An Observational Study to Find Out infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India

Not Applicable

• Conditions: Health Condition 1: null- Infection

• Registration Number: CTRI/2012/11/003137
• Lead Sponsor: AO Clinical Investigation and Documentation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 1000

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).

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.

5) 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) Subjects with fractures older than 14 days at the time of enrollment.

2) Previous wound infection or osteomyelitis at the same limb (according to subject history).

3) External fixation (before internal fixation or as main intervention).

4) Previous fracture with retained hardware in injured extremity that will interfere with implant fixation.

5) Immunological deficiency disease.

6) Tumor related fractures.

7) Any severe systemic disease: class V-VI of the American Society of Anesthesiologists (ASA) physical status classification (Appendix 5).

8) Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment.

9) Subject is a prisoner.

10) 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
Percentage of tibia fracture patients with infection and Distribution of infection based on time from surgery (early, delayed, late) and location (superficial or deep)Timepoint: 1 year after surgery.

Secondary Outcome Measures

Name	Time	Method
Influencing Factors (hospital standard hygienic and antibiotic protocol, subject demographics, time between injury and surgery and between admission and surgery, fracture type based on AO Müller classification, soft tissue damage according to the Tscherne classification for closed fractures and the Gustilo classification for open fractures, fracture management and implant type, duration of surgery)Timepoint: within 1 year after surgery;Complication Rate in patients with and without infectionTimepoint: within 1 year after surgery.;Health-Related Quality of Life Measured by EurolQol-5 Dimensions (EQ-5D) in patients with and without infectionTimepoint: within 1 year after surgery. <br/ ><br>;Infection ManagementTimepoint: within 1 year after surgery.;Treatment OutcomeTimepoint: within 1 year after surgery.