Status:
ACTIVE_NOT_RECRUITING
M6-C Post Approval Study (PAS)
Lead Sponsor:
Spinal Kinetics
Conditions:
Cervical Degenerative Disc Disease
Cervical Radiculopathy
Eligibility:
All Genders
21-68 years
Brief 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 (A...
Eligibility Criteria
Inclusion
- 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
- Subjects who were withdrawn or withdrew consent to participate in the investigation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
Key Trial Info
Start Date :
November 30 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT04122248
Start Date
November 30 2019
End Date
June 30 2026
Last Update
July 30 2025
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Desert Institute for Spine Care
Phoenix, Arizona, United States, 85020
2
The CORE Institute
Sun City West, Arizona, United States, 85375
3
Spine MD
Beverly Hills, California, United States, 90210
4
Memorial Orthopedic Surgical Group
Long Beach, California, United States, 90806