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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:

  1. The study population included or focused on those in the emergency department. Yes
  2. The patients were adequately randomized. Yes
  3. The randomization process was concealed. Yes
  4. The patients were analyzed in the groups to which they were randomized. Yes
  5. The study patients were recruited consecutively (i.e. no selection bias). Unsure.
  6. The patients in both groups were similar with respect to prognostic factors. Yes
  7. All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No
  8. All groups were treated equally except for the intervention. Yes
  9. Follow-up was complete (i.e. at least 80% for both groups). Yes
  10. All patient-important outcomes were considered. Yes
  11. The treatment effect was large enough and precise enough to be clinically significant. Yes
  12. 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? This is where shared decision-making comes into play.

Generalizability: Can Every ED Do This?

Not every ED has toddler-sized boots just lying around, and they’re not cheap. Should we be stocking these in every department? Or, in systems with limited resources, are there other pediatric needs that should take priority? This study raises the question of what innovations are nice to have vs need to have, especially outside of tertiary centers.

What About Doing Nothing?

We have to mention intervention bias aka “Don’t just do something, stand there!”

This trial compared a boot to a cast but what if we just did nothing? No immobilization or any kind, no risk of skin rashes or sores, just advice and reassurance? How would these kids turn out? There are probably some kids who don’t even present to the ED and recover without any intervention. We actually don’t know the true denominator of kids who sustain these injuries.

This is similar to the FORCE trial for buckle fractures of the wrist covered in SGEM #372 with the amazing Dr. Tessa Davis. That trial combined rigid immobilization to a soft bandage and found that they were equivalent with respect to pain. Are we over-managing stable injuries out of habit? The idea of a “no treatment” arm might have seemed radical, but it could be the next frontier. After all, sometimes it is just as important to know when not to do something.

Comment on Authors’ Conclusion Compared to SGEM Conclusion: We agree with the authors’ conclusions.

SGEM Bottom Line:  A removable boot is non-inferior to circumferential casting for toddlers’ fractures for pain and comes with fewer childcare challenges and quicker return to activity.

Case Resolution:

Our two-year-old with a toddler’s fracture after a trip down the slide has X-rays confirming that classic, nondisplaced spiral fracture of the distal tibia, the kind we’ve traditionally managed with a long-leg cast and routine ortho follow-up.

But now, with this new evidence in hand, we’ve got options. The study suggests that a removable walking boot, used for comfort and worn at the family’s discretion, can provide similar pain outcomes to casting, while making life a bit easier for both the child and their caregivers. No need for a scheduled fracture clinic visit, and less disruption to daily life.

So instead of reaching straight for the plaster, you take a moment to talk with the family. You explain the injury, the options, and the pros and cons of a cast versus a boot. And together, you agree on a plan that balances safety, comfort, and convenience because in the end, that’s what good pediatric emergency care is all about.

Clinical Application:

This was a great study. Based on their data, their conclusion is fair and well-supported.

But from an SGEM perspective, we’d say: not so fast. Yes, the boot met the non-inferiority threshold for pain, and families found it more convenient. But the study excluded occult fractures, wasn’t fully blinded, and required a product that many departments might not have ready access to. Plus, the increased rate of minor skin complications, while not statistically significant, is still worth considering, especially if boots are used without proper fitting or education.

While this study moves the needle toward less restrictive management, the SGEM take might be: boots are a good option, not necessarily the only one, and shared decision-making, including the possibility of doing less altogether, still deserves a place in the conversation.

What do I tell the patient or family?

 A fracture does mean that the bone is broken. But we have gradually learned that not all broken bones need to be treated the same. There are some options we can discuss. One option is to place a cast or splint. The other option is to use a removable boot. The boot may make your life easier in terms of not having to carry him around all the time and also giving him baths. It may lead to some more skin redness or sores compared to a cast. The final option would be not to do any immobilization. There is less data for this option right now, but most of these types of fractures are quite stable and heal very well on their own. What thoughts or questions do you have?

Remember to be skeptical of anything you learn, even if you heard it on the Skeptics’ Guide to Emergency Medicine.