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

July 2, 2022 updated by: khaled Gamal Amir, Assiut University

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

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt, 71511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ilizarov device
Ilizarov fixation in open type III pediatric tibial shaft fractures
Procedure: Ilizarov
Ilizarov fixation in open type III pediatric and adolescent tibial shaft fractures
Other Names:
  • ORIF with broad DCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Union of tibial fracture
Time Frame: 1 year
Assess Union of the fracture using radiographic union scale in tibial fracture(RUST)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine alignment
Time Frame: 1 year
Determine alignment using slit scanogram for both Lower limbs
1 year
Patient reported outcome measures
Time Frame: 1 year
Patient reported outcome measures using Stanmore limb reconstruction score (SLRS)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2022

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

July 2, 2022

First Posted (ACTUAL)

July 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2022

Last Update Submitted That Met QC Criteria

July 2, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Khaled381991

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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