title: Long-term Outcomes of the US FDA IDE Prospective, Randomized Controlled Clinical Trial Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion.
abstract: METHODS
  Prospective, multicenter, randomized clinical trial.
  
  
  OBJECTIVE
  To evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in treatment of patients with symptomatic single-level degenerative spondylosis between C3-C4 and C7-T1 with or without prior cervical fusion.
  
  
  BACKGROUND
  The 2-year results of the PCM Cervical Disc trial have been reported previously. The current study reports the long-term results of the same trial.
  
  
  METHODS
  Patients with single-level cervical spondylosis and radiculopathy with or without myelopathy unresponsive to nonoperative treatment were enrolled. The per protocol patient sample at 5 years included 293 patients (163 PCM, 130 ACDF). Adverse events and secondary surgical procedures are reported on the cohorts through current follow-up, which include 110 patients (68 PCM, 42 ACDF) at 7 years.
  
  
  RESULTS
  At 5 years postoperative, all patient-reported outcomes-neck and arm pain visual analogue scale score, neck disability index, and general health (36-Item Short Form Health Survey physical and mental component scores: physical component summary, mental component summary)-were significantly improved from baselines in both groups, and mean scores were significantly better in the PCM group for neck disability index (P=0.001), neck pain (P=0.002), general health (Pphysical component summary=0.014; Pmental component summary=0.004), and patient satisfaction (P=0.005). PCM patients trended toward fewer 2- to 7-year device-related serious adverse events (1/214, 0.5% PCM; 2/190, 1.1% ACDF) and secondary surgical procedures (7/211, 3.3% PCM; 14/290, 7.6% ACDF). Adjacent-level degeneration was radiographically more frequent after ACDF (33.1% PCM, 50.9% ACDF; P=0.006) and was the primary indication for the increase in late-term secondary surgical procedures after ACDF.
  
  
  CONCLUSIONS
  The long-term results show good clinical outcomes after ACDF and PCM arthroplasty. PCM patients showed greater improvement in neck disability index and neck pain scores with a lower rate of radiographical adjacent-level degeneration and a trend toward fewer secondary surgical procedures. These data support PCM arthroplasty to be a viable and sustainable alternative to ACDF.
  
  
  METHODS
  1.
authors.affiliation: *Midwest Orthopaedics at Rush University Medical Center, Chicago, IL †Chicago Back Institute, Chicago, IL ‡Kye Gilder Consulting, LLC, San Diego, CA §NuVasive, Inc., San Diego, CA; and ¶University of Maryland St. Joseph Medical Center, Baltimore, MD.
authors.forename: Frank M
authors.initials: FM
authors.lastname: Phillips
authors.forename: Fred H
authors.initials: FH
authors.lastname: Geisler
authors.forename: Kye M
authors.initials: KM
authors.lastname: Gilder
authors.forename: Christopher
authors.initials: C
authors.lastname: Reah
authors.forename: Kelli M
authors.initials: KM
authors.lastname: Howell
authors.forename: Paul C
authors.initials: PC
authors.lastname: McAfee
mesh_terms: D001696:Biomechanical Phenomena; D002574:Cervical Vertebrae / Q000503:physiopathology / Q000601:surgery*; D018795:Device Approval; D004185:Disability Evaluation; D017586:Diskectomy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D019547:Neck Pain / Q000175:diagnosis / Q000209:etiology / Q000601:surgery; D010147:Pain Measurement; D010149:Postoperative Pain / Q000175:diagnosis / Q000209:etiology; D011474:Prosthesis Design; D011843:Radiculopathy / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D020127:Recovery of Function; D013118:Spinal Cord Diseases / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D013123:Spinal Fusion / Q000009:adverse effects / Q000379:methods*; D055009:Spondylosis / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D013997:Time Factors; D059145:Total Disc Replacement / Q000009:adverse effects / Q000295:instrumentation*; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration