M6-C Post Approval Study (PAS)

NCT04122248 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CA-C004
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

Cervical Degenerative Disc Disease; Cervical Radiculopathy; Cervical Spinal Cord Compression; Cervical Disc Herniation

Keywords

artificial cervical disc arthroplasty

Outcome Measures

Primary Outcomes (1)

• Overall subject success

  A study subject will be considered an overall success if he/she meets the following criteria: * No serious adverse event(s) classified as device or device procedure related (as determined by the CEC), and * No subsequent surgical procedure at the index level (including revision, removal, reoperation, or supplemental fixation), and * Maintenance or improvement in neurological function, and * Improvement on the NDI of at least 15 points.

  10 year follow-up

Secondary Outcomes (5)

• Neck Disability Index (NDI)

  annually to 10 years

• Neck and arm pain

  annually to 10 years

• SF-36 Health Survey

  annually to 10 years

• Patient Satisfaction

  annually to 10 years

• Odom's Criteria

  annually to 10 years

Study Arms (2)

M6-C

Subjects treated with an M6-C device

Other: standard radiographic imaging; Device: cervical total disc replacement

ACDF

Subjects treated with Anterior Cervical Discectomy and Fusion (ACDF)

Other: standard radiographic imaging

Interventions

standard radiographic imaging OTHER

standard radiographic imaging

ACDF; M6-C

cervical total disc replacement DEVICE

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.

Also known as: cervical disc arthroplasty, cervical artificial disc replacement

M6-C

Eligibility Criteria

• Age: 21 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects eligible for study enrollment will include subjects implanted in the M6-C™ IDE pivotal study

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

Sponsors & Collaborators

• Spinal Kinetics: lead

Study Sites (21)

Desert Institute for Spine Care

Phoenix, Arizona, 85020, United States

Location

The CORE Institute

Sun City West, Arizona, 85375, United States

Location

Spine MD

Beverly Hills, California, 90210, United States

Location

Memorial Orthopedic Surgical Group

Long Beach, California, 90806, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

ClinTech Center for Spine

Johnstown, Colorado, 80534, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Medstar Hospital/Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Midwest Orthopedics

Chicago, Illinois, 60612, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Spine Institute of Lousianna

Shreveport, Louisiana, 71101, United States

Location

HSS

New York, New York, 10021, United States

Location

Upstate Medical University

Syracuse, New York, 13057, United States

Location

CNSA

Charlotte, North Carolina, 28204, United States

Location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

EmergeOrtho

Durham, North Carolina, 27704, United States

Location

The Ohio State University - Wexner Medical Center

Columbus, Ohio, 43202, United States

Location

Center for Sports Medicine & Orthopedics

Chattanooga, Tennessee, 37404, United States

Location

Texas Back Institute

Plano, Texas, 75093, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 10, 2019
• Study Start: November 30, 2019
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)