🧭 REBEL Rundown
🗝️ Key Points
- 🥾 Boot is reasonable: For uncomplicated, radiographically confirmed toddler’s fractures, use a removable walking boot instead of routine casting.
- 🧒 Pain outcomes were similar: Boot treatment was noninferior to casting for pain at 4 weeks.
- 🏃 Kids recovered function faster: More children in the boot group returned to baseline activity compared with the cast group.
- 👨👩👧 Less caregiver burden: Boots made bathing and carrying the child easier than casting.
- 👀 Check the skin: Counsel parents to monitor for irritation, erythema, or pressure sores.
📝 Introduction
A toddler’s fracture is a spiral or oblique nondisplaced fracture of the distal tibia that most commonly occurs in children 1–4 years of age. The physical findings and radiological appearance are often subtle, consisting of a faint oblique line crossing the distal tibia, best visualized on the internal oblique radiograph.1 The annual incidence of fractures in children under two years of age ranges from 5.3 to 9.5 per 1,000, with Tibia and fibula fractures (one of the most common pediatric fractures) accounting for 17.3% to 27.6% of all fractures in this age group.2 Toddler’s fractures are considered stable fractures with excellent healing potential due to the thick periosteum and inherent stability of the tibia at this age. Although once thought to be associated with non-accidental trauma, subsequent studies have shown that an isolated toddler’s fracture is an expected accidental injury pattern in ambulatory young children.
Traditional management typically involves 3 to 4 weeks of circumferential casting and orthopedic follow-up. Protocols vary by institution, but most include either a long-leg or short-leg cast for immobilization. However, emerging evidence suggests that less restrictive approaches—such as removable walking boots, splints, or even observation—may yield comparable outcomes with fewer complications and less caregiver burden. Additional high-quality studies can help to elucidate the optimal management approach.
🧾 Paper
Boutin A, Colaco K, Stimec J, et al. Removable boot vs casting of toddler’s fractures: a randomized clinical trial. JAMA Pediatrics. 2025;179(7):713-721. PMID: 40257790
⚙️ What They Did
📈 Results
A total of 129 patients were enrolled, with 65 randomized to the boot group and 64 to the cast group. One patient was lost to follow-up in the boot group (99% follow-up), and 10 patients were lost in the cast group (84% follow-up).
- Primary outcome (EVENDOL pain score, per protocol analysis)
- Cast: 1.84 +/- 2.19
- Boot: 1.23 +/- 1.54
- Difference: -0.61 (95% CI −1.31 to 0.19)
- Secondary outcomes / adverse events
- Return to baseline activities as reported by caregiver
- Cast: 41%
- Boot: 77%
- 36% increase in return to baseline in the boot group
- Skin complications, defined as either skin rash, erythema, or pressure sores
- Cast: 50%
- Boot: 72%
- Increase in 22% (95% CI -6 to 50%). Not statistically significant, but may be clinically significant.
- In the 73 patients with skin complications, 67 patients (92%) reported mild erythema, and 6 patients reported a pressure sore (8%).
- Caregiver burden
- Bathing difficulty: 73% cast vs 41% boot
- Carrying child: 65% cast vs 44% boot
- There was an overall improvement in both categories with boot application vs traditional casting
- Caregiver satisfaction
- No significant difference
- Return to baseline activities as reported by caregiver
💥 Critical Results
💪🏽 Strengths
- Randomized multicenter design: Randomization across four tertiary pediatric EDs improves internal validity and reduces the likelihood that institutional practice patterns drove the results.
- Clinically relevant noninferiority question: The trial asks a practical ED-facing question: whether a less restrictive, removable boot strategy can safely replace routine casting and orthopedic follow-up for uncomplicated toddler’s fractures.
- Appropriate use of both intention-to-treat and per-protocol analyses: Reporting both analyses strengthens interpretation in a noninferiority trial, where protocol deviations and nonadherence can influence conclusions.
- Prespecified noninferiority margin: The investigators clearly defined a 2-point EVENDOL pain margin, allowing readers to judge whether the accepted difference was clinically reasonable.
- Blinded outcome assessment: Although families could not be blinded, the primary 4-week assessment was performed by a blinded assessor, reducing ascertainment bias for the primary outcome.
- High follow-up for the primary outcome overall: Primary outcome follow-up was strong, with only one patient lost in the boot group and 10 lost in the cast group.
- Patient- and caregiver-centered outcomes: The study went beyond radiographic healing and included pain, return to baseline activity, caregiver burden, satisfaction, unscheduled visits, and complications.
- Pragmatic intervention: Caregiver-directed boot use after the first week reflects real-world practice and makes the results easier to apply in the ED.
- Radiograph-confirmed fractures: Limiting enrollment to visible toddler’s fractures improves diagnostic certainty and avoids mixing occult injuries or alternative causes of limp into the study population.
⚠️ Limitations
- Families and treating clinicians were not blinded: This creates risk of reporting bias for subjective outcomes such as pain, activity level, caregiver burden, satisfaction, and skin irritation.
- Differential loss to follow-up: Follow-up was excellent in the boot group but lower in the cast group. This matters because unequal attrition can bias noninferiority results, particularly when outcome data are subjective.
