Five-Year Results of the ProDisc-L Multicenter, Prospective, Randomized, Controlled Trial Comparing ProDisc-L With Circumferential Spinal Fusion for Single-Level Disabling Degenerative Disk Disease

Lumbar total disk replacement (TDR) has been used in Europe for many years and since 2000 in the United States with the initiation of the Food and Drug Administration investigational device exemption trials. Patients enrolled in those prospective, randomized, controlled trials have now reached 5-year follow-up, the results of which are reported here for the ProDisc-L device. The follow-up rate at 5 years was 81.8% of the 236 patients randomized to either TDR or combined anterior/posterior instrumented fusion. In general, the results were stable from the 2- to 5-year follow-up periods. Both groups remained significantly improved from baseline, with noninferiority of the TDR compared with fusion being maintained. At 5-year follow-up, the range of motion of the levels treated with TDR was 7.7°. The study found that TDR and fusion are both viable treatments for chronic painful degenerative disk disease, with clinical improvements being maintained throughout the 5-year follow-up.