Prospective, Randomized Comparison of Cervical Total Disk Replacement Versus Anterior Cervical Fusion: Results at 48 Months Follow-up

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, Donna D. Ohnmeiss

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70 Scopus citations

Abstract

STUDY DESIGN: This was a prospective, randomized, controlled multicenter trial.

OBJECTIVE: The 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 DATA: ACDF 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.

METHODS: Patients 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.

RESULTS: The 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

CONCLUSIONS: Significant 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.

Original languageEnglish (US)
Pages (from-to)E237-E243
JournalJournal of Spinal Disorders and Techniques
Volume28
Issue number4
DOIs
StatePublished - May 1 2015

ASJC Scopus subject areas

  • Medicine(all)

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    Hisey, M. S., Bae, H. W., Davis, R. J., Gaede, S., Hoffman, G., Kim, K. D., Nunley, P. D., Peterson, D., Rashbaum, R. F., Stokes, J., & Ohnmeiss, D. D. (2015). Prospective, Randomized Comparison of Cervical Total Disk Replacement Versus Anterior Cervical Fusion: Results at 48 Months Follow-up. Journal of Spinal Disorders and Techniques, 28(4), E237-E243. https://doi.org/10.1097/BSD.0000000000000185