• Domagoj Coric, Todd Albert, and Kris Radcliff.
• Neurosurgery. 2015 Aug 1;62 Suppl 1:221.

IntroductionThe purpose of this study is to independently review and report the 5-year results of an Investigational Device Exemption study of total disc replacement (TDR) (Mobi-C) vs anterior cervical discectomy and fusion (ACDF) for the treatment of 2-level, contiguous, symptomatic cervical degenerative disc disease.MethodsThis study reports the 5-year results of a prospective, US FDA IDE pivotal trial of the Mobi-C cervical artificial disc for the treatment of contiguous 2-level cervical disease. The comparative control treatment was ACDF. A total of 330 patients were enrolled. The primary clinical outcome was an FDA-defined composite measure of study success at 60 months involving improvement in neck disability index (NDI) = 15 points, avoidance of reoperation, and absence of device-related adverse events or neurological complications. Validated outcomes measures including NDI, Visual Analog Scale (VAS), and SF-12 were utilized.ResultsA total of 225 patients received the Mobi-C TDR device and 105 patients received ACDF. The Mobi-C and ACDF follow-up rates were 90.7% and 88.6%, respectively. Both groups showed significant improvements in all outcome scores relative to baseline at each time point up to 60 months. There was a significantly increased percentage of successful TDR patients (61%) vs ACDF patients (31%) at 60 months. The TDR patients had significantly more improvement than ACDF patients in NDI score, SF12 PCS, and overall satisfaction with treatment at 60 months. Finally, the overall reoperation rate was significantly higher in the ACDF group at 16% compared with 4% in the TDR group.ConclusionAnterior cervical surgery for contiguous 2-level pathology was safe and effective in improving patient outcome and quality of life at 5 years in both groups. There were fewer incidences of index level and adjacent level reoperation in the disc replacement group. Overall, we conclude that TDR was superior to ACDF for treatment of 2-level contiguous pathology at 5 years.

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