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

Completed

• Conditions: Tibia Fracture

• Registration Number: NCT01691599
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

Brief 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?

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-25
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2021-07-21
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of infection	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)

Secondary Outcome Measures

Name	Time	Method
Change in Quality of life measurement (EQ-5D)	Baseline and up to 5 day postoperative and 3months and 6months and 12 months

Trial Locations

Locations (11)

Hi Tech Hospital; 🇮🇳 Gandhinagar, Gujarat, India

Dr. B.R. Ambedkar Medical College Hospital; 🇮🇳 Bangalore, Karnataka, India

MOSC Medical College; 🇮🇳 Kochi, Kerala, India

Kolhapur Institute of Orthopedics and Trauma; 🇮🇳 Kolhapur, Maharashtra, India

Dr. Balabhai Nanavati Hospital; 🇮🇳 Mumbai, Maharashtra, India

Dr. R. N. Cooper Hospital; 🇮🇳 Mumbai, Maharashtra, India

Jai Hospital Pvt. Ltd.; 🇮🇳 Nashik, Maharashtra, India

Sancheti Hospital; 🇮🇳 Pune, Maharashtra, India

Orthopedic Hospital and Post Graduate Institute of Swasthiyog Pratishthan; 🇮🇳 Sangli, Maharashtra, India

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, Punjab, India

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