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

July 21, 2021 updated by: AO Clinical Investigation and Publishing Documentation

Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India (INFINITI): a Prospective Multi-center Observational Study.

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?

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bihar, India, 800 004
        • Mukhopadhaya Orthopaedic Clinic and Research Centre
    • Gujarat
      • Gandhinagar, Gujarat, India, 382006
        • Hi Tech Hospital
    • Karnataka
      • Bangalore, Karnataka, India, 560 045
        • Dr. B.R. Ambedkar Medical College Hospital
    • Kerala
      • Kochi, Kerala, India, 625 007
        • MOSC Medical College
    • Maharashtra
      • Kolhapur, Maharashtra, India, 416 001
        • Kolhapur Institute of Orthopedics and Trauma
      • Mumbai, Maharashtra, India, 400 056
        • Dr. Balabhai Nanavati Hospital
      • Mumbai, Maharashtra, India, 400 056
        • Dr. R. N. Cooper Hospital
      • Nashik, Maharashtra, India, 422 002
        • Jai Hospital Pvt. Ltd.
      • Pune, Maharashtra, India, 411005
        • Sancheti Hospital
      • Sangli, Maharashtra, India, 416 416
        • Orthopedic Hospital and Post Graduate Institute of Swasthiyog Pratishthan
    • Punjab
      • Chandigarh, Punjab, India, 160 012
        • Post Graduate Institute of Medical Education and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with open or closed tibia fractures

Description

Inclusion Criteria:

  1. Men and women who are 18 years of age or older.
  2. Open or closed tibia fracture treated by internal fixation (plate or nail), or by external fixation with planned conversion to plate or nail.
  3. Ability to understand the content of the subject information / informed consent form and to be willing to participate in the clinical investigation.
  4. Written informed consent. Subjects with bilateral fractures will be included. In these subjects, the most severe fracture will be the one included in the study.

Exclusion Criteria:

  1. Previous wound infection or osteomyelitis at the same limb (according to subject history).
  2. Subjects who plan to undergo conversion surgery at a different hospital.
  3. Previous fracture with retained hardware in injured extremity that will interfere with implant fixation.
  4. Immunological deficiency disease.
  5. Tumor related fractures.
  6. Any severe systemic disease: class V-VI of the American Society of Anesthesiologists (ASA) physical status classification (Appendix 5).
  7. Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment.
  8. Subject is a prisoner.
  9. Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Tibia fractures
Patients with open and closed tibia fracture treated with internal fixation in India

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of infection
Time Frame: From surgery until the date of first documented infection assessed up to 1 year
LAB (CRP + ESR level, Leukocyte count / diff.) and bacteriology of wound swabs / aspirated liquids and sensitivity testing, if the patient is suspected for a surgical site infection (SSI)
From surgery until the date of first documented infection assessed up to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Quality of life measurement (EQ-5D)
Time Frame: Baseline and up to 5 day postoperative and 3months and 6months and 12 months
Baseline and up to 5 day postoperative and 3months and 6months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AO Clinical Investigation and Publishing Documentation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 20, 2012

First Posted (Estimate)

September 25, 2012

Study Record Updates

Last Update Posted (Actual)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INFINITI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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