Augmented vs Double-Row Rotator Cuff Repairs
Research type
Research Study
Full title
Randomised Clinical Trial Comparing Arthroscopic Double Row Large‐Massive Rotator Cuff Repairs With And Without Extracellular Matrix Augment.
IRAS ID
211499
Contact name
Ali Narvani
Contact email
Sponsor organisation
Ashford and St.Peter's Hospital NHS FT
Duration of Study in the UK
3 years, 0 months, 2 days
Research summary
Rotator cuff tears (RCT) are common, especially in elderly. Re-tear rate after rotator cuff repairs is still too high (40% of the population aged over 60 years) despite the evolution of materials and surgical techniques.
The discussion is still intense regarding the possibility of using scaffolds or patches in order to make the repairs stronger and more secure. The aims of the study are to assess the long term benefits of augmenting a rotator cuff repair with an Decellularized Human Dermal Allograft in terms of outcome and re-tear rate.
Patients with large-massive RCT added to the waiting list for surgery will be randomized if they meet the inclusion/exclusion criteria of the study. The patients will be randomized and divided in 2 groups: patients who undergo an arthroscopic double row rotator cuff repair (group A) and patients who undergo an arthroscopic double row rotator cuff repair augmented with a dermal allograft (group B). Disability of the arm, shoulder and hand questionnaire (DASH), ASES (American Shoulder and Elbow Score), Constant Score (CS) and pain visual analogue scale (VAS) will be used to score shoulder function. All the data will be collected pre-operatively and at 3 weeks and 3, 6, 12 and 24 months. Soft tissue imaging will be used to assess the repair in all the patients 1 year after the procedure.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
18/NW/0459
Date of REC Opinion
12 Sep 2018
REC opinion
Further Information Favourable Opinion