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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 Contiguous Two-Level Symptomatic Cervical Radiculopathy

Primary Objective

To evaluate the safety and effectiveness of the Spinal Kinetics M6-C™ artificial cervical disc in patients with contiguous twolevel symptomatic cervical radiculopathy with or without cord compression.

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Description

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 contiguous two-level symptomatic cervical radiculopathy.

Details
Age
Child to Adult
Eligibility
Patients eligible for study enrollment will present with degenerative cervical radiculopathy requiring surgical intervention, confirmed clinically and radiographically, at two contiguous vertebral levels from C3 to C7. Qualified patients will have confirmed functional impairment as indicated by a minimum score of 30% (30/100) on the NDI and have not adequately responded to conservative medical care over a period of at least 6 weeks.Patients eligible for study enrollment will present with degenerative cervical radiculopathy requiring surgical intervention, confirmed clinically and radiographically, at two contiguous vertebral levels from C3 to C7. Qualified patients will have confirmed functional impairment as indicated by a minimum score of 30% (30/100) on the NDI and have not adequately responded to conservative medical care over a period of at least 6 weeks.
Locations

Highlands Ranch Hospital
Lone Tree Medical Center
University of Colorado Hospital

Principal Investigator
Photograph of Vikas Patel

Vikas Patel

Study ID

Protocol Number: 22-0694

More information available at ClinicalTrials.gov: NCT04982835

Categories

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