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

NCT05265598 | Completed

• 1 other identifier: 2021-01113; mu22Clauss
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prosthetic-joint Infection

Keywords

debridement, antibiotics and implant retention (DAIR); sonication fluid analysis

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• patients in the database who
• have non-bacterial microbiological positive cultures (e.g. fungal infection) and
• have not received a sonication of the removed prosthesis during the diagnostic process

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, 4031, Switzerland

Location

Study Officials

• Martin Clauss, PD Dr. med.

  Department of Orthopaedics and Traumatology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: June 30, 2021
• Primary Completion: March 11, 2023
• Study Completion: August 31, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

CH (1)