Comparison of Cross Pin Configurations in Supracondylar Humerus Fracture Treatment: 2 Pins Versus 3 Pins

Supracondylar Humerus Fracture Clinical Trial

Official title:

The Comparison of Cross Pin Configurations in the Treatment of Gartland Type III Supracondylar Humerus Fractures: 2 Pins Versus 3 Pins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582123
• Other study ID #: 2014/250
• Status: Completed
• Phase: N/A
• Start date: January 15, 2015
• Est. completion date: January 24, 2020

Study information

• Verified date: October 2020
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this prospective randomized controlled trial is to evaluate and compare the outcome of the 2wire vs 3 wire crossed pin configurations in the management of supracondylar humeral fractures in children.

Description:

Fortyfive children with supracondylar humeral fractures were randomly divided into two groups. One group was treated with 2 crossed pins and the other group with 3 crossed pins. The mean age was 6.04±2.49 (1-12).. The follow-up period was 5 years, with no patients lost to follow up.

Intervention: Twentytwo patients were managed by 2 crossed and 23 by 3 crossed pin method. All surgeries were performed by the same surgeon.

Main Outcome Measurements: Postoperative stability, ulnar nerve injury, range of motions, and pin tract infections were evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 24, 2020
• Est. primary completion date: January 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

Inclusion Criteria:

• The inclusion criteria was children with closed extension Type III of supracondylar fracture of humerus.

Exclusion Criteria:

• Patients with Type I and Type II injuries, flexion type injuries, open fractures and patients above the age of 12 years were excluded from the study.

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Supracondylar Humerus Fracture

Intervention

Procedure:
• crossed pin configuration
comparison of two crossed pin fixation methods

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	functional outcome of two fixation techniques	comparison of Flynn's criteria	5 years