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Update on Cervical Disc Arthroplasty Brian Su, MD John Ratliff, MD Associate Professor Departments of Neurosurgery and Orthopedic Spine Surgery Thomas.

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Presentation on theme: "Update on Cervical Disc Arthroplasty Brian Su, MD John Ratliff, MD Associate Professor Departments of Neurosurgery and Orthopedic Spine Surgery Thomas."— Presentation transcript:

1 Update on Cervical Disc Arthroplasty Brian Su, MD John Ratliff, MD Associate Professor Departments of Neurosurgery and Orthopedic Spine Surgery Thomas Jefferson University

2 Almost all published after 2001 Almost all published after in last year (2 prospective RCT) 34 in last year (2 prospective RCT)

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4 Becoming a billion dollar business Becoming a billion dollar business

5 CDR mandates a critical look CDR mandates a critical look Background Background Analysis of IDE studies of FDA cleared CDR Analysis of IDE studies of FDA cleared CDR Bottom line results Bottom line results How they compare to previous studies How they compare to previous studies CDR for myelopathy CDR for myelopathy Adjacent level disease and longest available follow up Adjacent level disease and longest available follow up CPT coding changes CPT coding changes

6 Background First clinical report of CDR First clinical report of CDR Bristol-Cummins Bristol-Cummins 22 implanted for myelopathy in endstage cervical disease 22 implanted for myelopathy in endstage cervical disease Evolved into Prestige I, II, and ST (Medtronic) Evolved into Prestige I, II, and ST (Medtronic)

7 Current CDR As of 7/2009 FDA approved CDR As of 7/2009 FDA approved CDR Prestige ST (Medtronic) Prestige ST (Medtronic) Bryan (Medtronic) Bryan (Medtronic) ProDisc-C (Synthes) ProDisc-C (Synthes) Several others under IDE Several others under IDE

8 All IDE Studies Controls: Allograft and plate Controls: Allograft and plate 2 year FU 2 year FU Radiculopathy or myelopathy from single- level disease Radiculopathy or myelopathy from single- level disease Exclusion criteria Exclusion criteria Marked spondylosis/Facet joint arthrosis Marked spondylosis/Facet joint arthrosis <2 º motion at index segment <2 º motion at index segment >50% disc space collapse >50% disc space collapse Segmental instability (>3 mm translation) Segmental instability (>3 mm translation) Cervical kyphosis Cervical kyphosis

9 Prestige ST IDE Prestige ST stainless steel metal on metal ball and trough articulation Prestige ST stainless steel metal on metal ball and trough articulation CDR (276 pts) vs. ACDF (265 pts) for single level disease CDR (276 pts) vs. ACDF (265 pts) for single level disease

10 Prestige ST IDE NDI better in CDR group up to 3 mo only NDI better in CDR group up to 3 mo only Collar use? Collar use? No difference in SF 36, neck or arm pain, or return to work status No difference in SF 36, neck or arm pain, or return to work status In 2007 became first CDR FDA approved In 2007 became first CDR FDA approved

11 Prestige ST IDE CDR (27 pts) vs ACDF (28 pts) CDR (27 pts) vs ACDF (28 pts) 2 yr FU; no difference between groups 2 yr FU; no difference between groups Only one other clinical study Only one other clinical study First RCT of CDR First RCT of CDR

12 Bryan IDE Polyurethane nucleus between titanium shell Polyurethane nucleus between titanium shell CDR (242 pts) vs. ACDF (221 pts) CDR (242 pts) vs. ACDF (221 pts) Better SF-36 score and arm pain relief at 1 yr for CDR not significant at 2 yrs Better SF-36 score and arm pain relief at 1 yr for CDR not significant at 2 yrs

13 Bryan IDE Lower neck pain score for CDR at all time points Lower neck pain score for CDR at all time points

14 Bryan IDE Lower NDI score for CDR at all time points Lower NDI score for CDR at all time points Difference may not be clinically significant Difference may not be clinically significant

15 Bryan IDE Earlier return to work at 1.5 and 3 months in CDR group but not at 2 yrs Earlier return to work at 1.5 and 3 months in CDR group but not at 2 yrs RTW 13 days sooner in CDR group RTW 13 days sooner in CDR group

16 Bryan IDE 2 other studies on Bryan CDR neither with control group 2 other studies on Bryan CDR neither with control group

17 ProDisc-C IDE Metal on UHMWPE with CoCrMo alloy and midline keel Metal on UHMWPE with CoCrMo alloy and midline keel CDR (103 pts) vs. ACDF (106 pts) CDR (103 pts) vs. ACDF (106 pts) No differences in any clinical outcome measures at 1 or 2 yrs No differences in any clinical outcome measures at 1 or 2 yrs

