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

NCT04640727 | Enrolling By Invitation

• 1 other identifier: GuangzhouWCMC-004
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Humeral Fractures

Keywords

Open reduction and internal fixation; Closed reduction and internal fixation; completely displaced and rotated lateral condylar fracture

Outcome Measures

Primary Outcomes (1)

• Hardacre criteria

  Excellent：No limitation of Range of Motion， No alteration of Carrying Angle，No symptoms Good： Functional range of motion (lacking no more 15" of complete extension)，Inconspicuous alteration of Carrying Angle，No arthritic and neurologic symptoms Poor：Disabling loss of function， Conspicuous alteration of Carrying Angle，have Arthritic symptom, ulnar neuritis, roentgen findings of nonunion, avascular necrosis

  1 years follow up

Secondary Outcomes (4)

• duration of operation

  during the operation

• amount of bleeding

  during the operation

• Radiation exposure

  during the operation

• The interepicondylar width (IEW)

  3 months after the surgery

Study Arms (2)

open reduction and internal fixation

open reduction and internal fixation used in treating completely displaced and rotated lateral condylar fracture in children

Procedure: open reduction

closed reduction and internal fixation

closed reduction and internal fixation used in treating completely displaced and rotated lateral condylar fracture in children

Procedure: closed reduction

Interventions

open reduction PROCEDURE

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.

open reduction and internal fixation

closed reduction PROCEDURE

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

closed reduction and internal fixation

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

After Internal Review Board approval, all Type III lateral condyle fractures according to Jakob classification were reviewed at our institution from 2017 to 2021

You may qualify if:

• completely displaced and rotated lateral condyle fractures of the humerus (Jakob Stage 3)

You may not qualify if:

• \- 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，

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead

Study Sites (1)

Guangzhou Women & Children Medical Center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Humeral Fractures

Interventions

Open Fracture Reduction; Closed Fracture Reduction

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Hongwen Xu, doctor

  Guangzhou Women & Children Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guangzhou Women and Children's Medical Center

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 23, 2020
• Study Start: December 1, 2020
• Primary Completion: August 1, 2022
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)