Lyon PJI Retrospective Cohort Study

January 19, 2022 updated by: Hospices Civils de Lyon

Lyon Prosthetic Joint Infection Retrospective Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69004
        • Recruiting
        • Hospices Civils De Lyon
        • Contact:
          • Eugenie Mabrut, CRA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients having had a PJI between 2018 and 2020 managed at the CRIOAc Lyon

Description

Inclusion Criteria:

  • patients having had a PJI between 2018 and 2020

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PJI
Patients having had a PJI
Other: PJI
patients having had a PJI managed at the CRIOAc Lyon, with or without relapse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of PJI
Time Frame: between 2018 and 2020
proportion of PJI among all BJI
between 2018 and 2020
Description of PJI
Time Frame: between 2018 and 2020
acute/chronic
between 2018 and 2020
Description of type of prosthesis PJI
Time Frame: between 2018 and 2020
number of prosthesis
between 2018 and 2020
Description of patients having had a PJI
Time Frame: between 2018 and 2020
type of patients: age
between 2018 and 2020
Description of comorbidities of patients having had a PJI
Time Frame: between 2018 and 2020
type of comorbidities..
between 2018 and 2020
rate of bacteria
Time Frame: between 2018 and 2020
epidemiologic description of PJI
between 2018 and 2020
description of antibiotic used
Time Frame: between 2018 and 2020
type of antibiotic : name
between 2018 and 2020
description of antibiotic treatment
Time Frame: between 2018 and 2020
duration of antibiotic treatment
between 2018 and 2020
description of surgical treatment
Time Frame: between 2018 and 2020
type of surgery: 1-step exchange, 2- step exchange, DAIR
between 2018 and 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of failure
Time Frame: between 2018 and 2020
proportion of patients having a failure
between 2018 and 2020
description of the failure
Time Frame: between 2018 and 2020
type of failure : persistence or surinfection and management of failure
between 2018 and 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 268

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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