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

Supracondylar Humerus Fracture Clinical Trial

Official title:

Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices: A Prospective Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04122781
• Other study ID #: NMRPD1J1171
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: September 2019
• Source: Chang Gung Memorial Hospital
• Contact: Hsuan-Kai Kao
• Phone: +88633281200
• Email: samiyadondon[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Years

Eligibility

Inclusion Criteria:

• Pediatric supracondylar humeral fracture

• Patients receiving closed reduction and percutaneous pinning

Exclusion Criteria:

• Open fracture

• Open reduction

• Neurovascular exploration

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Supracondylar Humerus Fracture

Intervention

Device:
• Novel K-wire fixation devices
The patients received surgery using novel K-wire fixation devices

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan city

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographs measurement	Baumann angle and the location of anterior humeral line on the radiographs	through study completion, an average of 1 year
Primary	Elbow range of motion	Elbow flexion an extension angle	through study completion, an average of 1 year
Primary	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.	4 weeks