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M6-C Post Approval Study (PAS)

NCT04122248 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 152

Last updated 2025-07-30

No results posted yet for this 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.

Conditions

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

Interventions

OTHER

standard radiographic imaging

standard radiographic imaging

DEVICE

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.

Sponsors & Collaborators

  • Spinal Kinetics

    lead INDUSTRY

Eligibility

Min Age
21 Years
Max Age
68 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-30
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04122248 on ClinicalTrials.gov