- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04780308
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
Completed
Intervention / Treatment
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
Additional Relevant MeSH Terms
Other Study ID 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.
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