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ACTIVE NOT RECRUITING
NCT04982835
NA

M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study

Sponsor: Orthofix Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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