Study of Tibial Shaft Fractures in Children

Study Overview
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Brief Summary
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Tibial shaft fracture is one of the most common fractures in children and adolescents. It encompasses approximately 15 % of all long-bone fractures and is third behind only fractures of the femur and both bones of the forearm. (2). Although most authorities agree that closed tibial shaft fractures are best treated by immobilization in a long-leg cast, there is no clear consensus as to when to allow weight bearing on the injured extremity. While most recent articles have recommended long-leg casts with the knee bent in flexion of 30-60 degrees to preclude weight-bearing(1,2,3,4), other authors have recommended much less flexion, 0-5 degrees, to encourage early weight bearing.(5). The purpose of this randomized controlled prospective study is to determine if the position of immobilization of the knee influences the rate of healing, delayed union, and nonunion As well, we will assess if the type of immobilization affects the function of the patient during the period of treatment using the Activities Scale for Kids - Performance (ASK-P) child self-report musculoskeletal outcome measure . A minimum of 36 patients in each group for a total of 72 patients between 4 and 14 years of age (open physis) with closed fractures of the tibia, with or without fracture of the fibula, will be included in the study

Official Title
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Early Weight-Bearing in the Closed Treatment of Tibial Shaft Fractures in Children

Conditions
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Tibial Shaft Fractures in Children

Intervention / Treatment
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* Procedure: Long leg cast in full extension
* Procedure: Long leg cast with 45 degrees of flexion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 4 and 14 years of age (open physis) Patients seen at the Los Angeles Orthopaedic Medical center within 7 days of the original injury All closed tibia and tibia and fibula shaft fractures regardless of fracture pattern Exclusion Criteria: Fractures with greater than 2 cm of initial shortening Open fractures Patients that have other orthopaedic medical issues such as hemophilia

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 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 |
| --- | --- |
| Experimental: Long leg cast in full extension<br>Long leg cast in full extension with instructions to begin immediate weight bearing as tolerated on the injured extremity | Procedure: Long leg cast in full extension<br>* Long leg cast in full extension with instructions to begin immediate weight bearing as tolerated on the injured extremity<br>|
| Experimental: Long leg cast with 45 degrees of flexion<br>Long leg cast with 45 degrees of flexion at the knee with instructions not to bear weight on the injured extremity | Procedure: Long leg cast with 45 degrees of flexion<br>* Long leg cast with 45 degrees of flexion at the knee with instructions not to bear weight on the injured extremity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Activities Scale for Kids - Performance (ASK-P) | The Activities Scale for Kids (ASK) is a 30 item child self-report musculoskeletal outcome measure that focuses on the child's physical disability, and is scored with a summary score with no sub-scales. The performance format ASK-P will be used in this study. The scoring system is from 0-100 with 100 being the best possible score. | May 2007 - May 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Healing | Radiographic union will be defined as the presence of callus bridging of 3 out of 4 cortices as seen on anterior posterior and lateral radiographs. | May 2007 - May 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tibia, shaft, fracture, children