Pediatric Type III Supracondylar Humeral Fracture

Supracondylar Humerus Fracture Clinical Trial

— Fracture  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04780308
• Other study ID #: 2014/18/05
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: February 20, 2015

Study information

• Verified date: February 2021
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 20, 2015
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Pediatric Fractures
• Supracondylar Humerus Fracture

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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