Trials / Active Not Recruiting
Active Not RecruitingNCT04122248
M6-C Post Approval Study (PAS)
M6-C Artificial Cervical Disc IDE Post Approval Study
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 152 (actual)
- Sponsor
- Spinal Kinetics · Industry
- Sex
- All
- Age
- 21 Years – 68 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
- Cervical Degenerative Disc Disease
- Cervical Radiculopathy
- Cervical Spinal Cord Compression
- Cervical Disc Herniation
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-11-30
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2019-10-10
- Last updated
- 2025-07-30
Locations
21 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04122248. Inclusion in this directory is not an endorsement.