title: Multi-center, prospective, randomized, controlled investigational device exemption clinical trial comparing Mobi-C Cervical Artificial Disc to anterior discectomy and fusion in the treatment of symptomatic degenerative disc disease in the cervical spine.
abstract: BACKGROUND
  Anterior cervical discectomy and fusion (ACDF) is the gold standard for treating symptomatic cervical disc degeneration. Cervical total disc replacements (TDRs) have emerged as an alternative for some patients. The purpose of this study was to evaluate the safety and effectiveness of a new TDR device compared with ACDF for treating single-level cervical disc degeneration.
  
  
  METHODS
  This was a prospective, randomized, controlled, multicenter Food and Drug Administration (FDA) regulated Investigational Device Exemption (IDE) study. A total of 245 patients were treated (164 TDR: 81 ACDF). The primary outcome measure was overall success based on improvement in Neck Disability Index (NDI), no subsequent surgical interventions, and no adverse events (AEs) classified as major complications. Secondary outcome measures included SF-12, visual analog scale (VAS) assessing neck and arm pain, patient satisfaction, radiographic range of motion, and adjacent level degeneration. Patients were evaluated preoperatively and postoperatively at 6 weeks, 3, 6, 12, 18, and 24 months. The hypothesis was that the TDR success rate was non-inferior to ACDF at 24 months.
  
  
  RESULTS
  Overall success rates were 73.6% for TDR and 65.3% for ACDF, confirming non-inferiority (p < 0.0025). TDR demonstrated earlier improvements with significant differences in NDI scores at 6 weeks and 3 months, and VAS neck pain and SF-12 PCS scores at 6 weeks (p<0.05). Operative level range of motion in the TDR group was maintained throughout follow-up. Radiographic evidence of inferior adjacent segment degeneration was significantly greater with ACDF at 12 and 24 months (p < 0.05). AE rates were similar.
  
  
  CONCLUSIONS
  Mobi-C TDR is a safe and effective treatment for single-level disc degeneration, producing outcomes similar to ACDF with less adjacent segment degeneration.
  
  
  METHODS
  Level I.
  
  
  CONCLUSIONS
  This study adds to the literature supporting cervical TDR as a viable option to ACDF in appropriately selected patients with disc degeneration.
authors.affiliation: Texas Back Institute, Denton, TX.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Hisey
authors.affiliation: The Spine Institute at St. John's Health Center, Santa Monica, CA.
authors.forename: Hyun W
authors.initials: HW
authors.lastname: Bae
authors.affiliation: GBMC Healthcare Greater Baltimore Neurosurgical Associates, Baltimore MD.
authors.forename: Reginald
authors.initials: R
authors.lastname: Davis
authors.affiliation: Oklahoma Spine & Brain Institute, Tulsa, OK.
authors.forename: Steven
authors.initials: S
authors.lastname: Gaede
authors.affiliation: Orthopedic North East, Fort Wayne, IN.
authors.forename: Greg
authors.initials: G
authors.lastname: Hoffman
authors.affiliation: University of California Davis Medical Center, Sacramento, CA.
authors.forename: Kee
authors.initials: K
authors.lastname: Kim
authors.affiliation: Spine Institute of Louisiana, Shreveport, LA.
authors.forename: Pierce D
authors.initials: PD
authors.lastname: Nunley
authors.affiliation: Neurological Specialists of Austin, Austin, TX.
authors.forename: Daniel
authors.initials: D
authors.lastname: Peterson
authors.affiliation: Texas Back Institute, Plano, TX.
authors.forename: Ralph
authors.initials: R
authors.lastname: Rashbaum
authors.affiliation: Neurological Specialists of Austin, Austin, TX.
authors.forename: John
authors.initials: J
authors.lastname: Stokes
keywords: Cervical Spine; anterior cervical fusion; clinical outcome; randomized study; total disc replacement