Functional Outcome Following Fracture of the Distal Radius

NCT ID: NCT01435070

Last Updated: 2011-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-10-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Distal radius fracture

Patients aged 18 years and older with a fracture of the distal radius, within 3 cm of the radiocarpal joint

Kirschner wire fixation

Intervention Type: PROCEDURE

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.

Volar Locking Plate fixation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

K-wire fixation; open reduction and internal fixation; plate and screw fixation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Coventry and Warwickshire NHS Trust

OTHER

Sponsor Role: collaborator

DePuy International

INDUSTRY

Sponsor Role: collaborator

University of Warwick

OTHER

Sponsor Role: lead

Responsible Party

Caroline Plant

Mrs Caroline Plant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Costa, FRCS, PhD

Role: STUDY_CHAIR

Warwick Orthopaedics

Juul Achten, PhD

Role: STUDY_DIRECTOR

Warwick Orthopaedics

Caroline E Plant, BSc, MBChB

Role: PRINCIPAL_INVESTIGATOR

Warwick Orthopaedics

Locations

Warwick Medical School

Coventry, Warwickshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Caroline E Plant, MBChB

Role: CONTACT

c.e.gaymer@warwick.ac.uk

02476964000 ext. 28628

Matthew Costa, PhD, MBChB

Role: CONTACT

Matthew.Costa@warwick.ac.uk

02476964000 ext. 28618

Facility Contacts

Juul Achten, PhD

Role: primary

J.Achten@warwick.ac.uk

02476964000 ext. 28614

Other Identifiers

IIS2010025

Identifier Type: -

Identifier Source: org_study_id