~56 spots leftby Apr 2026

M6-C Artificial Cervical Disc for Degenerative Disc Disease

Recruiting at27 trial locations
FP
Overseen byFrank Phillips, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Spinal Kinetics
Must not be taking: Chronic steroids
Disqualifiers: Osteoporosis, Rheumatoid arthritis, Insulin diabetes, others
No Placebo Group
Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C™ artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopathy at vertebral levels from C3 to C7 with or without spinal cord compression.

Will I have to stop taking my current medications?

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.

What data supports the effectiveness of the M6-C Artificial Cervical Disc treatment for Degenerative Disc Disease?

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.12345

Is the M6-C Artificial Cervical Disc generally safe for humans?

The 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.13567

What makes the M6-C Artificial Cervical Disc treatment unique for degenerative disc disease?

The 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.12356

Research Team

FP

Frank Phillips, MD

Principal Investigator

Rush University Medical Center

Eligibility 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

You have been diagnosed with Cervical Radiculopathy
You have been diagnosed with Cervical Radiculopathy
Willing and able to be in a study for at least 2 years and possibly up to 5 years
See 6 more

Exclusion Criteria

Specific neck pain as the only symptom
Bone diseases such as osteoporosis that impact spine surgery
More than 2 specific places on the spine requiring surgery
See 2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either a two-level cervical artificial disc procedure or an instrumented ACDF procedure as per site group assignment

6 weeks
1 visit (in-person)

Follow-up

Participants are evaluated clinically, radiographically, and via patient-reported outcomes at multiple intervals

24 months
5 visits (in-person) at 6 weeks, 3 months, 6 months, 12 months, and 24 months

Treatment Details

Interventions

  • ACDF (Procedure)
  • M6-C Artificial Cervical Disc (Artificial Cervical Disc)
Trial OverviewThe trial is testing the safety and effectiveness of the M6-C Artificial Cervical Disc against traditional anterior cervical discectomy and fusion (ACDF) in treating two-level symptomatic cervical radiculopathy. It's a prospective study where participants are concurrently controlled across multiple centers.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: M6-C Artificial Cervical DiscExperimental Treatment1 Intervention
The M6-C is an investigational device composed of two outer and inner endplates made of titanium with a polycarbonate urethane nucleus (plastic center) and a polyethylene fiber annulus (strong thread-like binding). Around the polyethylene annulus is a polyurethane sheath (plastic cover). The outer endplates have keels to anchor the disc to bone. The outer endplates and keels are both coated with a titanium plasma spray. The M6-C is provided in two heights (6mm and 7mm) and four footprints (Medium, Medium Long, Large, Large Long).
Group II: Anterior Cervical Discectomy & Fusion (ACDF)Active Control1 Intervention
ACDF will be performed using one of four FDA-approved anterior cervical plate systems and corticocancellous allograft bone. The four plating systems used in this study are: * Orthofix CETRA Anterior Cervical Plate System * Medtronic Sofamor/Danek Venture Anterior Cervical Plate System * DePuy Synthes: SKYLINE Anterior Cervical Plate System * Stryker Aviator Anterior Cervical Plating System

Find a Clinic Near You

Who Is Running the Clinical Trial?

Spinal Kinetics

Lead Sponsor

Trials
3
Recruited
730+

Findings from Research

In a feasibility trial involving 36 patients with symptomatic degenerative cervical radiculopathy, the M6-C artificial cervical disc showed significant improvements in functional impairment, pain severity, and quality of life over 24 months, with a 46% reduction in Neck Disability Index scores and a 51% reduction in neck pain scores.
The M6-C disc replacement demonstrated an acceptable safety profile, with no serious device-related adverse events or need for reoperations, while maintaining range of motion at the treated level.
Initial clinical experience with a next-generation artificial disc for the treatment of symptomatic degenerative cervical radiculopathy.Reyes-Sanchez, A., Miramontes, V., Olivarez, LM., et al.[2022]
Artificial disc replacement is effective in treating cervical spondylosis, with significant improvement in neurological function as measured by the JOA score after surgery.
The procedure maintains the range of motion in both the replaced and adjacent segments, with only a 12.8% rate of adjacent segment degeneration observed, suggesting a protective effect on nearby discs.
[Adjacent segment degeneration after cervical artificial disc replacement at early mid-term follow-up].Yapu, L., Xia, H., Ai, F., et al.[2016]
This case report highlights the first instance of mechanical failure in an M6 cervical disc replacement, specifically due to wear debris leading to osteolysis, which emphasizes the need for ongoing monitoring after such surgeries.
Histological analysis revealed polyethylene particles in the surrounding tissue without acute inflammation, suggesting that wear debris can contribute to implant failure without immediate inflammatory response.
Early Implant Failure of a 2-Level M6-Cervical Total Disc Replacement: A Case Report.Clark, NJ., Francois, EL., Freedman, BA., et al.[2023]

References

Initial clinical experience with a next-generation artificial disc for the treatment of symptomatic degenerative cervical radiculopathy. [2022]
[Adjacent segment degeneration after cervical artificial disc replacement at early mid-term follow-up]. [2016]
Early Implant Failure of a 2-Level M6-Cervical Total Disc Replacement: A Case Report. [2023]
[Preliminary clinical study on artificial cervical disc replacement by Mobi-C prosthesis]. [2011]
Comparison of M6-C and Mobi-C cervical total disc replacement for cervical degenerative disc disease in adults. [2022]
Delayed periprosthetic collection after cervical disc arthroplasty. [2019]
Safety and Validity of Anterior Cervical Disc Replacement for Single-level Cervical Disc Disease: Initial Two-year Follow-up of the Prospective Observational Post-marketing Surveillance Study for Japanese Patients. [2022]