Functional Outcome Following Fracture of the Distal Radius

Study Overview
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Brief Summary
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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.

Official Title
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A Correlation of Functional Outcome Measures of Fractures of the Distal Radius Following Operative Management

Conditions
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Distal Radius Fractures

Intervention / Treatment
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* Procedure: Kirschner wire fixation
* Procedure: Volar Locking Plate fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Distal radius fracture<br>Patients aged 18 years and older with a fracture of the distal radius, within 3 cm of the radiocarpal joint | Procedure: Kirschner wire fixation<br>* 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.<br>* Other names: K-wire fixation;Procedure: Volar Locking Plate fixation<br>* The locking-plate is applied through an incision over the volar (palm) aspect of the wrist. The surgical approach, the type of plate and the number and configuration of screws will be left to the discretion of the surgeon. The screws in the distal portion of the bone will be fixed-angle, i.e. screwed into the plate, but this is standard technique for use of these plates. The type of proximal screw will be left to the discretion of the surgeon; these may be locking or non-locking screws. The use of a cast will left to the discretion of the surgeon.<br>* Other names: plate and screw fixation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip strength | Maximum grip strength applied to a hand-held dynamometer, measured in kilograms | 1 year post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pinch strength | 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. | 1 year post-operatively | 
| Wrist arc motion | The range of motion in flexion-extension, radioulnar deviation and supination-pronation of the wrist and forearm. | 1 year post-operatively | 
| Patient rated wrist evaluation (PRWE) | The PRWE score is a validated self-reported questionnaire. It consists of 15 items specifically related to the function of the wrist. | 1 year post-operatively | 
| 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 | 1 year post-operatively | 
| 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. | 1 year post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colles' fracture, Radius fracture, grip strength, pinch strength, range of movement, PRWE, DASH, EQ-5D, Kirschner wire, Volar locking plate