Kirschner Wires Fixation Versus Cannulated Screws Internal Fixation for Displaced Lateral Condyle Humeral Fracture in Children

NCT ID: NCT05409053

Last Updated: 2022-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2023-11-30

Brief Summary

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Lateral condyle fracture of the distal humerus is the second most common injury around the elbow and accounts for 20% of all the elbow fractures in children.The average age for the fracture involving the lateral condyle is around six years.

There are different treatment options of the lateral condyle fractures include

* non-operative management with plaster cast immobilization for undisplaced or minimally displaced fractures.
* Whereas the fractures displaced \>2 mm need operative management. The objective of treatment in the displaced fracture is to obtain and maintain the articular congruity.

In the operative management, the reduction technique includes open or closed methods.

Detailed Description

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Conditions

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Lateral Condyle Humerus Fracture in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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screw fixation

lateral condyle humerus fracture open reduction and internal fixation by canullated screws

Group Type ACTIVE_COMPARATOR

open reduction

Intervention Type PROCEDURE

the displaced fractures will be treated with open reduction so as to achieve the near anatomical alignment

k wire fixation

lateral condyle humerus fracture open reduction and internal fixation by K wire

Group Type ACTIVE_COMPARATOR

open reduction

Intervention Type PROCEDURE

the displaced fractures will be treated with open reduction so as to achieve the near anatomical alignment

Conservative management

Undisplaced fractured treated conservatively by above elbow slab

Group Type OTHER

Conservative management

Intervention Type OTHER

the non displaced fractures will be treated with closed reduction and castor slab

Closed reduction and percutaneous pinning

Undisplaced fractured treated closed reduction and percutaneous pinning

Group Type OTHER

Closed reduction

Intervention Type PROCEDURE

the non displaced fractures will be treated with closed reduction and percutaneous pinning

Interventions

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open reduction

the displaced fractures will be treated with open reduction so as to achieve the near anatomical alignment

Intervention Type PROCEDURE

Closed reduction

the non displaced fractures will be treated with closed reduction and percutaneous pinning

Intervention Type PROCEDURE

Conservative management

the non displaced fractures will be treated with closed reduction and castor slab

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children up to 14 years.
* closed lateral condylar fracture.
* displacement more than 2mm .
* fracture Less than two weeks of injury.

Exclusion Criteria

* Patients with open fractures.
* otherassociated injury in the same elbow .
* elbow with preexisting anatomical deformity .
Minimum Eligible Age

2 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Bassam Abdelrahim Abdelbasset

resident doctor at orthopaedic department sohag university hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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bassam A abdalraheem, resident

Role: CONTACT

01099392948

El-shazly s mousa, professor

Role: CONTACT

Facility Contacts

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Osama R ElSherif, professor

Role: primary

References

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Franks D, Shatrov J, Symes M, Little DG, Cheng TL. Cannulated screw versus Kirschner-wire fixation for Milch II lateral condyle fractures in a paediatric sawbone model: a biomechanical comparison. J Child Orthop. 2018 Feb 1;12(1):29-35. doi: 10.1302/1863-2548.12.170090.

Reference Type BACKGROUND
PMID: 29456751 (View on PubMed)

Justus C, Haruno LS, Riordan MK, Wilsford L, Smith T, Antekeier S, McKay SD. Closed and Open Reduction of Displaced Pediatric Lateral Condyle Humeral Fractures, a Study of Short-Term Complications and Postoperative Protocols. Iowa Orthop J. 2017;37:163-169.

Reference Type BACKGROUND
PMID: 28852352 (View on PubMed)

Cardona JI, Riddle E, Kumar SJ. Displaced fractures of the lateral humeral condyle: criteria for implant removal. J Pediatr Orthop. 2002 Mar-Apr;22(2):194-7.

Reference Type BACKGROUND
PMID: 11856929 (View on PubMed)

Baharuddin M, Sharaf I. Screw osteosynthesis in the treatment of fracture lateral humeral condyle in children. Med J Malaysia. 2001 Dec;56 Suppl D:45-7.

Reference Type BACKGROUND
PMID: 14569766 (View on PubMed)

Other Identifiers

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soh-Med-22-03-08

Identifier Type: -

Identifier Source: org_study_id

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