Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results.
| Autor: | Radcliff K; Rothman Orthopedic Institute, Philadelphia, Pennsylvania., Zigler J; Texas Back Institute, Plano, Texas., Braxton E; Vail Health Vail Summit Orthopaedics and Neurosurgery, Vail, Colorado., Buttermann G; Midwest Spine & Brain Institute, Stillwater, Minnesota., Coric D; Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina., Derman P; Texas Back Institute, Plano, Texas., Garcia R; Orthopedic Care Center, Aventura, Florida., Jorgensen A; Ortho San Antonio, San Antonio, Texas., Ferko NC; CRG-EVERSANA Canada, Inc, Burlington, Ontario, Canada., Situ A; CRG-EVERSANA Canada, Inc, Burlington, Ontario, Canada., Yue J; Frank H. Netter School of Medicine, Quinnipiac University, Hamden, Connecticut. |
|---|---|
| Jazyk: | angličtina |
| Zdroj: | International journal of spine surgery [Int J Spine Surg] 2021 Aug; Vol. 15 (4), pp. 612-632. Date of Electronic Publication: 2021 Jul 15. |
| DOI: | 10.14444/8083 |
| Abstrakt: | 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. (This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2021 ISASS.) |
| Databáze: | MEDLINE |
| Externí odkaz: |
|