title: A prospective, randomized, controlled clinical investigation comparing PCM cervical disc arthroplasty with anterior cervical discectomy and fusion. 2-year results from the US FDA IDE clinical trial.
abstract: METHODS
  Prospective, multicenter, randomized Food and Drug Administration approved investigational device exemption clinical trial.
  
  
  OBJECTIVE
  To evaluate the safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in the treatment of patients with degenerative spondylosis and neurological symptoms at 1 level between C3-C4 and C7-T1.
  
  
  BACKGROUND
  Cervical disc arthroplasty in the treatment of symptomatic cervical spondylosis has been studied in other series. The PCM Cervical Disc is a nonconstrained motion-sparing alternative to ACDF.
  
  
  METHODS
  Patients 18 to 65 years of age with single-level symptomatic cervical spondylosis with radiculopathy and/or myelopathy unresponsive to nonoperative treatment were enrolled, including patients with prior nonadjacent or adjacent single-level fusions. The per-protocol patient sample at 2 years included 342 patients (189 PCM, 153 ACDF). Longitudinal outcomes were comparatively evaluated.
  
  
  RESULTS
  At 2 years postoperatively, clinical measures-neck and arm pain visual analogue scale, Neck Disability Index (NDI), SF-36, and neurological status-were significantly improved from preoperative baselines in both groups. Mean NDI score at 2 years was significantly lower in PCM group (P = 0.029). There were no statistical differences between groups in rates of surgery-related serious adverse events (5.6% PCM, 7.4% ACDF) or secondary surgical procedures (5.2% PCM, 5.4% ACDF). Patients with PCM reported lower dysphagia scores (8.8/100 vs. 12.1/100; P = 0.045) and higher patient satisfaction (82.8/100 vs. 81.4/100). Overall success, a composite endpoint including minimum 20% NDI improvement, no major complications, no neurological worsening, no secondary surgical procedures, and meeting radiographical criteria of motion for PCM and fusion for ACDF, was significantly greater in the PCM group (75.1% vs. 64.9%; P = 0.020).
  
  
  CONCLUSIONS
  The treatment of symptomatic single-level cervical spondylosis with PCM achieves clinical outcomes that are at least equivalent to ACDF while maintaining motion. At 2 years, patients with PCM had lower NDI scores, statistically lower rate of prolonged dysphagia, greater patient satisfaction, and superior overall success.
authors.affiliation: Midwest Orthopaedics at Rush University Medical Center, Chicago, IL 60612, USA. fphillips@rushortho.com
authors.forename: Frank M
authors.initials: FM
authors.lastname: Phillips
authors.forename: Joe Y B
authors.initials: JY
authors.lastname: Lee
authors.forename: Fred H
authors.initials: FH
authors.lastname: Geisler
authors.forename: Andrew
authors.initials: A
authors.lastname: Cappuccino
authors.forename: Christopher D
authors.initials: CD
authors.lastname: Chaput
authors.forename: John G
authors.initials: JG
authors.lastname: DeVine
authors.forename: Christopher
authors.initials: C
authors.lastname: Reah
authors.forename: Kye M
authors.initials: KM
authors.lastname: Gilder
authors.forename: Kelli M
authors.initials: KM
authors.lastname: Howell
authors.forename: Paul C
authors.initials: PC
authors.lastname: McAfee
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002574:Cervical Vertebrae / Q000503:physiopathology / Q000601:surgery*; D004185:Disability Evaluation; D017586:Diskectomy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019547:Neck Pain / Q000175:diagnosis / Q000503:physiopathology; D010147:Pain Measurement; D011446:Prospective Studies; D016059:Range of Motion, Articular; D013118:Spinal Cord Diseases / Q000150:complications / Q000503:physiopathology / Q000601:surgery; D013123:Spinal Fusion / Q000379:methods*; D055009:Spondylosis / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D011795:Surveys and Questionnaires; D013997:Time Factors; D059145:Total Disc Replacement / Q000379:methods*; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult