Removable Boot vs Casting of Toddler's Fractures: A Randomized Clinical Trial.

Importance: Toddler's fractures (TF) of the tibia are commonly treated with casts and fracture clinic follow-up. However, a prefabricated removable boot might be sufficient and reduce unnecessary follow-up. Objectives: To determine whether pain in children with TF treated with a removable boot is not worse than those managed with a circumferential cast at 4 weeks postinjury. Design, Setting, and Participants: This pragmatic, multicenter, assessor-blinded, noninferiority randomized clinical trial was conducted between October 2019 and February 2024 at 4 urban, tertiary care, pediatric Canadian emergency departments. Children aged between 9 months and 4 years with a radiograph-visible TF were eligible for inclusion. Interventions: Prefabricated walking boot for up to 3 weeks (removable at caregivers' discretion) vs circumferential cast immobilization (site standard of care) for 3 weeks. Main Outcomes and Measure: The primary outcome was pain score, measured with the Evaluation Enfant Douleur (EVENDOL) scale (maximum score: 15). Additional outcomes included return to baseline activities, complications, parental satisfaction and care burden. Results: In 129 enrolled children, the mean (SD) age was 2.2 (0.8) years, and 56 children (43%) were female. Of these, 118 children (92%) completed the 4-week follow-up, and the boot (n = 64) vs cast (n = 54) groups demonstrated mean (SD) EVENDOL pain scores of 1.21 (1.54) and 1.76 (2.13), respectively (difference, -0.55; 95% CI, -1.23 to 0.13). The percentage of participants who returned to baseline activities "almost all of the time" was 49 of 64 children (77%) in the boot group and 22 of 54 (41%) in the cast group (difference, 36%; 95% CI, 9%-63%). Skin complications occurred in both groups (boot: 46 total complications [72%], with 5 stage 1 pressure sores; cast: 27 total complications (50%), with 1 pressure sore]; difference, 22%; 95% CI, -6% to 50%). There was no statistically significant difference in the percentage of caregivers who were satisfied or very satisfied with the treatment (difference, 9%; 95% CI, -24% to 43%). Fewer caregivers reported bathing care burden (difference, -32%; 95% CI, -47% to -18%) and challenges with carrying the child (difference, -21%; 95% CI, -27% to -15%) in the boot vs cast group. Conclusions and Relevance: In this multicenter randomized clinical trial examining the management of children with TF, a removable boot without physician follow-up was noninferior to circumferential casting with respect to pain recovery. While there was a clinically relevant but not statistically significant trend toward more skin complications in the boot group, there was no difference in caregiver satisfaction, and the boot strategy demonstrated reduced childcare-related challenges. Trial Registration: ClinicalTrials.gov Identifier: NCT03971448.