disc replacement vs. fusion surgery sanjay jatana, md concepts, rationale, and results february 22,...
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Disc Replacement vs. Fusion Surgery
Sanjay Jatana, MD
Concepts, Rationale, and Results
February 22, 2013
Disclosures
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
Sanjay Jatana, MD
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
Cervical Fusion Indications
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
Fusion Rates
One Level ACDF 93-95% Two Level ACDF 70-75% (100%) Three Level ACDF 50-60%
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 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
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
“Improve the Environment”
Don’t Fuse Laminectomy Laminoplasty Multilevel arthroplasty
Anterior Corpectomy/Discectomy Accept pseudoarthrsis rate and address as needed
Mechanical – Plate, Screw designs Biological – Bone, Cells, BMP’s
EJ – 6mo, 1year
Spinal Fusion
Positive Stops motion at a
vertebral motion segment
Affords Stability Long track record Maintains vertebral
alignment Maintains central &
foraminal decompression
Negative 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
Treat the neurologic problem from anterior approach
Fill the VOID that is created by the decompression.
Lumbar Disc Replacement
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
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 Long-standing topic of debate. Strict operational criteria, ISIS
VAS, pressure difference at pain from opening pressure, anesthetic response, control levels, CT scan to evaluate grade of annular tear.
False positive Rate is 10% 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#
**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
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 rangeZigler, JE., Delamarter, RB., et al., SPINE in publication 2012
Prodisc-C C5-6 Primary
Prodisc-C 7 year Results
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
CDR 100% would have it again (91.7% fusion) One – level problem
Murrey, DB., Zigler, JE. et al., NASS Annual Mtg, 2012.
Bryan CDREight-Year Clinical and Radiological Follow-Upof 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 5/84 (6%) 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)
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 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 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 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
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.
Pimanta, LH., Marchi, L., Oliveira, L., NASS Annual Mtg., 2012
Disc Replacement Technology
Unanswered questionsLong term wearRevision strategiesInsurance coverageMulti-level approval and success
Disc Replacement vs. Fusion Surgery
Sanjay Jatana, MD
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
Summary 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%/yearCervical 2-3%/year
Summary
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 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 DiseaseACDF vs. Arthroplasty
• 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
Sanjay Jatana, MD
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
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