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Microbiological Epidemiology in Patients Experiencing Microbiological or Clinical Failure Following Reimplantation After a 2-stage Exchange Strategy for Hip or Knee Prosthetic Joint Infection

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ClinicalTrials.gov Identifier: NCT03627000
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Eugénie MABRUT, Hospices Civils de Lyon

Brief Summary:

This study concerns patients having had an infection on their prosthesis (hip, knee,..) and for whom a 2-step exchange of prosthesis has been done.

A 2-step exchange consists in explantation of the prosthesis and implementation of a spacer at the first stage, and reimplantation of a new prosthesis in a second stage. Patients with late prosthetic joint infection are at risk for superinfection at the time of reimplantation.

The aim is to determine the microbiological epidemiology in patients experiencing failure following reimplantation to establish, based on the drug susceptibilities, which cement could be the most active.


Condition or disease Intervention/treatment
Bone and Joint Infection Bacterial Infections EPIDEMIOLOGY Other: failure after reimplantation

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Study Type : Observational
Actual Enrollment : 114 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Microbiological Epidemiology in Patients Experiencing Microbiological or Clinical Failure Following Reimplantation After a 2-stage Exchange Strategy for Hip or Knee Prosthetic Joint Infection
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
failure after reimplantation
description of the failure at the reimplantation
Other: failure after reimplantation
description of cinical and microbiological failure




Primary Outcome Measures :
  1. rate of treatment failure [ Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption) ]
    Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin


Secondary Outcome Measures :
  1. rate of bacteria involved in microbiological failure [ Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption) ]
    description of microbiological failure : bacteria responsible of microbiological failure

  2. rate of clinical failure [ Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption) ]
    description of clinical failure



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
patients with prosthetic joint infection having had a 2-step exchange managed at the Croix Rousse Hospital from the reimplantation, between 2013 and 2015.
Criteria

Inclusion Criteria:

  • patients with prosthetic joint infection having had a 2-step exchange at least from the reimplantation, between 2013 and 2015.

Exclusion Criteria:

-


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): NCT03627000


Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Tristan FERRY, Md,PhD Hospices Civils de Lyon Hôpital de la Croix-Rousse

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Responsible Party: Eugénie MABRUT, Clinical Research Assistant, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03627000     History of Changes
Other Study ID Numbers: 17-089-2
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
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

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases