographic Degeneration
CDR / Fusion Prodisc – C
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48% CDR, 78% Fusion (p<0.0001)
Increase ROM superior level Fusion (p<0.0233)
Increase ROM inferior level Fusion (p<0.0876)
Adjacent level degeneration lower in the CDR group.
Higher rate of ALD in the fusion group related to higher ROM
at adjacent levels.
Spivak, JM., Delamarter, RB., et al., NASS Annual Mtg, 2012
Artificial Disc Replacement
Positive
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Early mobilization
Maintains motion at painful
disc level
Less stress shifted to adjacent
levels
Similar if not better than a
fusion
More cost effective with less
time off from work
Negative
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No long term data in USA
Requires more attention to
decompression of neural structures
Long term wear effects of bearing
surface unknown
Aging of spine and implant survival
unknown
May ultimately require fusion of
the motion segment
Revision more complicated
Lumbar Total Disc Replacement
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Overall beneficial (Charite, XLTDR, Phisio-L, Maverick, Prodisc, Mibidisc, Active-L)
Long term complications
Persistent LBP 9.1%
 Facet Degeneration 25%
 Misplacements 8.5%
 Subsidence 7%
 Partial explantations 2%
 Fracture 2%
 Retrievals 6.21%
Model dependent, facet pain, core fracture, pedicle fracture, scoliosis, HO
formation, CrCo allergy, subsidence, mal-positioning.
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Pimanta, LH., Marchi, L., Oliveira, L., NASS Annual Mtg., 2012
Disc Replacement Technology
Unanswered questions
Long term wear
Revision strategies
Insurance coverage
Multi-level approval and success
Disc Replacement vs. Fusion Surgery
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Lumbar & Cervical fusion indications & examples
Cervical fusion results and problems
 Ongoing research
Lumbar fusion concepts and results re: low back pain
Rationale for fusion vs. disc replacement
Lumbar & Cervical disc replacement results
Disc replacement positives/negatives
Fusion positives/negatives
Summary
Sanjay Jatana, MD
Summary
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Fusion surgery for LBP caused by a
symptomatic degenerative disc in properly
selected patients has an acceptable success rate.
Fusion surgery on the cervical spine for one and
two level problem still offers good to excellent
results
Both lead to adjacent level degeneration
Lumbar 3%/year
Cervical 2-3%/year
Summary
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Disc Replacement technology is safe and
effective. (FDA/IDE )
Disc replacement in the low back is also
acceptable treatment but long term revision and
conversion to a fusion is a likely reality.
Cervical disc replacement offers a better
solution than fusion for one and two level
disease in properly selected patients.
Summary
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Revision strategies are easier with less potential
complications for cervical disc replacement.
Overall lumbar disc replacement at 7 years is
equal to lumbar fusion
Overall cervical disc replacement is better than
fusion for single level patient with a disc
herniation re: result, neck pain, revision rates.
Patients need to understand that additional
surgery is likely in the future with either
option.
Adjacent Segment Disease
ACDF vs. Arthroplasty
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Analysis of Prospective Studies (6), 2-5yr FU
Sample size 1,586 (ACDF = 777, TDA = 809)
70% overall follow-up
36 (6.9%) ACDF repeat surgery (50 patients*)
30 (5.1%) TDA repeat surgery (58 patients*)
NO Detectable difference in rate of ASD
More time
Verma, K., et al. Rothman Institute, CSRS, 2012
* 2.9% yearly incedence of symptomatic adjacent level
Disc Replacement vs. Fusion Surgery
Confusion (from Latin confusĭo, -ōnis, noun of
action from confundere "to pour together", or "to
mingle together"[1] also "to confuse") is the state of
being bewildered or unclear in one’s mind about
something:[2] Wikipedia
Sanjay Jatana, MD

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