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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/15/2021.

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

Clinicaltrials.gov identifier NCT03936972

Recruitment Status Completed

First Posted May 3, 2019

Last update posted May 3, 2019

Study Description

Brief 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.

  • Condition or Disease:Tibia Fracture
  • Intervention/Treatment: Procedure: ilizarov circular frame and uni-planarexternal fixator
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Actual Enrollment: 93 participants
  • Observational Model: Cohort
  • Time Perspective: Retrospective
  • 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
  • Actual Study Start Date: January 2008
  • Actual Primary Completion Date: December 2014
  • Actual Study Completion Date: December 2014
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: 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
: 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
Outcome Measures
  • Primary Outcome Measures: 1. fracture healing [ Time Frame: 6-9 months ]
    Radiographic union score (RUST) for tibial fractures was used. months later on non-union.
  • Secondary Outcome Measures: 1. Union [ Time Frame: 6-9 months ]
    Union was defined fracture healing after 6 months and delayed union after 9
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Non-Probability Sample
  • Study Population: Adult participants both genders presenting with open fracture of tibia specifically Gustillo type III (Severe injury).
Criteria

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.

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Aga Khan University

More Information
  • Responsible Party: Aga Khan University
  • ClinicalTrials.gov Identifier: NCT03936972 History of Changes
  • Other Study ID Numbers: 5120 29-Dec-17
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: May 3, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Plan Description: Not allowed as per hospital policy
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Aga Khan University: tibia fracture; ilizarov; open fracture; external fixator
  • Additional relevant MeSH terms: Fractures, Bone Tibial Fractures