Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices
Primary Purpose
Supracondylar Humerus Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Novel K-wire fixation devices
Sponsored by
About this trial
This is an interventional treatment trial for Supracondylar Humerus Fracture focused on measuring supracondylar humerus fracture, Kirschner wire
Eligibility Criteria
Inclusion Criteria:
- Pediatric supracondylar humeral fracture
- Patients receiving closed reduction and percutaneous pinning
Exclusion Criteria:
- Open fracture
- Open reduction
- Neurovascular exploration
Sites / Locations
- Chang Gung Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
with novel K-wire fixation devices
without novel K-wire fixation devices
Arm Description
Patients with supracondylar humeral fractures treated by percutaneous K-wire fixation and novel K-wire fixation devices
Patients with supracondylar humeral fractures treated by percutaneous K-wire fixation
Outcomes
Primary Outcome Measures
Radiographs measurement
Baumann angle and the location of anterior humeral line on the radiographs
Elbow range of motion
Elbow flexion an extension angle
Pin sites condition
The pin sites were inspected and graded according to the system of Dahl. Grade 0 was normal skin, grade 1 was pain or erythema without discharge, grade 2 was serous discharge, grade 3 was purulent discharge, grade 4 was radiographic osteolysis and grade 5 was ring sequestrum or osteomyelitis.
Secondary Outcome Measures
Full Information
NCT ID
NCT04122781
First Posted
September 22, 2019
Last Updated
May 12, 2020
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04122781
Brief Title
Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices
Official Title
Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices: A Prospective Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial 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
A novel K-wire external fixation device was developed by the investigators. The K-wires can be connected by the device. After connection, the structure of the K-wires is transformed to an external skeletal fixator. Therefore, the K-wires are stabilized and unable to migrate independently. The stability of fracture fixation is better in patient with this K-wire external fixation device.
The purposes of this study are to optimize the K-wire external fixation device and test its function in real clinical practice.
Detailed Description
Supracondylar humeral fractures are the most common elbow fractures in children. Closed reduction and internal fixation using percutaneous Kirschner wires (K-wires) are widely recommended for Gartland type II and III fractures. After percutaneous pinning, the K-wires are bent at the skin edge and cut. The cutoff point is about 1 cm outside of the skin.
The diameters of the K-wires are between 1.5-3.0 mm. The surface of the K-wire is smooth. Therefore, the K-wires are easy to rotation and migration. Proximal migration or rotation of a K-wire could injure the skin. Distal migration of a K-wire could result in loss of reduction and fixation. Therefore, stabilization of the K-wires is important.
A novel K-wire external fixation device was developed by the investigators. The K-wires can be connected by the device. After connection, the structure of the K-wires is transformed to an external skeletal fixator. Therefore, the K-wires are stabilized and unable to migrate independently. The stability of fracture fixation is better in patient with this K-wire external fixation device.
The investigators got a one-year grant from the Ministry of Science and Technology in Taiwan last year. The preliminary data revealed that the torque and torsional stiffness with the K-wire external fixation device was greater than traditional pinning.
The purposes of this study are to optimize the K-wire external fixation device and test its function in real clinical practice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supracondylar Humerus Fracture
Keywords
supracondylar humerus fracture, Kirschner wire
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective Comparative Study
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
with novel K-wire fixation devices
Arm Type
Experimental
Arm Description
Patients with supracondylar humeral fractures treated by percutaneous K-wire fixation and novel K-wire fixation devices
Arm Title
without novel K-wire fixation devices
Arm Type
Active Comparator
Arm Description
Patients with supracondylar humeral fractures treated by percutaneous K-wire fixation
Intervention Type
Device
Intervention Name(s)
Novel K-wire fixation devices
Intervention Description
The patients received surgery using novel K-wire fixation devices
Primary Outcome Measure Information:
Title
Radiographs measurement
Description
Baumann angle and the location of anterior humeral line on the radiographs
Time Frame
through study completion, an average of 1 year
Title
Elbow range of motion
Description
Elbow flexion an extension angle
Time Frame
through study completion, an average of 1 year
Title
Pin sites condition
Description
The pin sites were inspected and graded according to the system of Dahl. Grade 0 was normal skin, grade 1 was pain or erythema without discharge, grade 2 was serous discharge, grade 3 was purulent discharge, grade 4 was radiographic osteolysis and grade 5 was ring sequestrum or osteomyelitis.
Time Frame
4 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pediatric supracondylar humeral fracture
Patients receiving closed reduction and percutaneous pinning
Exclusion Criteria:
Open fracture
Open reduction
Neurovascular exploration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsuan-Kai Kao
Phone
+88633281200
Ext
2423
Email
samiyadondon@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsuan-Kai Kao
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan city
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shui Tseng
Email
tsengshui@cgmh.org.tw
12. IPD Sharing Statement
Plan to Share IPD
No
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Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices
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