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DRAFFT: Distal Radius Acute Fracture Fixation Trial

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Protocol Summary

A randomised controlled trial of percutaneous fixation with Kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a dorsally displaced fracture of the distal radius

Registrations
  • ISRCTN 31379280
  • Ethical Approval 10/H1210/10
  • UK CRN Portfolio 8956

Trial Design
  • Multicentre Randomised Controlled Trial
  • 1:1 Randomisation
  • Stratified by centre, patient age (under 50, 50 and over) and intra-articular extension

Inclusion Criteria
  • A dorsally displaced fracture of the distal radius within 3cm of the radio-carpal joint
  • Patient would benefit from fixation
  • Patient is aged 18 years or over
  • Injury is less than 2 weeks old

Exclusion Criteria
  • Fracture extends more than 3cm from the radio-carpal joint
  • The fracture is open with a Gustillo grading greater than 1
  • The articular surface cannot be reduced by indirect techniques
  • Contra-indications to anaesthetic
  • Evidence that the patient would be unable to adhere to trial procedures or complete questionnaires

Primary Outcome
  • To quantify and draw inferences on observed differences in the Patient Rated Wrist Evaluation (PRWE) between the trial treatment groups at one year post-injury

Secondary Outcomes
  • To quantify and draw inferences on observed differences in the Disabilities of Arm, Shoulder and Hand score (DASH) between trial treament groups at one year post injury
  • To determine complication rate of k-wire fixation versus locking-plate fixation at one year post injury
  • To investigate, using appropriate statistical and econmic analysis measures, the resource use, and comparative cost effectiveness, of k-wire fixation versus locking-plate fixation

Target Recruitment
  • A minimum of 390 participants

Centres
  • University Hospital Coventry and Warwickshire, Miss Alison Edwards
  • The James Cook University Hospital, Prof Amar Rangan
  • The Royal Victoria Hospital, Newcastle, Mr Andrew Gray
  • Ipswich Hospital, Mr Christopher Roberts
  • Frenchay Hospital, Mr Tim Chesser
  • St Thomas' Hospital, Mr Sameer Gidwani
  • University Hospital North Staffordshire, Mr Kevin Smith
  • John Radcliffe Hospital, Prof Keith Willett
  • Addenbrookes Hospital, Mr Phillip Johnston
  • Leicester General Hospital, Prof Joesph Dias
  • Northampton General Hospital, Mr David Gidden
  • Poole Hospital, Mr Simon Richards
  • Wansbeck General Hospital, Mr Jaime Candal-Couto
  • Wexham Park Hospital, Mr Callum Clark
  • Royal Blackburn Hospital, Mr Makaram Srinivasan
  • Peterborough City Hospital, Mr Jonathan Jones
  • University Hospital of North Tees, Mr Rajesh Nanda
  • North Tyneside General Hospital, Mr Jaime Candal-Couto

Funder
  • NIHR HTA (08/116/97)

Schedule
  • Start date : 1 July 2010
  • End date: 31 December 2013

Chief Investigator
  • Professor Matthew Costa

Sponsors
  • University of Warwick
  • University Hospitals Coventry and Warwickshire NHS Trust

 

Key Links

ISRCTN - DRAFFT

Key People
  • Professor Matthew Costa: Professor of Trauma and Orthopaedic Surgery
  • Prof Sallie Lamb: Professor of Rehabilitation & Director of CTU
  • Dr Juul Achten: Senior Research Fellow
  • Dr Nick Parsons: Statistician
  • Prof Damian Griffin: Professor of Trauma and Orthopaedic Surgery
  • Dr Richard Edlin: Assistant Professor of Health Economics
  • Prof Amar Rangan: Orthopaedic Consultant