Status:
ACTIVE_NOT_RECRUITING
Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc
Lead Sponsor:
NuVasive
Conditions:
Cervical Disc Disease
Degenerative Disc Disease
Eligibility:
All Genders
Brief Summary
A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc in subjects who were enrolled in the post approval study...
Eligibility Criteria
Inclusion
- Subject was enrolled in the Simplify Disc post approval study (NCT04630626) at a participating study site
- Subject understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study
Exclusion
- Subject had an SSI at the index level during the post approval study (NCT04630626)
- Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)
Key Trial Info
Start Date :
February 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT05258435
Start Date
February 9 2022
End Date
April 1 2028
Last Update
December 22 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Hoag Orthopedics
Orange, California, United States, 92686
2
The Spine Institute for Spine Restoration
Santa Monica, California, United States, 90403
3
Spine Education and Research
Thornton, Colorado, United States, 80229
4
Kennedy-White Orthopaedic Center
Sarasota, Florida, United States, 34232