Titanium Elastic Nailing Versus Hip Spica Cast in Treatment of Femoral Fractures in Children

Study Overview
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Brief Summary
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The purpose of this study is to determine which method is better for treatment of femoral fracture in children in outcomes.

Detailed Description
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There is no consensus on treatment of closed femoral shaft fractures in children 6-12years old. We aimed to compare hip spica cast with titanium elastic nailing (TEN) in the treatment of femoral shaft fractures in children.

Official Title
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Study of Surgical Method Versus Casting for Treatment of Femoral Fracture in Children

Conditions
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Femoral Shaft Fracture

Intervention / Treatment
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* Procedure: titanium elastic nailing
* Device: Hip spica casting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients 6-12 years old with femoral shaft fracture without exclusion criteria Exclusion Criteria: Segmental, Winquist type III and IV comminuted fractures, previously diagnosed neuromuscular disease (e.g., cerebral palsy), metabolic bone disorders (e.g. osteomalacia), or pathological fractures.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: hip spica casting<br>Patients in the spica cast group treated with skeletal traction and spica cast applied for them | Device: Hip spica casting<br>* we applied cast for three weeks in patients with femoral shaft fracture<br>* Other names: TEN;|
| Other: titanium elasting nailing<br>For patients in the Titanium Elasting Nailing group, the nail applied retrogradely in femoral shaft fracture | Procedure: titanium elastic nailing<br>* we inserted titanium nail in femoral fractures retrogradely<br>* Other names: TEN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | identification of Length of hospital stay (days)for patients who treated with titanium elastic nailing or casting | at 1 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time to walking with aids | identification of the time to walking with aids in patients who treated with titanium elastic nailing or casting | at 1 months post-operatively | 
| parent's satisfaction | identification of parent's satisfaction with questionnair in patients who treated with titanium elastic nailing or casting | at 1 months post-operatively | 
| the time absent from school | identification of the time absent from school in patients who treated with titanium elasting nailing or casting | at 1 months post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spica Cast, TEN, Femoral Shaft Fracture, Children