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Functional Outcome Following Fracture of the Distal Radius

U

University of Warwick

Status

Unknown

Conditions

Distal Radius Fractures

Treatments

Procedure: Volar Locking Plate fixation
Procedure: Kirschner wire fixation

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01435070
IIS2010025

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Distal radius fracture
Description:
Patients aged 18 years and older with a fracture of the distal radius, within 3 cm of the radiocarpal joint
Treatment:
Procedure: Kirschner wire fixation
Procedure: Volar Locking Plate fixation

Trial contacts and locations

1

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Central trial contact

Matthew Costa, PhD, MBChB; Caroline E Plant, MBChB

Data sourced from clinicaltrials.gov

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