Functional Outcome Following Fracture of the Distal Radius
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Distal Radius Fractures |
Procedure: Kirschner wire fixation Procedure: Volar Locking Plate fixation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Correlation of Functional Outcome Measures of Fractures of the Distal Radius Following Operative Management |
- Grip strength [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ]Maximum grip strength applied to a hand-held dynamometer, measured in kilograms
- Pinch strength [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ]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 [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ]The range of motion in flexion-extension, radioulnar deviation and supination-pronation of the wrist and forearm.
- Patient rated wrist evaluation (PRWE) [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ]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) [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ]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 [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Distal radius fracture
Patients aged 18 years and older with a fracture of the distal radius, within 3 cm of the radiocarpal joint
|
Procedure: Kirschner 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. Other Name: K-wire fixation
Procedure: Volar 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.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All adult patients presenting to University Hospital Coventry with an acute fracture of the distal radius requiring operative management
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
Contacts and Locations| Contact: Caroline E Plant, MBChB | 02476964000 ext 28628 | c.e.gaymer@warwick.ac.uk |
| Contact: Matthew Costa, PhD, MBChB | 02476964000 ext 28618 | Matthew.Costa@warwick.ac.uk |
| United Kingdom | |
| Warwick Medical School | Recruiting |
| Coventry, Warwickshire, United Kingdom, CV22DX | |
| Contact: Juul Achten, PhD 02476964000 ext 28614 J.Achten@warwick.ac.uk | |
| Principal Investigator: Caroline E Plant, MBChB | |
| Study Chair: | Matthew Costa, FRCS, PhD | Warwick Orthopaedics |
| Study Director: | Juul Achten, PhD | Warwick Orthopaedics |
| Principal Investigator: | Caroline E Plant, BSc, MBChB | Warwick Orthopaedics |
More Information
No publications provided
| Responsible Party: | Caroline Plant, Mrs Caroline Plant, University of Warwick |
| ClinicalTrials.gov Identifier: | NCT01435070 History of Changes |
| Other Study ID Numbers: | IIS2010025 |
| Study First Received: | August 30, 2011 |
| Last Updated: | September 14, 2011 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by University of Warwick:
|
Colles' fracture Radius fracture grip strength pinch strength range of movement |
PRWE DASH EQ-5D Kirschner wire Volar locking plate |
Additional relevant MeSH terms:
|
Fractures, Bone Radius Fractures Wounds and Injuries Forearm Injuries Arm Injuries |
ClinicalTrials.gov processed this record on May 21, 2013