CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study
Trial Parameters
Brief Summary
The study is a prospective, first-in-human, multi-center, non-randomized, single-arm study to assess the safety and efficacy of the CEM-Cage used with the CEM-Plate in patients who are appropriate candidates for a 2-level anterior cervical discectomy and fusion (ACDF). Fifty patients will be enrolled in the study and, after undergoing a 2-level ACDF, will be evaluated at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.
Eligibility Criteria
Inclusion Criteria: 1. Males and females aged 22-79 years. 2. Documented diagnosis of cervical spine radiculopathy or myelopathy. 3. Symptomatic cervical degenerative disc disease at 2 contiguous levels between C2 through T1. 4. Baseline NDI score ≥30 and/or baseline mJOA score ≤16. 5. Pathology at the level to be treated correlating to the primary symptoms confirmed by imaging (computed tomography (CT), CT myelography, magnetic resonance imaging (MRI), or plain radiography). 6. Unresponsive to non-operative, conservative treatment for at least 6 weeks from symptom onset or presence of progressive cervical myelopathy or signs of nerve root/spinal cord compression despite continued non-operative treatment. 7. Ability to speak, read, and understand the IRB approved Informed Consent document. 8. Willingness to give informed consent for participation in the study. Exclusion Criteria: 1. Any prior cervical surgeries at the symptomatic levels; prior surgery or cervical fusion procedure at an