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  • Ultrasound Directed Reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomised controlled trial

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Original research
Ultrasound Directed Reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomised controlled trial
  1. Hamza Malik1,
  2. Darryl Wood2,
  3. Oliver Stone3,
  4. Anthony Gough3,
  5. Gordon Taylor4,
  6. Karen M Knapp5,
  7. Daniel Heggs6,
  8. Andrew Appelboam7
  1. 1 Emergency Medicine, Royal Devon University Healthcare NHS Foundation Trust, Exeter, Devon, UK
  2. 2 Emergency Department, Barking Havering and Redbridge University Hospitals NHS Trust, Romford, London, UK
  3. 3 Trauma and orthopaedics, Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK
  4. 4 Research Design Service South West, University of Exeter Medical school, St Luke’s Campus, Exeter, UK
  5. 5 Medical Imaging, University of Exeter, Exeter, Devon, UK
  6. 6 Clinical Trials Unit, University of Exeter, Exeter, UK
  7. 7 Academic Department of Emergency Medicine, Royal Devon University Healthcare NHS Foundation Trust, Exeter, Devon, UK
  1. Correspondence to Dr Andrew Appelboam, Academic Department of Emergency Medicine, Royal Devon University Healthcare NHS Foundation Trust, Exeter, Devon, UK; andy.appelboam{at}nhs.net

Abstract

Background There is a high rate of surgical fixation of displaced Colles’ type distal radial wrist fractures despite fracture manipulation in the ED. Point-of-care ultrasound has been used to guide ED manipulations but its effect on the quality of fracture reduction or subsequent need for surgical fixation is unknown. This study aims to assess the feasibility of conducting a definitive randomised controlled trial to assess the use of ultrasound to guide these fracture manipulations.

Methods We conducted a pragmatic randomised controlled feasibility trial in two EDs in England over a 6-month period (7 October 2019 to 6 April 2020). Adult patients with wrist fractures undergoing manipulation in the ED were randomised 1:1 to ultrasound-guided distal radial fracture manipulation or manipulation with sham ultrasound. The primary outcome for this study was trial recruitment rate. Other measures were recorded to assess potential future definitive trial outcomes and feasibility.

Results Of 120 patients meeting inclusion criteria, 48 (40%) were recruited and randomised in the two centres, giving overall recruitment rates of 0.3 and 1.8 participants per week at each site, respectively, and 1 participant per week overall. The most common reason that patients were not included was research staff availability. After 6 weeks, six patients in each group (26% intervention, 24% control) had undergone surgical fixation, with 98% data completeness for this potential definitive trial primary outcome. Randomisation, blinding and data collection processes were effective but there were data limitations in the X-ray assessment of fracture positions.

Conclusion A definitive study of a similar design would be feasible within UK ED practice but organisational factors and research staff availability should be considered when estimating the predicted recruitment rate and required sites. 6-week surgical fixation rate was the most reliable outcome measure.

Trial registration ClinicalTrials.gov (NCT03868696).

  • emergency department
  • ultrasonography
  • fractures
  • extremity

Data availability statement

Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information.

https://doi.org/10.1136/emermed-2023-213279

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    Data availability statement

    Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information.

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    Footnotes

    • Handling editor Richard Body

    • Twitter @KarenMKnapp

    • Contributors AA was responsible for the conception of this research and acts as guarantor. AA, HM, DW, GT, KK contributed to the research design and writing up the protocol. HM, GT, KK, DH, OS, AG contributed to data acquisition, interpretation and analysis. GT was responsible for statistical analysis. All authors contributed to drafting, reviewing and approval of the final version of the manuscript. AA and HM take the overall responsibility of the manuscript.

    • Funding This trial was funded by the Royal College of Emergency Medicine (RCEM) (Grant Number G/2018/5).

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.