Trial Status: Under Analysis
Recruitment closed: March 2019
DRAFFT-2 is funded by the NIHR Health Technology Assessment programme.
HTA Project Reference: 15/27/01
Distal Radius Acute Fracture Fixation Trial 2
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.
The study protocol publication can be found here.
The statistical and health economics analysis plan can be found here.