Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2019
CompletedFirst Submitted
Initial submission to the registry
September 22, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedMay 13, 2020
September 1, 2019
1.3 years
September 22, 2019
May 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Radiographs measurement
Baumann angle and the location of anterior humeral line on the radiographs
through study completion, an average of 1 year
Elbow range of motion
Elbow flexion an extension angle
through study completion, an average of 1 year
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.
4 weeks
Study Arms (2)
with novel K-wire fixation devices
EXPERIMENTALPatients with supracondylar humeral fractures treated by percutaneous K-wire fixation and novel K-wire fixation devices
without novel K-wire fixation devices
ACTIVE COMPARATORPatients with supracondylar humeral fractures treated by percutaneous K-wire fixation
Interventions
The patients received surgery using novel K-wire fixation devices
Eligibility Criteria
You may qualify if:
- Pediatric supracondylar humeral fracture
- Patients receiving closed reduction and percutaneous pinning
You may not qualify if:
- Open fracture
- Open reduction
- Neurovascular exploration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Taoyuan, Taiwan
Study Officials
- PRINCIPAL INVESTIGATOR
Hsuan-Kai Kao
Chang Gung Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2019
First Posted
October 10, 2019
Study Start
April 15, 2019
Primary Completion
July 31, 2020
Study Completion
July 31, 2020
Last Updated
May 13, 2020
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share