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Active Not RecruitingNCT04122248

M6-C Post Approval Study (PAS)

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.

Lead sponsor: Spinal Kinetics•21 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Spinal Kinetics

A prospective, concurrently controlled, multi-center pivotal study to evaluate the safety and effectiveness of the M6-C™ Artificial Cervical Disc compared to anterior cervical discectomy and fusion (ACDF) was performed in the United States under IDE #G050254. To fulfill the concurrent control design of the study, there were clinical sites that evaluated the safety and effectiveness of the M6-C™ Artificial Cervical Disc and there were other clinical sites that evaluated ACDF. Subjects in the study were treated between May 2014 and June 2016 and remain in follow-up. The M6-C™ Artificial Cervical Disc received FDA approval to market on February 6, 2019. As a condition of approval, the FDA requested that the sponsor perform a post market approval study (PAS). The subjects enrolled and remaining in the M6-C IDE pivotal study are the prospective patient population for the PAS.

Age

21 - 68 years

Sex

ALL

Healthy Volunteers

No

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•Subjects who were withdrawn or withdrew consent to participate in the investigation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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 30, 2025Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

Phase—

Enrollment152

Start dateNov 2019

Last updatedJul 30, 2025

Condition

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

Locations shown

Desert Institute for Spine Care

Phoenix, Arizona

The CORE Institute

Sun City West, Arizona

Spine MD

Beverly Hills, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 30, 2025Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions