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

Not Applicable

Completed

• Conditions: Fracture Arm
• Interventions: Procedure: traditional Kirschner wires; Procedure: absorbable cartilage nail

• Registration Number: NCT03112447
• Lead Sponsor: Children's Hospital of Chongqing Medical University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2007-08-01
• Primary Completion: 2012-08-01
• Study Completion: 2012-08-01
• Study First Submitted: 2017-03-06
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-12
• Last Update Submitted: 2017-04-12
• Study First Posted: 2017-04-13
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
traditional Kirschner wire Group	traditional Kirschner wires	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
absorbable cartilage nail Group	absorbable cartilage nail	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

Primary Outcome Measures

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