Clinical trial NCT04122781: Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices
Official title: Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices: A Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Supracondylar Humerus Fracture
Keywords: supracondylar humerus fracture
Kirschner wire
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 30
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective Comparative Study
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Pediatric supracondylar humeral fracture
* Patients receiving closed reduction and percutaneous pinning

Exclusion Criteria:

* Open fracture
* Open reduction
* Neurovascular exploration

Primary outcomes:
measure: Radiographs measurement
timeFrame: through study completion, an average of 1 year
measure: Elbow range of motion
timeFrame: through study completion, an average of 1 year
measure: Pin sites condition
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan city
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Hsuan-Kai Kao
role: PRINCIPAL_INVESTIGATOR
References: