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Cervical total disc replacement using a novel compressible prosthesis: Results from a prospective Food and Drug Administration–regulated feasibility study with 24-month follow-up

Carl Lauryssen, MD,1 Domagoj Coric, MD,2 Thomas Dimmig, MD,3 David Musante, MD,3 Donna D. Ohnmeiss, PhD,4 Harrison A. Stubbs, PhD5

1Institute for Advanced Spinal Research in California, Beverly Hills, CA 2Carolina Neurosurgery and Spine Associates, Charlotte, NC 3Triangle Orthopaedic Associates, Durham, NC 4Texas Back Institute Research Foundation, Plano, TX 5Oakland, CA

Abstract 

Background

Anterior cervical fusion, an established procedure to treat cervical radiculopathy, sacrifices the natural function of the disc, while placing increased stresses on adjacent spinal levels. In contrast, the cervical total disc replacement (cTDR) maintains motion and decreases adjacent-level stresses. The purpose of this study was to investigate the safety and effectiveness of a next-generation cTDR device in patients with symptomatic cervical radiculopathy.

Methods

This is a multicenter Food and Drug Administration–regulated feasibility study to evaluate safety and effectiveness of the M6-C Artificial Cervical Disc for the treatment of patients with symptomatic cervical radiculopathy at 1 or 2 levels from C3 to C7. Neck Disability Index (NDI), visual analog scales (VAS) assessing neck and arm pain, Short Form 36 Health Survey (SF-36), safety, and radiographic outcomes were assessed preoperatively, at 6 weeks and 3, 6, 12, and 24 months postoperatively.

Results

Thirty patients were enrolled at 3 clinical sites. Patients were implanted at either 1 or 2 levels. Mean NDI improved from 67.8 to 20.8 (P < .0001) at 24 months. Significant improvement was also observed through 24-month follow-up in neck and arm pain VAS (P < .0001) and in physical (P < .005) and mental component scores of the SF-36 at 3, 6, and 12 months (P < .008). There were no serious adverse events related to the device or procedure as adjudicated by an independent clinical events committee. Radiographically, disc space height increased more than 50% with a correlative increase in the postoperative disc angle. Range of motion decreased slightly from baseline during early follow-up but increased slightly and were maintained throughout the follow-up period.

Conclusions

The M6-C cervical artificial disc represents a new generation of cTDR design. Results of this study found the M6-C device to produce positive clinical and radiographic outcomes similar to other cTDRs, warranting further investigation.

keywords: 
cervical total disc replacement, Cervical radiculopathy, M6-C artificial cervical disc, Fusion
Volume 6
doi: 
10.1016/j.ijsp.2012.02.001