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Status unknownNCT01435070Updated Sep 15, 2011

Functional Outcome Following Fracture of the Distal Radius

An observational study in Distal Radius Fractures, sponsored by University of Warwick. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-15.

Sponsored by University of Warwick · Observational

The sponsor has not verified this record recently (last verified Sep 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Distal Radius Fractures

Keywords

  • Colles' fracture
  • Radius fracture
  • grip strength
  • pinch strength
  • range of movement
  • PRWE
  • DASH
  • EQ-5D
  • Kirschner wire
  • Volar locking plate
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's planned enrollment of 50 is below the median of 100 across 675 observational studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

University of Warwick is the lead sponsor of 26 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)

Groups and cohorts

  • 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 · Procedure: Volar Locking Plate fixation

Interventions

  • ProcedureKirschner 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.

    Also known as: K-wire fixation

  • ProcedureVolar 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.

    Also known as: open reduction and internal fixation, plate and screw fixation

06

What researchers measure

Primary outcomes

  1. Grip strength

    Maximum grip strength applied to a hand-held dynamometer, measured in kilograms

    Time frame: 1 year post-operatively

Secondary outcomes

  1. 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.

    Time frame: 1 year post-operatively

  2. Wrist arc motion

    The range of motion in flexion-extension, radioulnar deviation and supination-pronation of the wrist and forearm.

    Time frame: 1 year post-operatively

  3. 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.

    Time frame: 1 year post-operatively

  4. 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

    Time frame: 1 year post-operatively

  5. 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.

    Time frame: 1 year post-operatively

07

Study locations

1 of 1 sites recruiting
  • Warwick Medical School
    Coventry, Warwickshire CV22DX, United Kingdom
    • Juul Achten, PhD · Contact · J.Achten@warwick.ac.uk · 02476964000
    • Caroline E Plant, MBChB · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01435070
Lead sponsor
University of Warwick
Collaborators
University Hospitals Coventry and Warwickshire NHS Trust, DePuy International
Responsible party
Caroline Plant (Mrs Caroline Plant, University of Warwick) — Principal investigator
First posted
Sep 15, 2011
Start date
Jan 2011
Primary completion
Jul 2013 (estimated)
Completion
Oct 2013 (estimated)
Last update
Sep 15, 2011

Study contacts

Caroline E Plant, MBChB
Contact
c.e.gaymer@warwick.ac.uk
02476964000 ext. 28628
Matthew Costa, PhD, MBChB
Contact
Matthew.Costa@warwick.ac.uk
02476964000 ext. 28618
Matthew Costa, FRCS, PhD
study chair · Warwick Orthopaedics
Juul Achten, PhD
study director · Warwick Orthopaedics
Caroline E Plant, BSc, MBChB
principal investigator · Warwick Orthopaedics

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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