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ACTIVE NOT RECRUITING
NCT04122248

M6-C Post Approval Study (PAS)

Sponsor: Spinal Kinetics

View on ClinicalTrials.gov

Summary

The M6-C Post Approval Study is a long term follow-up study of subjects previously enrolled and treated in the M6-C Artificial Cervical Disc IDE Study.

Official title: M6-C Artificial Cervical Disc IDE Post Approval Study

Key Details

Gender

All

Age Range

21 Years - 68 Years

Study Type

OBSERVATIONAL

Enrollment

152

Start Date

2019-11-30

Completion Date

2026-06-30

Last Updated

2025-07-30

Healthy Volunteers

No

Interventions

OTHER

standard radiographic imaging

standard radiographic imaging

DEVICE

cervical total disc replacement

Artificial disc replacement (ADR) in the cervical spine is a minimally invasive procedure that involves removing diseased disc tissue and replacing it with an artificial disc. The artificial disc is designed to preserve the spine\'s natural motion while remaining securely attached to the surrounding vertebral bones. The goal of ADR is to help preserve the motion of the cervical spine or spinal segment after surgery, which can improve the quality of life for patients.

Locations (21)

Desert Institute for Spine Care

Phoenix, Arizona, United States

The CORE Institute

Sun City West, Arizona, United States

Spine MD

Beverly Hills, California, United States

Memorial Orthopedic Surgical Group

Long Beach, California, United States

Stanford University

Stanford, California, United States

University of Colorado School of Medicine

Aurora, Colorado, United States

ClinTech Center for Spine

Johnstown, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Medstar Hospital/Georgetown University

Washington D.C., District of Columbia, United States

Midwest Orthopedics

Chicago, Illinois, United States

Indiana Spine Group

Carmel, Indiana, United States

Spine Institute of Lousianna

Shreveport, Louisiana, United States

HSS

New York, New York, United States

Upstate Medical University

Syracuse, New York, United States

CNSA

Charlotte, North Carolina, United States

OrthoCarolina Research Institute

Charlotte, North Carolina, United States

EmergeOrtho

Durham, North Carolina, United States

The Ohio State University - Wexner Medical Center

Columbus, Ohio, United States

Center for Sports Medicine & Orthopedics

Chattanooga, Tennessee, United States

Texas Back Institute

Plano, Texas, United States

West Virginia University

Morgantown, West Virginia, United States