title: A RCT comparing 7-year clinical outcomes of one level symptomatic cervical disc disease (SCDD) following ProDisc-C total disc arthroplasty (TDA) versus anterior cervical discectomy and fusion (ACDF).
abstract: The objective of this trial was to compare the safety and efficacy of TDA using the ProDisc-C implant to ACDF in patients with single-level SCDD between C3 and C7.
  
  
  
  We report on the single-site results from a larger multicenter trial of 13 sites using an approved US Food and Drug Administration protocol (prospective, randomized controlled non-inferiority design). Patients were randomized one-to-one to either the ProDisc-C device or ACDF. All enrollees were evaluated pre- and post-operatively at regular intervals through month 84. Visual Analog Scale (VAS) for neck and arm pain/intensity, Neck Disability Index (NDI), Short-Form 36 (SF-36), and satisfaction were assessed.
  
  
  
  Twenty-two patients were randomized to each arm of the study. Nineteen additional patients received the ProDisc-C via continued access. NDI improved with the ProDisc-C more than with ACDF. Total range of motion was maintained with the ProDisc-C, but diminished with ACDF. Neck and arm pain improved more in the ProDisc-C than ACDF group. Patient satisfaction remained higher in the ProDisc-C group at 7 years. SF-36 scores were higher in the TDA group than ACDF group at 7 years; the difference was not clinically significant. Six additional operations (two at the same level; four at an adjacent level) were performed in the ACDF, but none in the ProDisc-C group.
  
  
  
  The ProDisc-C implant appears to be safe and effective for the treatment of SCDD. Patients with the implant retained motion at the involved segment and had a lower reoperation rate than those with an ACDF.
authors: OrthoCarolina Spine Center, 2001 Randolph Road, Charlotte, NC, 28207, USA.
authors: Thomas P
authors: TP
authors: Loumeau
authors: OrthoCarolina Spine Center, 2001 Randolph Road, Charlotte, NC, 28207, USA. bruce.darden@orthocarolina.com.
authors: Bruce V
authors: BV
authors: Darden
authors: OrthoCarolina Spine Center, 2001 Randolph Road, Charlotte, NC, 28207, USA.
authors: Thomas J
authors: TJ
authors: Kesman
authors: OrthoCarolina Research Institute, 2001 Vail Avenue, Suite 300, Charlotte, NC, 28207, USA.
authors: Susan M
authors: SM
authors: Odum
authors: OrthoCarolina Research Institute, 2001 Vail Avenue, Suite 300, Charlotte, NC, 28207, USA.
authors: Bryce A
authors: BA
authors: Van Doren
authors: OrthoCarolina Spine Center, 2001 Randolph Road, Charlotte, NC, 28207, USA.
authors: Eric B
authors: EB
authors: Laxer
authors: OrthoCarolina, PA, 4601 Park Road, Suite 300, Charlotte, NC, 28209, USA.
authors: Daniel B
authors: DB
authors: Murrey
mesh_terms: D000328:Adult; D002574:Cervical Vertebrae / Q000601:surgery*; D004185:Disability Evaluation; D017586:Diskectomy / Q000379:methods*; D005260:Female; D006801:Humans; D055959:Intervertebral Disc Degeneration / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D007405:Intervertebral Disc Displacement / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009333:Neck / Q000503:physiopathology; D019547:Neck Pain / Q000209:etiology / Q000601:surgery; D010147:Pain Measurement / Q000379:methods; D017060:Patient Satisfaction; D011446:Prospective Studies; D019736:Prostheses and Implants; D011474:Prosthesis Design; D016059:Range of Motion, Articular; D012086:Reoperation / Q000706:statistics & numerical data; D013123:Spinal Fusion / Q000379:methods*; D059145:Total Disc Replacement / Q000379:methods*; D016896:Treatment Outcome; D014481:United States; D064232:Visual Analog Scale; D055815:Young Adult
keywords: Anterior cervical discectomy and fusion; Clinical trial; Outcomes; ProDisc-C; Symptomatic cervical disc disease; Total disc arthroplasty