Treatment of Medial Humeral Epicondyle Fractures in Children With Absorbable Cartilage Nails

Study Overview
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Brief Summary
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To compare surgical outcomes from medial epicondyle fracture fixation with absorbable cartilage nails to those from traditional Kirschner wire fixation.

Detailed Description
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From August 2007 to January 2012, 32 patients undergoing surgery for medial humeral epicondyle fractures in our hospital were randomized into group A (traditional Kirschner wire) or group B (absorbable cartilage nail). The same surgical team performed the operations, and patients were followed for over a year. Group A had open reduction with K-wire fixation, and group B was fixed with absorbable cartilage nails. The Bede scoring system was used to evaluate elbow function at follow-up.

Official Title
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Treatment of Medial Humeral Epicondyle Fractures in Children With Absorbable Cartilage Nails

Conditions
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Fracture Arm

Intervention / Treatment
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* Procedure: absorbable cartilage nail
* Procedure: traditional Kirschner wires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fractures with more than 2 mm of displacement were treated with cast immobilization Exclusion Criteria: fractures with less than 2 mm of displacement were treated with cast immobilization

Ages Eligible for Study
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Minimum Age: 8 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: absorbable cartilage nail Group<br>10 males and 7 females, ages 7-15 years (average, 11.8), and 3 patients with elbow dislocation, the fractures were fixed by absorbable cartilage nail | Procedure: absorbable cartilage nail<br>* The experiment group patients were fixed with absorbable cartilage nails<br>|
| Active Comparator: traditional Kirschner wire Group<br>10 males and 5 females, ages 8-14 years (average, 12.6), and 4 patients with elbow dislocation, the fractures were fixed by traditional Kirschner wires | Procedure: traditional Kirschner wires<br>* The control group were fixed with traditional Kirschner wires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Pain Intensity assessed with the Bede Scoring System | on 12th month | 
| Elbow Motion | Elbow Motion assessed in degrees | on 12th month | 
| Stability | Stability assessed using the following scoring system: Stable, Moderate Instability, Grossly Unstable. | on 12th month | 
| Elbow Function evaluation | A specific physician check the patients and ask them to perform the following activity.(comb hair,eat;perform hygiene;don shirt;don shoe) | on 12th month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medial epicondyle humerus, absorbable cartilage nail