Functional Outcome Following Fracture of the Distal Radius

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

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.

Study Overview

• Status: Unknown
• Conditions: Distal Radius Fractures
• Intervention / Treatment: Procedure: Kirschner wire fixation; Procedure: Volar Locking Plate fixation

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Caroline E Plant, MBChB; Phone Number: 28628 02476964000; Email: c.e.gaymer@warwick.ac.uk
• Study Contact Backup: Name: Matthew Costa, PhD, MBChB; Phone Number: 28618 02476964000; Email: Matthew.Costa@warwick.ac.uk

Study Locations

• United Kingdom
  • Warwickshire
    • Coventry, Warwickshire, United Kingdom, CV22DX
      • Recruiting
      • Warwick Medical School
      • Contact: Juul Achten, PhD; Phone Number: 28614 02476964000; Email: J.Achten@warwick.ac.uk
      • Principal Investigator: Caroline E Plant, MBChB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.; Other Names: K-wire fixation; 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.; Other Names: open reduction and internal fixation; plate and screw fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip strength	Maximum grip strength applied to a hand-held dynamometer, measured in kilograms	1 year post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pinch strength	The force in kilograms of the pinch between the thumb pad and the radial aspect of the middle phalanx of the index finger when applied to a pinch gauge.	1 year post-operatively
Wrist arc motion	The range of motion in flexion-extension, radioulnar deviation and supination-pronation of the wrist and forearm.	1 year post-operatively
Patient rated wrist evaluation (PRWE)	The PRWE score is a validated self-reported questionnaire. It consists of 15 items specifically related to the function of the wrist.	1 year post-operatively
Disabilities of Arm, Shoulder and Hand Score (DASH)	The DASH outcome measure is a 30-item, self-report questionnaire designed to provide a more general measure of physical function and symptoms in people with musculoskeletal disorders of the upper limb	1 year post-operatively
EQ-5D	A validated, generalised, quality of life questionnaire consisting of 5 domains related to daily activities with a 3-level answer possibility. The combination of answers leads to the QoL score.	1 year post-operatively

Collaborators and Investigators

• Sponsor: University of Warwick
• Collaborators: DePuy International; University Hospitals Coventry and Warwickshire NHS Trust
• Investigators: Study Chair: Matthew Costa, FRCS, PhD, Warwick Orthopaedics; Study Director: Juul Achten, PhD, Warwick Orthopaedics; Principal Investigator: Caroline E Plant, BSc, MBChB, Warwick Orthopaedics

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ANTICIPATED): July 1, 2013
• Study Completion (ANTICIPATED): October 1, 2013

Study Registration Dates

• First Submitted: August 30, 2011
• First Submitted That Met QC Criteria: September 14, 2011
• First Posted (ESTIMATE): September 15, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 15, 2011
• Last Update Submitted That Met QC Criteria: September 14, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: DASH; PRWE; grip strength; Radius fracture; Colles' fracture; EQ-5D; Kirschner wire; range of movement; pinch strength; Volar locking plate
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: IIS2010025