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

Study Overview
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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.

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

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

Intervention / Treatment
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* Procedure: Ilizarov


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ilizarov device<br>Ilizarov fixation in open type III pediatric tibial shaft fractures | Procedure: Ilizarov<br>* Ilizarov fixation in open type III pediatric and adolescent tibial shaft fractures<br>* Other names: ORIF with broad DCP;|

What is the study measuring?
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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 |