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M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study
Sponsor: Orthofix Inc.
Summary
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 Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
156
Start Date
2021-07-26
Completion Date
2026-12
Last Updated
2025-11-14
Healthy Volunteers
No
Conditions
Interventions
M6-C Artificial Cervical Disc
An incision will be made in the front of the neck and the damaged disc located between cervical vertebrae (neck bones) will be removed so that the M6-C artificial cervical disc can be placed into the space where the damaged disc was removed. This procedure will be performed using x-ray technology (fluoroscopy) guide the surgeon in placement of the M6-C in between the cervical vertebrae. This process will be repeated to replace the second damaged disc.
ACDF
One of four FDA-approved cervical plate systems will be used for the ACDF. An incision will be made in the front of the neck and the damaged disc located between cervical vertebrae (neck bones) will be removed. Then, a piece of donor bone will be placed in the space where the damaged disc was removed and a metal plate will be screwed into the bones above and below the disc. This procedure will be performed using x-ray technology (fluoroscopy) to guide the surgeon in the placement of the cervical plate system. This process will be repeated to treat the other damaged disc.
Locations (21)
Desert Institute for Spine Care
Phoenix, Arizona, United States
Beverly Hills Spine Surgery
Beverly Hills, California, United States
Memorial Orthopaedic Surgical Group
Long Beach, California, United States
Disc Sports & Spine Center
Newport Beach, California, United States
UC Irvine Medical Center
Orange, California, United States
Institute of Neuro Innovation
Santa Monica, California, United States
St. Charles Spine Institute
Thousand Oaks, California, United States
University of Colorado School of Medicine - Department of Orthopedics
Aurora, Colorado, United States
Steadman Philipon Research Institute
Vail, Colorado, United States
Orlando Health
Orlando, Florida, United States
Joseph Spine Institute
Tampa, Florida, United States
Longstreet Clinic
Gainesville, Georgia, United States
Axis Spine
Coeur d'Alene, Idaho, United States
Carle Health
Urbana, Illinois, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Michigan Orthopedic Surgeons
Southfield, Michigan, United States
The Orthopedic Center of St. Louis
St Louis, Missouri, United States
Metropolitan Neurosurgery Associates - Englewood Health
Englewood, New Jersey, United States
Mayfield Clinic
Cincinnati, Ohio, United States
St. David's Healthcare
Austin, Texas, United States
American Neurospine Institute/Medical City Frisco
Frisco, Texas, United States