M6-C Post Approval Study (PAS)

Running, not enrolling

Conditions studied: Cervical Degenerative Disc Disease, Cervical Radiculopathy, Cervical Spinal Cord Compression, Cervical Disc Herniation

In brief

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.

Key facts

Study ID

NCT04122248

Run by

Spinal Kinetics

People needed

152

Starts

2019-11-30

Expected to finish

2026-06-30

Last updated by the study team

2025-07-30

Who can join

Age: 21 and older, up to 68. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Since the subjects have already been screened as part of the IDE's pivotal study, and only subjects that participated in that study make up the subject cohort for this long-term follow-up study, there are no additional inclusion criteria

You may not qualify if…

• Subjects who were withdrawn or withdrew consent to participate in the investigation
• Subjects who do not consent to participate in long-term follow-up or provide personal contact information to the sponsor (solely for the purposes of tracking subjects to help ensure follow-up compliance)
• Patients with terminal failures (SSI or device- or procedure-related SAE) by Month 24 and all known patient deaths in the M6-C IDE study are excluded for enrollment into the PAS

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.