Prosthesis Related InfectionSonicHUSNCT05867108
Contribution of the Sonication of Implants to the Diagnosis of Joint Prosthesis Infection: A Retrospective Cohort Study
An observational study of Prosthesis Related Infection, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Studies on sonication suffer from a heterogeneity which makes their analysis complex, due to the absence of a gold standard allowing positive cases to be defined unequivocally. Thus, the sensitivity of the technique has been assessed on cases defined in different ways, which makes the studies difficult to compare… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthesis Related Infection
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2023to 3 Mar 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
- Adult, Older adult
Study population: Adult patients (age ≥18 years) have been hospitalized and operated on for a change of hip or knee joint prosthesis between 01/01/2019 and 07/31/2022
Who may be able to join
- Adult patients (age ≥18 years)
- Have been hospitalized and operated on for a change of hip or knee joint prosthesis between 01/01/2019 and 07/31/2022
- Have had at least 3 samples taken for microbiological purposes, pre- or intraoperatively
- the explanted prosthesis must have been analyzed by sonication.
- not opposing the reuse of its data for scientific research purposes
Who cannot join
- Opposition of the patient to the reuse of his data.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
ervice de Chirurgie Orthopédique Septique - CHU de Strasbourg - France
Strasbourg, 67091
Cécile RONDE- OUSTAU, MD, 33 3 68 76 50 62, cecile.ronde-oustau@chru-strasbourg.fr
Cécile RONDE- OUSTAU, MD
About this study
Official title: Contribution of the Sonication of Implants to the Diagnosis of Joint Prosthesis Infection: Retrospective Cohort Study From 2019 to 2022 at the University Hospitals of Strasbourg
Studies on sonication suffer from a heterogeneity which makes their analysis complex, due to the absence of a gold standard allowing positive cases to be defined unequivocally. Thus, the sensitivity of the technique has been assessed on cases defined in different ways, which makes the studies difficult to compare (number of samples taken, number of positive samples, variable duration of culture, etc.). It should nevertheless be noted that the majority of the series conclude with a higher sensitivity than that of standard samples, in particular in the event of a strain with difficult growth (Cutibacterium acnes, deficient Streptococci) or in the event of prior antibiotic therapy.
In the absence of a comparative reference allowing to conclude on the intrinsic performances of sonication as a diagnostic test, it seems interesting to evaluate its contribution in current practice, in particular in the difficult cases where the standard culture does not make it possible to fulfill the criterion. major (zero or only one positive sample). To the knowledge of the investigators, there is no study of this kind, which could make it possible to specify the place of this technique in the diagnostic procedure and to improve the care of patients.
- Conditions
- Prosthesis Related Infection
- Keywords
- Prosthesis Related Infection, Joint prosthesis infection, Sonication of implants, Cutibacterium acnes, Streptococci
- Medical subject headings
- Prosthesis-Related Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with only a peri-prosthetic sample whose culture is positive, and for whom the culture of the sonication fluid is positive and consistent with this first sample, with an objective of >5%.
Measured: 4 years after implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Jun 2023
- Primary completion3 Mar 2024 (estimated)
- Study completion3 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis Related InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile RONDE-OUSTAU, MD, Study director, University Hospitals of Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867108
- Sponsor's protocol ID
- 8956
- Acronym
- SonicHUS
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 22 Sep 2023
- 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 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of the Sonication of Implants to the Diagnosis of Joint Prosthesis Infection: Retrospective Cohort Study From 2019 to 2022 at the University Hospitals of Strasbourg
- ClinicalTrials.gov ID
- NCT05867108
- Acronym / sponsor ID
- SonicHUS / 8956
- Conditions
- Prosthesis Related Infection
- Keywords
- Prosthesis Related Infection, Joint prosthesis infection, Sonication of implants, Cutibacterium acnes, Streptococci
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 3 Mar 2024 (estimated)
- Study completion
- 3 Mar 2024 (estimated)
- First posted
- 19 May 2023 (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.
Studies on sonication suffer from a heterogeneity which makes their analysis complex, due to the absence of a gold standard allowing positive cases to be defined unequivocally. Thus, the sensitivity of the technique has been assessed on cases defined in different ways, which makes the studies difficult to compare (number of samples taken, number of positive samples, variable duration of culture, etc.). It should nevertheless be noted that the majority of the series conclude with a higher sensitivity than that of standard samples, in particular in the event of a strain with difficult growth (Cutibacterium acnes, deficient Streptococci) or in the event of prior antibiotic therapy.
In the absence of a comparative reference allowing to conclude on the intrinsic performances of sonication as a diagnostic test, it seems interesting to evaluate its contribution in current practice, in particular in the difficult cases where the standard culture does not make it possible to fulfill the criterion. major (zero or only one positive sample). To the knowledge of the investigators, there is no study of this kind, which could make it possible to specify the place of this technique in the diagnostic procedure and to improve the care of patients.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients (age ≥18 years) have been hospitalized and operated on for a change of hip or knee joint prosthesis between 01/01/2019 and 07/31/2022
Key inclusion criteria (5 listed)
- Adult patients (age ≥18 years)
- Have been hospitalized and operated on for a change of hip or knee joint prosthesis between 01/01/2019 and 07/31/2022
- Have had at least 3 samples taken for microbiological purposes, pre- or intraoperatively
- the explanted prosthesis must have been analyzed by sonication.
- not opposing the reuse of its data for scientific research purposes
Key exclusion criteria (1 listed)
- Opposition of the patient to the reuse of his data.
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
Proportion of subjects with only a peri-prosthetic sample whose culture is positive, and for whom the culture of the sonication fluid is positive and consistent with this first sample, with an objective of >5%.
Time frame: 4 years after implant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
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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.
Cécile RONDE-OUSTAU, MD study director
University Hospitals of Strasbourg
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 Prosthesis Related Infection, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Sep 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cécile RONDE-OUSTAU, MD (33 3 68 76 50 62, cecile.ronde-oustau@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with only a peri-prosthetic sample whose culture is positive, and for whom the culture of the sonication fluid is positive and consistent with this first sample, with an objective of >5%. (time frame: 4 years after implant). 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 Sep 2023.