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.
Any prior cervical surgeries at the symptomatic levels; prior surgery or cervical fusion procedure at any level.
Fewer than 2 or more than 2 vertebral levels requiring treatment.
Anatomy that is non-conducive to receiving investigational device.
More than one immobile vertebral level between C-1 to C-7 from any cause, including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions.
Single group
CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System
DeviceTwo-Level ACDF with CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System
Fusion
Flexion-extension plain radiographs and CT scans will be used to assess bony fusion at both surgical levels.
Device-Related Adverse Events
No serious adverse events related to the surgical procedure, no device-related serious adverse events, no subsequent surgical interventions at the index levels, and absence of clinically significant device malfunctions.
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ReVivo Medical, Corp.
Lead sponsor
Albany Medical College
Collaborator
The Cleveland Clinic
Collaborator
IGEA
Collaborator
