Five-year Reoperation Rates, Cervical Total Disc Replacement versus Fusion, Results of a Prospective Randomized Clinical Trial.

ABSTRACT: Study Design. Prospective randomized controlled trial (RCT).Objective. Determine the reasons for, and rates of, secondary surgical intervention through 5 years at both the index and adjacent levels in patients treated with cervical total disc replacement (TDR) or anterior cervical discectomy and fusion (ACDF). TDR patients were treated with ProDisc-C.Summary of Background Data. Several outcome-based prospective, randomized clinical trials have shown cervical TDR to be equivalent if not superior to fusion. The ability of TDR to allow decompression while maintaining motion has led many to suggest that adjacent level degeneration as well as reoperation rates may be decreased when compared to fusion.Methods. A total of 209 patients were treated and randomized (103 TDR and 106 ACDF) at 13 sites. A secondary surgical intervention at any level was considered a reoperation.Results. At 5 years, the ProDisc-C patients had statistically significant higher probability of no secondary surgery at the index and adjacent levels compared to the ACDF patients (97.1% vs 85.5%, p = 0.0079). No reoperations in ProDisc-C patients were performed for implant breakages or device failures. For ACDF patients, the most common reason for reoperation at the index level was pseudarthrosis, and for both ACDF and TDR patients the most common reason for adjacent level surgery was recurrent neck and/or arm pain.Conclusions. 5-year follow-up of a prospective RCT revealed 5-fold difference in re-operation rates when comparing ACDF treated patients (14.5%) to TDR (2.9%). These findings suggest the durability of TDR, as well its potential to slow the rate of adjacent level disease.