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

NCT03936972 | Completed

• 1 other identifier: 5120 29-Dec-17
• Study Type: observational
• Target: 93
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tibia Fracture

Keywords

tibia fracture; ilizarov; open fracture; external fixator

Outcome Measures

Primary Outcomes (1)

• fracture healing

  Radiographic union score (RUST) for tibial fractures was used. months later on non-union.

  6-9 months

Secondary Outcomes (1)

• Union

  6-9 months

Study Arms (2)

ilizarov circular frame

46 participants with open tibia fracture Gustillo type III only

Procedure: ilizarov circular frame and uni-planarexternal fixator

Ex. Fix

47 participants with open tibia fracture Gustillo type III only

Procedure: ilizarov circular frame and uni-planarexternal fixator

Interventions

ilizarov circular frame and uni-planarexternal fixator PROCEDURE

both are types of external fixators, but one is circular frame and other is uni-planar frame

Ex. Fix; ilizarov circular frame

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead

MeSH Terms

Conditions

Tibial Fractures; Fractures, Open

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 3, 2019
• Study Start: January 1, 2008
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2014
• Last Updated: May 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share