Brace Versus Casting in Pediatric Radial Head Fractures

Study Overview
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Brief Summary
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Commare the pain and function of Brace Versus Casting in Pediatric Radial Head Fractures after 1 month

Detailed Description
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Radial Head Fractures are common injury in children. In this study, healthy children with Mason type I or II radial head fractures are planned to be included. Outcome Measures: The primary outcome measure will be an assessment of functional daily activities as measured by the MAYO score at four weeks post injury. Secondary outcomes will include an assessment of pain scores using VAS. Sample Size and Analysis: Assuming a standard deviation of 10%, alpha = 0.05, beta = 0.2 and 10% dropout rate yields a sample size of 150 patients. Secondary analyses will include Fisher's Exact test to compare proportions of children with full range of motion of the injured ankle at four weeks and with full baseline activity level at four months, and the area under the curve of a pain-time profile curve will be compared using a Student's t-test.

Official Title
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Brace Versus Casting in Pediatric Radial Head Fractures

Conditions
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Radial Fracture

Intervention / Treatment
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* Device: elbow cast
* Device: Removable elbow brace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 5 to 18 years of age with one of the following fracture Undisplaced Maoson types I and II fractures of the radial head Exclusion Criteria: The diagnosis of elbow sprain or contusion; they occur primarily in adolescents with closed epiphyseal plates. All open fractures which require surgical debridement. All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease. Congenital anomalies of the elbow. Patients with coagulopathies. Multisystem trauma and multiple fractures of the same or opposite limb. Patients cognitively and developmentally delayed with inability to express pain and/or difficult assessment of baseline activity level. Injuries greater than 72 hours old. Past history of surgery or closed reduction of the same elbow within the last 6 months or ankle trauma of the same ankle within 3 months.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Elbow cast<br>Device: Elbow cast | Device: elbow cast<br>* elbow cast<br>|
| Experimental: Removable elbow brace<br>Device: Removable elbow brace | Device: Removable elbow brace<br>* Removable elbow brace<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mayo score | Functional outcome as measured by the Mayo score at 4 weeks from the time of the initial injury | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | VAS score | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, elbow fractures, management