title: Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial.
abstract: METHODS
  A prospective, randomized, multicenter study of surgical treatment of cervical disc disease.
  
  
  OBJECTIVE
  To assess the safety and efficacy of cervical disc arthroplasty using a new arthroplasty device at 24-months follow-up.
  
  
  BACKGROUND
  Cervical disc arthroplasty preserves motion in the cervical spine. It is an alternative to fusion after neurologic decompression, whereas anterior decompression and fusion provides a rigorous comparative benchmark of success.
  
  
  METHODS
  We conducted a randomized controlled multicenter clinical trial enrolling patients with cervical disc disease. Ultimately 242 received the investigational device (Bryan Cervical Disc), and 221 patients underwent a single-level anterior cervical discectomy and decompression and fusion as a control group. Patients completed clinical and radiographic follow-up examinations at regular intervals for 2 years after surgery.
  
  
  RESULTS
  Analysis of 12- and 24-month postoperative data showed improvement in all clinical outcome measures for both groups; however, 24 months after surgery, the investigational group patients treated with the artificial disc had a statistically greater improvement in the primary outcome variables: Neck disability index score (P = 0.025) and overall success (P = 0.010). With regard to implant- or implant/surgical-procedure-associated serious adverse events, the investigational group had a rate of 1.7% and the control group, 3.2%. There was no statistical difference between the 2 groups with regard to the rate of secondary surgical procedures performed subsequent to the index procedure. Patients who received the artificial cervical disc returned to work nearly 2 weeks earlier than the fusion patients (P = 0.015).
  
  
  CONCLUSIONS
  Two-year follow-up results indicate that cervical disc arthroplasty is a viable alternative to anterior cervical discectomy and fusion in patients with persistently symptomatic, single-level cervical disc disease.
authors.affiliation: Department of Orthopaedic Surgery, Emory University School of Medicine, The Emory Spine Center, Atlanta, GA, USA. john.heller@emoryhealthcare.or
authors.forename: John G
authors.initials: JG
authors.lastname: Heller
authors.forename: Rick C
authors.initials: RC
authors.lastname: Sasso
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Papadopoulos
authors.forename: Paul A
authors.initials: PA
authors.lastname: Anderson
authors.forename: Richard G
authors.initials: RG
authors.lastname: Fessler
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Hacker
authors.forename: Domagoj
authors.initials: D
authors.lastname: Coric
authors.forename: Joseph C
authors.initials: JC
authors.lastname: Cauthen
authors.forename: Daniel K
authors.initials: DK
authors.lastname: Riew
mesh_terms: D000328:Adult; D000368:Aged; D001178:Arthroplasty / Q000295:instrumentation* / Q000379:methods; D002574:Cervical Vertebrae / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D019299:Decompression, Surgical / Q000706:statistics & numerical data; D017586:Diskectomy / Q000706:statistics & numerical data; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D007403:Intervertebral Disc / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D007405:Intervertebral Disc Displacement / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures / Q000706:statistics & numerical data; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D019736:Prostheses and Implants / Q000639:trends*; D011859:Radiography; D013123:Spinal Fusion / Q000706:statistics & numerical data; D016896:Treatment Outcome