M6-C Post Approval Study (PAS)

NCT04122248 · tracked via the Priya Life Science USA tracker

Sponsor

Spinal Kinetics

Phase

Observational

Started

2019-11-30

Last updated

2025-07-30

Condition(s) studied

Cervical Degenerative Disc DiseaseCervical RadiculopathyCervical Spinal Cord CompressionCervical Disc Herniation

Investigational drug(s) / intervention(s)

standard radiographic imagingcervical total disc replacement

standard radiographic imaging: standard radiographic imaging

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.

Study 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.

Eligibility

Sex

ALL

Min age

21 Years

Max age

68 Years

Healthy volunteers

Inclusion Criteria: * 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for this long-term follow-up study, there are no additional inclusion criteria Exclusion Criteria: * Subjects who were withdrawn or withdrew consent to participate in the investigation * Subjects who do not consent to participate in long-term follow-up or provide personal contact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

Primary outcome measure(s)

Overall subject success — 10 year follow-up
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.

Trial sites (21)

Facility	City	Region
Desert Institute for Spine Care	Phoenix	Arizona
The CORE Institute	Sun City West	Arizona
Spine MD	Beverly Hills	California
Memorial Orthopedic Surgical Group	Long Beach	California
Stanford University	Stanford	California
University of Colorado School of Medicine	Aurora	Colorado
ClinTech Center for Spine	Johnstown	Colorado
Yale University School of Medicine	New Haven	Connecticut
Medstar Hospital/Georgetown University	Washington D.C.	District of Columbia
Midwest Orthopedics	Chicago	Illinois
Indiana Spine Group	Carmel	Indiana
Spine Institute of Lousianna	Shreveport	Louisiana
HSS	New York	New York
Upstate Medical University	Syracuse	New York
CNSA	Charlotte	North Carolina
OrthoCarolina Research Institute	Charlotte	North Carolina
EmergeOrtho	Durham	North Carolina
The Ohio State University - Wexner Medical Center	Columbus	Ohio
Center for Sports Medicine & Orthopedics	Chattanooga	Tennessee
Texas Back Institute	Plano	Texas
West Virginia University	Morgantown	West Virginia

Other trials for the same condition

The Synergy Disc To Anterior Cervical Discectomy and Fusion Active, not recruiting

NuVasive® ACP System Study Enrolling by invitation

Posterior Cervical Fixation Study Enrolling by invitation

Effectiveness of AlloWrap® for the Reduction of Inflammation in ACDF Procedures Enrolling by invitation

The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04122248 on ClinicalTrials.gov ↗ ← All trials in the USA