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

NCT ID: NCT03936972

Last Updated: 2019-05-03

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

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-01

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Tibia Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ilizarov circular frame

46 participants with open tibia fracture Gustillo type III only

ilizarov circular frame and uni-planarexternal fixator

Intervention Type PROCEDURE

both are types of external fixators, but one is circular frame and other is uni-planar frame

Ex. Fix

47 participants with open tibia fracture Gustillo type III only

ilizarov circular frame and uni-planarexternal fixator

Intervention Type PROCEDURE

both are types of external fixators, but one is circular frame and other is uni-planar frame

Interventions

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ilizarov circular frame and uni-planarexternal fixator

both are types of external fixators, but one is circular frame and other is uni-planar frame

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Obada Hasan, FCPS, MRCS

Senior Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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5120 29-Dec-17

Identifier Type: -

Identifier Source: org_study_id

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