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Cast vs Removable Boot for Toddler's Fracture

N/A
Recruiting
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Otherwise healthy, independently weight-bearing children aged 9 months to 4 years
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2, 4 and 12 weeks post-injury
Awards & highlights

Study Summary

This trial will compare the traditional cast to a walking boot for a common lower leg fracture in toddlers. The aim is to reduce pain and speed up recovery.

Who is the study for?
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).Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include skin irritation or discomfort from the cast, whereas the removable boot might have fewer issues as it can be adjusted or removed by parents for comfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is healthy, can stand on their own, and is between 9 months and 4 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2, 4 and 12 weeks post-injury
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2, 4 and 12 weeks post-injury for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
EValuation ENfant DOuLeur (EVENDOL) pain score at four weeks
Secondary outcome measures
Complications
Day-to-day issues
Immobilization strategy satisfaction
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Landmark Pediatric Walker Boot (LPWB)Experimental Treatment1 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 Control1 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.

Find a Location

Who is running the clinical trial?

Population Services InternationalOTHER
19 Previous Clinical Trials
263,166 Total Patients Enrolled
The Hospital for Sick ChildrenLead Sponsor
690 Previous Clinical Trials
6,945,318 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Toddlers Fractures - Cast Versus Removable Boot
Kathy Boutis 2020. "Toddlers Fractures - Cast Versus Removable Boot". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03971448.
~22 spots leftby Dec 2024
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