Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices

Chang Gung Medical Foundation

Status: Unknown

Conditions: Supracondylar Humerus Fracture

Treatments: Device: Novel K-wire fixation devices

Study type: Interventional

Funder types: Other

Identifiers

NCT04122781

NMRPD1J1171

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Open fracture
• Open reduction
• Neurovascular exploration

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

with novel K-wire fixation devices

Experimental group

Description:

Patients with supracondylar humeral fractures treated by percutaneous K-wire fixation and novel K-wire fixation devices

Treatment:

Device: Novel K-wire fixation devices

without novel K-wire fixation devices

Active Comparator group

Description:

Patients with supracondylar humeral fractures treated by percutaneous K-wire fixation

Treatment:

Device: Novel K-wire fixation devices