Functional Outcome Following Fracture of the Distal Radius

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Warwick.
Recruitment status was  Recruiting
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
  Purpose

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 Intervention
Distal Radius Fractures
Procedure: Kirschner wire fixation
Procedure: Volar Locking Plate fixation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Correlation of Functional Outcome Measures of Fractures of the Distal Radius Following Operative Management

Resource links provided by NLM:


Further study details as provided by University of Warwick:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435070

Contacts
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

Locations
United Kingdom
Warwick Medical School Recruiting
Coventry, Warwickshire, United Kingdom, CV22DX
Contact: Juul Achten, PhD    02476964000 ext 28614    J.Achten@warwick.ac.uk   
Principal Investigator: Caroline E Plant, MBChB         
Sponsors and Collaborators
University of Warwick
University Hospitals Coventry and Warwickshire NHS Trust
DePuy International
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
  More Information

No publications provided

Responsible Party: Caroline Plant, Mrs Caroline Plant, University of Warwick
ClinicalTrials.gov Identifier: NCT01435070     History of Changes
Other Study ID Numbers: IIS2010025
Study First Received: August 30, 2011
Last Updated: September 14, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Warwick:
Colles' fracture
Radius fracture
grip strength
pinch strength
range of movement
PRWE
DASH
EQ-5D
Kirschner wire
Volar locking plate

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

ClinicalTrials.gov processed this record on July 22, 2014