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

• Conditions: Humeral Fractures
• Interventions: Procedure: closed reduction; Procedure: open reduction

• Registration Number: NCT04640727
• Lead Sponsor: Guangzhou Women and Children's Medical Center

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.

Detailed Description

Lateral condylar humerus fractures are the second most common elbow fracture in children, accounting for approximately 17-20% of pediatric elbow fractures. Jakob et al. first described a novel classification based on the presence of cartilage bridging. It was modified by Foster et al. who identified the differences in outcomes between fractures with \< 2 mm and ≥ 2 mm displacement. most surgeons preferred open reduction and internal fixation (ORIF) to insure anatomic reduction of these unstable intra-articular fractures. Only a few reports have focused on closed reduction and Percutaneous Pinning (CRPP) of lateral condylar humeral fractures. In most studies, this technique was used only in cases with displacement between 2 and 4mm. CRPP has shown several advantages over ORIF, including less dissection of soft tissue around the fragment, low risk of vessel damage, low risk of non-union and avascular necrosis (AVN) of distal humerus physeal, shorter operating room times, and avoidance of an open incision with an unaesthetic scar. Song et al. introduced a new classification and an internal oblique view to better assess the displacement of the fragment, and they managed to achieve closed reduction of the fracture, even in cases with displacement exceeding 4mm or those with rotational displacement (graded as stage 5 according Song classification and Type III according to Jakob classification). Because the study was not controlled, we could not tell the difference between cases treated with CRPP and the cases treated with ORIF directly.

Since May 1, 2019, at our Institution, we have been treating type III lateral condyle fractures with CRPP. The primary objective of this study was to report the efficacy and safety of CRPP of lateral condyle fracture. The secondary aim was to compare the outcomes between CRPP and ORIF.

Study Timeline

• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-23
• Study Start: 2020-12-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-20
• Primary Completion: 2022-08-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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，

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
closed reduction and internal fixation	closed reduction	closed reduction and internal fixation used in treating completely displaced and rotated lateral condylar fracture in children
open reduction and internal fixation	open reduction	open reduction and internal fixation used in treating completely displaced and rotated lateral condylar fracture in children

Primary Outcome Measures

Name	Time	Method
Hardacre criteria	1 years follow up	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

Secondary Outcome Measures

Name	Time	Method
duration of operation	during the operation	From TIME OUT to long-arm cast immobilization completed
amount of bleeding	during the operation	From TIME OUT to long-arm cast immobilization completed
Radiation exposure	during the operation	From TIME OUT to long-arm cast immobilization completed
The interepicondylar width (IEW)	3 months after the surgery	The interepicondylar width (IEW) has previously been described to quantify the magnitude of lateral spurring. The IEW was measured on the initial injury radiograph as well as the postoperative radiograph obtained approximately 3 months after surgery. The magnitude of lateral spurring, expressed as a ratio of the postoperative to the injury IEW, was defined as normal if it was \<1.05, mild spurring from 1.05 to 1.1, moderate spurring from 1.1 to 1.2, and severe spurring \>1.2

Trial Locations

Locations (1)

Guangzhou Women & Children Medical Center; 🇨🇳 Guangzhou, Guangdong, China