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Lyon PJI Retrospective Cohort Study

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ClinicalTrials.gov Identifier: NCT04722926
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : January 20, 2022
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Bone and Joint Infection Other: PJI

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Lyon Prosthetic Joint Infection Retrospective Cohort Study
Actual Study Start Date : January 10, 2022
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. rate of PJI [ Time Frame: between 2018 and 2020 ]
    proportion of PJI among all BJI

  2. Description of PJI [ Time Frame: between 2018 and 2020 ]
    acute/chronic

  3. Description of type of prosthesis PJI [ Time Frame: between 2018 and 2020 ]
    number of prosthesis

  4. Description of patients having had a PJI [ Time Frame: between 2018 and 2020 ]
    type of patients: age

  5. Description of comorbidities of patients having had a PJI [ Time Frame: between 2018 and 2020 ]
    type of comorbidities..

  6. rate of bacteria [ Time Frame: between 2018 and 2020 ]
    epidemiologic description of PJI

  7. description of antibiotic used [ Time Frame: between 2018 and 2020 ]
    type of antibiotic : name

  8. description of antibiotic treatment [ Time Frame: between 2018 and 2020 ]
    duration of antibiotic treatment

  9. description of surgical treatment [ Time Frame: between 2018 and 2020 ]
    type of surgery: 1-step exchange, 2- step exchange, DAIR


Secondary Outcome Measures :
  1. rate of failure [ Time Frame: between 2018 and 2020 ]
    proportion of patients having a failure

  2. description of the failure [ Time Frame: between 2018 and 2020 ]
    type of failure : persistence or surinfection and management of failure


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
Criteria

Inclusion Criteria:

  • patients having had a PJI between 2018 and 2020

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04722926


Contacts
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Contact: Eugenie Mabrut, CRA . 04 26 73 29 38 eugenie.mabrut@chu-lyon.fr
Contact: Tristan Ferry, MD,PhD . 04 26 73 29 38 tristan.ferry@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon Recruiting
Lyon, France, 69004
Contact: Eugenie Mabrut, CRA         
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Additional Information:

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04722926    
Other Study ID Numbers: 268
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: January 20, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
prosthesis joint infection
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Additional relevant MeSH terms:
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Infections
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases