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Clinical Trials in China / NCT04640727
Enrolling by invitation Observational

ORIF Versus CRIF of Completely Displaced and Rotated Lateral Condylar Fractures of the Humerus in Children

NCT04640727 · tracked via the Priya Life Science China tracker
Sponsor
Guangzhou Women and Children's Medical Center
Phase
Observational
Started
2020-12-01
Last updated
2022-01-20

Condition(s) studied

Humeral Fractures

Investigational drug(s) / intervention(s)

open reductionclosed reduction

open reduction: A sterile tourniquet is applied and an oblique posterolateral skin incision is made. Superficial dissection is carried out in the plane of the fracture hematoma until the distal lateral corner of the proximal fragment is identified. Once the metaphyseal side of the fracture has been identified, the dissection is carried across the joint to expose the medial articular surface. After exposure of the proximal fragment, the orientation of the distal fragment is defined and the soft tissues are sharply released off the anterior aspect of the distal fragment, with extension carried distally to the radial head. After irrigation and débridement of the fracture hematoma, the distal fragment is reduced with a towel clip. It is important to judge the reduction at the level of the articular surface rather than the metaphysis because plastic deformation or comminution of the metaphyseal fragment may be present. Pins (usually 0.062 inch) are placed percutaneously to secure the fracture.

closed reduction: we applied a gentle varus force to the elbow while the patient was under general anesthesia, and we attempted to reposition the rotated fragment by directly pushing or by using Kirschner wires as joysticks . After repositioning, we applied gradual direct compression to the distal fracture fragment anteromedially.We then applied slight valgus force to the elbow with the forearm supinated and the elbow fully extended to maintain the reduction. After the fracture reduction was confifirmed to be within 2 mm, especially as seen on the anteroposterior, lateral radiographs,and internal obliquewe used smooth Kirschner wires to perform percutaneous pinning

Study summary

Open reduction and internal fixation has been widely used in treating completely displaced and rotated lateral condylar fracture in children and it usually produces good results. Only a few studies reported Closed reduction and internal fixation is an effective treatment for completely displaced and rotated lateral condyle fractures of the humerus, but evidence on its effectiveness and safety is scarce. The aim of the trial was to compare functional and outcome use in patients treated completely displaced and rotated lateral condylar fracture with ORIF versus CRIF.

Eligibility

Sex
ALL
Min age
1 Year
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * completely displaced and rotated lateral condyle fractures of the humerus (Jakob Stage 3) Exclusion Criteria: \- presented more than 7 days after the fracture , Capitulum humerus cannot be clearly identified on X-ray, had experienced a previous lateral condyle fractures on the same limbs, pathological fracture, open fracture, Combined with other fractures at the same time,

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Guangzhou Women & Children Medical Center Guangzhou Guangdong

More Guangzhou Women and Children's Medical Center trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04640727 on ClinicalTrials.gov ↗ ← All trials in China