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Completed

NCT Number: NCT05265598

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. number of bacteria

    Time frame: one time assessment at baseline

    number of bacteria detected during revision surgery will be taken from the sonication fluid and the quantitative analysis of the microbiological samples

  2. duration of the infection

    Time frame: one time assessment at baseline

    duration of the infection

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Is This PJI Really Acute: A Quantitative Sonication Fluid Analysis

Acronym: Sonic

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Mar 3, 2022
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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