Prospective, multicenter clinical trial comparing M6-C compressible six degrees of freedom cervical disc with anterior cervical discectomy and fusion for the treatment of single level degenerative cervical radiculopathy
The Spine Journal Oct 28, 2020
Phillips FM, Coric D, Sasso R, et al. - A prospective, multicenter, concurrently- and historically-controlled, FDA-approved investigational device exemption (IDE) clinical trial was designed to assess the safety and efficacy of the novel M6-C compressible artificial cervical disc in comparison with anterior cervical discectomy and fusion (ACDF) for individuals with single-level degenerative cervical radiculopathy. Researchers compared 160 M6-C individuals to a matched subset of 189 ACDF controls (46 concurrent and 143 historical controls) applying propensity score subclassification to control for selection bias. For the treatment of degenerative cervical radiculopathy, M6-C treatment demonstrated both safety and effectiveness. Treatment with M6-C indicated non-inferiority for the primary endpoint, displaying a similar ability to achieve Composite Clinical Success at 24 months. Nevertheless, for the secondary endpoints, M6-C individuals highlighted significantly improved pain and function in comparison with ACDF individuals, while maintaining range of motion, improving quality of life, and reducing analgesic and opioid usage at 2 years postoperatively relative to baseline.
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