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OpenTrials
Completed

NCT Number: NCT03627000

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

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.

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Key information

Conditions

Bone and Joint Infection Bacterial Infections Bacterial Infections and Mycoses Epidemiology Infections

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

failure after reimplantation

Other

description of cinical and microbiological failure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 13, 2018
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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