Clinical Trial Finder

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.

Patients will be concurrently enrolled in the M6-C treatment group and the ACDF control group. Patients should have failed at least six weeks of conservative treatment or demonstrate progressive symptoms despite continued non-operative treatment. For the study, 263 patients will undergo either a two-level cervical artificial disc procedure, or an instrumented (ACDF) procedure as per site group assignment. Patients will be evaluated clinically, radiographically, and via the collection of patient-reported outcomes at 6 Weeks, 3 Months, 6 Months, 12 Months and 24 Months. The primary endpoint is Overall Success at 24 Months.

Arms

Interventions