Ilizarov Frame or Uni Planar External Fixator in the Cost-conscious Era

Completed

• Conditions: Tibia Fracture
• Interventions: Procedure: ilizarov circular frame and uni-planarexternal fixator

• Registration Number: NCT03936972
• Lead Sponsor: Aga Khan University

Brief Summary

Tibial shaft fracture is a common injury worldwide. Their treatment, prognosis, and outcome are determined by the mechanism of injury, presence of communition, soft tissue injury and displacement. In developing countries, lack of education,socioeconomic backgrounds, delay in presentation and appropriate planning for surgery add further to complicate the situation and may end in delayed union, non-union, multiple surgeries and ultimate results in increased morbidity. This study was conducted to determine the outcome of open tibia shaft fracture treated with Ilizarov or AO External Fixator.

Detailed Description

Tibial shaft fracture is a common injury worldwide. Their treatment, prognosis, and outcome are determined by the mechanism of injury, presence of communition, soft tissue injury and displacement. In developing countries, lack of education,socioeconomic backgrounds, delay in presentation and appropriate planning for surgery add further to complicate the situation and may end in delayed union, non-union, multiple surgeries and ultimate results in increased morbidity. This study was conducted to determine the outcome of open tibia shaft fracture treated with Ilizarov or AO External Fixator. It was retrospective Cohort study. Two groups were compared in terms of fracture healing, mechanism of injury, fracture classification, Participant's ambulation at discharge, New Injury Severity Score (NISS), duration of hospital stay, duration of fracture union, need for secondary procedures and complications. Investigators concluded that circular fixator application has favorable outcomes for Gustilo grade III open tibial shaft fractures as compared to uniplanar external fixator.

Study Timeline

• Study Start: 2008-01-01
• Primary Completion: 2014-12-31
• Study Completion: 2014-12-31
• Status Verified: 2019-05
• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-02
• Last Update Submitted: 2019-05-02
• Study First Posted: 2019-05-03
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

Participants with open tibia shaft fracture type III (A, B, C) as per Gustillo classification of open fractures stabilized with external fixation either circular or uniplanar external fixator were included

Exclusion Criteria

• All closed and type I and II open tibia shaft fractures according to Gustillo classification of open fracture, Intra-articular fracture extending to knee and ankle joints were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ex. Fix	ilizarov circular frame and uni-planarexternal fixator	47 participants with open tibia fracture Gustillo type III only
ilizarov circular frame	ilizarov circular frame and uni-planarexternal fixator	46 participants with open tibia fracture Gustillo type III only

Primary Outcome Measures

Name	Time	Method
fracture healing	6-9 months	Radiographic union score (RUST) for tibial fractures was used. months later on non-union.

Secondary Outcome Measures

Name	Time	Method
Union	6-9 months	Union was defined fracture healing after 6 months and delayed union after 9