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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.
Mr
Harvinder
Singh
+44 (0)7739714549
Harvinder.P.Singh@uhl-tr.nhs.uk
Dr
Stephen
Brealey
+44 (0)1904 321357
stephen.brealey@york.ac.uk
Mrs
Sam
Swan
+44 (0)1904 328511
sam.swan@york.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
A radiological diagnosis of a displaced fracture of the distal clavicle that does not involve the acromioclavicular joint.
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.
Fractures of the clavicle, which primarily occur in young males, constitute 2.6–5% of all fractures in adults. Distal clavicle fractures account for 20-25% of all clavicle fractures. These are treated with an operation, involving fracture fixation, or with sling immobilisation. Patients treated with surgery may have a reduced risk of the fracture not healing (non-union) and may have quicker recovery. However, they are at risk of complication; (estimated at 48%) including infection, plate breakage and refracture after metal removal. Upper limb support with a sling, typically between 2 and 4 weeks, restricts activity whilst providing comfort during the early painful stages of healing. The risk of non-union with a sling can be up to 35-40% but appears to cause minimal functional deficits in most individuals. If a non-union occurs, and surgical intervention is indicated, it can prolong the treatment period and increase costs. Using HES data for 2019 and HRG codes the cost to the NHS of surgical fixation in this fracture population is approximately £6 million per annum. At a time when the NHS is under more pressure than ever with the impact of COVID-19, it is important to answer the question of whether a potentially cheaper, safe and non-surgical option can replace more costly and invasive surgery.
The study aims to determine whether self-reported functional outcome, measured by the Disability of Arm, Shoulder and Hand (DASH) at one year, following sling immobilisation is not inferior to surgical fixation in adults with a displaced fracture of the distal clavicle and whether this is a cost-effective treatment option.
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:
You can take part if:
You may not be able to take part if:
1. The index injury is >21 days.2. An upper extremity fracture both more proximal or distal to the same affected shoulder e.g. floating shoulder.3. The fracture is open. 4. The fracture is complicated by local tumour deposits.5. The fracture is associated with a nerve palsy or vessel injury.6. Comorbidities precluding surgery or anaesthesia.7. Unable or unwilling to give consent.8. Must not be related to any member of the local study team.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mrs
Sam
Swan
+44 (0)1904 328511
sam.swan@york.ac.uk
Mr
Harvinder
Singh
+44 (0)7739714549
Harvinder.P.Singh@uhl-tr.nhs.uk
Dr
Stephen
Brealey
+44 (0)1904 321357
stephen.brealey@york.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 of Leicester NHS Trust and funded by National Institute for Health and Care Research.
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 56625
You can print or share the study information with your GP/healthcare provider or contact the research team directly.