Contribution of the Sonication of Implants to the Diagnosis of Joint Prosthesis Infection: A Retrospective Cohort Study

NCT ID: NCT05867108

Last Updated: 2023-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-03-03

Brief Summary

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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.

Detailed Description

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Conditions

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Prosthesis Related Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

\- Opposition of the patient to the reuse of his data.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cécile RONDE-OUSTAU, MD

Role: STUDY_DIRECTOR

University Hospitals of Strasbourg

Locations

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ervice de Chirurgie Orthopédique Septique - CHU de Strasbourg - France

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cécile RONDE-OUSTAU, MD

Role: CONTACT

33 3 68 76 50 62

Facility Contacts

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Cécile RONDE- OUSTAU, MD

Role: primary

33 3 68 76 50 62

Other Identifiers

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8956

Identifier Type: -

Identifier Source: org_study_id

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