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OpenTrials
Completed

NCT Number: NCT03112447

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

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

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Key information

Conditions

Fracture Arm

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

absorbable cartilage nail

Procedure

The experiment group patients were fixed with absorbable cartilage nails

traditional Kirschner wires

Procedure

The control group were fixed with traditional Kirschner wires

Primary outcomes

  1. Pain Intensity

    Time frame: on 12th month

    Pain Intensity assessed with the Bede Scoring System

  2. Elbow Motion

    Time frame: on 12th month

    Elbow Motion assessed in degrees

  3. Stability

    Time frame: on 12th month

    Stability assessed using the following scoring system: Stable, Moderate Instability, Grossly Unstable.

  4. Elbow Function evaluation

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Children's Hospital of Chongqing Medical University

Other

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Apr 13, 2017
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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