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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
1 medial 1 lateral K-wire
Pediatric Gartland Type 3 supracondylar humeral fractures fixed by 1 medial 1 lateral K-wire
Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires
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
Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires
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
Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires
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
Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires
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
Procedure: Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014/18/05

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings