Trial ID or NCT#

NCT01609374

Status

NOT RECRUITING

Purpose

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.

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Lawrence Shuer, MD
Neurosurgeon, Epilepsy neurosurgeon, Spine neurosurgeon, Pain neurosurgeon, Neuro-oncologist
Professor of Neurosurgery at the Stanford University Medical Center
John Ratliff, MD, FACS
Spine neurosurgeon, Stereotactic neurosurgeon, Neuro-oncologist, Peripheral nerve surgeon
Professor of Neurosurgery at the Stanford University Medical Center

Contact us to find out if this trial is right for you.

CONTACT

Kara Richardson
(650) 736-6171