Cost Of Failure Following Reimplantation After a 2-Stage Exchange Strategy For Hip Or Knee Prosthetic Joint Infection

Cost of 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 of this study is to determine the global cost of management of prosthetic joint infection.

Study Overview

• Status: Completed
• Conditions: Prosthetic Joint Infection
• Intervention / Treatment: Other: Global cost of management of PJI

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hospices Civils de Lyon

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.

Description

Inclusion Criteria:

• patients with prosthetic joint infection having had a 2-step exchange and managed at the CRIOAc from at least 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
Global cost of management of PJI	Other: Global cost of management of PJI; estimation of the global cost to manage PJI with 2-step exchange over 3 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global cost of management of PJI	The following data are collected : duration of hospitalization at the Croix Rousse hospital (surgery unit, department of infectiology, other…) and in post-acute care structures, bacteriology, surgeries, medical treatments… and all acts realized throughout the management of the PJI.	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
• Collaborators: Heraeus Medical GmbH
• Investigators: Principal Investigator: Tristan Ferry, Md,PhD, Hospices Civils de Lyon - Hôpital de la Croix-Rousse

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): July 1, 2018
• Study Completion (ACTUAL): July 1, 2018

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (ACTUAL): August 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: prosthetic joint infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Infections; Communicable Diseases; Arthritis, Infectious
• Other Study ID Numbers: 17-089

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