18 IDE ProDisc-C Significant differences at 2 yrs in favor of CDR Significant differences at 2 yrs in favor of CDR Secondary surgeries Secondary surgeries 9% ACDF vs 2% CDR 9% ACDF vs 2% CDR More patients on narcotics More patients on narcotics 19% ACDF vs 10% CDR 19% ACDF vs 10% CDR Unblinded surgeon discretion used to prescribe further treatments Unblinded surgeon discretion used to prescribe further treatments

19 IDE Pro-Disc C 2 other studies on Pro-Disc C 2 other studies on Pro-Disc C Bertagnoli et al (no control group) Bertagnoli et al (no control group) Nabhan et al prospective RCT vs ACDF Nabhan et al prospective RCT vs ACDF

20 Conflict of Interest

21 Adjacent to Fusion PCM Disc: Unconstrained CoCr and UHMWPE press fit PCM Disc: Unconstrained CoCr and UHMWPE press fit Adjacent to prior fusion (26 pts) vs. primary CDR (126 pts) Adjacent to prior fusion (26 pts) vs. primary CDR (126 pts) Part of IDE study even though no ACDF control group Part of IDE study even though no ACDF control group

22 Adjacent to Fusion No differences in improvement in NDI and VAS scores between two groups No differences in improvement in NDI and VAS scores between two groups

23 ROM Preserving ROM adjacent IDP/facet forces? Preserving ROM adjacent IDP/facet forces? 3 IDE studies with 7º ROM at treated segment 3 IDE studies with 7º ROM at treated segment 15% of patients with ROM or ankylosis 15% of patients with ROM or ankylosis

24 Adjacent Level Disease Prevention of ALD is main focus of CDR Prevention of ALD is main focus of CDR Hilibrand et al repeatedly referenced in CDR papers regarding adjacent level disease Hilibrand et al repeatedly referenced in CDR papers regarding adjacent level disease

25 Adjacent Level Disease 2.9%/yr symptomatic adjacent level disease 2.9%/yr symptomatic adjacent level disease In agreement with progression in non-fusion procedures (Henderson 1983 Neurosurgery) In agreement with progression in non-fusion procedures (Henderson 1983 Neurosurgery)

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29 Adjacent Level Disease Only 1 clinical study on ALD in CDR vs fusion Only 1 clinical study on ALD in CDR vs fusion Bryan vs. Affinity cage Bryan vs. Affinity cage 2 yr FU 2 yr FU Patients from separate RCT trials Patients from separate RCT trials Cohort of patients 6 yrs apart Cohort of patients 6 yrs apart

30 Adjacent Level Disease 7% symptomatic in fusion group vs 0% in CDR 7% symptomatic in fusion group vs 0% in CDR Radiographs not blinded Radiographs not blinded Posterior osteophytes not included Posterior osteophytes not included Not CDR vs ACDF Not CDR vs ACDF

31 Long Term Results Potential 7 yr FU of first RCT CDR not reported Potential 7 yr FU of first RCT CDR not reported

32 Future Problems MRI imaging may be impossible in some devices MRI imaging may be impossible in some devices Sekhon, Duggal, et al. Spine 32: 2007 Sekhon, Duggal, et al. Spine 32: 2007 Non-titanium devices make MRI imaging impossible due to artifact Non-titanium devices make MRI imaging impossible due to artifact PCM, Prodisc C PCM, Prodisc C Could not visualize either the operated upon nor adjacent levels Could not visualize either the operated upon nor adjacent levels With titanium devices, imaging was feasible With titanium devices, imaging was feasible

33 Summary 3 CDR currently approved 3 CDR currently approved Know indications/exclusion criteria Know indications/exclusion criteria IDE studies show early benefit but for the most part equivalent to ACDF IDE studies show early benefit but for the most part equivalent to ACDF Bryan CDR less neck pain and NDI at 2 yrs Bryan CDR less neck pain and NDI at 2 yrs CDR ok for myelopathy and adjacent to fusion CDR ok for myelopathy and adjacent to fusion Benefits in ALD promising Benefits in ALD promising No published reports longer than 2 yr FU No published reports longer than 2 yr FU

34 Natural history is unclear Natural history is unclear Adjacent segment disease important Adjacent segment disease important Arthroplasty rapidly evolving Arthroplasty rapidly evolving Long term impact of cervical arthroplasty remains unclear Long term impact of cervical arthroplasty remains unclear Conclusion


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