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Open Access Study protocol

UK DRAFFT - 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

Matthew L Costa1*, Juul Achten1, Nick R Parsons1, Amar Rangan2, Richard P Edlin3, Jaclyn Brown4 and Sarah E Lamb4

Author Affiliations

1 Division of Health Sciences, Warwick Medical School, The University of Warwick, Clifford bridge road, Coventry, CV2 2DX, UK

2 Wolfson Research Institute, School of Medicine & Health, Durham University, Queen's Campus, University Boulevard, Teesside TS17 6BH, UK

3 Leeds Institute of Health Sciences, Leeds University, Charles Thackrah Building, 101 Clarendon Road, Leeds, LS2 9LJ, UK

4 Clinical Trials Unit, Warwick Medical School, The University of Warwick, Gibbet Hill Campus, Coventry, CV4 7AL, UK

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BMC Musculoskeletal Disorders 2011, 12:201  doi:10.1186/1471-2474-12-201

Published: 13 September 2011

Abstract

Background

Fractures of the distal radius are extremely common injuries in adults. However, the optimal management remains controversial. In general, fractures of the distal radius are treated non-operatively if the bone fragments can be held in anatomical alignment by a plaster cast or orthotic. However, if this is not possible, then operative fixation is required. There are several operative options but the two most common in the UK, are Kirschner-wire fixation (K-wires) and volar plate fixation using fixed-angle screws (locking-plates). The primary aim of this trial is to determine if there is a difference in the Patient-Reported Wrist Evaluation one year following K-wire fixation versus locking-plate fixation for adult patients with a dorsally-displaced fracture of the distal radius.

Methods/design

All adult patients with an acute, dorsally-displaced fracture of the distal radius, requiring operative fixation are potentially eligible to take part in this study. A total of 390 consenting patients will be randomly allocated to either K-wire fixation or locking-plate fixation. The surgery will be performed in trauma units across the UK using the preferred technique of the treating surgeon. Data regarding wrist function, quality of life, complications and costs will be collected at six weeks and three, six and twelve months following the injury. The primary outcome measure will be wrist function with a parallel economic analysis.

Discussion

This pragmatic, multi-centre trial is due to deliver results in December 2013.

Trial registration

Current Controlled Trials ISRCTN31379280

UKCRN portfolio ID 8956