M6-C Artificial Cervical Disc for Degenerative Disc Disease

Recruiting in Palo Alto (17 mi)

+27 other locations

Overseen by Frank 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. ^{1 2 3 4 5}

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 3 5 6 7}

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 5 6}

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

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

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 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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Michigan Orthopedic Surgeons Southfield, MI

St. Charles Spine Institute Thousand Oaks, CA

St. David's Healthcare Austin, TX

Joseph Spine Institute Tampa, FL

More Trial Locations

Who Is Running the Clinical Trial?

Spinal Kinetics Lead Sponsor

References

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] A feasibility trial was conducted to evaluate the initial safety and clinical use of a next-generation artificial cervical disc (M6-C artificial cervical disc; Spinal Kinetics, Sunnyvale, CA) for the treatment of patients with symptomatic degenerative cervical radiculopathy. A standardized battery of validated outcome measures was utilized to assess condition-specific functional impairment, pain severity, and quality of life.

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

[Adjacent segment degeneration after cervical artificial disc replacement at early mid-term follow-up]. [2016] To study the effectiveness of artificial disc replacement for cervical diseases and the adjacent segment degeneration.

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

Early Implant Failure of a 2-Level M6-Cervical Total Disc Replacement: A Case Report. [2023] We report a case of implant failure after primary 2-level M6-cervical disc replacement (M6-C; Spinal Kinetics) at C4-5 and C5-6. At revision surgery, a full-thickness tear was identified in the sheath of the C5-6 implant. Histology from periprosthetic tissue demonstrated polyethylene particles without acute inflammation. Tissue cultures were positive for Propionibacterium acnes, but ultrasonicate cultures were negative for both prostheses. An independent laboratory test confirmed mechanical failure of the C5-6 prosthesis.

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

[Preliminary clinical study on artificial cervical disc replacement by Mobi-C prosthesis]. [2011] To study the clinical application of Mobi-C prosthesis in treatment of anterior cervical discectomy and artificial disc replacement (ADR).

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] Cervical total disc replacement (CTDR) is complicated by adjacent segment degeneration (ASD). Since non-physiological spine kinematics after CTDR was postulated to cause ASD, M6-C prosthesis has been developed to better replicate the natural kinematics of the intervertebral disc. This retrospective cohort study aims to compare the short-term outcomes between patients receiving either the M6-C or Mobi-C prostheses.

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

Delayed periprosthetic collection after cervical disc arthroplasty. [2019] Cervical disc arthroplasty is a treatment option for symptomatic cervical disc disease. There is a paucity of literature on long-term safety outcomes, durability, and device-related failure rates. The M6-C artificial cervical disc is a device with titanium alloy endplates and a complex polymeric centerpiece. To date, trials have exhibited acceptable safety profiles.This case series describes the presentation, management, and pathological findings of a delayed prevertebral periprosthetic mass anterior to the M6-C disc. Four patients at 3 different institutions underwent cervical disc replacement with the M6-C disc. Two to seven years postoperatively, they presented with dysphagia secondary to a compressive mass anterior to the disc. Case notes were reviewed to collect data on symptoms, management, and outcomes. The patients were systemically well and presented with progressive dysphagia. They had imaging findings of a mass anterior to the disc. They underwent a decompressive procedure, with 2 patients undergoing device removal and fusion. In 2 cases, a soft-tissue mass was seen intraoperatively, with frank pus. In 3 cases, Propionibacterium acnes was identified and antibiotic treatment given. Histopathology demonstrated mixed inflammatory infiltrates with foreign body-type granulomas. Postoperatively, the dysphagia resolved.The development of delayed dysphagia in a patient with an M6-C disc should prompt investigation to identify a mass lesion. To the authors' knowledge, this is the first report of delayed infection, or suspected delayed-type hypersensitivity reaction, following M6-C disc implantation. It is important for this to be added to the device safety concerns. Further prospective studies are needed to establish the incidence and the long-term safety and failure rates of the M6-C disc.

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] Anterior cervical disc replacement (ACDR) using cervical artificial disc (CAD) has the advantage of maintaining the range of motion (ROM) at the surgical level, subsequently reducing the postoperative risk of adjacent disc disease. Following the approval for the clinical use in Japan, a post-marketing surveillance (PMS) study was conducted for two different types of CAD, namely, Mobi-C (metal-on-plastic design) and Prestige LP (metal-on-metal design). The objective of this prospective observational multicenter study was to analyze the first 2-year surgical results of the PMS study of 1-level ACDR in Japan. A total of 54 patients were registered (Mobi-C, n = 24, MC group; Prestige LP, n = 30, PLP group). Preoperative neurological assessment revealed radiculopathy in 31 patients (57.4%) and myelopathy in 15 patients (27.8%). Preoperative radiological assessment classified the disease category as disc herniation in 15 patients (27.8%), osteophyte in 6 patients (11.1%), and both in 33 patients (61.1%). The postoperative follow-up rates at 6 weeks, 6 months, 1 year, and 2 years after ACDR were 92.6%, 87.0%, 83.3%, and 79.6%, respectively. In both groups, patients' neurological condition improved significantly after surgery. Radiographic assessment revealed loss of mobility at the surgical level in 9.5% of patients in the MC group and in 9.1% of patients in the PLP group. No secondary surgeries at the initial surgical level and no serious adverse events were observed in either group. The present results suggest that 1-level ACDR is safe, although medium- to long-term follow-up is mandatory to further verify the validity of ACDR for Japanese patients.