DRAFFT: Distal Radius Acute Fracture Fixation Trial
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
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