An interventional study of Novel K-wire fixation devices in Supracondylar Humerus Fracture, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged Up to 20 Years. Per ClinicalTrials.gov, last updated 2020-05-13.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 30 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with supracondylar humeral fractures treated by percutaneous K-wire fixation and novel K-wire fixation devices
Device: Novel K-wire fixation devices
Patients with supracondylar humeral fractures treated by percutaneous K-wire fixation
Device: Novel K-wire fixation devices
The patients received surgery using novel K-wire fixation devices
Radiographs measurement
Baumann angle and the location of anterior humeral line on the radiographs
Time frame: through study completion, an average of 1 year
Elbow range of motion
Elbow flexion an extension angle
Time frame: 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.
Time frame: 4 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital