Comparison of surgical procedures for patients with a fracture of the wrist

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2016
INTERVENTION: Participants are randomised to one of two groups, stratified by centre, intra‐articular extension of the fracture and age of the patient (above or below 50 years). K‐wire Fixation group: The wires are passed through the skin over the dorsal aspect of the distal radius and into the bone in order to hold the fracture in the correct (anatomical) position. The size and number of wires, the insertion technique and the configuration of wires will be left entirely to the discretion of the surgeon. A plaster cast will be applied at the end of the procedure to supplement the wire fixation as per standard surgical practice. This cast holds the wrist still and is left on until the wires are removed at the follow‐up appointment. Plaster Cast group: This technique involves the application of a plaster cast which is shaped (moulded) over the skin to hold the bone fragments in position. The plaster cast will remain in situ for 4‐6 weeks. The study follow‐up will range from events and at activities at the routine 6 week follow‐up appointment. During this appointment radiographs and a short questionnaire on complications. This complications questionnaire will be completed by the Research Associate. The study follow‐up will also require patients to complete questionnaires for Patient Rated Wrist Evaluation, EuroQolEQ‐5D, complications and resource use at 3, 6 and 12 months post‐operatively. CONDITION: Dorsally displaced fracture of the distal radius ; Musculoskeletal Diseases ; Dorsally displaced fracture of the distal radius PRIMARY OUTCOME: Wrist function is measured using the Patient Rated Wrist Evaluation (PWRE) at baseline, 3, 6 and 12 months post‐operatively. SECONDARY OUTCOME: 1. Quality of life is measured using the EQ‐5D at Baseline, 3, 6 and 12 months post‐operatively.; 2. Complications are measured using a questionnaire filled in by either a research associate at 6 weeks. In addition, complications will also be measured using a questionnaire completed by the patient at 3, 6 and 12 months post‐operatively.; 3.Radiographic evaluation will be used to assess the quality of reduction at baseline, 6 weeks and 12 months after the injury; 4. Resource use will be monitored for the economic analysis. Unit cost data will be obtained from national databases such as the BNF and PSSRU Costs of Health and Social Care. Where these are not available the unit cost will be estimated in consultation with the UHCW finance department. The cost consequences following discharge, including NHS costs and patients' out‐of‐pocket expenses will be recorded via a short questionnaire which will be administered at 3, 6 and 12 months post surgery. Patient self‐reported information on service use has been shown to be accurate in terms of the intensity of use of different services. INCLUSION CRITERIA: 1. Sustained a dorsally displaced fracture of the distal radius, which is defined as a fracture within 3 cm of the radio‐carpal joint. 2. Aged of 16 and able to give informed consent. 3. The treating Consultant Surgeon believes that they would benefit from manipulation of the fracture.
Epistemonikos ID: 99163815488e21943ab91a2eaa63c6a3fddceb28
First added on: Aug 24, 2024