Artificial Cervical Disk
PI: Kee Kim, M.D.
A Multi-Center, Prospective, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of the Mobi-C® Prosthesis to Conventional Anterior Cervical Discectomy and Fusion in the Treatment of Symptomatic Degenerative Disc Disease in the Cervical Spine.
The study will be limited to subjects whose symptoms have not adequately responded to non-operative conservative treatment after radiculopathy or myeloradiculopathy symptom onset.
The study is a prospective, randomized, multi-center, concurrently controlled investigation, in which the study device will be compared to the control treatment consisting of conventional anterior cervical discectomy and fusion (ACDF) in accordance with the Smith-Robinson procedure. ACDF is defined as a complete disc removal and nerve decompression with grafting of allograft bone between the vertebrae adjacent to the degenerated disc to eliminate articulation at the damaged segment. Following discectomy and grafting, a semi-constrained, rotational anterior cervical plate will be placed. The Mobi-C cervical disc prosthesis is designed to provide an additional therapeutic option to maintain motion segment position and spacing while preserving flexibility in the affected cervical vertebral level.
This is a single and/or two level cervical disc replacement study. It will be randomized in a 2 to 1 ratio, with patients followed for two years post-surgery.