Long term outcome of Rotator Cuff repair with Graftjacket Allograft v1
Research type
Research Study
Full title
Long term outcomes of the use the GraftJacket allograft as an interpositional graft for the management of irreparable rotator cuff tears.
IRAS ID
186454
Contact name
Amit Modi
Contact email
Sponsor organisation
University Hospitals of leicester NHS trust
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
The management of irreparable rotator cuff tears is challenging. Direct surgical repair for irreparable rotator cuff tears has a high risk of failure. It is often complex requiring either complex muscle transfers or in elderly patients a reverse shoulder replacement. The graft jacket is an alternative treatment to enable patients rotator cuff muscles to remain active and to preserve their shoulder function.
This study is to evaluate the effectiveness of a human tissue dermis (skin) derived Allograft used for repairing large (3-5cm) and massive (>5cm) rotator cuff tears. The primary purpose of this study is to determine whether rotator cuff repair with an interposition graft using the GraftJacket allograft provides a viable alternative, based on observed clinical outcomes. This study will report patient progress and results at early (6 month) and late (1 year, 2 years and beyond) time points in patients treated for large and massive rotator cuff tears (>3cm).
The study will be conducted at the Leicester General Hospital. All patients with large and irreparable rotator cuff tears of greater than 3cm will be included.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
18/NW/0578
Date of REC Opinion
7 Aug 2018
REC opinion
Favourable Opinion