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.
Lay summary of study results:
What was the problem? Many people get shoulder pain. For some, this can because of a tear in the muscles that keep the shoulder joint stable (rotator cuff tears) These rotator cuff tears are very common. Some people with a painful rotator cuff tear with pain and loss of function that is not improved by simple treatments, may need surgery. For many people who have surgery, the rotator cuff tear is repaired. However, some tears cannot be repaired, and we do not know the best treatment when this happens.What treatments were we testing?
One option is to use keyhole surgery to clear space around the tendons and allow the shoulder to move better. This is called arthroscopic debridement. As well as arthroscopic debridement, surgeons have been using a device called the InSpace balloon, to try to provide some cushioning between the bones in the shoulder as it was thought this would help. The InSpace balloon is a dissolvable device, filled with water, which is placed by the surgeon just above the shoulder joint after an arthroscopic debridement. In this study, we compared the standard operation, arthroscopic debridement, to the same procedure with the InSpace balloon inserted.What did we do?
We invited people from 24 NHS hospitals with rotator cuff tears that could not be repaired; 117 people took part. People either had arthroscopic debridement surgery, or arthroscopic debridement surgery with the InSpace balloon. A computer decided, at random, which treatment people would have to ensure it was a fair comparison. We did not tell people which treatment they had as this also helps ensure the results are fair. We asked people questions about their shoulder pain and function, and about their general health. These was done with questionnaires taken three, six and twelve months after the 2 operation. Some people also had their movement and strength assessed (we could not do this after covid restrictions started). We used a new method for doing this study. We set some statistical rules at the start of the study to decide whether to stop early or to continue. We monitored the results that were coming in and stopped entering people into the study if the statistical rules told us that we already had enough people taking part.What did we find out?
By using our news set of statistical rules, we only needed 117 people to take part in the study. This is about half the number of people we would normally expect to need to get a result, which means we were able to finish around a year earlier than expected. Twelve months after their operation, most people felt better than they did before the surgery. People who had the arthroscopic debridement surgery alone, without the balloon, had better results. They felt less pain and were able to use their shoulder more than people who had surgery with the balloon. The questionnaires give a score for how much people are affected by their shoulder problems (it is scored out of 48). At the start of the study the average score was 22.4. On average, people who had an arthroscopic debridement alone improved by 12.6 points over a year, using our main score. People who had an arthroscopic debridement with the InSpace balloon improved by 7.2 points over a year. In both groups, some people improved by more and some by less. The difference between the two treatments was very unlikely to be due to chance. We did not see any differences for whether people needed any extra treatments, visits to hospital, or further surgery. The results of the study were reviewed by NICE who made a recommendation that the balloon should not be used for this patient group.In Summary
On average, people improved with both treatments, but they improved more when the balloon was not inserted. We do not recommend the InSpace balloon for people with a rotator cuff tear that cannot be repaired.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