Illizarov Fixation in Open Type III (A&B) Pediatric and Adolescent Tibial Shaft Fractures

NCT ID: NCT05448053

Last Updated: 2022-07-07

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-31

Brief Summary

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The Ilizarov method is our usual treatment of choice for open, complex, physeal or unstable fractures and for patients in whom non-operative or other treatments have failed .

Detailed Description

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Tibial fractures are the third most common injury involving a long bone in children. Most occur in the distal third, and approximately 10% are open.High-energy injuries with soft tissue compromise or segmental bone loss, present specific challenges. There is a significant risk of nonunion (7.5%),malunion (17%),infection (10%),and loss of reduction (32%).Many forms of treatment are available including a cast, elastic nailing, and external fixation using either a monolateral fixator, or a circular frame . In complex adult tibial fractures, evidence for the effectiveness of definitive external fixation using a circular frame continues to emerge.Fixators may be used for the correction of tibial deformities in children.Currently, only relatively small case series have been published describing their use for trauma in children and adolescents, albeit with good results.

Conditions

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Open Type III (A&B)Pediatric and Adolescent Tibial Shaft Fractures Ilizarov Fixation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ilizarov device

Ilizarov fixation in open type III pediatric tibial shaft fractures

Group Type EXPERIMENTAL

Ilizarov

Intervention Type PROCEDURE

Ilizarov fixation in open type III pediatric and adolescent tibial shaft fractures

Interventions

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Ilizarov

Ilizarov fixation in open type III pediatric and adolescent tibial shaft fractures

Intervention Type PROCEDURE

Other Intervention Names

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ORIF with broad DCP

Eligibility Criteria

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Inclusion Criteria

* Patients aged 8-16 years old.
* Diagnosed to have open grade IIIA and IIIB tibial fracture according to Gustilo-Anderson fracture classification system.
* Fractures of the shaft of the tibia or distal tibial fractures involving the ankle joint and were complicated by bone and/or soft-tissue loss of more than 3 cm.
* An external fixator could be placed in the proximal lower extremity, distal lower extremity, or foot, and normal bone segments available for osteotomy.
* Admitted in the duration between 1st of January 2022 until end of December 2023.

Exclusion Criteria

* Patients requiring free flap or local flap transfer to close the wound.
* Open grade IIIC tibial fractures (with vascular injury).
* Loss to follow-up.
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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khaled Gamal Amir

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut university

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Khaled Gamal

Role: CONTACT

01141110942

Facility Contacts

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Khaled Gamal

Role: primary

01141110942

Other Identifiers

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Khaled381991

Identifier Type: -

Identifier Source: org_study_id

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