m6®-c artificial cervical disc two-level ide pivotal study

Conditions: Cervical Disc Degenerative Disorder

Summary: 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.

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 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 \ 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.

Keywords: artificial cervical disc degenerative disc disease total disc replacement spinal kinetics