Functional Outcome Following Fracture of the Distal Radius
- Conditions
- Distal Radius Fractures
- Interventions
- Procedure: Kirschner wire fixationProcedure: Volar Locking Plate fixation
- Registration Number
- NCT01435070
- Lead Sponsor
- University of Warwick
- Brief Summary
Patients attending the University Hospital Coventry UK with a broken wrist requiring an operation, will be invited to enter the study. At the first visit, they will have an xray of the wrist and will be asked to complete a number of questionnaires. The questions are to determine if they normally have pain in the wrist and how well they can perform their daily activities. The patient will then have an operation, and the fracture in the wrist will be held in the correct position with either a metal plate and screws or wires.
At 6 weeks following the operation the patient will be reassessed and an xray will be taken. At 3 months, 6 months and 12 months after the operation patients will perform tests to assess the strength of their grip, pinch and movement of their wrist. In addition they will complete the the same questionnaires from their first visit. At the 12 month visit patients will have another xray.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Sustained a dorsally displaced fracture of the distal radius, which is defined as a fracture within 3cm of the radio-carpal joint
- The treating Consultant surgeon believes that they would benefit from operative fixation of the fracture
- Aged over 18years (either sex) and able to give informed consent
- The fracture extends more than 3 cm from the radio-carpal joint
- The fracture open with a Gustillo grading greater than 1
- There are contra-indications to general anaesthetic
- There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Distal radius fracture Kirschner wire fixation Patients aged 18 years and older with a fracture of the distal radius, within 3 cm of the radiocarpal joint Distal radius fracture Volar Locking Plate fixation Patients aged 18 years and older with a fracture of the distal radius, within 3 cm of the radiocarpal joint
- Primary Outcome Measures
Name Time Method Grip strength 1 year post-operatively Maximum grip strength applied to a hand-held dynamometer, measured in kilograms
- Secondary Outcome Measures
Name Time Method Pinch strength 1 year post-operatively The force in kilograms of the pinch between the thumb pad and the radial aspect of the middle phalanx of the index finger when applied to a pinch gauge.
Wrist arc motion 1 year post-operatively The range of motion in flexion-extension, radioulnar deviation and supination-pronation of the wrist and forearm.
Patient rated wrist evaluation (PRWE) 1 year post-operatively The PRWE score is a validated self-reported questionnaire. It consists of 15 items specifically related to the function of the wrist.
Disabilities of Arm, Shoulder and Hand Score (DASH) 1 year post-operatively 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
EQ-5D 1 year post-operatively 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.
Trial Locations
- Locations (1)
Warwick Medical School
🇬🇧Coventry, Warwickshire, United Kingdom