M6®-C Artificial Cervical Disc Two-Level IDE Pivotal Study
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
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Clinical Trial Information
Trial Contact: Carlo, Charlene S; Monserrate, Francheska
Trial Phone: 321.841.1324 ; 321-841-4717
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IRB No: 21.147.09
Protocol Abbrev: M6-C
Principal Investigator: Virgilio Matheus, MD, FACS
Phase: Device: Significant Risk
Age Group: Adult
Secondary Protocol No: CA-C003
Treatment: As a control site patients will undergo Anterior Cervical Discectomy & Fusion (ACDF) using one of three FDA approved anterior cervical plate system and corticocancellous allograft bone.
Therapies Involved: Surgery
ClinicalTrials.gov ID: NCT04982835
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Objective
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 at vertebral levels from C3 to C7 with or without spinal cord compression.
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Key Eligibility
Degenerative cervical radiculopathy with or without spinal cord compression requiring surgical treatment at two contiguous levels from C3 to C7.
