Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices: A Prospective Comparative Study

Conditions
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Supracondylar Humerus Fracture

Intervention / Treatment
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* Device: Novel K-wire fixation devices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric supracondylar humeral fracture Patients receiving closed reduction and percutaneous pinning Exclusion Criteria: Open fracture Open reduction Neurovascular exploration

Ages Eligible for Study
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Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective Comparative Study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with novel K-wire fixation devices<br>Patients with supracondylar humeral fractures treated by percutaneous K-wire fixation and novel K-wire fixation devices | Device: Novel K-wire fixation devices<br>* The patients received surgery using novel K-wire fixation devices<br>|
| Active Comparator: without novel K-wire fixation devices<br>Patients with supracondylar humeral fractures treated by percutaneous K-wire fixation | Device: Novel K-wire fixation devices<br>* The patients received surgery using novel K-wire fixation devices<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supracondylar humerus fracture, Kirschner wire