Title: DRAFFT 2: Distal Radius Acute Fracture Fixation Trial 2
Funder: Department of Health and Social Care

Abstract: Setting: This trial will be recruiting from a minimum of 24 trauma centres across the UK. Patients: All adult patients presenting at the trial centres with an acute fracture of the distal radius will be screened. Those with a dorsally displaced fracture which, in the opinion of the treating surgeon, would benefit from manipulation and surgical fixation will be eligible. The broad eligibility criteria will ensure that the results of the study can readily be generalised to the wider patient population. Interventions: Each patient will then be randomly allocated to either manipulation and surgical fixation with K-wires or manipulation and plaster casting. The allocation sequence will be stratified by centre, intra-articular extension of the fracture and age of the patient (above or below 50 years). Both of these interventions are widely used within the NHS and all of the surgeons will be familiar with both techniques. The first technique involves the application of a plaster cast which is shaped (moulded) over the skin to hold the bone fragments in position. This technique is simple and quick to perform, there is little risk of complications and the materials used are cheap. However, the plaster cast is not applied directly to the bone fragments and therefore it is possible for the bone fragments to re-displace under the cast, particularly when the swelling starts to settle a few days after the surgery. The second technique involves the surgical fixation of the bone fragments using Kirschner wires (K-wires). During this procedure smooth metal 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. Post-operatively all of the patients in both groups will be issued with the same standardised written rehabilitation instructions. The research associate will perform a clinical assessment and make a record of any early complications at 6 weeks. Routine radiographs will also be taken at 6 weeks. The functional outcome and resource use data will be collected using questionnaires at 3 months, 6 months and 12 months post-operatively. These questionnaires will be administered by a research assistant blind to the treatment allocation. Outcome measures: The primary outcome measure for this study is the Patient Rated Wrist Evaluation (1). The PRWE score is a validated questionnaire which is self-reported. It consists of 15 items specifically related to the function of the wrist. The PRWE is the most sensitive outcome measure for patients sustaining this specific injury. The secondary outcome measures in this trial are : EQ-5D; a validated, generalised, health related quality of life questionnaire Complications; all complications will be recorded. Radiographic evaluation; Standard posterior-anterior and lateral radiographs will be taken at baseline and 6-weeks after the injury. Resource use will be monitored for the economic analysis

Lay abstract: 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 for patients who are having surgery for their broken wrist. Patients will be asked to take part if their treating surgeon believes their injury would benefit from ‘manipulation’ of the broken bone in order to improve the position of the wrist. The manipulation is done under local or general anaesthetic. Patients who agree to take part will be allocated to one of two treatments by chance, using a computer system. The two treatments under investigation in this trial are different ways of holding the broken bones in the best position while they heal. They are both used routinely throughout the NHS, but we don’t know which one works best. The first technique involves the application of a plaster cast which is shaped (moulded) over the skin to hold the bone fragments in position. This technique is simple and quick to perform, there is little risk of complications and the materials used are cheap. However, the plaster cast is not applied directly to the bone fragments and therefore it is possible for the bone fragments to fall back out of position under the cast. The second technique involves the 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 surgery is more expensive than the cast treatment and there are small risks from the operation eg bleeding or infection. However, because the wires fix the bone in place, there is less chance of the bones falling back out of position. After surgery, all of the patients in both groups will be issued with the same standardised written instructions with regard to exercising their wrist and returning to normal activities. The surgical and research team will assess all patients, look at an x-ray and make a record of any early complications at 6 weeks, as per routine clinical practice. We will ask all patients to report their own recovery using a validated questionnaire at 3 months, 6 months and 12 months after the treatment. The questionnaire will ask about the patient’s wrist function, their general quality of life and also about any costs they have incurred related to their injury. The trial will help us to find out if surgical fixation of the broken bones of the wrist provides better outcomes for the patient compared with plaster cast treatment, and at what cost to the NHS.

Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS