M6®-C Artificial Cervical Disc Two-Level IDE Pivotal Study
Details
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.
Eligibility
You can join if...
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 greater than or equal to 30% (raw score of greater than or equal to 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.