Overview

This trial is active, not recruiting.

Conditions cervical radiculopathy, degenerative disc disease
Treatments m6-c artificial cervical disc, anterior plate system with corticocancellous allograft bone
Phase phase 3
Sponsor Spinal Kinetics
Start date April 2014
End date May 2017
Trial size 243 participants
Trial identifier NCT01609374, CA-C002

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
m6-c artificial cervical disc
Total disc replacement
(Active Comparator)
anterior plate system with corticocancellous allograft bone
Cervical fusion

Primary Outcomes

Measure
Safety Evaluation through 24 months
time frame: 24 months
Effectiveness Evaluation through 24 months
time frame: 24 months

Secondary Outcomes

Measure
Effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF)
time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

All study subjects must present with degenerative cervical radiculopathy with or without spinal cord compression, confirmed clinically and radiologically, requiring surgical intervention at a single vertebral level from C3 to C7. Inclusion 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 weeks 3. Neck Disability Index score of ≥ 30% (raw score of ≥ 15/50) 4. Neck or arm pain VAS ≥ 4 on a scale of 0 to 10 5. Willing and able to comply with the requirements of the protocol including follow-up requirements 6. Willing and able to sign a study specific informed consent 7. Skeletally mature and ≥ 18 years old and ≤ 75 years old Exclusion Criteria: 1. More than one cervical level requiring surgery 2. Previous anterior cervical spine surgery 3. Axial neck pain as the solitary symptom 4. Previous posterior cervical spine surgery (e.g., posterior element decompression) that destabilizes the cervical spine 5. Advanced cervical anatomical deformity (e.g., ankylosing spondylitis, scoliosis) at the operative or adjacent levels 6. Symptomatic facet arthrosis 7. Less than 4º of motion in flexion/extension at the index level 8. Instability as evidenced by subluxation > 3 mm at the index or adjacent levels as indicated on flexion/extension x-rays 9. 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-rays 10. Severe cervical myelopathy (i.e., Nurick's Classification > 2) 11. Active systemic infection or infection at the operative site 12. Co-morbid medical conditions of the spine or upper extremities that may affect the cervical spine neurological and/or pain assessment 13. 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 wrist 15. History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism 16. Taking medications that may interfere with bony/soft tissue healing including chronic steroid use 17. Known allergy to titanium, stainless steels, polyurethane, polyethylene, or ethylene oxide residuals 18. Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia 19. Insulin-dependent type 1 or type 2 diabetes 20. Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion 21. Pregnant, or intend to become pregnant, during the course of the study 22. 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 sought 25. Incarcerated at the time of study enrollment 26. Current participation in other investigational study that may impact study outcomes

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Spinal Kinetics.