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

Completed

• Conditions: Bone and Joint Infection; EPIDEMIOLOGY; Bacterial Infections
• Interventions: Other: failure after reimplantation

• Registration Number: NCT03627000
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Primary Completion: 2018-04-01
• Study Completion: 2018-04-01
• Status Verified: 2018-08
• Study First Submitted: 2018-08-08
• Study First Submitted QC: 2018-08-08
• Last Update Submitted: 2018-08-08
• Study First Posted: 2018-08-13
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

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

Read More

Exclusion Criteria

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
failure after reimplantation	failure after reimplantation	description of the failure at the reimplantation

Primary Outcome Measures

Name	Time	Method
rate of treatment failure	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

Name	Time	Method
rate of clinical failure	Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)	description of clinical failure
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)	description of microbiological failure : bacteria responsible of microbiological failure