START:REACTS
Research type
Research Study
Full title
Sub-acromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery
IRAS ID
233804
Contact name
Andrew Metcalfe
Contact email
Sponsor organisation
University Hospital of Coventry and Warwickshire
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Rotator cuff tears are common, with 30% of the population aged 60-69 having a tear. Rotator cuff tears can cause restricted movement, disability, pain and substantial expense to society through both costs of treatment and sick leave. Current treatment consists of physiotherapy, injection and tendon repair. When a repair is not possible, surgical debridement of the space around the tendons may be performed to allow the shoulder to function better. However pain and disability often persist. The InSpace balloon is a dissolvable device which sits beneath the acromion, protecting the humerus from catching on the bone above it as the shoulder moves, and potentially allowing early rehabilitation. The device is costly (£1250 per insertion) but there is no evidence that it is effective clinically or that it does not causes harm. The aim of this study is to compare arthroscopic debridement (the standard treatment) to arthroscopic debridement with the InSpace balloon. We will recruit 212 people needing shoulder surgery from at least 16 centres. Patients will be randomly allocated to one or other treatment. As the incisions and post –operative physiotherapy are the same, neither the patient nor the person assessing the results will know which treatment has been given. This will ensure a fair and unbiased comparison. Patients will be seen at three, six, and 12 months when we will measure strength, range of motion and pain. We will also use questionnaires to assess disability, quality of life, and costs, including lost earnings. A group of 56 patients will also have shoulder scans taken six-weeks and six-months after surgery, to assess the way the balloon is thought to work. This study will determine whether the use of this device improves shoulder function, pain and quality of life following shoulder surgery for rotator cuff tears that can not be repaired. [COVID 19 amendment 07/05/2020] Due to Covid-19 it has become clear that the collection of the primary outcome (Constant-Murley Score) measurements, which must be done in person at the participating hospitals would have to be discontinued for the duration of the crisis. The primary outcome was therefore changed to the Oxford Shoulder Score (OSS) which is a patient reported outcome measure. The OSS behaves in a similar way to the Constant Score and is well validated. The Constant Score will remain a secondary outcome on the 12 Months time point. Scores collected so far will still be used as a secondary outcome. Collection may continue when hospital visits resume. Outcome scores can be collected by post and telephone. This will ensure that the trial does not need to be halted due to the Covid-19 crisis and that participants can be followed up directly. We have also expanded the methods for collection of data using phone and electronic systems such as email and a mobile application to facilitate collection of data during the Covid-19 crisis.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
18/WM/0025
Date of REC Opinion
13 Feb 2018
REC opinion
Further Information Favourable Opinion