title: Lumbar Total Disc Replacement for Discogenic Low Back Pain: Two-year Outcomes of the activL Multicenter Randomized Controlled IDE Clinical Trial.
abstract: METHODS
  A prospective, multicenter, randomized, controlled, investigational device exemption (IDE) noninferiority trial.
  
  
  OBJECTIVE
  The aim of this study was to evaluate the comparative safety and effectiveness of lumbar total disc replacement (TDR) in the treatment of patients with symptomatic degenerative disc disease (DDD) who are unresponsive to nonsurgical therapy.
  
  
  BACKGROUND
  Lumbar TDR has been used to alleviate discogenic pain and dysfunction while preserving segmental range of motion and restoring stability. There is a paucity of data available regarding the comparative performance of lumbar TDR.
  
  
  METHODS
  Patients presenting with symptomatic single-level lumbar DDD who failed at least 6 months of nonsurgical management were randomly allocated (2:1) to treatment with an investigational TDR device (activL, n = 218) or FDA-approved control TDR devices (ProDisc-L or Charité, n = 106). The hypothesis of this study was that a composite effectiveness outcome at 2 years in patients treated with activL would be noninferior (15% delta) to that in controls.
  
  
  RESULTS
  The primary composite endpoint of this study was met, which demonstrated that the activL TDR was noninferior to control TDR (P < 0.001). A protocol-defined analysis of the primary composite endpoint also confirmed that activL was superior to controls (P = 0.02). Radiographic success was higher with activL versus controls (59% vs. 43%; P < 0.01). Mean back pain severity improved by 74% with activL and 68% with controls. Oswestry Disability Index scores decreased by 67% and 61% with activL and controls, respectively. Patient satisfaction with treatment was over 90% in both groups at 2 years. Return to work was approximately 1 month shorter (P = 0.08) with activL versus controls. The rate of device-related serious adverse events was lower in patients treated with activL versus controls (12% vs. 19%; P = 0.13). Surgical reintervention rates at the index level were comparable (activL 2.3%, control 1.9%).
  
  
  CONCLUSIONS
  The single-level activL TDR is safe and effective for the treatment of symptomatic lumbar DDD through 2 years.
  
  
  METHODS
  2.
authors.affiliation: *Orthopedic Care Center†Yale School of Medicine‡Texas Back Institute§Carolina Neurosurgery and Spine Associates¶Anschutz Medical Campus, University of Colorado||SENTA Clinic and Scripps Health**Illinois Neurological Institute††Midwest Spine Institute‡‡Rush University Medical Center§§Hospital for Special Surgery¶¶Florida Orthopaedic Institute||||Miller Scientific Consulting, Inc.
authors.forename: Rolando
authors.initials: R
authors.lastname: Garcia
authors.forename: James J
authors.initials: JJ
authors.lastname: Yue
authors.forename: Scott
authors.initials: S
authors.lastname: Blumenthal
authors.forename: Dom
authors.initials: D
authors.lastname: Coric
authors.forename: Vikas V
authors.initials: VV
authors.lastname: Patel
authors.forename: Scott P
authors.initials: SP
authors.lastname: Leary
authors.forename: Dzung H
authors.initials: DH
authors.lastname: Dinh
authors.forename: Glenn R
authors.initials: GR
authors.lastname: Buttermann
authors.forename: Harel
authors.initials: H
authors.lastname: Deutsch
authors.forename: Federico
authors.initials: F
authors.lastname: Girardi
authors.forename: James
authors.initials: J
authors.lastname: Billys
authors.forename: Larry E
authors.initials: LE
authors.lastname: Miller
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D007403:Intervertebral Disc / Q000601:surgery*; D055959:Intervertebral Disc Degeneration / Q000601:surgery*; D017116:Low Back Pain / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D059145:Total Disc Replacement / Q000009:adverse effects* / Q000379:methods*