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Clinical Trials/NCT03112447
NCT03112447
Completed
Not Applicable

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

Children's Hospital of Chongqing Medical University0 sites32 target enrollmentStarted: August 1, 2007Last updated:
ConditionsFracture Arm

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Children's Hospital of Chongqing Medical University
Enrollment
32
Primary Endpoint
Elbow Motion

Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
8 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Elbow Motion

Time Frame: on 12th month

Elbow Motion assessed in degrees

Stability

Time Frame: on 12th month

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

Pain Intensity

Time Frame: on 12th month

Pain Intensity assessed with the Bede Scoring System

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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Children's Hospital of Chongqing Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Guoxin Nan

Vice President of Department orthopeadic department

Children's Hospital of Chongqing Medical University

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