Supracondylar Humerus Fracture
Conditions
Keywords
supracondylar humerus fracture, Kirschner wire
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.
Interventions
DEVICENovel K-wire fixation devices
The patients received surgery using novel K-wire fixation devices
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A prospective Comparative Study
Eligibility
Sex/Gender
ALL
Age
No minimum to 20 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric supracondylar humeral fracture * Patients receiving closed reduction and percutaneous pinning
Exclusion criteria
* Open fracture * Open reduction * Neurovascular exploration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographs measurement | through study completion, an average of 1 year | Baumann angle and the location of anterior humeral line on the radiographs |
| Elbow range of motion | through study completion, an average of 1 year | Elbow flexion an extension angle |
| Pin sites condition | 4 weeks | 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. |
Countries
Taiwan
Contacts
Primary ContactHsuan-Kai Kao
Outcome results
None listed