PT  - JOURNAL ARTICLE
AU  - Radcliff, Kris
AU  - Zigler, Jack
AU  - Braxton, Ernest
AU  - Buttermann, Glen
AU  - Coric, Dom
AU  - Derman, Peter
AU  - Garcia, Rolando
AU  - Jorgensen, Anton
AU  - Ferko, Nicole C.
AU  - Situ, Aaron
AU  - Yue, James
TI  - Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results
AID  - 10.14444/8083
DP  - 2021 Aug 01
TA  - International Journal of Spine Surgery
PG  - 612--632
VI  - 15
IP  - 4
4099  - https://www.ijssurgery.com/content/15/4/612.short
4100  - https://www.ijssurgery.com/content/15/4/612.full
SO  - Int J Spine Surg2021 Aug 01; 15
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.