Clinical trial NCT03936972: Ilizarov Frame or Uni Planar External Fixator in the Cost-conscious Era
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tibia Fracture
Keywords: tibia fracture; ilizarov; open fracture; external fixator
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 93
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants both genders presenting with open fracture of tibia specifically Gustillo type III (Severe injury).

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.

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.

Eligibility 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.

Primary outcomes:
measure: fracture healing
timeFrame: 6-9 months
Secondary outcomes:
measure: Union
timeFrame: 6-9 months
Other outcomes:
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