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Search / Trial NCT03971448

Toddlers Fractures - Cast Versus Removable Boot

Launched by THE HOSPITAL FOR SICK CHILDREN · May 30, 2019

Trial Information

Current as of September 25, 2025

Completed

Keywords

Cast Removable Device/Boot Immobilization Strategy Emergency Department

ClinConnect Summary

This clinical trial is studying how well a removable walking boot works compared to a traditional cast for treating toddler's fractures, which are common injuries in young children aged 9 months to 4 years. These fractures usually happen when a child twists their leg while playing. While casts have been the standard treatment, they can cause discomfort and require multiple doctor visits for changes and x-rays, even though these fractures heal very well on their own. The researchers want to see if the walking boot can provide good pain relief and help children get back to their normal activities faster, while also reducing healthcare costs.

To participate in this trial, children must be otherwise healthy and able to walk independently, and they should have come to the emergency department with a lower leg injury within five days. Unfortunately, children with certain medical conditions or multiple injuries, as well as those whose parents can’t provide consent or communicate effectively, won’t be eligible. Families involved in the study can expect to follow their child’s recovery closely, with less need for frequent hospital visits, as doctors will later check in with them to ensure their child is healing properly.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Otherwise healthy, independently weight-bearing children aged 9 months to 4 years
  • Present to the ED at SickKids, LHSC or CHU Sainte-Justine within five days of a lower extremity injury
  • Diagnosed clinically and radiographically with an accidental TF will be eligible for enrolment
  • Exclusion Criteria:
  • Children at risk for pathological fractures (Appendix 1) or those with chronic conditions (arthritis or neuromuscular disorders) since these children have different management requirements and potentially different pain and recovery timelines
  • Children with multi-limb injuries
  • Children with neuromotor deficits such that assessment of recovery or pain is confounded by the deficits
  • Children whose parents/guardians who are unable to provide consent or complete follow-up procedures due to an insurmountable language barrier, or no access to a phone or electronic mail
  • Children with diagnostic uncertainty of a TF (e.g. occult TF) or those whose TF might be the result of non-accidental injury

About The Hospital For Sick Children

The Hospital for Sick Children (SickKids) is a leading pediatric health care and research institution located in Toronto, Canada. With a commitment to advancing child health through innovative research, education, and clinical care, SickKids is recognized globally for its expertise in pediatric medicine. The hospital actively sponsors clinical trials aimed at improving treatment outcomes and enhancing the quality of life for children with various health conditions. By fostering collaboration among multidisciplinary teams and leveraging state-of-the-art facilities, SickKids strives to translate research findings into tangible advancements in pediatric care, ensuring that children receive the best possible treatments based on the latest scientific evidence.

Locations

Toronto, Ontario, Canada

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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