SGEM#490: These (Removable) Boots are Made for Walking

Reference:  Boutin A, et al. Removable Boot vs Casting of Toddler’s Fractures: A Randomized Clinical Trial. JAMA Pediatr. Published April 2025. Date: July 23, 2025 Dr. Andrew Tagg Guest Skeptic: Dr. Andrew (Andy) Tagg is an Emergency Physician with a special interest in education and lifelong learning. He is the co-founder and website lead of Don’t Forget the Bubbles (DFTB). Case: A two-year-old boy presents to your pediatric emergency department (ED) with a limp and refusal to bear weight. His parents aren’t exactly sure what happened. They were at the park and suspected that he might have twisted his leg coming down a slide. On your exam, he does not have a fever. He does not have any swelling or deformity of his bilateral lower extremities. You order X-rays, which confirm a nondisplaced spiral fracture of the distal tibia, a classic toddler’s fracture. After you disclose his diagnosis, his worried parents ask you, “A fracture? Does that mean it’s broken? Will he need to get a cast? He’s such an active little guy, typically.” Background: Toddler’s fractures are subtle, nondisplaced spiral fractures of the tibia. They typically occur in children between the ages of 9 months and 4 years. They often present in children who are just beginning to walk, hence the term “toddler’s fracture.” These kids can come in with inability to bear weight, a limp, or nonspecific pain. Another challenge is that the history you get may or may not help guide you. These injuries usually result from low-energy trauma, such as a twisting injury during a fall. That can happen multiple times a day when you’re learning to walk! The mechanism of injury is so subtle sometimes that parents or caretakers may not recall any inciting event. The findings on X-ray can be quite subtle as well. AP and lateral views may reveal a very small hairline fracture that’s easily missed. In some situations,  X-rays will be negative despite clinical exam findings suggestive of a toddler’s fracture. In those situations, repeated X-rays in a week or so can show some evidence of periosteal reaction. The traditional management has included immobilization with a long leg or short leg cast, based on the belief that toddlers are unlikely to limit activity independently and require rigid immobilization to promote healing and pain relief. However, growing concerns about the discomfort, skin breakdown, need for follow-up visits, and potential complications from casting have led to interest in less restrictive treatments. such as removable walking boots. Clinical Question: In children with radiographically confirmed toddler’s fractures, is treatment with a removable walking boot noninferior to a circumferential cast? Reference:  Boutin A, et al. Removable Boot vs Casting of Toddler’s Fractures: A Randomized Clinical Trial. JAMA Pediatr. Published April 2025. Population: Children aged 9 months to 4 years with radiograph-visible tibial toddler’s fractures seen in 4 Canadian pediatric emergency departments. Exclusion: Presented more than 5 days after injury or had an increased risk for pathological fracture or delayed healing Intervention: Removable prefabricated walking boot. Parents were told to use the boot for one week, then use it as needed for symptoms for up to three weeks. This was based on caregiver discretion, with no scheduled follow-up. Comparison: Standard circumferential casting. This varied across sites: Two sites did a long-leg splint in the ED, followed by a fiberglass cast. Another site did a short or long leg splint/cast in the ED, followed by a long leg fiberglass cast. The final site placed a short-leg splint in the ED, followed by a short-leg fiberglass cast. The casts were applied within seven days of the ED visit. Two sites had casts that were peelable, meaning they could be removed by caregivers at home. The other two sites had patients return to the clinic for cast removal. Outcome: Primary: Evaluation Enfant Douleur (EVENDOL) pain score at 4 weeks Secondary: Return to activity, complications, caregiver satisfaction, care burden, healthcare utilization. Trial: Pragmatic, multicenter, assessor-masked, noninferiority randomized clinical trial Authors’ Conclusions : 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 Quality Checklist for Randomized Clinical Trials: The study population included or focused on those in the emergency department. Yes The patients were adequately randomized. Yes The randomization process was concealed. Yes The patients were analyzed in the groups to which they were randomized. Yes The study patients were recruited consecutively (i.e. no selection bias). Unsure. The