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Clinical Trials/NCT03627000
NCT03627000
Completed
Not Applicable

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

Hospices Civils de Lyon0 sites114 target enrollmentOctober 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bone and Joint Infection
Sponsor
Hospices Civils de Lyon
Enrollment
114
Primary Endpoint
rate of treatment failure
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2016
End Date
April 1, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eugénie MABRUT

Clinical Research Assistant

Hospices Civils de Lyon

Eligibility 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

  • Not provided

Outcomes

Primary Outcomes

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 Outcomes

  • rate of clinical failure(Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption))
  • rate of bacteria involved in microbiological failure(Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption))

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