Functional Outcome Following Fracture of the Distal Radius

This study is currently recruiting participants.
Verified September 2011 by University of Warwick
Sponsor:
Collaborators:
University Hospitals Coventry and Warwickshire NHS Trust
DePuy International
Information provided by (Responsible Party):
Caroline Plant, University of Warwick
ClinicalTrials.gov Identifier:
NCT01435070
First received: August 30, 2011
Last updated: September 14, 2011
Last verified: September 2011

August 30, 2011
September 14, 2011
January 2011
July 2013   (final data collection date for primary outcome measure)
Grip strength [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ]
Maximum grip strength applied to a hand-held dynamometer, measured in kilograms
Same as current
Complete list of historical versions of study NCT01435070 on ClinicalTrials.gov Archive Site
  • Pinch strength [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ]
    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.
  • Wrist arc motion [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ]
    The range of motion in flexion-extension, radioulnar deviation and supination-pronation of the wrist and forearm.
  • Patient rated wrist evaluation (PRWE) [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ]
    The PRWE score is a validated self-reported questionnaire. It consists of 15 items specifically related to the function of the wrist.
  • Disabilities of Arm, Shoulder and Hand Score (DASH) [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ]
    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
  • EQ-5D [ Time Frame: 1 year post-operatively ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Distal Radius Fractures
  • 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
Distal radius fracture
Patients aged 18 years and older with a fracture of the distal radius, within 3 cm of the radiocarpal joint
Interventions:
  • Procedure: Kirschner wire fixation
  • Procedure: Volar Locking Plate fixation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
October 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Caroline E Plant, MBChB 02476964000 ext 28628 c.e.gaymer@warwick.ac.uk
Contact: Matthew Costa, PhD, MBChB 02476964000 ext 28618 Matthew.Costa@warwick.ac.uk
United Kingdom
 
NCT01435070
IIS2010025
No
Caroline Plant, University of Warwick
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
University of Warwick
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP