Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices
- Conditions
- Supracondylar Humerus Fracture
- Interventions
- Device: Novel K-wire fixation devices
- Registration Number
- NCT04122781
- Lead Sponsor
- Chang Gung Memorial Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Pediatric supracondylar humeral fracture
- Patients receiving closed reduction and percutaneous pinning
- Open fracture
- Open reduction
- Neurovascular exploration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description with novel K-wire fixation devices Novel K-wire fixation devices Patients with supracondylar humeral fractures treated by percutaneous K-wire fixation and novel K-wire fixation devices without novel K-wire fixation devices Novel K-wire fixation devices Patients with supracondylar humeral fractures treated by percutaneous K-wire fixation
- Primary Outcome Measures
Name Time Method 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.
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chang Gung Memorial Hospital
🇨🇳Taoyuan city, Taiwan