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Treatment of Medial Humeral Epicondyle Fractures in Children With Absorbable Cartilage Nails

Primary Purpose

Fracture Arm

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
absorbable cartilage nail
traditional Kirschner wires
Sponsored by
Children's Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture Arm focused on measuring medial epicondyle humerus, absorbable cartilage nail

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • fractures with more than 2 mm of displacement were treated with cast immobilization

Exclusion Criteria:

  • fractures with less than 2 mm of displacement were treated with cast immobilization

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    absorbable cartilage nail Group

    traditional Kirschner wire Group

    Arm Description

    10 males and 7 females, ages 7-15 years (average, 11.8), and 3 patients with elbow dislocation, the fractures were fixed by absorbable cartilage nail

    10 males and 5 females, ages 8-14 years (average, 12.6), and 4 patients with elbow dislocation, the fractures were fixed by traditional Kirschner wires

    Outcomes

    Primary Outcome Measures

    Pain Intensity
    Pain Intensity assessed with the Bede Scoring System
    Elbow Motion
    Elbow Motion assessed in degrees
    Stability
    Stability assessed using the following scoring system: Stable, Moderate Instability, Grossly Unstable.
    Elbow Function evaluation
    A specific physician check the patients and ask them to perform the following activity.(comb hair,eat;perform hygiene;don shirt;don shoe)

    Secondary Outcome Measures

    Full Information

    First Posted
    March 6, 2017
    Last Updated
    April 12, 2017
    Sponsor
    Children's Hospital of Chongqing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03112447
    Brief Title
    Treatment of Medial Humeral Epicondyle Fractures in Children With Absorbable Cartilage Nails
    Official Title
    Treatment of Medial Humeral Epicondyle Fractures in Children With Absorbable Cartilage Nails
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2007 (Actual)
    Primary Completion Date
    August 1, 2012 (Actual)
    Study Completion Date
    August 1, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Children's Hospital of Chongqing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To compare surgical outcomes from medial epicondyle fracture fixation with absorbable cartilage nails to those from traditional Kirschner wire fixation.
    Detailed Description
    From August 2007 to January 2012, 32 patients undergoing surgery for medial humeral epicondyle fractures in our hospital were randomized into group A (traditional Kirschner wire) or group B (absorbable cartilage nail). The same surgical team performed the operations, and patients were followed for over a year. Group A had open reduction with K-wire fixation, and group B was fixed with absorbable cartilage nails. The Bede scoring system was used to evaluate elbow function at follow-up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fracture Arm
    Keywords
    medial epicondyle humerus, absorbable cartilage nail

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    absorbable cartilage nail Group
    Arm Type
    Experimental
    Arm Description
    10 males and 7 females, ages 7-15 years (average, 11.8), and 3 patients with elbow dislocation, the fractures were fixed by absorbable cartilage nail
    Arm Title
    traditional Kirschner wire Group
    Arm Type
    Active Comparator
    Arm Description
    10 males and 5 females, ages 8-14 years (average, 12.6), and 4 patients with elbow dislocation, the fractures were fixed by traditional Kirschner wires
    Intervention Type
    Procedure
    Intervention Name(s)
    absorbable cartilage nail
    Intervention Description
    The experiment group patients were fixed with absorbable cartilage nails
    Intervention Type
    Procedure
    Intervention Name(s)
    traditional Kirschner wires
    Intervention Description
    The control group were fixed with traditional Kirschner wires
    Primary Outcome Measure Information:
    Title
    Pain Intensity
    Description
    Pain Intensity assessed with the Bede Scoring System
    Time Frame
    on 12th month
    Title
    Elbow Motion
    Description
    Elbow Motion assessed in degrees
    Time Frame
    on 12th month
    Title
    Stability
    Description
    Stability assessed using the following scoring system: Stable, Moderate Instability, Grossly Unstable.
    Time Frame
    on 12th month
    Title
    Elbow Function evaluation
    Description
    A specific physician check the patients and ask them to perform the following activity.(comb hair,eat;perform hygiene;don shirt;don shoe)
    Time Frame
    on 12th month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: fractures with more than 2 mm of displacement were treated with cast immobilization Exclusion Criteria: fractures with less than 2 mm of displacement were treated with cast immobilization

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Treatment of Medial Humeral Epicondyle Fractures in Children With Absorbable Cartilage Nails

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