• Michael S Hisey, Hyun W Bae, Reginald J Davis, Steven Gaede, Greg Hoffman, Kee D Kim, Pierce D Nunley, Daniel Peterson, Ralph F Rashbaum, John Stokes, and Donna D Ohnmeiss.
• *Texas Back Institute, Denton, TX †The Spine Institute at St John's Health Center, Santa Monica, CA ‡GBMC Healthcare Greater Baltimore Neurosurgical Associates, Baltimore, MD §Oklahoma Spine & Brain Institute, Tulsa, OK ∥Orthopedic North East, Fort Wayne, IN ¶University of California Davis Medical Center, Sacramento, CA #Spine Institute of Louisiana, Shreveport, LA **Neurological Specialists of Austin, Austin ††Texas Back Institute ‡‡Texas Back Institute Research Foundation, Plano, TX.
• J Spinal Disord Tech. 2015 May 1;28(4):E237-43.

Study DesignThis was a prospective, randomized, controlled multicenter trial.ObjectiveThe purpose of this study was to compare clinical outcomes at 4-year follow-up of patients receiving cervical total disk replacement (TDR) with those receiving anterior cervical discectomy and fusion (ACDF).Summary Of Background DataACDF has been the traditional treatment for symptomatic disk degeneration. Several studies found single-level TDR to be as safe and effective as ACDF at ≥2 years follow-up.MethodsPatients from 23 centers were randomized in a 2:1 ratio with 164 receiving the investigational device (Mobi-C Cervical Disc Prosthesis) and 81 receiving ACDF using an anterior plate and allograft. Patients were evaluated preoperatively and 6 weeks, 3, 6, 12, 18, 24, 36, and 48 months postoperatively. Outcome assessments included a composite success score, Neck Disability Index, visual analog scales assessing neck and arm pain, patient satisfaction, major complications, subsequent surgery, segmental range of motion, and adjacent-segment degeneration.ResultsThe composite success rate was similar in the 2 groups at 48-month follow-up. Mean Neck Disability Index, visual analog scale, and SF-12 scores were significantly improved in early follow-up in both groups with improvements maintained throughout 48 months. On some measures, TDR had significantly greater improvement during early follow-up. At no follow-up were TDR scores significantly worse than ACDF scores. Subsequent surgery rate was significantly higher for ACDF compared with TDR (9.9% vs. 3.0%, P<0.05). Range of motion was maintained with TDR having a mean baseline value of 8 degrees compared with 10 degrees at 48 months. The incidence of adjacent-segment degeneration was significantly higher with ACDF at inferior and superior segments compared with TDR (inferior: 50% vs. 30%, P<0.025; superior: 53% vs. 34%, P<0.025).ConclusionsSignificant improvements were observed in pain and function. TDR patients maintained motion and had significantly lower rates of reoperation and adjacent-segment degeneration compared with ACDF. This study supports the safety and efficacy of TDR in appropriately selected patients.

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