• Frank M Phillips, Fred H Geisler, Kye M Gilder, Christopher Reah, Kelli M Howell, and Paul C McAfee.
• *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.
• Spine. 2015 May 15; 40 (10): 674-83.

Study DesignProspective, multicenter, randomized clinical trial.ObjectiveTo 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.Summary Of Background DataThe 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.MethodsPatients 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.ResultsAt 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.ConclusionThe 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.Level Of Evidence1.

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