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
Clinical Trial Information
Trial Contact: Carlo, Charlene S; Monserrate, Francheska
IRB No: 21.147.09
Protocol Abbrev: M6-C
Principal Investigator: Virgilio Matheus, MD
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
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.
Degenerative cervical radiculopathy with or without spinal cord compression requiring surgical treatment at two contiguous levels from C3 to C7.