- Small sample size: With only 129 enrolled patients, the trial was not powered to detect rare but important events such as displacement, delayed healing, refracture, or clinically meaningful gait problems.
- Short primary follow-up window: The primary outcome was assessed at 4 weeks, with phone follow-up at 12 weeks. This is reasonable for pain recovery but limits confidence about uncommon longer-term orthopedic outcomes.
- Subjective primary outcome: EVENDOL is validated, but pain scoring in preverbal or minimally verbal children still depends on observation and caregiver interpretation.
- Skin complications require careful interpretation: Skin issues were numerically more common in the boot group, although most were mild erythema. This may reflect removable device fit, sock/stockinette use, caregiver checks, or reporting differences.
- Caregiver-directed treatment may not work equally well for all families: The boot strategy assumes caregivers can monitor skin, remove and reapply the boot appropriately, and return for care if symptoms worsen.
- Limited generalizability outside pediatric tertiary EDs: Results may differ in community EDs, urgent care settings, or systems without ready access to appropriately sized pediatric walking boots.
- Only uncomplicated, radiographically visible fractures were studied: These findings should not be extended to displaced fractures, proximal tibial fractures, pathologic fractures, delayed presentations, nonambulatory children, or cases with concern for nonaccidental trauma.
- Comparator reflects one version of standard care: The cast group included circumferential casting and orthopedic follow-up, but some centers already use splints, CAM boots, or observation. The trial does not directly compare all less restrictive strategies.
🗣️ Discussion
Evidence Supporting Less Restrictive Management
This study provides high-quality evidence supporting less restrictive management of radiographically confirmed toddler’s fractures. The findings demonstrate that a removable walking boot without scheduled physician follow-up yields comparable pain outcomes to casting. Additionally, the study reports a decrease in caregiver burden with a removable boot compared to standard treatment. The inclusion of only radiograph-visible fractures enhances the clinical applicability of the results to emergency department practice and helps to reduce error in clinical interpretability.
Noninferiority Design and Interpretation
The statistical analysis was appropriate for a noninferiority framework, with both intention-to-treat and per-protocol analyses performed and a clearly prespecified 2-point EVENDOL margin. Noninferiority trials do not prove two treatments are identical; they ask whether the new strategy is not unacceptably worse than standard care. Here, the confidence interval for pain stayed within the prespecified margin, supporting boot treatment as noninferior to casting. This interpretation should remain limited to uncomplicated, radiographically confirmed toddler’s fractures.
Skin Complications and Generalizability
Although there was a trend toward increased mild skin complications in the boot group, these were largely minor and potentially mitigated with proper sock or stockinette use and routine skin checks. The clinical relevance of minor erythema may vary among caregivers and clinicians, especially given the benefits of a removable boot compared to standard casting. The skin complication rate was not statistically significant, but still an important finding that should be communicated to parents. The study was conducted in tertiary care Canadian pediatric emergency departments; therefore, clinicians should consider the applicability of the findings to their own practice settings, as there are meaningful differences in healthcare delivery between the United States and Canada.
📘 Author's Conclusion
“In this multicenter randomized noninferiority trial of children aged 9 months to 4 years with radiographically confirmed toddler’s fractures, treatment with a removable walking boot was noninferior to circumferential casting with respect to pain at 4 weeks. Children managed with a boot returned to baseline activities sooner and caregivers reported lower care burden, although there was a nonsignificant trend toward more mild skin complications. The findings support a less restrictive, caregiver-directed management strategy with a removable boot and no scheduled physician follow-up for uncomplicated toddler’s fractures.”
💬 Our Conclusion
In children aged 9 months to 4 years with a radiographically confirmed toddler’s tibial fracture, treatment with a removable walking boot is appropriate. Parents should be counseled to monitor for skin irritation, and routine orthopedic follow-up is not necessary.
🚨 Clinical Bottom Line
For uncomplicated, radiographically confirmed toddler’s fractures: place the child in a removable walking boot, counsel parents on skin checks, and avoid routine casting or orthopedic follow-up.
❓ FAQ
- Can a toddler’s fracture be treated with a boot instead of a cast?
Yes. For uncomplicated, radiographically confirmed toddler’s fractures, a removable walking boot is a reasonable alternative to casting, with similar pain outcomes at 4 weeks. - How long should a toddler fracture boot be worn?
A toddler fracture boot is typically worn until the child is cleared by a specialist or follow-up clinician. Families should follow local orthopedic guidance and avoid stopping immobilization early without clear instructions. - What should parents watch for with a toddler fracture boot?
Parents should monitor for skin irritation, redness, pressure sores, worsening pain, refusal to bear weight, or any concern that the boot does not fit properly.
📚 References
Disclosure: AI LLM have been used to improve Grammar and Flow
Post Peer Reviewed By: Mark Ramzy, DO (X/IG: @MRamzyDO), Anand Swaminathan, MD (X/IG:@EMSwami), and Marco Propersi DO, (X/IG: @Marco_Propersi)
Meet the Authors
Molly Estes, MD
Thomas Scott, MD
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