Distal Radius Fractures
Conditions
Keywords
Colles' fracture, Radius fracture, grip strength, pinch strength, range of movement, PRWE, DASH, EQ-5D, Kirschner wire, Volar locking plate
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.
Interventions
PROCEDUREKirschner 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 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.
PROCEDUREVolar Locking Plate fixation
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.
Sponsors
University Hospitals Coventry and Warwickshire NHS Trust
DePuy International
University of Warwick
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grip strength | 1 year post-operatively | Maximum grip strength applied to a hand-held dynamometer, measured in kilograms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Contacts
Primary ContactCaroline E Plant, MBChB
Backup ContactMatthew Costa, PhD, MBChB
Outcome results
None listed