Rotator cuff tears repair with or without Dermal patch Augmentation V1
Research type
Research Study
Full title
Pilot randomised trial on Surgical repair of Large Rotator cuff tears with or without a Human Acellular dermal matrix patch as an Augment.
IRAS ID
293292
Contact name
Harvinder Pal Singh
Contact email
Sponsor organisation
University Hospitals of Leicester NHS trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 3 days
Research summary
We are planning to conduct a Pilot study of 40 patients of Pragmatic randomised controlled trial comparing rotator cuff tendons repair (small tendons around the shoulder ) with or without augmentative patch. It includes patients between age groups 50 to 75 years with large (≥ 3cm and < 5 cm ) rotator cuff tear that can be fully repaired using open or mini open repair with or without an augmentation with a human dermal matrix allograft (processed skin graft from a human donor ). Our main aim is to examine whether the addition of the patch helps to reduce the rate of re-tear of the rotator cuff tendons at one year following surgery. Patients are randomized to receive either a repair with addition of an augmentative patch or a repair without a patch and have an identical follow-up after surgery. Patients are followed up in outpatient at 6 weeks , 3 months and 12 months after randomization and receive an Magnetic Resonant Imaging (MRI) scan 12 months after surgery. The primary outcome measure is to assess the Re-tear rate of rotator cuff at 12 months after surgery. The secondary outcome measure is to assess functional scores of the shoulder at 12 months . The tertiary outcome measures are to check the cost effectiveness of each procedure .
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
21/EM/0187
Date of REC Opinion
27 Sep 2021
REC opinion
Further Information Favourable Opinion