Status:
ACTIVE_NOT_RECRUITING
Rotator Cuff Healing Using a Nanofiber Scaffold in Patients Greater Than 55 Years
Lead Sponsor:
Atreon Orthopedics
Conditions:
Rotator Cuff Tears
Full-thickness Rotator Cuff Tears
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
Randomized controlled trial of patients over the age of 55 treated with and without a nanofiber scaffold during rotator cuff repair.
Detailed Description
1. INTRODUCTION This document is a protocol for a human research study. This study is to be conducted according to United States standards of Good Clinical Practice in accordance with applicable F...
Eligibility Criteria
Inclusion
- Age 55 and older
- Able to provide informed consent
- Primary diagnosis of rotator cuff tear
Exclusion
- Revision rotator cuff surgery
- Partial thickness rotator cuff tears
- Massive (greater than 5cm) rotator cuff tears
- Patients with current tobacco history
Key Trial Info
Start Date :
June 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2025
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT04325789
Start Date
June 29 2020
End Date
March 15 2025
Last Update
January 23 2025
Active Locations (4)
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1
Central Indiana Orthopedics
Fishers, Indiana, United States, 46037
2
Associated Orthopedists of Detroit
Saint Clair Shores, Michigan, United States, 48080
3
The Christ Hospital & The Lindner Reseach Center at The Christ Hospital
Cincinnati, Ohio, United States, 45219
4
Steadman Hawkins Clinic of the Carolinas - Patewood
Greenville, South Carolina, United States, 29615