Restore CLINICAL TRIAL
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
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.
Official Title
Prospective, Non-Randomized, 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
Eligibility Criteria
- 1. 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.)2. Inadequate response to conservative medical care over a period of at least 6 weeks3. Neck Disability Index score of ≥ 30% (raw score of ≥ 15/50)4. Neck or arm pain VAS ≥ 4 on a scale of 0 to 105. Willing and able to comply with the requirements of the protocol including follow-up requirements6. Willing and able to sign a study specific informed consent7. Skeletally mature and ≥ 18 years old and ≤ 75 years old
- 1. More than one cervical level requiring surgery2. Previous anterior cervical spine surgery3. Axial neck pain as the solitary symptom4. Previous posterior cervical spine surgery (e.g., posterior element decompression) that destabilizes the cervical spine5. Advanced cervical anatomical deformity (e.g., ankylosing spondylitis, scoliosis) at the operative or adjacent levels6. Symptomatic facet arthrosis7. Less than 4º of motion in flexion/extension at the index level8. Instability as evidenced by subluxation \> 3 mm at the index or adjacent levels as indicated on flexion/extension x-rays9. Advanced degenerative changes (e.g., spondylosis) at the index vertebral level as evidenced by bridging osteophytes, central disc height \< 4mm and/or \< 50% of the adjacent normal intervertebral disc, or kyphotic deformity \> 11º on neutral x-rays10. Severe cervical myelopathy (i.e., Nurick's Classification \> 2)11. Active systemic infection or infection at the operative site12. Co-morbid medical conditions of the spine or upper extremities that may affect the cervical spine neurological and/or pain assessment13. Metabolic bone disease such as osteoporosis that contradicts spinal surgery (for females over 50 and males over 55 years old, or if the score on the Osteoporosis Self-Assessment Test is \< 2, a dual energy x-ray absorptiometry \[DEXA scan\] of the spine is required; if the bone mineral density T-score in the spine is ≤ -2.5 the patient must be excluded)14. History of an osteoporotic fracture of the spine, hip or wrist15. History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism16. Taking medications that may interfere with bony/soft tissue healing including chronic steroid use17. Known allergy to titanium, stainless steels, polyurethane, polyethylene, or ethylene oxide residuals18. Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia19. Insulin-dependent type 1 or type 2 diabetes20. Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion21. Pregnant, or intend to become pregnant, during the course of the study22. Severe obesity (Body Mass Index \> 40)23. 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.24. Involved in current or pending spinal litigation where permanent disability benefits are being sought25. Incarcerated at the time of study enrollment26. Current participation in other investigational study that may impact study outcomes
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Kara Richardson
650-736-6171
View on ClinicalTrials.gov
