M6-C Artificial Cervical Disc for Degenerative Disc Disease

Not currently recruiting at 29 trial locations

Overseen By David Wootten, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Orthofix Inc.

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the M6-C artificial cervical disc, to determine if it outperforms the usual surgery for neck problems. It targets individuals with two-level cervical radiculopathy, a condition causing neck and arm pain due to nerve issues in the spine. The trial compares the new disc with standard surgery that fuses neck bones together, known as Anterior Cervical Discectomy and Fusion (ACDF). Ideal candidates are those who have experienced neck and arm pain that hasn't improved with other treatments for at least six weeks. As an unphased trial, this study provides patients the opportunity to explore innovative treatment options that could potentially enhance their quality of life.

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 prior data suggests that the M6-C Artificial Cervical Disc is safe for treating degenerative disc disease?

Research has shown that the M6-C Artificial Cervical Disc is generally safe for patients. One study found that recipients of the M6-C disc experienced better outcomes over five years compared to those who underwent traditional spinal fusion surgery. "Clinical success" refers to the treatment's ability to reduce symptoms effectively without causing major issues.

Data from three years also demonstrated that the M6-C disc met important safety and effectiveness standards, indicating that most patients tolerate it well. However, like any medical treatment, potential risks exist. Some individuals might experience complications, though these are uncommon.

In summary, research supports the M6-C disc as a safe and promising alternative to traditional surgery for neck problems. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatment for degenerative disc disease, which often involves Anterior Cervical Discectomy & Fusion (ACDF) using various cervical plate systems, the M6-C Artificial Cervical Disc offers a different approach. The M6-C is unique because it mimics the natural movement of a healthy disc, thanks to its innovative design featuring a polycarbonate urethane nucleus and a polyethylene fiber annulus. This design allows for motion preservation in the spine, potentially leading to better long-term outcomes and less stress on adjacent discs. Researchers are excited about the M6-C because it could provide patients with a more natural range of motion compared to traditional fusion methods, which can limit flexibility.

What evidence suggests that the M6-C Artificial Cervical Disc is effective for degenerative disc disease?

Research has shown that the M6-C Artificial Cervical Disc, one of the treatments studied in this trial, holds promise for treating neck pain caused by nerve issues. In one study, patients with the M6-C disc experienced better outcomes over five years compared to those who underwent traditional fusion surgery, known as anterior cervical discectomy and fusion (ACDF), which is another treatment arm in this trial. Specifically, patients with the M6-C disc demonstrated greater improvement in their symptoms. The M6-C disc is designed to mimic the movement of a natural, healthy disc, helping to maintain neck flexibility. These findings suggest that the M6-C Artificial Cervical Disc might be a more effective option than traditional fusion surgery for some patients. ^{1 2 5 6 7}

Who Is on the Research Team?

Jay Erturan, MD, JD

Principal Investigator

Orthofix Inc.

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?

Orthofix Inc.

Lead Sponsor

Trials

18

Recruited

6,600+

Spinal Kinetics

Industry Sponsor

Trials

3

Recruited

730+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S1529943023034915

Prospective, multicenter clinical trial comparing the M6-C ...

Subjects treated with the M6-C artificial disc demonstrated superior 5-year achievement of clinical success when compared to ACDF controls.

2.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf17/P170036B.pdf

M6-C® Summary of Safety and Effectiveness Data

The M6-C™ Artificial Cervical Disc is indicated for reconstruction of the disc following single level discectomy in skeletally mature patients ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37951477/

Prospective, multicenter clinical trial comparing the M6-C ...

Subjects treated with the M6-C artificial disc demonstrated superior 5-year achievement of clinical success when compared to ACDF controls.

4.

ir.orthofix.com

ir.orthofix.com/news/news-details/2021/Orthofix-Announces-First-Patient-Implant-in-the-M6-C-Artificial-Cervical-Disc-Two-Level-IDE-Study/default.aspx

Orthofix Announces First Patient Implant in the M6-C ...

“The M6-C artificial cervical disc two-level study will provide additional data to validate the effectiveness of disc replacement over fusion in ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6989925/

Comparison of M6-C and Mobi-C cervical total disc ...

This retrospective cohort study aims to compare the short-term outcomes between patients receiving either the M6-C or Mobi-C prostheses.

6.

orthofix.com

orthofix.com/wp-content/uploads/2025/09/PK_0324_A1_02-M6-C-US.pdf

M6-C™ Artificial Cervical Disc

Safety and Effectiveness Results. Safety Results ... An analysis of the 36-month data using the same parameters safety and effectiveness endpoints was conducted.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04122248

NCT04122248 | M6-C Post Approval Study (PAS)

A prospective, concurrently controlled, multi-center pivotal study to evaluate the safety and effectiveness of the M6-C™ Artificial Cervical Disc compared ...