Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05867108
Status:
RECRUITING
Last Update Posted:
2023-09-22
First Post:
2023-05-10
Brief Title:
Contribution of the Sonication of Implants to the Diagnosis of Joint Prosthesis Infection A Retrospective Cohort Study
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SonicHUS
Brief 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 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None