Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial

Study Overview
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Brief Summary
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Toddler's fractures of the tibia are by definition non-displaced and of a stable pattern. Children have thickened periosteum compared with adults, which therefore may impart stability to the fracture without the need for additional immobilization. The goal of the study is to evaluate whether or not there is a difference in children treated with and without cast immobilization in regards to time to ambulation; perceived pain; difficulty in dressing & bathing; radiographic displacement or angulation; and time missed from work or daycare. Our null hypothesis is that there will be no difference in clinical or radiographic outcomes between the groups.

Official Title
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Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial

Conditions
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Tibial Fractures

Intervention / Treatment
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* Procedure: Short leg cast
* Procedure: No Immobilization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Children ages 1-5 years old with radiographic evidence of a non-displaced spiral or oblique fracture of the tibial shaft or metaphysis. Exclusion Criteria: • Children with clinical suspicion but lack of radiographic evidence for toddler's fracture Fractures displaced >2mm Open fractures Pathologic fracture Fractures involving the physis Previous fracture of the ipsilateral extremity Concomitant fracture involving the ipsilateral or contralateral leg Concomitant head injury Non-ambulatory children (i.e., those who have not yet begun to walk) Children with bone-metabolism disorders (i.e., osteogenesis imperfect, rickets) Children who are geographically prohibited from following up in our system Children whose caregivers are not proficient in English Presentation >7 days from injury Cases considered to be non-accidental trauma

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Short Leg Cast<br>Patient will be placed in a short leg cast for approximately 3 weeks or until radiographic union | Procedure: Short leg cast<br> <br> |
| Experimental: No immobilization<br>No cast or splint will be applied to the injured extremity | Procedure: No Immobilization<br> <br> |
| Other: Observational<br>Patient will be treated based on the parents comfort. This arm will consist of individuals in which the parent/guardian did not agree to randomization, but did consent for observational follow-up regardless of treatment. | Procedure: Short leg cast<br> <br> Procedure: No Immobilization<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days to Ambulation | Recorded in parent journal, date of first ambulation without assistance. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture displacement | Displacement of the fracture greater than 2 mm in any direction. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toddler's fracture, tibial fracture, children