Status:
ACTIVE_NOT_RECRUITING
Evaluation of Regeneten Augmentation for Subscapularis Healing After Total Shoulder Arthroplasty (RESTOR)
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Smith & Nephew, Inc.
Conditions:
Arthroplasty, Replacement, Shoulder
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate whether augmentation of subscapularis repair with the Regeneten implant after anatomic total shoulder arthroplasty (TSA) can improve rates of subscapularis hea...
Detailed Description
Subscapularis management is an area of controversy in the literature for total shoulder arthroplasty (TSA). Regeneten has been suggested as a bioinductive implant to aid in rotator cuff healing. We hy...
Eligibility Criteria
Inclusion
- Patients healthy enough to undergo primary anatomic TSA
- Being treated with subscapularis tenotomy or subscapularis peel.
- Age 50 or above
- Intact rotator cuff including subscapularis as determined by preoperative examination and imaging (typically preoperative CT, MRI if indicated or available).
Exclusion
- Revision arthroplasty
- Reverse arthroplasty
- Requiring a lesser tuberosity osteotomy
- Intraoperative identification of rotator cuff tear requiring repair
- Object to using cow derived material
- Prior index shoulder surgery requiring treatment to the subscapularis
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2027
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04861714
Start Date
July 14 2020
End Date
April 1 2027
Last Update
July 31 2025
Active Locations (1)
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1
The Ohio State University Sports Medicine Center
Columbus, Ohio, United States, 43221