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

2. Disclosures Conflict of Interest: None Conflict of Interest: None Paid Consultant: Zimmer Paid Consultant: Zimmer FDA IDE Study site : PCM disc replacement FDA IDE Study site : PCM disc replacement Hospital Agreement: Rose Spine Institute 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 Cervical fusion results and problems Ongoing research Ongoing research Rationale for fusion vs. disc replacement Rationale for fusion vs. disc replacement Cervical disc replacement results Cervical disc replacement results Disc replacement positives/negatives Disc replacement positives/negatives Fusion positives/negatives Fusion positives/negatives Summary Summary

5. Cervical Fusion Indications SPINAL ISTABILITY due to SPINAL ISTABILITY due to Acute fracture with or without progressive neurological progression, tumor, abscess, infection, deformity Acute fracture with or without progressive neurological progression, tumor, abscess, infection, deformity SPINAL STENOSIS with Spondylolisthesis or documented instability POSTERIOR APPROACH SPINAL STENOSIS with Spondylolisthesis or documented instability POSTERIOR APPROACH PRIOR SPINAL SUGERY with PRIOR SPINAL SUGERY with Adjacent segment degeneration Adjacent segment degeneration Recurrent Disc Herniation Recurrent Disc Herniation Spondylolisthesis Spondylolisthesis Pseudoarthrosis (12 months) Pseudoarthrosis (12 months) DISC HERNIATION DISC HERNIATION SPINAL STENOSIS WITH TREATMENT FROM ANTERIOR APPROACH SPINAL STENOSIS WITH TREATMENT FROM ANTERIOR APPROACH

6. AR, 3 level Fusion

7. Pseudoarthrosis Fusion Rates Fusion Rates One Level ACDF 93-95% One Level ACDF 93-95% Two Level ACDF 70-75% (100%) Two Level ACDF 70-75% (100%) Three Level ACDF 50-60% 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, 1997Bohlman, 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% Overall success range from 70-90% Historical standard of care 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 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 Surgery for neck pain is less successful As more levels get involved, problems exist that have not been solved As more levels get involved, problems exist that have not been solved Levels above and below breakdown over time Levels above and below breakdown over time

11. Prodisc-C for ALD

12. OPTIONS

13. Anterior Cervical Fusion & Non-union Pseudoarthrosis rates vary Pseudoarthrosis rates vary Patients may be asymptomatic for a long time Patients may be asymptomatic for a long time No agreed upon radiographic criteria, probably underestimated No agreed upon radiographic criteria, probably underestimated Treatment Options not perfect Treatment Options not perfect Revision anterior fusion Revision anterior fusion Posterior spinal fusion Posterior spinal fusion BMP use in the neck is OFF-LABEL BMP use in the neck is OFF-LABEL Not 100% successful Not 100% successful Higher complications Higher complications Stand alone laminectomy / laminoplasty / foraminotomy Stand alone laminectomy / laminoplasty / foraminotomy, non fusion options have limitations

14. AR – 3 - LEVEL PSF

15. “Improve the Environment” Don’t Fuse Don’t Fuse Laminectomy Laminectomy Laminoplasty Laminoplasty Multilevel arthroplasty Multilevel arthroplasty Anterior Corpectomy/Discectomy Anterior Corpectomy/Discectomy Accept pseudoarthrsis rate and address as needed Accept pseudoarthrsis rate and address as needed Mechanical – Plate, Screw designs Mechanical – Plate, Screw designs Biological – Bone, Cells, BMP’s Biological – Bone, Cells, BMP’s

16. EJ – 6mo, 1year

17. 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

18. Rationale Differences Cervical Disc Replacement Treat the neurologic problem from anterior approach Treat the neurologic problem from anterior approach Fill the VOID that is created by the decompression. 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 Pain with Fusion or Disc Replacement Replacing a painful disc rather than fusion is ATTRACTIVE Replacing a painful disc rather than fusion is ATTRACTIVE Ability to diagnose a painful disc is IMPRECISE Ability to diagnose a painful disc is IMPRECISE History & Physical Exam, X-rays: Low sensitivity & specificity History & Physical Exam, X-rays: Low sensitivity & specificity MRI: 19-28% false positive findings in younger patients MRI: 19-28% false positive findings in younger patients Injections can help with facet joint pain Injections can help with facet joint pain Discogram is the only test to establish disc as the cause Discogram is the only test to establish disc as the cause

20. Provocation Discography Long-standing topic of debate. Long-standing topic of debate. Strict operational criteria, ISIS Strict operational criteria, ISIS VAS, pressure difference at pain from opening pressure, anesthetic response, control levels, CT scan to evaluate grade of annular tear. 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% False positive Rate is 10% Systematic analysis with strict operational criteria False positive rate is 6% and specificity of 94%.** 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# 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.

