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.

Study Overview

• Status: Completed
• Conditions: Bacterial Infections; Bone and Joint Infection; EPIDEMIOLOGY
• Intervention / Treatment: Other: failure after reimplantation

• Study Type: Observational
• Enrollment (Actual): 114

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with prosthetic joint infection having had a 2-step exchange managed at the Croix Rousse Hospital from the reimplantation, between 2013 and 2015.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
failure after reimplantation; description of the failure at the reimplantation	Other: failure after reimplantation; description of cinical and microbiological failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Arthritis, Infectious; Bacterial Infections
• Other Study ID Numbers: 17-089-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No