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

A randomised controlled trial of percutaneous fixation with Kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a displaced fracture of the distal radius

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31379280
Enrollment
390
Registered
2010-03-29
Start date
2010-07-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dorsally displaced fracture of the distal radius Injury, Occupational Diseases, Poisoning Fracture of forearm

Interventions

K-wire Fixation: 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 nu
these may be locking or non-locking screws as the bone in this area provides a much better purchase for the screws. Some surgeons use a temporary plaster cast to hold the patients? wrist still but the

Sponsors

University of Warwick (UK)
Lead Sponsor
University Hospitals Coventry and Warwickshire NHS Trust (UK)
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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. The treating Consultant Surgeon believes that they would benefit from operative fixation of the fracture 3. Aged over 18 years (either sex) and able to give informed consent

Exclusion criteria

Exclusion criteria: 1. The fracture extends more than 3 cm from radio-carpal joint 2. The fracture is open with a Gustillo grading greater than 1 3. The articular surface of the fracture cannot be reduced by indirect techniques (in a small number of fractures, the joint surface is so badly disrupted that the surgeon will have to open up the fracture in order to restore the anatomy under direct vision) 4. There are contra-indications to surgery, defined as: 4.1. Severe cardiac impairment, e.g. heart or valve replacement, arrhythmia, previous myocardial infarction 4.2. Severe respiratory impairment, e.g. chronic obstructive pulmonary disease, asthma that has required hospital admission 4.3. Any other systemic medical condition that would produce a specific contraindication to a general anaesthetic 5. There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires, such as cognitive impairment or intravenous drug abuse

Design outcomes

Primary

MeasureTime frame
Primary outcome measure as of 24/01/2012: Patient Rated Wrist Evaluation (PWRE). The PRWE score is a validated questionnaire which is self-reported (filled out by the patient). It consists of 15 items specifically related to the function of the wrist. This data will be collected at baseline, 3, 6 and 12 months post-operatively. The PRWE is the most sensitive outcome measure for patients sustaining this specific injury. Analysis will be performed on the complete data set as well as on the subgroup of patients over the age of 50 years. Previous primary outcome measure: Patient Rated Wrist Evaluation (PWRE). The PRWE score is a validated questionnaire which is self-reported (filled out by the patient). It consists of 15 items specifically related to the function of the wrist. This data will be collected at baseline, 3, 6 and 12 months post-operatively. The PRWE is the most sensitive outcome measure for patients sustaining this specific injury.

Secondary

MeasureTime frame
1. Disabilities of Arm, Shoulder and Hand score (DASH) - the DASH Outcome Measure is a 30-item, self-report questionnaire designed to provide a more general measure of physical function and symptoms in people with musculoskeletal disorders of the upper limb 2. EQ-5D - a validated, generalised, quality of life questionnaire consisting of 5 domains related to daily activities with a 3-level answer possibility. The combination of answers leads to the QoL score. 3. Complications - all complications will be recorded 4. Radiographic evaluation - standard posterior-anterior and lateral radiographs will be taken at baseline, 6 weeks and 12 months after the injury. These radiographs are those routinely used for the investigation of patients with a suspected fracture of the distal radius and for the follow-up of such patients following any intervention, so there will be no need to request any additional or special investigations. Although the technique for taking these radiographs is well-established, each centre will be provided with a written protocol to ensure that exactly the same views are obtained at each hospital. An assessment of the quality of the reduction, and the risk of subsequent loss of reduction, will be made using the criteria recommended by Mackenney et al. 5. 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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026