Five-year Results of a Randomized Controlled Trial for Lumbar Artificial Discs in Single-level Degenerative Disc Disease.

ABSTRACT

STUDY DESIGN: A prospective, multicenter, randomized, controlled, investigational device exemption (IDE) noninferiority trial. OBJECTIVE: The aim of this study was to compare the 5-year safety and effectiveness of the activL Artificial Disc with Control Total Disc Replacement (TDR) systems (ProDisc-L or Charité) in the treatment of patients with symptomatic single-level lumbar degenerative disc disease (DDD). SUMMARY OF BACKGROUND DATA The activL Artificial Disc received Food and Drug Administration approval in 2015 based on 2-year follow-up data. METHODS: Eligible patients presented with symptomatic, single-level, lumbar DDD who failed ≥6 months of nonsurgical management. At entry, 324 patients were randomly allocated (2  1) to treatment with activL (n = 218) or Control (n = 106, including n = 65 ProDisc-L and n = 41 Charité) TDR. At 5-year follow up, a total of 261 patients (176 activL patients and 85 Control patients) were available for analysis. RESULTS: The primary composite endpoint at 5 years for activL patients was noninferior to Control TDR. Relative to baseline, reductions in back pain severity and improvements in Oswestry Disability Index (ODI) were maintained for both the activL and Control TDR groups through 5 years. The activL group showed significantly better range of motion for flexion-extension rotation, flexion-extension translation, and disc angle, compared with Control TDR. Freedom from a serious adverse event through 5 years was 64% in activL patients, 47% in Control patients (log-rank P = 0.0068). Freedom from index-level and adjacent-level reoperation was high for TDR patients, ranging between 94% and 99%, respectively. CONCLUSION: Long-term evidence supports lumbar total disc replacement as safe. The next-generation activL Artificial Disc is more effective at preserving range of motion than first-generation lumbar TDRs (ProDisc-L and Charité) and offers a higher safety profile. Other primary and secondary outcomes are similar between disc designs. LEVEL OF EVIDENCE 2.