This is a 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 symptomatic cervical radiculopathy with or without cord compression. Some participating sites will enroll just M6-C patients, while others will enroll just ACDF patients.
Patients eligible for study enrollment will present with degenerative cervical radiculopathy requiring surgical intervention, confirmed clinically and radiographically, at one vertebral level from C3 to C7.
A total of 243 subjects will be included at up to 20 sites.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Diagnosis of degenerative cervical radiculopathy with or without spinal cord compression requiring surgical treatment at one level 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
✓. Neck Disability Index score of ≥ 30% (raw score of ≥ 15/50)
✓. Neck or arm pain VAS ≥ 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 ≥ 18 years old and ≤ 75 years old
Exclusion criteria
✕. More than one cervical level requiring surgery
✕. Previous anterior cervical spine surgery
✕. Axial neck pain as the solitary symptom
✕. Previous posterior cervical spine surgery (e.g., posterior element decompression) that destabilizes the cervical spine
✕. Advanced cervical anatomical deformity (e.g., ankylosing spondylitis, scoliosis) at the operative or adjacent levels