Prosthetic-joint InfectionSonicNCT05265598
Is This PJI Really Acute: A Quantitative Sonication Fluid Analysis (Sonic)
An observational study of Prosthetic-joint Infection, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic-joint Infection
- How many people
- 176 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jun 2021to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Orthopaedics and Traumatology, University Hospital Basel
Basel, 4031
About this study
Official title: 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.
Read the 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.
- Conditions
- Prosthetic-joint Infection
- Keywords
- debridement, antibiotics and implant retention (DAIR), sonication fluid analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one time assessment at baseline
duration of the infection
duration of the infection
Measured: one time assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start30 Jun 2021
- Primary completion11 Mar 2023
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic-joint InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Clauss, PD Dr. med., Principal investigator, Department of Orthopaedics and Traumatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265598
- Sponsor's protocol ID
- 2021-01113; mu22Clauss
- Acronym
- Sonic
- Status last verified
- Jan 2025
- First submitted
- 22 Feb 2022
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is This PJI Really Acute: A Quantitative Sonication Fluid Analysis
- ClinicalTrials.gov ID
- NCT05265598
- Acronym / sponsor ID
- Sonic / 2021-01113; mu22Clauss
- Conditions
- Prosthetic-joint Infection
- Keywords
- debridement, antibiotics and implant retention (DAIR), sonication fluid analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 11 Mar 2023 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- patients in the database who
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
duration of the infection
Time frame: one time assessment at baseline
duration of the infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Clauss, PD Dr. med. principal investigator
Department of Orthopaedics and Traumatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthetic-joint Infection, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of bacteria (time frame: one time assessment at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.