Can a removable boot suffice as treatment for toddler’s fracture?

A prefabricated, removable walking boot may be a suitable alternative to a circumferential cast for the treatment of toddler’s fracture (TF), a study suggests.

The mean EVENDOL* pain scores did not significantly differ between the boot and cast arms at 4 weeks post-injury in the intention-to-treat (1.21 vs 1.76; mean difference [MD], -0.55; 95 percent confidence interval [CI], -1.23–0.13) and per-protocol analyses (1.23 vs 1.84; MD, -0.61; 95 percent CI, -1.31–0.10), and in the subanalysis of radiology-confirmed TF (1.30 vs 1.86; MD, -0.56; 95 percent CI, -1.31–0.19). [PAS 2025, abstract 2035.2]

The upper bounds of the CIs across the three analyses support the noninferiority of the boot to the cast since these were <2 points, noted Dr Ariane Boutin from Sainte-Justine Hospital, University of Montreal in Quebec, Canada, at PAS 2025.

“We chose [the EVENDOL] pain scale over others since it considers a child’s interaction with the environment, can be assessed during ambulation, and can differentiate between pain from other types of distress, such as anxiety, which is highly relevant in toddlers,” she added. EVENDOL is a validated 15-point scale that may be used to assess pain in children aged 0–7 years. [JAMA Pediatr 2019;173:1186-1197; Pain 2012;153:1573-1582]

Secondary outcomes

The incidence of skin rash/erythema was higher with the boot than the cast (72 percent vs 50 percent; MD, 22 percent), but the between-group difference was not statistically significant.

Five kids in the boot arm had pressure sores vs one in the cast arm. The pressure sores in the boot arm were identified within 3 days of boot placement. Prompt corrective measures were applied, and future sores were mitigated with daily checks and routine use of a sock.

Skin itching was less frequent with the boot vs cast (28 percent vs 39 percent), but the difference between arms was not significant. Device breakage was exclusive to the cast arm.

Seventy-seven percent of kids wearing the boot were able to return to baseline activities as opposed to only 41 percent of those on a cast.

Fewer caregivers reported bathing (41 percent vs 72 percent) and carrying difficulties (44 percent vs 68 percent) with the boot vs the cast, and more preferred the former (80 percent vs 30 percent) as the latter was tied to a greater care burden and inconvenience in terms of placement and removal.

A parent-acceptable alternative

“TFs are stable and have an excellent prognosis, but the most widely accepted standard of care is a full-length cast for up to 4 weeks, along with orthopaedic surgeon follow-ups and repeat radiographs,” Boutin noted.

She added that this conservative approach has not been shown to significantly improve patient recovery compared with less restrictive methods. “As a result, there has been a growing shift in clinical practice towards the use of splints, removable boots, and even no immobilization in managing TF.”

However, existing data on these alternatives are mostly single-centre retrospective studies with small sample sizes. In the few prospective trials available, occult fractures were included, and outcomes were measured by unblinded assessors using unvalidated tools. “Hence, we need stronger evidence before we can confidently recommend these alternatives for managing TF,” said Boutin.

In this assessor-blinded trial, 129 weight-bearing children (mean age 2.2 years) with radiographically apparent, isolated, undisplaced (<2 mm) TF were randomized to the boot (1–3 weeks; n=64) or a cast (3 weeks; n=54) with no scheduled follow-up. Nearly two-thirds of the fractures were attributed to a fall, and most were located at the distal third of the tibia (68 percent) and were spiral/oblique (~75 percent).

“[Taken together,] a boot without scheduled physician follow-up was an effective, safe, and parent-acceptable alternative to circumferential casting for TF,” noted Boutin. The boot also reduced parent care-related challenges during recovery and the inconvenience of clinic visits for cast placement and removal.