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

Tibia Fracture Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03936972
• Other study ID #: 5120 29-Dec-17
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Fractures, Bone
• Tibia Fracture
• Tibial Fractures

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