M6-C Artificial Cervical Disc for Degenerative Disc Disease
Trial Summary
The trial does not specify if you need to stop taking your current medications, but it excludes those taking medications that interfere with bone or soft tissue healing, like chronic steroids. It's best to discuss your specific medications with the trial team.
Research shows that the M6-C artificial cervical disc is designed to mimic the natural movement of the spine, which may help reduce issues in nearby spine segments. A study comparing M6-C with another disc replacement found that M6-C might better replicate natural spine movement, potentially improving outcomes for patients with cervical degenerative disc disease.
12345The M6-C Artificial Cervical Disc has shown an acceptable safety profile in trials, but there have been reports of delayed complications like swallowing difficulties due to a mass near the disc, which may require further investigation and treatment. Some cases involved infection with a specific bacteria (Propionibacterium acnes), and there have been instances of mechanical failure, indicating the need for more long-term safety studies.
13567The M6-C Artificial Cervical Disc is designed to better mimic the natural movement of the spine compared to other artificial discs, potentially reducing the risk of adjacent segment degeneration (ASD), which is a common complication with other cervical total disc replacements.
12356Eligibility Criteria
Adults aged 18-75 with neck or arm pain and degenerative cervical radiculopathy needing surgery at two levels from C3 to C7. Participants must have tried non-surgical treatments for at least 6 weeks without success, be able to follow the study protocol, and not have had certain previous surgeries or conditions like severe myelopathy, infections, metabolic bone diseases, severe obesity, or mental conditions affecting self-assessment.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either a two-level cervical artificial disc procedure or an instrumented ACDF procedure as per site group assignment
Follow-up
Participants are evaluated clinically, radiographically, and via patient-reported outcomes at multiple intervals
Participant Groups
M6-C Artificial Cervical Disc is already approved in United States, European Union for the following indications:
- Reconstruction of the disc following single level discectomy in skeletally mature patients with intractable degenerative cervical radiculopathy with or without spinal cord compression at one level from C3 to C7
- Degenerative cervical radiculopathy with or without spinal cord compression