Spica Casting in Pediatric Femur Fractures: Study of Single Leg Versus Double Leg Spica Casts

Study Overview
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Brief Summary
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Prospective randomized controlled trial comparing use of single leg spica with double leg spica casts in the treatment of pediatric femur fractures in children ages 2 through 6 years old.

Detailed Description
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Introduction double-leg spica casting is the treatment of choice at many centers for the treatment of diaphyseal femur fractures in children 2 to 6 years old. Investigators hypothesize that these patients can be effectively treated with single-leg spica casting and that such treatment will result in easier care and better patient function during treatment. Methods Prospective randomized controlled study of patients between 2 and 6 years old with diaphyseal femur fractures patients randomly assigned to either immediate single or double-leg spica casting groups after consent was obtained Radiographs serially evaluated for maintenance of reduction with respect to length, varus/valgus angulation and procurvatum/recurvatum angulation After casts removal, the Activity Scale for Kids (Performance Version) questionnaire and a custom written survey were given to parents evaluating ease of care and function of children during treatment.

Official Title
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Spica Casting in Pediatric Femur Fractures: A Prospective Randomized Controlled Study of Single Leg vs Double Leg Spica Casts

Conditions
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Femur Fracture

Intervention / Treatment
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* Other: Spica casting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diaphyseal femur fracture age between 2 and 6 years old Exclusion Criteria: underlying bone disorder neuromuscular disease

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double leg spica cast<br>The current accepted treatment is the double leg spica cast in the treatment of pediatric diaphyseal femur fractures. | Other: Spica casting<br>* single versus double leg spica casting<br>|
| Experimental: Single leg spica casts<br>The study group is the single leg spica cast group | Other: Spica casting<br>* single versus double leg spica casting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptable fracture healing | evaluation of shortening, angulation, and rotation radiographically at time of fracture healing | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, femur, femoral, fracture, spica, cast, diaphyseal, single, double, patient age 2 to 6 years old