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
About this trial
This is an interventional treatment trial for Fracture Arm focused on measuring medial epicondyle humerus, absorbable cartilage nail
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
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
NCT ID
NCT03112447
First Posted
March 6, 2017
Last Updated
April 12, 2017
Sponsor
Children's Hospital of Chongqing Medical University
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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