Functional Outcome Following Fracture of the Distal Radius

NCT01435070 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2011-09-15

No results posted yet for this study

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

  • Distal Radius Fractures

Interventions

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.

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.

Sponsors & Collaborators

  • University Hospitals Coventry and Warwickshire NHS Trust

    collaborator OTHER
  • DePuy International

    collaborator INDUSTRY
  • University of Warwick

    lead OTHER

Principal Investigators

  • Matthew Costa, FRCS, PhD · Warwick Orthopaedics

  • Juul Achten, PhD · Warwick Orthopaedics

  • Caroline E Plant, BSc, MBChB · Warwick Orthopaedics

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-07-31
Completion
2013-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01435070 on ClinicalTrials.gov