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Disc Replacement vs. Fusion Surgery

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  1. Disc Replacement vs. Fusion Surgery Sanjay Jatana, MD Concepts, Rationale, and Results February 22, 2013

  2. Disclosures • Conflict of Interest: None • Paid Consultant: Zimmer • FDA IDE Study site : PCM disc replacement • Hospital Agreement: Rose Spine Institute

  3. State of the Art

  4. 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

  5. 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

  6. AR, 3 level Fusion

  7. 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

  8. 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

  9. Patient TT – C5 Stabilized C5-6 Rotation = 1.1º; C4-5 Rotation = 5.0º

  10. 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

  11. Prodisc-C for ALD

  12. OPTIONS

  13. 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

  14. AR – 3 - LEVEL PSF

  15. “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

  16. EJ – 6mo, 1year

  17. Spinal Fusion Positive Negative Irreversible Approach related denervation and soft tissue scarring Long term effects on adjacent levels Non-union (pseudoarthrosis) Hardware related problems • Stops motion at a vertebral motion segment • Affords Stability • Long track record • Maintains vertebral alignment • Maintains central & foraminal decompression

  18. 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

  19. Treatment of Low Back & Neck Painwith 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

  20. Provocation Discography **Wolfer LR, Derby R, Lee JE, Lee SH, Pain Physician, 11: 4, 513-38 2008 #Johnson RG, Spine, 14:4, 424-26, 1989. • 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#

  21. BRYAN Disc Replacement

  22. Prodisc-C and ACDF FDA Study Results 5 year Zigler, JE., Delamarter, RB., et al., SPINE in publication 2012 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

  23. Prodisc-C C5-6 Primary

  24. PCM 2005 PG

  25. PCM 2005 CB

  26. Prodisc-C 7 year Results Murrey, DB., Zigler, JE. et al., NASS Annual Mtg, 2012. • 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

  27. 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, pp639–646,2011. FRANCE Randomized, Controlled, Multicenter, Clinical Trial Comparing BRYAN Cervical Disc ArthroplastyWith Anterior Cervical Decompression and Fusion in CHINA XuesongZhang , MD , Xuelian Zhang , PhD , Chao Chen , PhD , YonggangZhang , MD , ZhengWang , MD , Bin Wang , MD , * Wangjun Yan , MD , Ming Li , MD , Wen Yuan , MD , and Yan Wang , MD SPINE Volume 37, Number 6, pp433–438 2012. Comparison of BRYAN Cervical Disc ArthroplastyWith Anterior Cervical Decompression and Fusion Clinical and Radiographic Results of a Randomized, Controlled, Clinical Trial John G. Heller, MD,RickC. Sasso, MD,StephenM. Papadopoulos, MD,PaulA. Anderson, MD, Richard G. Fessler, MD, PhD, Robert J. Hacker, MD, DomagojCoric, MD, Joseph C. Cauthen, MD, and Daniel K. Riew, MD SPINE Volume 34, Number 2, pp101–107 2009. USA

  28. REOPERATION CDR 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) • 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) Reoperation rate less and survival longer for CDR group Blumenthal, SL., et al., NASS Annual Mtg, 2012.

  29. Adjacent Level Radiographic Degeneration CDR / Fusion Prodisc – C Spivak, JM., Delamarter, RB., et al., NASS Annual Mtg, 2012 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.

  30. Artificial Disc Replacement Positive 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 • 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

  31. 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

  32. Disc Replacement Technology Unanswered questions Long term wear Revision strategies Insurance coverage Multi-level approval and success

  33. 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

  34. 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%/year Cervical 2-3%/year

  35. 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.

  36. 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.

  37. Adjacent Segment DiseaseACDF vs. Arthroplasty Verma, K., et al. Rothman Institute, CSRS, 2012 * 2.9% yearly incedence of symptomatic adjacent level • 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

  38. Disc Replacement vs. Fusion Surgery Sanjay Jatana, MD Confusion (from Latinconfusĭo, -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