Displaced Distal Clavicle Trial (DIDACT)
Research type
Research Study
Full title
Surgery compared with sling immobilisation in the management of adults with a displaced fracture of the distal clavicle (DIDACT): a multi-centre, pragmatic, parallel group,non-inferiority, randomised controlled trial
IRAS ID
321203
Contact name
Harvinder P Singh
Contact email
Sponsor organisation
University Hospitals of Leicester NHS Trust
Clinicaltrials.gov Identifier
143349, Edge ID
Duration of Study in the UK
3 years, 7 months, 31 days
Research summary
Clavicle (collar bone) fractures make up around 5% of all bone fractures. Usually, people fracture the middle part of their collarbone but sometimes the outer part on top of the shoulder breaks and separates. This is called a “displaced distal clavicle fracture”. These fractures can be very painful, make it hard to move your arm, disturb sleep and affect the appearance of your shoulder.
Patients either undergo surgery to repair the collarbone with plates and screws or they wear a sling to let the fracture heal naturally. Surgery may offer greater certainty that the bone will heal, although there are risks, such as infection, and may require a second operation to remove the plate. A sling can avoid the risks of surgery. Although natural healing may take longer, and may eventually still need surgery. Patients and surgeons have said it is a priority to find out which is the best way to treat this type of fracture.
There is not much research to confirm whether surgery or using a sling is better for people with displaced distal clavicle fractures. The best way to see which treatment works better is to compare them both in a ‘randomised trial’. This means that patients or surgeons do not choose a treatment. Patients who agree to take part in the study will be given one of the treatments at random. This ensures an equal chance of getting either treatment and allow a fair comparison between treatments. Patients will complete questionnaires at 6 weeks, 3, 6 and 12 months. This study will help surgeons and patients know which treatment to choose for this type of broken collarbone. We also want to know the costs of treating a patient with a sling or surgery to find out the best value for money to the NHS.
REC name
East of England - Essex Research Ethics Committee
REC reference
23/EE/0123
Date of REC Opinion
11 Jul 2023
REC opinion
Further Information Favourable Opinion