Extrait

Background and study aims All adult patients with a broken wrist (fracture of the distal radius) are given a temporary wrist support and referred to the local fracture service for treatment. Most broken wrists can be treated without the need for surgery. However, for the more serious wrist injuries, the treating surgeon may recommend an operation to restore the normal position of the wrist bones. This study is comparing two different ways of holding the broken bones in the best position while they heal. They are both used routinely throughout the NHS, but the most effective technique is unknown. The first technique involves the application of a plaster cast which is shaped (moulded) over the skin to hold the bone fragments in position. The second technique involves the surgical fixation of the bone fragments using metal wires (K-wires). The aim of this study is to find out whether surgical fixation of the broken bones of the wrist is more effective than plaster cast treatment. Who can participate? Patients aged 16 years and over who are having surgery to treat a broken wrist. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group have a plaster cast shaped (moulded) over the skin to hold the bone fragments in position. The cast remains in place for around 4-6 weeks. Those in the second group undergo surgical fixation of the bone fragments using metal wires (K-wires). During this surgery smooth wires with a sharp point are passed across the fracture site through the skin to hold the bone fragments in position while they heal. A plaster cast is applied over the top of the wires to hold the wrist joint still, but the cast does not have to be moulded into position as the wires themselves hold the bone in place. The surgical and research team assess all patients, look at an x-ray and make a record of any early complications at 6 weeks, according to standard clinical procedure. Patients are also asked to report their own recovery using a questionnaire at 3 months, 6 months and 12 months after the treatment. The questionnaire also asks about the patient s wrist function, their general quality of life and any costs they have incurred related to their injury. What are the possible benefits and risks of participating? There are no direct benefits or risks involved for participants taking part in this study. Where is the study run from? Oxford University Hospitals NHS Trust (UK) When is the study starting and how long is it expected to run for? July 2016 to October 2019 Who is funding the study? National Institute for Health Research, Health Technology Assessment Programme (UK) Who is the main contact? Dr Katy Mironov [email protected]

Critère d'inclusion

• Dorsally displaced fracture of the distal radius

Liens

• isrctn
• ictrp