Status:
COMPLETED
Superior Capsular Reconstruction With InternalBrace Study
Lead Sponsor:
Wrightington, Wigan and Leigh NHS Foundation Trust
Collaborating Sponsors:
Edge Hill University
University of Central Lancashire
Conditions:
Superior Capsular Reconstruction
Eligibility:
All Genders
18-80 years
Brief Summary
The aim of the study is to investigate the clinical and radiological outcomes after superior capsular reconstruction with InternalBrace (SCRIB) performed for irreparable rotator cuff tears.
Detailed Description
Massive rotator cuff tears which are irreparable in adults without severe gleno-humeral joint osteoarthritis pose a challenging problem. Tendon retraction, muscle atrophy and fatty infiltration often ...
Eligibility Criteria
Inclusion
- Adult patients between 18 and 80 years old.
- Massive Rotator cuff tears (Patte stage 3), as visualised on the MRI Scan
- Failure of non-surgical treatment.
- Patients consenting for allograft usage
- Arthroscopic assessment identifying an irreparable tear. A rotator cuff tear is deemed irreparable if it is not possible to achieve complete cover-age of the humeral head following arthroscopic release.
Exclusion
- Pre-operative
- Patients with neurological cause of weakness
- Patients with advanced arthritis affecting the joint (Kellgren-Lawrence Grade 3 to 4)
- Fixed Humeral head superior displacement (Hamada Grade 3 to 4)
- Intra-operative
- \- Advanced cartilage loss
Key Trial Info
Start Date :
February 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 24 2025
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT05360654
Start Date
February 22 2022
End Date
March 24 2025
Last Update
April 2 2025
Active Locations (1)
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1
Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust
Wigan, United Kingdom, WN6 9EP