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

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.