M6-C Artificial Cervical Disc for Degenerative Disc Disease

Recruiting at 27 trial locations

Overseen By David Wootten, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spinal Kinetics

Must not be taking: Chronic steroids

Disqualifiers: Osteoporosis, Rheumatoid arthritis, Insulin diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

263 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 3 4 6 7}

Who Is on the Research Team?

Frank Phillips, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• ACDF
• M6-C Artificial Cervical Disc

Trial Overview The 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.

How Is the Trial Designed?

Group I: M6-C Artificial Cervical Disc Experimental Treatment 1 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 Control 1 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

M6-C Artificial Cervical Disc is already approved in United States, European Union for the following indications:

Approved in United States as M6-C Artificial Cervical Disc for:

• 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

Approved in European Union as M6-C Artificial Cervical Disc for:

• Degenerative cervical radiculopathy with or without spinal cord compression

Who Is Running the Clinical Trial?

Spinal Kinetics

Lead Sponsor

Trials

3

Recruited

730+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Implant Failure of a 2-Level M6-Cervical Total Disc Replacement: A Case Report. Clark, NJ., Francois, EL., Freedman, BA., et al.[2023]

The Mobi-C prosthesis was successfully used in 20 patients with degenerative cervical disease, showing no perioperative complications and effective healing of all incisions.

Significant improvements were observed in cervical spinal function and quality of life, with COA scores increasing from 32.10 to 38.20, VAS scores decreasing from 5.10 to 3.20, and NDI scores improving from 39.20 to 29.40 after an average follow-up of 16.5 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preliminary clinical study on artificial cervical disc replacement by Mobi-C prosthesis]. Bao, D., Ma, Y., Chen, X., et al.[2011]

In a study of 62 patients who underwent cervical total disc replacement (CTDR) with either the M6-C or Mobi-C prostheses, no significant differences in short-term clinical or radiological outcomes were observed between the two devices.

Both prostheses showed similar rates of heterotopic ossification (HO), with 71.2% in the M6-C group and 62.5% in the Mobi-C group, indicating that the M6-C prosthesis does not significantly reduce the risk of HO compared to Mobi-C.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of M6-C and Mobi-C cervical total disc replacement for cervical degenerative disc disease in adults. Hui, N., Phan, K., Kerferd, J., et al.[2022]

In a case series of four patients who underwent cervical disc replacement with the M6-C disc, two to seven years post-surgery, all presented with dysphagia due to a compressive mass, highlighting a potential long-term complication associated with this device.

The study identified Propionibacterium acnes in three cases, suggesting a delayed infection or hypersensitivity reaction, which emphasizes the need for further investigation and monitoring of patients with M6-C discs for similar complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed periprosthetic collection after cervical disc arthroplasty. Harris, L., Dyson, E., Elliot, M., et al.[2019]

In a study of 54 patients undergoing 1-level anterior cervical disc replacement (ACDR) in Japan, both types of cervical artificial discs (Mobi-C and Prestige LP) showed significant improvement in neurological conditions post-surgery, indicating their efficacy.

The procedure was found to be safe, with no serious adverse events or need for secondary surgeries at the surgical level, although 9.5% of patients with Mobi-C and 9.1% with Prestige LP experienced loss of mobility at the surgical site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Takami, T., Hara, T., Hara, M., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Initial clinical experience with a next-generation artificial disc for the treatment of symptomatic degenerative cervical radiculopathy. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Adjacent segment degeneration after cervical artificial disc replacement at early mid-term follow-up]. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Early Implant Failure of a 2-Level M6-Cervical Total Disc Replacement: A Case Report. [2023]

4. China pubmed.ncbi.nlm.nih.gov

[Preliminary clinical study on artificial cervical disc replacement by Mobi-C prosthesis]. [2011]

5. China pubmed.ncbi.nlm.nih.gov

Comparison of M6-C and Mobi-C cervical total disc replacement for cervical degenerative disc disease in adults. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Delayed periprosthetic collection after cervical disc arthroplasty. [2019]

7. Japan pubmed.ncbi.nlm.nih.gov

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]