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

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: Open Type III (A&B)Pediatric and Adolescent Tibial Shaft Fractures; Ilizarov Fixation
• Intervention / Treatment: Procedure: Ilizarov

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

• Study Contact: Name: Khaled Gamal; Phone Number: 01141110942; Email: khaledalamir@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt, 71511
    • Recruiting
    • Assiut University
    • Contact: Khaled Gamal; Phone Number: 01141110942; Email: khaledalamir@yahoo.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	Determine alignment using slit scanogram for both Lower limbs	1 year
Patient reported outcome measures	Patient reported outcome measures using Stanmore limb reconstruction score (SLRS)	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

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: Wounds and Injuries; Fractures, Bone
• 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