Clinical Trials Directory

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UnknownNCT01435070

Functional Outcome Following Fracture of the Distal Radius

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

Status
Unknown
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
University of Warwick · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREKirschner wire fixationThe 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 fixationThe 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.

Timeline

Start date
2011-01-01
Primary completion
2013-07-01
Completion
2013-10-01
First posted
2011-09-15
Last updated
2011-09-15

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT01435070. Inclusion in this directory is not an endorsement.