Comparison of Cross Pin Configurations in Supracondylar Humerus Fracture Treatment: 2 Pins Versus 3 Pins
Primary Purpose
Supracondylar Humerus Fracture
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
crossed pin configuration
Sponsored by
About this trial
This is an interventional treatment trial for Supracondylar Humerus Fracture
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
comparison of two cross pin fixation methods
Arm Description
Fixation of supracondylar humerus fractures with 2 crossed pins and 3 crossed pins are compared in terms of Flynn's criteria
Outcomes
Primary Outcome Measures
functional outcome of two fixation techniques
comparison of Flynn's criteria
Secondary Outcome Measures
Full Information
NCT ID
NCT04582123
First Posted
October 5, 2020
Last Updated
October 5, 2020
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04582123
Brief Title
Comparison of Cross Pin Configurations in Supracondylar Humerus Fracture Treatment: 2 Pins Versus 3 Pins
Official Title
The Comparison of Cross Pin Configurations in the Treatment of Gartland Type III Supracondylar Humerus Fractures: 2 Pins Versus 3 Pins
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2015 (Actual)
Primary Completion Date
January 24, 2020 (Actual)
Study Completion Date
January 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supracondylar Humerus Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
comparison of two cross pin fixation methods
Arm Type
Other
Arm Description
Fixation of supracondylar humerus fractures with 2 crossed pins and 3 crossed pins are compared in terms of Flynn's criteria
Intervention Type
Procedure
Intervention Name(s)
crossed pin configuration
Intervention Description
comparison of two crossed pin fixation methods
Primary Outcome Measure Information:
Title
functional outcome of two fixation techniques
Description
comparison of Flynn's criteria
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Comparison of Cross Pin Configurations in Supracondylar Humerus Fracture Treatment: 2 Pins Versus 3 Pins
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