Cast vs Removable Boot for Toddler's Fracture

Overseen By Kathy Boutis, MD, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Pathological fractures, Chronic conditions, Multi-limb injuries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 3-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a removable walking boot can match the effectiveness of a traditional cast for children with toddler's fractures, common lower leg fractures in kids aged 9 months to 4 years. The study aims to determine if the boot can manage pain and help children resume normal activities faster than a cast. Children who are otherwise healthy, can walk independently, and have been diagnosed with a toddler's fracture after a recent leg injury might be suitable candidates for the trial. The goal is to find a treatment that is effective, convenient, and cost-effective. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance treatment options for young children.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that a removable walking boot works as well as a full-leg cast for treating toddler's fractures, particularly in pain recovery. Studies have found the boot equally effective in helping children heal from these injuries.

The good news is that using a removable boot does not carry more risks than a cast. It may even help avoid issues like skin irritation or poor fit associated with traditional casts. No major safety concerns have been reported with the boot, making it a safe option for young children with a stable leg fracture.

Overall, both treatments are considered safe, but the boot provides more convenience and comfort without sacrificing effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a removable walking boot for toddler's fractures because it offers more flexibility and comfort than traditional fiberglass casts. Unlike the standard care, which involves keeping a hard, above-knee walking cast on for three weeks, the boot can be adjusted based on the child's comfort and needs. This potentially reduces the overall time a child must wear the device and allows for easier bathing and mobility.

What evidence suggests that this trial's treatments could be effective for toddler's fractures?

This trial will compare the effectiveness of a removable walking boot with a traditional cast for treating toddler fractures. Research has shown that a removable walking boot works as well as a traditional cast in helping toddlers heal from fractures. Studies have found that toddlers wearing a boot experience the same pain relief as those with a full cast. Additionally, children in a boot often resume normal activities more quickly, with many returning to normal within four weeks. The boot's removability makes it easier for parents to assist in their child's recovery. Overall, using a boot is a convenient and effective way to manage toddler fractures. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for healthy, walking toddlers aged 9 months to 4 years who come to specific hospitals within five days of hurting their lower leg. They must be diagnosed with a toddler's fracture (a common shin injury from twisting the leg).

Inclusion Criteria

You have been diagnosed with an accidental traumatic injury.

You must have visited the emergency departments at SickKids, LHSC, or CHU Sainte-Justine within five days of injuring your lower body.

My child is healthy, can stand on their own, and is between 9 months and 4 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either a removable below knee device or a circumferential walking cast

3-6 weeks

2-3 visits (in-person)

Follow-up

Participants are monitored for pain control and recovery using the EVENDOL pain scale

4 weeks

1 visit (in-person)

Extended Follow-up

Participants are monitored for complications and weight-bearing ability

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cast
• Removable Walking Boot

Trial Overview The study compares two ways to treat toddler's fractures: the traditional full-leg cast and a new removable walking boot. It will look at how well each method controls pain and helps kids get back to normal activities.

How Is the Trial Designed?

Group I: Landmark Pediatric Walker Boot (LPWB) Experimental Treatment 1 Intervention

The Landmark Pediatric Walker Boot (LPWB) will be placed in the ED and will be kept on for a minimum of one week, and then for a duration dictated by the patient's comfort.

Group II: Fiberglass above-knee walking cast (AKWC) Active Control 1 Intervention

The standard treatment arm will be a posterior splint placed in the ED by the ED clinical team (nurse/physician) and then a fiberglass AKWC to be placed ideally within 72 hours in the fracture clinic. This AKWC will be in place for 3 weeks, which is currently the most common strategy to manage TF.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Population Services International

Collaborator

Trials

25

Recruited

270,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40257790/

Removable Boot vs Casting of Toddler's Fractures A removable boot without physician follow-up was noninferior to circumferential casting with respect to pain recovery.

2. ovid.com ovid.com/journals/japed/pdf/10.1001/jamapediatrics.2025.0560~removable-boot-vs-casting-of-toddlers-fractures-a-randomized

Removable Boot vs Casting of Toddler's Fractures A ... Meaning A removable boot was noninferior to circumferential casting with respect to pain recovery in the management of children with a toddler's fracture.

3. trialx.com trialx.com/clinical-trials/listings/260987/toddlers-fractures-cast-versus-removable-boot/

Toddlers Fractures - Cast Versus Removable Boot The removable pediatric walking boot will be at least as effective as the walking above-knee cast with respect to pain with ambulation as ...

4. thesgem.com thesgem.com/2025/10/sgem490-these-removable-boots-are-made-for-walking/

SGEM#490: These (Removable) Boots are Made for Walking Children treated with a boot were more likely to return to their usual activities by four weeks, with over three-quarters back to normal ...

5. facebook.com facebook.com/JAMAPediatrics/posts/in-children-with-toddlers-fractures-a-removable-boot-was-as-effective-as-circumf/1844561136170376/

In children with toddler's fractures, a removable boot was ... In children with toddler's fractures, a removable boot was as effective as circumferential casting for pain recovery and demonstrated better ...

6. withpower.com withpower.com/trial/phase-fractures-bone-2020-c0276

Cast vs Removable Boot for Toddler's Fracture Trial Overview The study compares two ways to treat toddler's fractures: the traditional full-leg cast and a new removable walking boot. It will look at how ...