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Randomised controlled trial comparing immobilisation in above-knee plaster of Paris to controlled ankle motion boots in undisplaced paediatric spiral tibial fractures
  1. Kate Bradman1,
  2. Katherine Stannage2,
  3. Sharon O'Brien1,
  4. Simon Green1,
  5. Natasha Bear3,
  6. Meredith Borland1,4
  1. 1Emergency, Perth Children's Hospital, Nedlands, Western Australia, Australia
  2. 2Department of Orthopaedic Surgery, Perth Children's Hospital, Perth, Western Australia
  3. 3Institute of Health Research, The University of Notre Dame Australia, Fremantle, Western Australia, Australia
  4. 4Paediatric and Emergency Medicine, The University of Western Australia Faculty of Medicine Dentistry and Health Sciences, Perth, Western Australia, Australia
  1. Correspondence to Dr Kate Bradman, Emergency, Perth Children's Hospital, Nedlands, Western Australia, Australia; kate.bradman{at}health.wa.gov.au

Abstract

Background Management of common childhood spiral tibial fractures, known as toddler’s fractures, has not significantly changed in recent times despite the availability of immobilisation devices known as controlled ankle motion (CAM) boots. We compared standard therapy with these devices on quality-of-life measures.

Methods A prospective randomised controlled trial, comparing immobilisation with an above-knee plaster of Paris cast (AK-POP) with a CAM boot in children aged 1–5 years with proven or suspected toddler’s fractures presenting to a tertiary paediatric ED in Perth, Western Australia, between March 2018 and February 2020. The primary outcome measure was ease of personal care, as assessed by a Care and Comfort Questionnaire (eight questions scored from 0, very easy, to 8, impossible) completed by the caregiver and assessed during three treatment time-points and preintervention and postintervention. Secondary outcome measures included weight-bearing status as well as complications of fracture healing and number of pressure injuries.

Results 87 patients were randomised (44 CAM boot, median age 2 (IQR 1.5–2.3), 71% male; 43 AK-POP, median age 2 (IQR 1.7–2.8), 80% male), a significant difference in the care and comfort score was demonstrated at all treatment time-points; with the AK-POP group reporting greater personal care needs on assessment on day 2, day 7–10 and 4-week review (all p≤0.001). Weight-bearing status was significantly different at day 7–10 (77.5% CAM vs 53.8% AK-POP, p=0.027). There was no difference in fracture healing or pressure areas between the two treatment groups.

Conclusions Immobilisation of toddler’s fractures in a CAM boot allows faster return to activities of daily living and weight-bearing without any effect on fracture healing.

Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12618001311246).

  • paediatric emergency med
  • paediatric injury
  • paediatrics
  • paediatric orthopadics

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. All study data are stored in a single password protected database and hard copy data are being stored in accordance with WA Health Research Governance Policy and Procedures.

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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. All study data are stored in a single password protected database and hard copy data are being stored in accordance with WA Health Research Governance Policy and Procedures.

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Footnotes

  • Handling editor Gene Yong-Kwang Ong

  • Correction notice Since this article was first published online minor grammatical changes have been made. The term men has been changed to male in the abstract section.

  • Contributors KB conceived and coordinated the study from inception to completion and was the principle author of the paper. SOB assisted with study design and education, data collection and ongoing study supervision throughout the trial. SG assisted with data collection. KS and MB supervised and provided expert advice throughout the study design and review of the final paper. NB was involved in study design and analysis of results.

  • Funding This study was funded by a PCH Foundation Project Grant (PMHF Grant ID: 9761). The funders of this study had no role in the study design, data collection, data analysis, data interpretation, writing of the study manuscript or decision for manuscript submission. The corresponding author (KB) had full access to all the data in the trial and had final responsibility for the decision to submit for publication.

  • Competing interests None declared.

  • 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.

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