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OpenTrials
Completed

NCT Number: NCT03936972

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ilizarov circular frame and uni-planarexternal fixator

Procedure

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

Primary outcomes

  1. fracture healing

    Time frame: 6-9 months

    Radiographic union score (RUST) for tibial fractures was used. months later on non-union.

Secondary outcomes

  1. Union

    Time frame: 6-9 months

    Union was defined fracture healing after 6 months and delayed union after 9

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

In the Cost-conscious Era: Ilizarov Circular Frame or Uniplanar External Fixator for Management of Open Tibia Shaft Fracture, Retrospective Cohort Study From a Level-1 Trauma Center

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
May 3, 2019
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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