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Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India

NCT01691599 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2021-07-22

No results posted yet for this study

Summary

The objectives of this study are to investigate infection rates and management for open and closed tibia fracture subjects in India treated with internal fixation. These objectives will be carried out by answering the following questions:

1. What is the infection rate within one year of surgery for open and closed tibia fracture subjects in India treated with internal fixation?
2. What is the distribution of infection per type of infection, stratified by time (early, delayed, late) and location (superficial or deep) in open and closed tibia fracture subjects in India treated with internal fixation?

Secondary objectives

1. How are infections managed in open and closed tibia fracture subjects in India treated with internal fixation?
2. What is the treatment outcome for open and closed tibia fracture subjects in India treated with internal fixation?
3. What is the influence of the following clinic and subject factors on the occurrence of infection within one year for open and closed tibia fracture subjects in India treated with internal fixation?

1. Hospital standard hygienic and antibiotic protocol for infection prevention
2. Subject demographics
3. Time between injury and surgery and between admission and surgery
4. Fracture type (AO Müller classification)
5. Soft tissue damage (according to the Tscherne classification for closed fractures or Gustilo classification for open fractures)
6. Fracture management and implant type
7. Surgical details such as duration of surgery
4. Is there a difference in health-related quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) between subjects with and without infections?
5. Is there a difference in the number of complications not related to infection (adverse events and serious adverse events) between subjects with and without infections?

Conditions

  • Tibia Fracture

Sponsors & Collaborators

  • AO Clinical Investigation and Publishing Documentation

    lead OTHER

Principal Investigators

  • Prakash J Doshi, MD · Chief of Orthopaedics and Traumatology, Dr. Balabhai Nanavati Hospital, India

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01691599 on ClinicalTrials.gov