Degenerative Disc Disease Clinical Trial
Official title:
Prospective, Non-Randomized, 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
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.
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