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

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

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.

Study Overview

• Status: Completed
• Conditions: Supracondylar Humerus Fracture
• Intervention / Treatment: Procedure: crossed pin configuration

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: comparison of two cross pin fixation methods; Fixation of supracondylar humerus fractures with 2 crossed pins and 3 crossed pins are compared in terms of Flynn's criteria	Procedure: crossed pin configuration; comparison of two crossed pin fixation methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional outcome of two fixation techniques	comparison of Flynn's criteria	5 years

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2015
• Primary Completion (Actual): January 24, 2020
• Study Completion (Actual): January 24, 2020

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: 2014/250

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No