Functional Outcome Following Fracture of the Distal Radius

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01435070
Recruitment Status : Unknown
Verified September 2011 by Caroline Plant, University of Warwick.
Recruitment status was:  Recruiting
First Posted : September 15, 2011
Last Update Posted : September 15, 2011
University Hospitals Coventry and Warwickshire NHS Trust
DePuy International
Information provided by (Responsible Party):
Caroline Plant, University of Warwick

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.

Condition or disease Intervention/treatment
Distal Radius Fractures Procedure: Kirschner wire fixation Procedure: Volar Locking Plate fixation

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Correlation of Functional Outcome Measures of Fractures of the Distal Radius Following Operative Management
Study Start Date : January 2011
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : October 2013

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U.S. FDA Resources

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 Name: 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

Primary Outcome Measures :
  1. Grip strength [ Time Frame: 1 year post-operatively ]
    Maximum grip strength applied to a hand-held dynamometer, measured in kilograms

Secondary Outcome Measures :
  1. Pinch strength [ Time Frame: 1 year post-operatively ]
    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.

  2. Wrist arc motion [ Time Frame: 1 year post-operatively ]
    The range of motion in flexion-extension, radioulnar deviation and supination-pronation of the wrist and forearm.

  3. Patient rated wrist evaluation (PRWE) [ Time Frame: 1 year post-operatively ]
    The PRWE score is a validated self-reported questionnaire. It consists of 15 items specifically related to the function of the wrist.

  4. Disabilities of Arm, Shoulder and Hand Score (DASH) [ Time Frame: 1 year post-operatively ]
    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

  5. EQ-5D [ Time Frame: 1 year post-operatively ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01435070

Contact: Caroline E Plant, MBChB 02476964000 ext 28628
Contact: Matthew Costa, PhD, MBChB 02476964000 ext 28618

United Kingdom
Warwick Medical School Recruiting
Coventry, Warwickshire, United Kingdom, CV22DX
Contact: Juul Achten, PhD    02476964000 ext 28614   
Principal Investigator: Caroline E Plant, MBChB         
Sponsors and Collaborators
University of Warwick
University Hospitals Coventry and Warwickshire NHS Trust
DePuy International
Study Chair: Matthew Costa, FRCS, PhD Warwick Orthopaedics
Study Director: Juul Achten, PhD Warwick Orthopaedics
Principal Investigator: Caroline E Plant, BSc, MBChB Warwick Orthopaedics

Responsible Party: Caroline Plant, Mrs Caroline Plant, University of Warwick Identifier: NCT01435070     History of Changes
Other Study ID Numbers: IIS2010025
First Posted: September 15, 2011    Key Record Dates
Last Update Posted: September 15, 2011
Last Verified: September 2011

Keywords provided by Caroline Plant, University of Warwick:
Colles' fracture
Radius fracture
grip strength
pinch strength
range of movement
Kirschner wire
Volar locking plate

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries