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Clinical Trials/NCT04122781
NCT04122781
Unknown
Not Applicable

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

Chang Gung Memorial Hospital1 site in 1 country30 target enrollmentApril 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Supracondylar Humerus Fracture
Sponsor
Chang Gung Memorial Hospital
Enrollment
30
Locations
1
Primary Endpoint
Pin sites condition
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2019
End Date
July 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Open fracture
  • Open reduction
  • Neurovascular exploration

Outcomes

Primary Outcomes

Pin sites condition

Time Frame: 4 weeks

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.

Radiographs measurement

Time Frame: through study completion, an average of 1 year

Baumann angle and the location of anterior humeral line on the radiographs

Elbow range of motion

Time Frame: through study completion, an average of 1 year

Elbow flexion an extension angle

Study Sites (1)

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