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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with novel K-wire fixation devices | Experimental | Patients with supracondylar humeral fractures treated by percutaneous K-wire fixation and novel K-wire fixation devices |
|
| without novel K-wire fixation devices | Active Comparator | Patients with supracondylar humeral fractures treated by percutaneous K-wire fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel K-wire fixation devices | Device | The patients received surgery using novel K-wire fixation devices |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsuan-Kai Kao | Contact | +88633281200 | 2423 | samiyadondon@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hsuan-Kai Kao | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Recruiting | Taoyuan City | Taiwan |
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A prospective Comparative Study
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