patients in both groups were similar with respect to prognostic factors. Yes All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No All groups were treated equally except for the intervention. Yes Follow-up was complete (i.e. at least 80% for both groups). Yes All patient-important outcomes were considered. Yes The treatment effect was large enough and precise enough to be clinically significant. Yes Financial conflicts of interest. Some authors reported grant funding from healthcare institutions or relevant foundations, but no direct industry sponsorship from Big Boot Results: They enrolled 129 children in the study, with 65 children randomized to the boot group and 64 children randomized to the cast group. The mean age was 2.2 years. Key Results: Removable boot was non-inferior compared to circumferential casting in the management of children with Toddler Fractures. Primary Outcome: This was pain at 4 Weeks on the EVENDOL scale. The non-inferiority margin was defined as 2 points on the EVENDOL scale. The boot group had a EVENDOL mean score of 1.2 (SD 1.5) while the cast group had a mean score of 1.8 (SD 2.1). We mentioned before that they did both an intention-to-treat and per-protocol analysis. The upper bound of the confidence interval was well below the threshold of 2, supporting non-inferiority. Secondary Outcomes: Children treated with a boot were more likely to return to their usual activities by four weeks, with over three-quarters back to normal compared to just 41% in the cast group. This was a difference of 36% (95% CI 9-63%). By 12 weeks, everyone had returned to normal weight bearing and baseline activities. Any other positives for the boot group? They also reported fewer day-to-day challenges. Bathing was easier. Only 41% in the boot group moderately/strongly agreed that bathing the child was a challenge compared to 72% of the cast group (Difference -32%, 95% CI -47 to -18%). There was less need to carry their child around (44% vs 68%; Difference -22%, 95% CI -27 to -15%). Skin complications like mild redness or pressure sores were slightly more common in the boot group, but these were not statistically significant (difference of 22%, 95% CI -6 to 50%). These were generally minor and picked up early. Overall satisfaction was high in both groups; 80% satisfied in the boot group compared to 70% in the cast group (difference 9%, 95% CI -20 to 39%). Though caregivers in the boot group were more likely to say they'd choose the same treatment again mainly because of the care burden and inconvenience of getting the cast placed and removed. There was no difference in unplanned doctor visits or repeat X-rays between the two groups. Radiograph-Visible Fractures Only This study only included radiograph-visible toddler fractures, the clear, obvious ones. But a large chunk of toddler’s fractures don’t show up on the initial X-ray. Those occult injuries may have different trajectories and pain profiles, and we often treat them similarly in practice. So, while the findings are robust for visible fractures, we can’t automatically apply them to every limping toddler with a presumed injury and a normal X-ray. The fracture morphologies included were also interesting. Toddlers' fractures are classically nondisplaced spiral fractures. This study included buckle fracture and transverse fractures too. They even included a few fractures with very minimal displacement, albeit those types of fractures only represented a smaller portion of the population. This feature may add a bit to the generalizability and makes us wonder…could we adopt the less is more approach for even more fracture types? Masking and Bias: The Pragmatic Trade-Off This was a pragmatic trial, which is great for real-world relevance, but only the outcome assessors were blinded. Parents and clinicians knew exactly which treatment was given, which might influence how they reported things like activity levels or skin problems. That’s a potential source of reporting bias, especially when dealing with subjective outcomes. Still, the fact that the EVENDOL scores, assessed blindly via video, aligned with parental reports adds some weight to the findings. Harms vs Benefits: What Matters Most? The boot came out ahead in terms of day-to-day practicality. It’s easier to bathe. There’s less carrying. The kids also returned to their activities quicker. That’s huge for families. Skin complications in the boot group were more common. Most of these (92%) were mild erythema but there were a few minor pressure sores. What’s more meaningful to parents? A slightly higher risk of a rash or being able to get through a week without plastic-wrapping their child’s leg for every bath?