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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03936972
Other study ID # 5120 29-Dec-17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2008
Est. completion date December 31, 2014

Study information

Verified date May 2019
Source Aga Khan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date December 31, 2014
Est. primary completion date December 31, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
ilizarov circular frame and uni-planarexternal fixator
both are types of external fixators, but one is circular frame and other is uni-planar frame

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Aga Khan University

Outcome

Type Measure Description Time frame Safety issue
Primary fracture healing Radiographic union score (RUST) for tibial fractures was used. months later on non-union. 6-9 months
Secondary Union Union was defined fracture healing after 6 months and delayed union after 9 6-9 months
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