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

    Trial Phone: 321.841.1324 ; 321-841-4717

  • 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 ID: NCT04982835

  • 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.

  • Key Eligibility

    Degenerative cervical radiculopathy with or without spinal cord compression requiring surgical treatment at two contiguous levels from C3 to C7.