NCT04780308

Brief Summary

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2015

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

4 years

First QC Date

February 7, 2021

Last Update Submit

February 28, 2021

Conditions

Supracondylar Humerus FracturePediatric Fractures

Keywords

pediatricsupracondylar humeral fracturek wiresclosed reductionpin configuration

Outcome Measures

Primary Outcomes (3)

  • Baumann Angle

    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

    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

    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

Study Arms (5)

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

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

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

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

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

Interventions

Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wiresPROCEDURE

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 1 lateral K-wire1 medial 2 lateral K-wire2 lateral K-wire2 medial 1 lateral K-wire3 lateral K-wire

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients under 16 years.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2021

First Posted

March 3, 2021

Study Start

January 1, 2010

Primary Completion

December 31, 2013

Study Completion

February 20, 2015

Last Updated

March 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share