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Cost Of Failure Following Reimplantation After a 2-Stage Exchange Strategy For Hip Or Knee Prosthetic Joint Infection

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ClinicalTrials.gov Identifier: NCT03612076
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : August 8, 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 of this study is to determine the global cost of management of prosthetic joint infection.


Condition or disease Intervention/treatment
Prosthetic Joint Infection Other: Global cost of management of PJI

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Study Type : Observational
Actual Enrollment : 115 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cost of Failure Following Reimplantation After a 2-stage Exchange Strategy for Hip or Knee Prosthetic Joint Infection
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Global cost of management of PJI Other: Global cost of management of PJI
estimation of the global cost to manage PJI with 2-step exchange over 3 years




Primary Outcome Measures :
  1. Global cost of management of PJI [ Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption) ]
    The following data are collected : duration of hospitalization at the Croix Rousse hospital (surgery unit, department of infectiology, other…) and in post-acute care structures, bacteriology, surgeries, medical treatments… and all acts realized throughout the management of the PJI.



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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.
Criteria

Inclusion Criteria:

  • patients with prosthetic joint infection having had a 2-step exchange and managed at the CRIOAc from at least 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): NCT03612076


Locations
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France
Hospices Civils de Lyon
Lyon, France, 69004
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: NCT03612076     History of Changes
Other Study ID Numbers: 17-089
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 8, 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

Keywords provided by Eugénie MABRUT, Hospices Civils de Lyon:
prosthetic joint infection

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