Functional Outcome Following Fracture of the Distal Radius
|ClinicalTrials.gov Identifier: NCT01435070|
Recruitment Status : Unknown
Verified September 2011 by Caroline Plant, University of Warwick.
Recruitment status was: Recruiting
First Posted : September 15, 2011
Last Update Posted : September 15, 2011
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 or disease||Intervention/treatment|
|Distal Radius Fractures||Procedure: Kirschner wire fixation Procedure: Volar Locking Plate fixation|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||A Correlation of Functional Outcome Measures of Fractures of the Distal Radius Following Operative Management|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||October 2013|
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 fixationProcedure: 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.
- Grip strength [ Time Frame: 1 year post-operatively ]Maximum grip strength applied to a hand-held dynamometer, measured in kilograms
- Pinch strength [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435070
|Contact: Caroline E Plant, MBChB||02476964000 ext firstname.lastname@example.org|
|Contact: Matthew Costa, PhD, MBChB||02476964000 ext 28618||Matthew.Costa@warwick.ac.uk|
|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|