Five-year results of a randomized controlled trial for lumbar artificial discs in single-level degenerative disc disease
Spine Dec 14, 2019
Yue JJ, Garcia R, Blumenthal S, et al. - In this prospective, multicenter, randomized, controlled, investigational device exemption noninferiority trial, 324 individuals were randomized to treatment with activL (n = 218) or control (n = 106, including n = 65 ProDisc-L and n = 41 Charité) Total Disc Replacement (TDR) to contrast the 5-year safety and efficiency of the activL Artificial Disc with Control TDR systems (ProDisc-L or Charité) in the treatment of people with symptomatic single-level lumbar degenerative disc disease. Long-term evidence sustains lumbar TDR as a safe method. Thus, compared with first-generation lumbar TDRs (ProDisc-L and Charité), the next-generation activL Artificial Disc is more efficient at conserving the range of motion and proposes a greater safety profile. Moreover, other primary and secondary outcomes are comparable between disc designs.
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