156
Participants
Start Date
July 26, 2021
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2026
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.
Upstate Medical University, East Syracuse
Longstreet Clinic, Gainesville
Orlando Health, Orlando
Joseph Spine Institute, Tampa
Mayfield Clinic, Cincinnati
Michigan Orthopedic Surgeons, Southfield
Carle Health, Urbana
The Orthopedic Center of St. Louis, St Louis
American Neurospine Institute/Medical City Frisco, Frisco
Ascension Texas Spine and Scoliosis, Austin
St. David's Healthcare, Austin
University of Colorado School of Medicine - Department of Orthopedics, Aurora
Steadman Philipon Research Institute, Vail
Axis Spine, Coeur d'Alene
University of Utah Medical Center, Salt Lake City
Desert Institute for Spine Care, Phoenix
Beverly Hills Spine Surgery, Beverly Hills
Institute of Neuro Innovation, Santa Monica
Memorial Orthopaedic Surgical Group, Long Beach
St. Charles Spine Institute, Thousand Oaks
Disc Sports & Spine Center, Newport Beach
UC Irvine Medical Center, Orange
Hartford Healthcare Bone & Joint Institute, Hartford
Brigham & Women's Hospital, Boston
Baystate Health, Springfield
Metropolitan Neurosurgery Associates - Englewood Health, Englewood
Lead Sponsor
Spinal Kinetics
INDUSTRY