title: Randomized, controlled, multicenter, clinical trial comparing BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion in China.
abstract: METHODS
  Prospective, randomized, controlled, multicenter clinical trial.
  
  
  OBJECTIVE
  To compare outcomes of cervical disc arthroplasty with those of anterior cervical decompression and fusion (ACDF) in a Chinese population.
  
  
  BACKGROUND
  Cervical disc arthroplasty has been found to be superior to ACDF for maintaining range of motion (ROM) at the index spinal segment and possibly will avoid abnormal stress to adjacent segments.
  
  
  METHODS
  A total of 120 patients from 3 large hospitals in China were randomly assigned to treatment with cervical disc arthroplasty (n = 60) using the BRYAN prosthesis or ACDF (n = 60) and were observed postoperatively for 24 months.
  
  
  RESULTS
  The 2 groups had similar preoperative demographics and baseline characteristics including ROM, neck disability index, and visual analogue scale for neck and arm pain. The total disc replacement (TDR) group had a significantly longer operation time than the ACDF group (P < 0.001). Outcome data obtained after 24 months revealed a significant difference between the groups in mean change from baseline in ROM at the index level (P < 0.001); ROM was maintained in the TDR group but reduced in the ACDF group. There were no significant between-group differences in the baseline changes in neck disability index or visual analogue scale scores for pain. One patient in the TDR group and 4 patients in the ACDF group required reoperations.
  
  
  CONCLUSIONS
  At 24 months after surgery, the cervical disc prosthesis yielded good clinical results while maintaining ROM at the index level. Cervical disc arthroplasty appears to be a viable alternative to ACDF.
authors.affiliation: Division of Orthopaedics, Chinese PLA General Hospital, Beijing, China.
authors.forename: Xuesong
authors.initials: X
authors.lastname: Zhang
authors.forename: Xuelian
authors.initials: X
authors.lastname: Zhang
authors.forename: Chao
authors.initials: C
authors.lastname: Chen
authors.forename: Yonggang
authors.initials: Y
authors.lastname: Zhang
authors.forename: Zheng
authors.initials: Z
authors.lastname: Wang
authors.forename: Bin
authors.initials: B
authors.lastname: Wang
authors.forename: Wangjun
authors.initials: W
authors.lastname: Yan
authors.forename: Ming
authors.initials: M
authors.lastname: Li
authors.forename: Wen
authors.initials: W
authors.lastname: Yuan
authors.forename: Yan
authors.initials: Y
authors.lastname: Wang
mesh_terms: D000328:Adult; D002574:Cervical Vertebrae / Q000601:surgery*; D002681:China; D019299:Decompression, Surgical / Q000379:methods*; D017586:Diskectomy / Q000379:methods; D005260:Female; D006801:Humans; D055959:Intervertebral Disc Degeneration / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011446:Prospective Studies; D016059:Range of Motion, Articular; D013123:Spinal Fusion / Q000379:methods*; D059145:Total Disc Replacement / Q000379:methods*; D016896:Treatment Outcome