22. BRYAN Disc Replacement

23. Prodisc-C and ACDF FDA Study Results 5 year Randomized controlled trial, 103 Prodisc-C, 106 ACDF Randomized controlled trial, 103 Prodisc-C, 106 ACDF NDI, VAS, SF-36 SINGLE LEVEL PROBLEM NDI, VAS, SF-36 SINGLE LEVEL PROBLEM 2 year, 5 year all clinically significant IMPROVEMENT from baseline 2 year, 5 year all clinically significant IMPROVEMENT from baseline 5 year: Prodisc-C had less NECK PAIN intensity and frequency 5 year: Prodisc-C had less NECK PAIN intensity and frequency Secondary surgery: Prodisc-C 2.9%, ACDF 11.3% Secondary surgery: Prodisc-C 2.9%, ACDF 11.3% NDI: 50 to 23 range, VAS Neck pain 7 to 2 range NDI: 50 to 23 range, VAS Neck pain 7 to 2 range Zigler, JE., Delamarter, RB., et al., SPINE in publication 2012

24. Prodisc-C C5-6 Primary

25. PCM 2005 PG

26. PCM 2005 CB

27. Prodisc-C 7 year Results 81.8% available for follow up 81.8% available for follow up NDI, VAS similar in both fusion and CDR NDI, VAS similar in both fusion and CDR Secondary procedures showed difference Secondary procedures showed difference 5.8% CDR, 16% fusion 5.8% CDR, 16% fusion 7.2% CDR developed bridging bone 7.2% CDR developed bridging bone 3.8% Fusion developed Non-union 3.8% Fusion developed Non-union CDR 100% would have it again (91.7% fusion) One – level problem CDR 100% would have it again (91.7% fusion) One – level problem Murrey, DB., Zigler, JE. et al., NASS Annual Mtg, 2012.

28. 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

29. 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.

30. Adjacent Level Radiographic Degeneration CDR / Fusion Prodisc – C 48% CDR, 78% Fusion (p<0.0001) 48% CDR, 78% Fusion (p<0.0001) Increase ROM superior level Fusion (p<0.0233) Increase ROM superior level Fusion (p<0.0233) Increase ROM inferior level Fusion (p<0.0876) Increase ROM inferior level Fusion (p<0.0876) Adjacent level degeneration lower in the CDR group. Adjacent level degeneration lower in the CDR group. Higher rate of ALD in the fusion group related to higher ROM at adjacent levels. 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

31. 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

32. Lumbar Total Disc Replacement Overall beneficial (Charite, XLTDR, Phisio-L, Maverick, Prodisc, Mibidisc, Active-L) Overall beneficial (Charite, XLTDR, Phisio-L, Maverick, Prodisc, Mibidisc, Active-L) Long term complications Long term complications Persistent LBP 9.1% Persistent LBP 9.1% Facet Degeneration 25% Facet Degeneration 25% Misplacements 8.5% Misplacements 8.5% Subsidence 7% Subsidence 7% Partial explantations 2% Partial explantations 2% Fracture 2% Fracture 2% Retrievals 6.21% Retrievals 6.21% Model dependent, facet pain, core fracture, pedicle fracture, scoliosis, HO formation, CrCo allergy, subsidence, mal-positioning. 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

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

34. Disc Replacement vs. Fusion Surgery Sanjay Jatana, MD Lumbar & Cervical fusion indications & examples Lumbar & Cervical fusion indications & examples Cervical fusion results and problems Cervical fusion results and problems Ongoing research Ongoing research Lumbar fusion concepts and results re: low back pain Lumbar fusion concepts and results re: low back pain Rationale for fusion vs. disc replacement Rationale for fusion vs. disc replacement Lumbar & Cervical disc replacement results Lumbar & Cervical disc replacement results Disc replacement positives/negatives Disc replacement positives/negatives Fusion positives/negatives Fusion positives/negatives Summary

35. Summary Fusion surgery for LBP caused by a symptomatic degenerative disc in properly selected patients has an acceptable success rate. 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 Fusion surgery on the cervical spine for one and two level problem still offers good to excellent results Both lead to adjacent level degeneration Both lead to adjacent level degeneration Lumbar 3%/year Cervical 2-3%/year

36. Summary Disc Replacement technology is safe and effective. (FDA/IDE ) 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. 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. Cervical disc replacement offers a better solution than fusion for one and two level disease in properly selected patients.

37. Summary Revision strategies are easier with less potential complications for cervical disc replacement. 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 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. 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. Patients need to understand that additional surgery is likely in the future with either option.

38. Adjacent Segment Disease ACDF vs. Arthroplasty Analysis of Prospective Studies (6), 2-5yr FU Analysis of Prospective Studies (6), 2-5yr FU Sample size 1,586 (ACDF = 777, TDA = 809) Sample size 1,586 (ACDF = 777, TDA = 809) 70% overall follow-up 70% overall follow-up 36 (6.9%) ACDF repeat surgery (50 patients*) 36 (6.9%) ACDF repeat surgery (50 patients*) 30 (5.1%) TDA repeat surgery (58 patients*) 30 (5.1%) TDA repeat surgery (58 patients*) NO Detectable difference in rate of ASD NO Detectable difference in rate of ASD More time More time Verma, K., et al. Rothman Institute, CSRS, 2012 * 2.9% yearly incedence of symptomatic adjacent level

39. 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 Latin [1] [2] WikipediaLatin [1] [2] Wikipedia