search
Back to results

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
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Supracondylar Humerus Fracture

Eligibility Criteria

1 Year - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 5, 2020
    Last Updated
    October 5, 2020
    Sponsor
    Bakirkoy Dr. Sadi Konuk Research and Training Hospital
    search

    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

    We'll reach out to this number within 24 hrs