Functional Outcome Following Fracture of the Distal Radius

NCT01435070 | Unknown

• 1 other identifier: IIS2010025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Colles' fracture; Radius fracture; grip strength; pinch strength; range of movement; PRWE; DASH; EQ-5D; Kirschner wire; Volar locking plate

Outcome Measures

Primary Outcomes (1)

• Grip strength

  Maximum grip strength applied to a hand-held dynamometer, measured in kilograms

  1 year post-operatively

Secondary Outcomes (5)

• Pinch strength

  1 year post-operatively

• Wrist arc motion

  1 year post-operatively

• Patient rated wrist evaluation (PRWE)

  1 year post-operatively

• Disabilities of Arm, Shoulder and Hand Score (DASH)

  1 year post-operatively

• EQ-5D

  1 year post-operatively

Study Arms (1)

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; Procedure: Volar Locking Plate fixation

Interventions

Kirschner wire fixation 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.

Also known as: K-wire fixation

Distal radius fracture

Volar Locking Plate fixation 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.

Also known as: open reduction and internal fixation, plate and screw fixation

Distal radius fracture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients presenting to University Hospital Coventry with an acute fracture of the distal radius requiring operative management

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Warwick: lead
• University Hospitals Coventry and Warwickshire NHS Trust: collaborator
• DePuy International: collaborator

Study Sites (1)

Warwick Medical School

Coventry, Warwickshire, CV22DX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Wrist Fractures; Colles' Fracture; Radius Fractures

Interventions

Open Fracture Reduction; Fracture Fixation, Internal; Bone Plates

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Forearm Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative; Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• Matthew Costa, FRCS, PhD

  Warwick Orthopaedics

  STUDY CHAIR

• Juul Achten, PhD

  Warwick Orthopaedics

  STUDY DIRECTOR

• Caroline E Plant, BSc, MBChB

  Warwick Orthopaedics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline E Plant, MBChB

CONTACT

02476964000; c.e.gaymer@warwick.ac.uk

Matthew Costa, PhD, MBChB

CONTACT

02476964000; Matthew.Costa@warwick.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mrs Caroline Plant

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 15, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 15, 2011

Record last verified: 2011-09

Locations

GB (1)