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

Distal Radius Acute Fracture Fixation Trial 2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11980540
Enrollment
476
Registered
2016-08-03
Start date
2016-10-31
Completion date
Unknown
Last updated
2024-09-23

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 Musculoskeletal Diseases Dorsally displaced fracture of the distal radius

Interventions

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 ar

Sponsors

University of Oxford (UK)
Lead Sponsor

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. Aged of 16 and able to give informed consent. 3. The treating Consultant Surgeon believes that they would benefit from manipulation of the fracture.

Exclusion criteria

Exclusion criteria: 1. Injury is more than two weeks old 2. Fracture extends more than 3 cm from radio carpal joint 3. Fracture is open with a Gustillo grading greater than 4. Articular surface of the fracture (specifically the radio-carpal joint) 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. 5. Evidence that the patient would be unable to adhere to trial procedures or complete questionnaires, such as cognitive impairment

Design outcomes

Primary

MeasureTime frame
Wrist function is measured using the Patient Rated Wrist Evaluation (PWRE) at baseline, 3, 6 and 12 months post-operatively.

Secondary

MeasureTime frame
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.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 21, 2026