O1025: Randomized Control Trial of Casting versus Removable-Boot in the Management of Toddler’s Fractures

Background: Toddler’s fracture (TF) are stable fractures with an excellent prognosis. Evidence is required to support a de-escalation of conservative treatment with a circumferential cast with orthopedic surgeon follow up to a removable walking boot as needed without follow up. The main objective of this study was to determine whether children with TF who are treated with a boot have pain scores at four weeks that are non-inferior to those managed with a circumferential cast.

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, pediatric 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: Of the 129 enrolled children, 65 were randomized to a boot and 64 to a cast (Figure 1). Participants had a mean age of 2.2 (SD 0.8) years and 73 (56.5%) were male. At four weeks, the mean EVENDOL pain score was 1.2 in the boot group and 1.8 in the cast group (diff -0.6; 95% CI -1.2, 0.13). Since the upper bound of the 95% confidence interval is less than 2, the null hypothesis of inferiority is rejected at the 2.5% level. Furthermore, significantly more children in the boot group (61/64; 95.3%) had returned to full weightbearing by four weeks relative to their casted counterparts (44/54; 81.5%), diff 13.5%; 95% CI 2.2%, 26.5%, p=0.02 (Table 1). There were no significant differences in clinical complications, unscheduled health care resource utilization, and parental satisfaction. However, the cast vs. boot group had significantly more care burden with respect to bathing (72.2% vs. 40.6%; diff 31.6%;95% CI 13.7%, 46.7%, p=0.0003) and carrying the child (64.8% vs. 43.8%; diff 20.8%; 95% CI 2.8, 37.0%,p=0.022).

Conclusion: In children with a TF, a boot without scheduled physician follow up was an effective, safe, and parent-acceptable alternative to circumferential casting. Families whose children received the boot also had reduced parent care-related challenges during recovery of the injury, while minimizing the inconveniences of fracture clinic visits for cast placement and removal.