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

Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627000
• Other study ID #: 17-089-2
• Status: Completed
• Start date: October 1, 2016
• Est. completion date: April 1, 2018

Study information

• Verified date: August 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Arthritis, Infectious
• Bacterial Infections
• Bone and Joint Infection
• Communicable Diseases
• EPIDEMIOLOGY
• Infection

Intervention

Other:
• failure after reimplantation
description of cinical and microbiological failure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of treatment failure	Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Secondary	rate of bacteria involved in microbiological failure	description of microbiological failure : bacteria responsible of microbiological failure	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Secondary	rate of clinical failure	description of clinical failure	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)