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

NCT ID: NCT03112447

Last Updated: 2017-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-01

Study Completion Date

2012-08-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Fracture Arm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

absorbable cartilage nail

Intervention Type PROCEDURE

The experiment group patients were fixed with absorbable cartilage nails

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

Group Type ACTIVE_COMPARATOR

traditional Kirschner wires

Intervention Type PROCEDURE

The control group were fixed with traditional Kirschner wires

Interventions

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absorbable cartilage nail

The experiment group patients were fixed with absorbable cartilage nails

Intervention Type PROCEDURE

traditional Kirschner wires

The control group were fixed with traditional Kirschner wires

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Guoxin Nan

Vice President of Department orthopeadic department

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CHChongqingMU2016

Identifier Type: -

Identifier Source: org_study_id

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