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Evaluation of M6-C Artificial Cervical Disc for Two-Level Treatment of Cervical Disc Degenerative Disorder

M6®-C Artificial Cervical Disc Two-Level IDE Pivotal Study

Not applicable Interventional Orthofix Inc. · NCT04982835

This study is testing whether the M6-C artificial cervical disc can help people with two-level neck pain feel better compared to traditional surgery.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment263 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorOrthofix Inc. Industry-sponsored
Locations26 sites (Phoenix, Arizona and 25 other locations)
Trial IDNCT04982835 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the M6-C artificial cervical disc compared to traditional anterior cervical discectomy and fusion (ACDF) for patients with two-level cervical radiculopathy. It involves a prospective, concurrently controlled, multi-center design where patients will be assigned to either the M6-C treatment group or the ACDF control group. Participants must have experienced inadequate relief from conservative treatments for at least six weeks or show progressive symptoms. Clinical, radiographic, and patient-reported outcomes will be collected at multiple follow-up points over two years to assess overall success.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with symptomatic cervical radiculopathy requiring surgical intervention at two contiguous levels from C3 to C7.

Not a fit: Patients who have not experienced inadequate response to conservative treatment or those with conditions not suitable for surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive and more effective treatment option for patients suffering from cervical disc degenerative disorders.

How similar studies have performed: Previous studies on artificial cervical discs have shown promising results, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosis of degenerative cervical radiculopathy with or without spinal cord compression requiring surgical treatment at two contiguous levels from C3 to C7 demonstrated by signs and/or symptoms of disc herniation and/or osteophyte formation (e.g. neck and/or arm pain, radiculopathy, etc.) and is confirmed by patient history and radiographic studies (e.g. MRI, CT, x-rays, etc.)
* Inadequate response to conservative medical care over a period of at least 6 weeks or have the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management
* Neck Disability Index score of ≥ 30% (raw score of ≥ 15/50)
* Neck or arm pain Visual Analog Scale Score ≥ 4 on a scale of 0 to 10
* Willing and able to comply with the requirements of the protocol including follow-up requirements
* Willing and able to sign a study specific informed consent
* Skeletally mature and at least 18 years old but not older than 75 years old

Exclusion Criteria:

* More than two cervical levels requiring surgery, or two non-contiguous levels requiring surgery
* Previous anterior cervical spine surgery
* Axial neck pain as the solitary symptom
* Previous posterior cervical spine surgery (such as a posterior element decompression) that destabilizes the cervical spine
* Advanced cervical anatomical deformity (such as ankylosing spondylitis, scoliosis) at either of the operative levels or adjacent levels
* Symptomatic facet arthrosis
* Less than four degrees of motion in flexion/extension at either of the index levels
* Instability as evidenced by subluxation greater than 3 millimeters at either of the index or adjacent levels as indicated on flexion/extension x-rays.
* Advanced degenerative changes (e.g., spondylosis) at either of the index vertebral levels as evidenced by bridging osteophytes, central disc height less than 4 millimeters and/or \< 50% of the adjacent normal intervertebral disc, or kyphotic deformity \> 11 degrees on neutral x-rays
* Severe cervical myelopathy (i.e., Nurick's Classification greater than 2)
* Active systemic infection or infection at the operative site
* Co-morbid medical conditions of the spine or upper extremities that may affect the cervical spine neurological and/or pain assessment
* Metabolic bone disease such as osteoporosis that contradicts spinal surgery
* History of an osteoporotic fracture of the spine, hip or wrist
* History of an endocrine or metabolic disorder (e.g. Paget's disease) known to affect bone and mineral metabolism
* Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
* Known allergy to titanium, stainless steels, polyurethane, polyethylene, or ethylene oxide residuals
* Fibromyalgia, Rheumatoid Arthritis (or other autoimmune disease), or a systemic disorder such as HIV or acute hepatitis B or C.
* Insulin dependent diabetes
* Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion
* Pregnant, or intend to become pregnant, during the course of the study
* Severe obesity (Body Mass Index greater than 45)
* Physical or mental condition (e.g. psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain or quality of life.
* Involved in current or pending spinal litigation where permanent disability benefits are being sought.
* Incarcerated at time of study enrollment
* Current participation in other investigational study.

Where this trial is running

Phoenix, Arizona and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cervical Disc Degenerative Disorderartificial cervical discdegenerative disc diseasetotal disc replacementSpinal Kinetics
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.