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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Elke
Gemperle Mannion
-
start@warwick.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Injury of muscle(s) and tendon(s) of the rotator cuff of shoulder
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Background and study aims
Within the shoulder there are a group of small muscles and tendons called the rotator cuff. Tears of the rotator cuff tendons are very common. They can be very painful and it can be difficult to move the shoulder normally. Many tears of the tendons can be repaired but some tears cannot. When a tear cannot be repaired, one common treatment is a keyhole operation to clear space around the tendons and remove the painful tissue. This is called an arthroscopic debridement. It is not known whether this operation helps in every case, but it is low risk and is thought to benefit most people with rotator cuff tears. A new device has recently been introduced in the UK with the aim of improving outcomes from surgery for this condition. It is a balloon made out of a biodegradable synthetic material (free of animal products), called the InSpace balloon. It is inserted at the end of an arthroscopic debridement operation and is filled with water. It is thought to act as a cushion inside the joint. It dissolves after about three months, by which time the patient has had a chance to strengthen the other muscles to give a longer lasting effect. It is not yet known whether it is any better or worse than the standard arthroscopic debridement operation. The aim of this study is to find out whether it is better to have an arthroscopic debridement operation, or the same operation with the addition of the InSpace balloon, in patients with a tear of the rotator cuff muscles that cannot be repaired. The National Institute of Health and Care Excellence (NICE) has studied the balloon and decided that it should only be used in research to determine if it works. The study will look at which operation is best at reducing pain and improving movement, strength, and quality of life, and whether the balloon is worth the additional cost.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/31815651 study design investigation (added 10/12/2019)2020 Protocol article in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7247380/ protocol (added 27/11/2020)2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35461618/ (added 22/04/2022)2023 Results article in https://doi.org/10.3310/TKJY2101 (added 10/05/2024)
You can take part if:
You may not be able to take part if:
1. Advanced gleno-humeral osteoarthritis on pre-operative imaging (in the opinion of the treating clinician). Advanced gleno-humeral OA may be interpreted as Kellgren Lawrence grade 3 or 4 changes on routine pre-operative radiographs(64), or the MRI equivalent if radiographs have not been taken2. Subscapularis deficiency*, defined as a tear involving more than the superior 1cm (approximately) of the subscapularis if repaired, or any tear that is not repaired. Minor, repairable, upper border tears are common and a repairable upper-border tear is not considered a contra-indication by the manufacturer3. The treating surgeon determines that interposition grafting or tendon transfers are indicated. Some surgeons prefer to treat younger, more active patients with operations designed to restore or replace rotator cuff function. There is no established age criterion for this, however and the decision is based on multiple factors including age, co-morbidities, occupation, level of activity, and surgeon preference4. Pseudoparalysis, as determined by the treating clinician5. Unrelated, symptomatic ipsilateral shoulder disorder that would interfere with strength measurement or ability to perform rehabilitation6. Other neurological or muscular condition that would interfere with strength measurement or ability to perform rehabilitation, in the opinion of the treating clinician7. Previous proximal humerus fracture that could influence shoulder function, as determined by the treating clinician8. Previous entry into the present trial (i.e. other shoulder)9. Unable to complete trial procedures10. Age under 18 11. Unable to consent to the trial12. Unfit for surgery as defined by the treating clinician
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Elke
Gemperle Mannion
-
start@warwick.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University Hospitals Coventry and Warwickshire NHS Trust; University of Warwick and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/61/18.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 37199
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
