Functional Outcome Following Fracture of the Distal Radius

Distal Radius Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01435070
• Other study ID #: IIS2010025
• Status: Recruiting
• Phase: N/A
• First received: August 30, 2011
• Last updated: September 14, 2011
• Start date: January 2011
• Est. completion date: October 2013

Study information

• Verified date: September 2011
• Source: University of Warwick
• Contact: Caroline E Plant, MBChB
• Phone: 02476964000
• Email: c.e.gaymer[@]warwick.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Radius Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Warwick Medical School	Coventry	Warwickshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Warwick	DePuy International, University Hospitals Coventry and Warwickshire NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grip strength	Maximum grip strength applied to a hand-held dynamometer, measured in kilograms	1 year post-operatively	No
Secondary	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	No
Secondary	Wrist arc motion	The range of motion in flexion-extension, radioulnar deviation and supination-pronation of the wrist and forearm.	1 year post-operatively	No
Secondary	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	No
Secondary	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	No
Secondary	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	No