Pediatric Type III Supracondylar Humeral Fracture (Fracture)

February 28, 2021 updated by: Alkan Bayrak, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

How Many K Wires do we Need in the Surgical Treatment of Pediatric Type III Supracondylar Humeral Fracture?

The purpose of this study was to compare pin configuration effects on early secondary displacement in the surgical treatment of pediatric supracondylar humeral fractures (SCHF).

Study Overview

Detailed Description

The study consisted of 100 (68M, 32F) children who underwent surgery between 2010 and 2013 for Gartland Type 3 (SCHF). The patients divided into five groups according to the top in configurations (crossed 1 lateral 1 medial, crossed 2 lateral 1 medial, crossed 1 lateral 2 medial, 2 lateral divergent, and 3 lateral divergent). The average age at the time of injury was 7.34 (between 2 and 14 years). Bauman angle (BA), Humerocapital angle (HCA), Anterior humeral line (AHL), flexion range, extension range, and Carrying angle (CA) were compared at preoperative, postoperative 1st-day, postoperative last control, and non-operated side. The mean follow-up time 24,96±11,06 with a range of 12-54 months.

Study Type

Observational

Enrollment (Actual)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients under 16 years.

Description

Inclusion Criteria

  • Pediatric Gartland Type 3 supracondylar humeral fracture
  • Patients operated between 2010-2013
  • Patients under 16 years old

Exclusion Criteria:

  • Pathological fractures
  • Conservative treated supracondylar fractures
  • Less than the 1-year follow-up
  • Patients with incomplete postoperative follow-up
  • Patients older than 16 years
  • Pediatric Gartland Type 1 and 2 supracondylar humeral fracture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1 medial 1 lateral K-wire
Pediatric Gartland Type 3 supracondylar humeral fractures fixed by 1 medial 1 lateral K-wire
The effects of the different types of K-wire configuration on Pediatric Gartland Type 3 supracondylar humeral fractures were evaluated. Pediatric Gartland Type 3 supracondylar humeral fractures operated under general anesthesia with open or closed reduction. After reduction checked by fluoroscopy K-wires applied in different configurations.
1 medial 2 lateral K-wire
Pediatric Gartland Type 3 supracondylar humeral fractures fixed by 1 medial 2 lateral K-wire
The effects of the different types of K-wire configuration on Pediatric Gartland Type 3 supracondylar humeral fractures were evaluated. Pediatric Gartland Type 3 supracondylar humeral fractures operated under general anesthesia with open or closed reduction. After reduction checked by fluoroscopy K-wires applied in different configurations.
2 medial 1 lateral K-wire
Pediatric Gartland Type 3 supracondylar humeral fractures fixed by 2 medial 1 lateral K-wire
The effects of the different types of K-wire configuration on Pediatric Gartland Type 3 supracondylar humeral fractures were evaluated. Pediatric Gartland Type 3 supracondylar humeral fractures operated under general anesthesia with open or closed reduction. After reduction checked by fluoroscopy K-wires applied in different configurations.
2 lateral K-wire
Pediatric Gartland Type 3 supracondylar humeral fractures fixed by 2 lateral K-wire
The effects of the different types of K-wire configuration on Pediatric Gartland Type 3 supracondylar humeral fractures were evaluated. Pediatric Gartland Type 3 supracondylar humeral fractures operated under general anesthesia with open or closed reduction. After reduction checked by fluoroscopy K-wires applied in different configurations.
3 lateral K-wire
Pediatric Gartland Type 3 supracondylar humeral fractures fixed by 3 lateral K-wire
The effects of the different types of K-wire configuration on Pediatric Gartland Type 3 supracondylar humeral fractures were evaluated. Pediatric Gartland Type 3 supracondylar humeral fractures operated under general anesthesia with open or closed reduction. After reduction checked by fluoroscopy K-wires applied in different configurations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baumann Angle
Time Frame: postoperative 1. day, 1. month and 12. month
This angle is formed by the humeral axis and a straight line through the epiphyseal plate of the capitellum. Preoperative and postoperative angle differences are measured in anteroposterior and lateral X rays. These differences are measured for reduction quality and these parameters shows the success of the surgery.
postoperative 1. day, 1. month and 12. month
Anterior Humeral Line
Time Frame: postoperative 1. day, 1. month and 12. month
A line drawn down the anterior surface of the humerus should intersect the middle third of the capitellum. Preoperative and postoperative angle differences are measured in anteroposterior and lateral X rays. These differences are measured for reduction quality and these parameters shows the success of the surgery.
postoperative 1. day, 1. month and 12. month
Humero-Capital Angle
Time Frame: postoperative 1. day, 1. month and 12. month
On lateral X-ray angle between capitellum and humeral shaft. Preoperative and postoperative angle differences are measured in anteroposterior and lateral X rays. These differences are measured for reduction quality and these parameters shows the success of the surgery.
postoperative 1. day, 1. month and 12. month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

December 31, 2013

Study Completion (Actual)

February 20, 2015

Study Registration Dates

First Submitted

February 7, 2021

First Submitted That Met QC Criteria

February 28, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

February 28, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Supracondylar Humerus Fracture

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