Is This PJI Really Acute: A Quantitative Sonication Fluid Analysis (Sonic) (Sonic)

Is This PJI Really Acute: A Quantitative Sonication Fluid Analysis

This retrospective study is to analyse microbiological cultures from the sonication fluid of the explanted prothesis to detect bacteria in the biofilm on the implant surface and to investigate whether the number of bacteria in the biofilm correlates with the duration of the PJI respectively with the period between symptom onset and date of revision surgery.

Study Overview

• Status: Completed
• Conditions: Prosthetic-joint Infection

Detailed Description

Implant associated infections in orthopaedics and trauma surgery are a well-known and feared complication. Prosthetic-joint infection (PJI) is caused by a biofilm which is located atop the surface of the implant which as growing with the duration of the PJI. This retrospective study is to analyse microbiological cultures from the sonication fluid of the explanted prothesis to detect bacteria in the biofilm on the implant surface and to investigate whether the number of bacteria in the biofilm correlates with the duration of the PJI respectively with the period between symptom onset and date of revision surgery.

• Study Type: Observational
• Enrollment (Actual): 176

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Department of Orthopaedics and Traumatology, University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who meet the required criteria will be extracted from an existing clinical consultation database of the clinic of infectious disease. All patients in this database were treated and recorded on a consultative base between 2011 and 2021 by the Department of Orthopaedics and Traumatology and the Department of Infectious Diseases at the University Hospital Basel for a suspected PJI.

Description

Inclusion Criteria:

• patients who underwent a revision surgery of hip, knee and shoulder arthroplasties operated at the university hospital of Basel between 2011 and 2021,
• patients who had a PJI as a suspected diagnosis and
• have microbiological cultures from sonication fluid from removed prosthesis.

Exclusion Criteria:

• patients in the database who

  1. have non-bacterial microbiological positive cultures (e.g. fungal infection) and
  2. have not received a sonication of the removed prosthesis during the diagnostic process

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of bacteria	number of bacteria detected during revision surgery will be taken from the sonication fluid and the quantitative analysis of the microbiological samples	one time assessment at baseline
duration of the infection	duration of the infection	one time assessment at baseline

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Martin Clauss, PD Dr. med., Department of Orthopaedics and Traumatology, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Actual): March 11, 2023
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: debridement, antibiotics and implant retention (DAIR); sonication fluid analysis
• Other Study ID Numbers: 2021-01113; mu22Clauss

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No