Displaced Distal Clavicle Trial: DIDACT
Collar bone (clavicle) fractures make up for around 5% of all bon fractures.
Usually people fracture the middle part of their collar bone, but sometimes the outer part of the collar bone on top of the shoulder breaks and separates. This is called a ‘displaced distal clavicle fracture’. These can be very painful, make it hard to move your arm, disturb sleep and affect the appearance of your shoulder.
Treatment for this fracture is either surgery (using plates and screws) or they wear a sling to let the fracture heal naturally.
Surgery may offer greater certainty that the bone will heal. However, patients are often concerned about the risks of surgery (e.g., infection). Sometimes the plate used to fix the collar bone may be removed in a later second surgery. Using a sling can avoid the risks of surgery. However, patients are concerned that natural healing might take longer and may need surgery later anyway.
Patients and surgeons have said it is important to find out which is the best way to treat this type of fracture.
What we are doing
The best way to compare which treatment works better is using a randomised trial, where patients and surgeons do not choose the treatment. Patients will be randomly assigned to either surgery or a sling.
Patients will complete questionnaires at 6 weeks, 3, 6 and 12 months following their injury.
We will also be evaluating the cost effectiveness of the two treatment options.
Patients who have experienced this fracture, as well as carers, have helped to design the study and data collection. They will also help us to develop information materials and how best to communicate the study results in a way that can be easily understood by patients.
Associate Professor Harvinder Singh
Professor Amar Rangan
University Hospitals of Leicester NHS Trust
NIHR Health Technology Assessment (HTA)
In set up