RT Journal Article SR Electronic T1 Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results JF International Journal of Spine Surgery JO Int J Spine Surg FD International Society for the Advancement of Spine Surgery SP 8083 DO 10.14444/8083 A1 Kris Radcliff A1 Jack Zigler A1 Ernest Braxton A1 Glen Buttermann A1 Dom Coric A1 Peter Derman A1 Rolando Garcia A1 Anton Jorgensen A1 Nicole C. Ferko A1 Aaron Situ A1 James Yue YR 2021 UL http://ijssurgery.com//content/early/2021/07/12/8083.abstract AB Background This study compared 7-year safety and efficacy outcomes of activL and ProDisc-L lumbar total disc replacements in patients with symptomatic, single-level lumbar degenerative disc disease (DDD). The objectives are to report 7-year outcomes of the trial, evaluate the outcomes for patients lost to follow-up, and determine whether early outcomes predict long-term outcomes.Methods This was a prospective, multicenter, randomized, controlled investigational device exemption study. Eligible patients with symptomatic, single-level lumbar DDD had failed ≥6 months of nonsurgical management. Patients (N = 283) were randomized to receive activL (n = 218) or ProDisc-L (n = 65). At 7 years, data were available from 206 patients (activL, 160; ProDisc-L, 46). Logistic regression models were fit to predict 7-year outcomes for patients lost to follow-up after 2 years.Results At 7 years, the activL group was noninferior to the ProDisc-L group on the primary composite endpoint (P = .0369). Both groups showed significant reductions in back/leg pain severity and improvements in disability index and quality-of-life relative to baseline (P < .0001). In both groups, opioid use was significantly reduced at 7 years (0%) relative to baseline (P < .01), and the overall reoperation rates were low (4.6%). activL patients showed a significantly better range of motion (ROM) for flexion-extension rotation than ProDisc-L patients (P = .0334). A significantly higher proportion of activL patients did not report serious adverse events (activL, 62%; ProDisc-L, 43%; P = .011). Predictive modeling indicated that >70% of patients (depending on outcome) lost to follow-up after 2 years would show clinically significant improvement at 7 years if improvements were achieved at 2 years.Conclusions The benefits of activL and ProDisc-L are maintained after 7 years, with significant improvements from baseline observed in pain, function, and opioid use. activL is more effective at preserving ROM than ProDisc-L and has a more favorable safety profile. Improvements in other primary and secondary outcomes were similar between both disc designs.Level of Evidence 1.