First-in-human Prospective Study to Assess the Safety and Efficacy of the CEM-Cage and CEM-Plate
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.
• Males and females aged 22-79 years.
• Documented diagnosis of cervical spine radiculopathy or myelopathy.
• Symptomatic cervical degenerative disc disease at 2 contiguous levels between C2 through T1.
• Baseline NDI score ≥30 and/or baseline mJOA score ≤16.
• 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).
• 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.
• Ability to speak, read, and understand the IRB approved Informed Consent document.
• Willingness to give informed consent for participation in the study.