Anterior cervical discectomy and fusion (ACDF) is a well-established treatment for symptomatic cervical radiculopathy. However, it presents several limitations, including loss of motion at the index level, risk of pseudarthrosis requiring revision, and acceleration of adjacent segment degeneration (ASD). Cervical total disc replacement (TDR) emerges as a motion-preserving procedure that effectively treats cervical radiculopathy while maintaining motion at the index level. According to the results published in The Spine Journal, an artificial cervical disc may yield better clinical outcomes compared to anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy.
The primary aim of the study was to evaluate the long-term safety and effectiveness of the M6-C compressible artificial cervical disc and compare it to ACDF at 5 years. The prospective, multicenter clinical trial conducted by Phillips and team categorized 349 patients with one-level symptomatic degenerative cervical radiculopathy, out of which 189 were given ACDF treatment and 160 were given the M6-C ACDF, between May 2014 and June 2016. The study measured composite clinical success at 60 months, function and pain, physical quality of life, and safety, neurologic, and radiographic assessments.
According to the researchers, the study unveiled that patient in the M6-C group achieved a composite clinical success rate of 82.3% at the 60-month follow-up, surpassing the ACDF treatment group’s success rate of 67%. Furthermore, the researchers observed that more patients in the M6-C group experienced an improvement in neck or arm pain and maintained or enhanced their quality of life from baseline to 60 months postoperatively compared to the ACDF group. Additionally, the M6-C group demonstrated preserved flexion-extension motion, exhibiting a significantly greater increase in baseline disc height and disc angle compared to the control group. Rates of subsequent surgical interventions for M6-C and device- or procedure-related serious adverse events were found to be similar to those of ACDF.
The clinical trial demonstrated that the M6-C cervical disc is a safe and effective treatment for single-level degenerative cervical radiculopathy. The group that received M6-C showed better clinical outcomes, including improved pain management and physical functioning, while also maintaining a range of motion that was comparable to the ACDF group. Rates of complications were similar in both groups, but M6-C subjects demonstrated superior clinical success when compared to ACDF controls.
These results underscore the potential advantages of M6-C over traditional ACDF, pointing towards its promising role in enhancing patient outcomes in the management of degenerative cervical radiculopathy. Further research and long-term follow-ups are warranted to validate these findings and establish the lasting benefits of the M6-C cervical disc in clinical practice.
Reference
Phillips FM, Coric D, Sasso R, Lanman T, Lavelle W, Lauryssen C, et al. A prospective, multicenter clinical trial comparing the M6-C compressible cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 5-year results of an FDA investigational device exemption study. The Spine Journal [Internet];2023 Nov 10.