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Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices: A Prospective Comparative Study
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.
Age
0 - 20 years
Sex
ALL
Healthy Volunteers
No
Chang Gung Memorial Hospital
Taoyuan, Taiwan
Start Date
April 15, 2019
Primary Completion Date
July 31, 2020
Completion Date
July 31, 2020
Last Updated
May 13, 2020
30
ESTIMATED participants
Novel K-wire fixation devices
DEVICE
Lead Sponsor
Chang Gung Memorial Hospital
NCT03759028
NCT06187584
NCT05780398
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