Abstract
Background Over the past 20 years, multiple randomized controlled trials have shown cervical disc arthroplasty (CDA) to be safe and effective for treating 1- and 2-level degenerative disc disease (DDD). The purpose of this postmarket study is to compare 10-year outcomes between CDA and anterior cervical discectomy and fusion (ACDF) from a randomized study at 3 centers.
Methods This study was a continuation of a randomized, prospective, multicenter clinical trial comparing CDA with the Mobi-C cervical disc (Zimmer Biomet) vs ACDF. Following completion of the 7-year US Food and Drug Administration study, 10-year follow-up was obtained from consenting patients at 3 high-enrolling centers. The clinical and radiographic endpoints collected at 10 years included composite success, Neck Disability Index, neck and arm pain, short form-12, patient satisfaction, adjacent-segment pathology, major complications, and subsequent surgery.
Results A total of 155 patients were enrolled (105 CDA; 50 ACDF). Follow-up was obtained from 78.1% of patients eligible after 7 years. At 10 years, CDA demonstrated superiority to ACDF. Composite success was 62.4% in CDA and 22.2% in ACDF (P < 0.0001). The cumulative risk of subsequent surgery at 10 years was 7.2% vs 25.5% (P = .001), and the risk of adjacent-level surgery was 3.1% vs 20.5% (P = .0005) in CDA vs ACDF, respectively. The progression to radiographically significant adjacent-segment pathology at 10 years was lower in CDA vs ACDF (12.9% vs 39.3%; P = 0.006). At 10 years, patient-reported outcomes and change from baseline were generally better in CDA patients. A higher percentage of CDA patients reported they were “very satisfied” at 10 years (98.7% vs 88.9%; P = 0.05).
Conclusions In this postmarket study, CDA was superior to ACDF for treating symptomatic cervical DDD. CDA was statistically superior to ACDF for clinical success, subsequent surgery, and neurologic success. Results through 10 years demonstrate that CDA continues to be a safe and effective surgical alternative to fusion.
Clinical Relevance The results of this study support the long-term safety and effectiveness of cervical disc arthroplasty with the Mobi-C.
Level of Evidence 1.
- cervical disc arthroplasty
- Mobi-C
- degenerative disc disease
- adjacent-segment pathology
- anterior cervical discectomy and fusion
Footnotes
Funding The device manufacturer, Zimmer Biomet, initiated and funded the Mobi-C© FDA IDE clinical trial and postapproval study. Zimmer Biomet contributed to the design and conduct of the study, and provided assistance with analysis of data, manuscript preparation, and review. ZimVie Spine paid the article processing charge. The authors received no additional financial support for the research and authorship of this article.
Declaration of Conflicting Interests Pierce Nunley reports royalties/licenses for Spineology, Stryker, ZimVie, Camber Spine and Accelus; consulting fees from Spineology, Camber Spine, Accelus, Centinel Spine, Intrinsic Therapeutics, Providence Medical, Neo Spine, NuVasive, NG Medical, ReGelTec, and Spinal Elements; payment/honoraria from Spineology, Camber Spine, Intrinsic Therapeutics, Providence Medical, and Neo Spine; leadership/fiduciary role for 3Spine; stock/stock options from Spineology, Camber Spine, ReGelTec, and 3Spine; and patent holder and consultant for Zimmer Biomet. Michael Hisey reports royalties/licenses; payment/honoraria and support for meetings/travel for lectures, presentations, speakers bureaus, manuscript writing, or education events; and patents for Zimmer Biomet. Micah Smith has nothing to disclose. Marcus Stone reports consulting fees from Spineology, Camber Spine, Organogenesis, Vyrsa, and ReGelTec; payment/honoraria and support for meetings/travel for lectures, presentations, speakers bureaus, manuscript writing, or education events from Spineology and Organogenesis; support for attending meetings/travel from Spineology; and a leadership or fiduciary role in Clinical Research I/O and the NASS Section on Surgical Engineering.
Ethics Approval Institutional review board approval and patient informed consent were obtained at each investigational site.
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