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

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

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.

Study Overview

• Status: Completed
• Conditions: Tibia Fracture
• Intervention / Treatment: Procedure: ilizarov circular frame and uni-planarexternal 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 Type: Observational
• Enrollment (Actual): 93

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult participants both genders presenting with open fracture of tibia specifically Gustillo type III (Severe injury).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ilizarov circular frame; 46 participants with open tibia fracture Gustillo type III only	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
Ex. Fix; 47 participants with open tibia fracture Gustillo type III only	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fracture healing	Radiographic union score (RUST) for tibial fractures was used. months later on non-union.	6-9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Union	Union was defined fracture healing after 6 months and delayed union after 9	6-9 months

Collaborators and Investigators

• Sponsor: Aga Khan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2008
• Primary Completion (ACTUAL): December 31, 2014
• Study Completion (ACTUAL): December 31, 2014

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (ACTUAL): May 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: tibia fracture; ilizarov; open fracture; external fixator
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: 5120 29-Dec-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not allowed as per hospital policy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No