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NCT04722926 Clinical Trial

Lyon PJI Retrospective Cohort Study

Bone and Joint Infection Clinical Trial

Official title:
Lyon Prosthetic Joint Infection Retrospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04722926
Other study ID # 268
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 10, 2022
Est. completion date March 1, 2024

Study information
Verified date January 2022
Source Hospices Civils de Lyon
Contact Eugenie Mabrut, CRA
Phone . 04 26 73 29 38
Email eugenie.mabrut@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Bone and joint infections (BJI), although infrequent (prevalence of 70 per 100,000 in France), have a significant economic and clinical impact. Between 2008 and 2013, the prevalence of BJI increased and infections involving joint prosthesis (PJI) represent a third of BJI in France. They are most often post-operative and more expensive than native IOAs. This study aims to describe PJI and understand the failure mechanisms of PJI in order to improve their management.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date March 1, 2024
Est. primary completion date November 1, 2022
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients having had a PJI between 2018 and 2020 Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• PJI
patients having had a PJI managed at the CRIOAc Lyon, with or without relapse

Locations
Country Name City State
France Hospices Civils de Lyon Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary rate of PJI proportion of PJI among all BJI between 2018 and 2020
Primary Description of PJI acute/chronic between 2018 and 2020
Primary Description of type of prosthesis PJI number of prosthesis between 2018 and 2020
Primary Description of patients having had a PJI type of patients: age between 2018 and 2020
Primary Description of comorbidities of patients having had a PJI type of comorbidities.. between 2018 and 2020
Primary rate of bacteria epidemiologic description of PJI between 2018 and 2020
Primary description of antibiotic used type of antibiotic : name between 2018 and 2020
Primary description of antibiotic treatment duration of antibiotic treatment between 2018 and 2020
Primary description of surgical treatment type of surgery: 1-step exchange, 2- step exchange, DAIR between 2018 and 2020
Secondary rate of failure proportion of patients having a failure between 2018 and 2020
Secondary description of the failure type of failure : persistence or surinfection and management of failure between 2018 and 2020
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