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Supportive bandage, removable splint, or walking casts for low-risk ankle fractures in children: a feasibility randomized controlled trial

Marson, Ben A.; Gurney, Matilda; Manning, Joseph C.; James, Marilyn; Ogollah, Reuben; Durand, Charlotte; Ollivere, Benjamin J.

Supportive bandage, removable splint, or walking casts for low-risk ankle fractures in children: a feasibility randomized controlled trial Thumbnail


Authors

Dr BEN MARSON Ben.Marson@nottingham.ac.uk
Clinical Associate Professor

Joseph C. Manning

Dr REUBEN OGOLLAH REUBEN.OGOLLAH@NOTTINGHAM.AC.UK
ASSOCIATE PROFESSOR OF MEDICAL STATISTICS AND CLINICAL TRIALS

Charlotte Durand



Abstract

Aims

It is unclear if a supportive bandage, removable splint, or walking cast offers the best outcome following low-risk ankle fractures in children. The aim of this study was to evaluate the feasibility of a randomized controlled trial to compare these treatments.

Methods

Children aged five to 15 years with low-risk ankle fractures were recruited to this feasibility trial from 1 February 2020 to 30 March 2023. Children were randomized to supportive bandage, removable splint, or walking cast for two weeks. Follow-up at two, six, and 12 weeks was undertaken to determine feasibility for a definitive trial. Outcomes collected included complications, the Patient-Reported Outcomes Measurement Information System (PROMIS) mobility score, Paediatric Quality of Life Inventory, youth version of the EuroQol five-dimension health questionnaire, and Activities Scale for Kids - Performance.

Results

A total of 87 children from six hospitals were randomized at a rate of 0.9 participants per site per month. Two children in the supportive bandage group crossed over to an alternative device. Complications were reported in six children. One child in the cast group developed skin blisters. One child in cast and one in bandage sustained a reinjury during the 12-week follow-up, and two children (one splint and one cast) required additional immobilization after the two-week treatment for persistent pain. Of the 84 participants who remained in the study at six weeks, 43 (51.2%) returned follow-up questionnaires at six weeks. Of the patient-reported outcome measures (PROMs), proxy-reported PROMIS mobility showed good responsiveness, low ceiling effects, and low missing item rates. In an exploratory analysis, small differences were observed between groups, with no evidence that any of the treatments were superior.

Conclusion

This feasibility study showed acceptable recruitment and retention rates. There remains equipoise regarding the best treatment of these injuries. All three treatments appear well tolerated with similar complication rates. A primary outcome of complications or treatment failure would provide the highest study retention with secondary PROMs and economic analysis.

Citation

Marson, B. A., Gurney, M., Manning, J. C., James, M., Ogollah, R., Durand, C., & Ollivere, B. J. (2025). Supportive bandage, removable splint, or walking casts for low-risk ankle fractures in children: a feasibility randomized controlled trial. The Bone & Joint Journal, 107-B(1), 108-117. https://doi.org/10.1302/0301-620x.107b1.bjj-2024-0354.r1

Journal Article Type Article
Acceptance Date Aug 27, 2024
Online Publication Date Jan 1, 2025
Publication Date Jan 1, 2025
Deposit Date Jul 1, 2025
Publicly Available Date Jul 18, 2025
Journal The Bone & Joint Journal
Print ISSN 2049-4394
Electronic ISSN 2049-4408
Publisher British Editorial Society of Bone and Joint Surgery
Peer Reviewed Peer Reviewed
Volume 107-B
Issue 1
Pages 108-117
DOI https://doi.org/10.1302/0301-620x.107b1.bjj-2024-0354.r1
Public URL https://nottingham-repository.worktribe.com/output/43800028
Publisher URL https://boneandjoint.org.uk/Article/10.1302/0301-620X.107B1.BJJ-2024-0354.R1
Additional Information Published: 2025-1-1

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Publisher Licence URL
https://creativecommons.org/licenses/by/4.0/

Copyright Statement
This article is distributed under the terms of the Creative Commons Attributions (CC BY 4.0) licence (https://creativecommons.org/licenses/by/ 4.0/), which permits unrestricted use, distribution, and reproduction in any medium or format, provided the original author and source are credited.





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