Journal article
Surgical fixation with K-wires versus plaster casting in the treatment of dorsally displaced distal radius fractures: protocol for Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT 2)
- Abstract:
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Introduction: Optimal management of distal radius fractures in adults remains controversial. Previous evidence and current clinical guidelines tell us that, if a closed reduction of a dorsally displaced fracture is possible, Kirschner wires (K-wires) are the preferred form of surgical fixation. However, the question remains whether there is any need to perform surgical fixation following a successful closed reduction, or is a simple plaster cast as effective? This is the protocol for a randomised controlled trial of manipulation and surgical fixation with K-wires versus manipulation and casting in the treatment of dorsally displaced distal radius fractures.
Methods and analysis: Adult patients with an acute dorsally displaced fracture of the distal radius are potentially eligible to take part. Prior to surgery, baseline demographic data, radiographs, data on pain/function using the Patient-Rated Wrist Evaluation Score (PRWE) and health-related quality of life (HRQoL) using the EuroQoL 5-dimension 5-level (EQ-5D-5L) will be collected. A randomisation sequence, stratified by centre, intra-articular extension of the fracture and age, will be administered via a secure web-based service. Each patient will be randomly allocated to either ‘manipulation and surgical fixation with K-wires’ or ‘manipulation and plaster casting’. A clinical assessment, radiographs and records of early complications will be recorded at 6 weeks. PRWE and HRQoL outcome data will be collected at 3, 6 and 12 months post-randomisation. Further information will be requested with regard to healthcare resource use and any complications.
Ethics and Dissemination: The National Research Ethic Committee approved this study on 6 October 2016 (16/SC/0462).
The National Institute for Health Research Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted on completion of the trial. The results of this trial will substantially inform clinical practice on the clinical and cost-effectiveness of the treatment of this injury.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 279.8KB, Terms of use)
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- Publisher copy:
- 10.1136/bmjopen-2018-028474
Authors
- Publisher:
- BMJ Publishing Group
- Journal:
- BMJ Open More from this journal
- Volume:
- 9
- Issue:
- 3
- Article number:
- e028474
- Publication date:
- 2019-03-23
- Acceptance date:
- 2019-01-28
- DOI:
- EISSN:
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2044-6055
- Pubs id:
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pubs:969934
- UUID:
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uuid:40c59c60-c259-4f05-ace3-67e88a38f1ab
- Local pid:
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pubs:969934
- Source identifiers:
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969934
- Deposit date:
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2019-02-11
Terms of use
- Copyright holder:
- Achten et al
- Copyright date:
- 2019
- Notes:
- © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial.
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