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

Fracture Arm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112447
• Other study ID #: CHChongqingMU2016
• Status: Completed
• Phase: N/A
• First received: March 6, 2017
• Last updated: April 12, 2017
• Start date: August 1, 2007
• Est. completion date: August 1, 2012

Study information

• Verified date: April 2017
• Source: Children's Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 1, 2012
• Est. primary completion date: August 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Fracture Arm
• Fractures, Bone

Intervention

Procedure:
• absorbable cartilage nail
The experiment group patients were fixed with absorbable cartilage nails
• traditional Kirschner wires
The control group were fixed with traditional Kirschner wires

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Chongqing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity	Pain Intensity assessed with the Bede Scoring System	on 12th month
Primary	Elbow Motion	Elbow Motion assessed in degrees	on 12th month
Primary	Stability	Stability assessed using the following scoring system: Stable, Moderate Instability, Grossly Unstable.	on 12th month
Primary	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