24 Removable boot versus casting of toddler’s fractures: A multicenter non-inferiority randomized controlled trial

Abstract Background Toddler’s fractures (TF) are commonly treated with casts and fracture-clinic follow-up. A prefabricated boot that can be removed at the parent’s discretion might be sufficient and eliminate further follow-up. Objectives To determine whether children with TF treated with a removable boot are as comfortable at 4-weeks post injury as those managed with a circumferential cast. Design/Methods This was a pragmatic, multi-centered, assessor-blinded, non-inferiority randomized, controlled clinical trial with patient enrollment between October 15, 2019 and February 5, 2024. This study was conducted at four urban, tertiary care, paediatric university-affiliated Canadian emergency departments. Children between nine months and four years of age with a radiograph-visible TF were eligible for participation. Enrolled children were randomized to a removable walking boot versus circumferential cast and no scheduled physician follow up in both groups. The main outcome measure was the child's pain score during ambulation at four weeks post injury measured with the EValuation ENfant DOuLeur (EVENDOL) scale (minimal important difference of 2 points with a maximum score of 15). Additional outcomes included complications, return to weight- bearing, parental care burden and satisfaction, and unscheduled health care resource utilization related to the index injury. Results In the 129 enrolled children, the mean age was 2.2 (SD 0.8) years and 118 (91.5%) completed the four-week follow-up. The boot (n=64) vs. cast (n=54) groups demonstrated mean EVENDOL pain scores of 1.2 and 1.8, respectively (diff -0.55; 95% CI -1.2, 0.1). In the boot group, 61/64 (95.3%) were weight-bearing “most/all of the time” versus 44/54 (81.5%) in the cast group (diff 13.8%; 95% CI 2.2%, 26.5%). Secondary skin erythema/pressure sores were more frequent in the boot than cast group (diff 21.9%; 95% CI 5.1, 37.1). There was no difference in the percent of parents who reported they were “satisfied/very satisfied” (diff 9.3%; 95% CI -6.2, 24.8). Fewer parents reported bathing care burden (diff -31.6%; 95% CI -46.7%, -13.7%) and challenges with carrying the child (diff -20.8%; 95% CI -37.0%, -2.8%) in the boot than in the cast group. Conclusion In the management of children with TF, a removable boot without physician follow-up was non-inferior to circumferential casting with respect to recovery. While there was a higher frequency of skin complications in the boot group, there was no difference in parental satisfaction between the groups, and the boot strategy demonstrated reduced childcare-related challenges.

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