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Clinical Trials in the USA / NCT04122248
Active, not recruiting Observational

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for this long-term follow-up study, there are no additional inclusion criteria Exclusion Criteria: * Subjects who were withdrawn or withdrew consent to participate in the investigation * Subjects who do not consent to participate in long-term follow-up or provide personal contact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

FacilityCityRegionStatus
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

NuVasive® ACP System Study Enrolling by invitation
Effectiveness of AlloWrap® for the Reduction of Inflammation in ACDF Procedures Enrolling by invitation
The Synergy Disc To Anterior Cervical Discectomy and Fusion Active, not recruiting
Posterior Cervical Fixation Study 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