M6-C Artificial Disc: FDA IDE Pivotal Study

Study Objective
The primary objective is to evaluate the safety and effectiveness of the Spinal Kinetics M6-C artificial cervical disc in patients with symptomatic cervical radiculopathy with or without cord compression.

The Study is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy. A total of 243 subjects will be treated; 162 M6-C subjects from up to 15 clinical sites, and 81 ACDF subjects at up to 5 clinical sites. The minimum required post-operative clinical evaluations of subjects will be conducted at 6 weeks, 3 months, 6 months, 1 year and 2 years. Evaluations beyond 2 years may be requested.

Who Will Qualify?
Patients eligible for the study will have a diagnosis of degenerative cervical radiculopathy with or without spinal cord compression requiring surgery at one level from C3 to C7, demonstrated by signs and/or symptoms of disc herniation and/or osteophyte formation (e.g. neck and/or arm pain, radiculopathy, etc.) and is confirmed by patient history and radiographic studies. Patients will have not adequately responded to conservative medical care over a period of at least six weeks. Patients must also be available for regular, scheduled follow-up visits by their treating physician for a minimum of two years post-surgery.

The M6-C Artificial Disc Study is now closed to enrollment due to completion.

Additional Information
Find out more information about The RESTORE Trial »

For more detail on the Study protocol, please visit:
https://www.clinicaltrials.gov/ct2/show/NCT01609374?term=NCT01609374&rank=1