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.

Study Overview

• Status: Completed
• Conditions: Fracture Arm
• Intervention / Treatment: Procedure: absorbable cartilage nail; Procedure: traditional Kirschner wires

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: absorbable cartilage nail Group; 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; The experiment group patients were fixed with absorbable cartilage nails
Active Comparator: traditional Kirschner wire Group; 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; The control group were fixed with traditional Kirschner wires

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2007
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: medial epicondyle humerus; absorbable cartilage nail
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: CHChongqingMU2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No