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

Prosthetic Joint Infection Clinical Trial

Official title:

Cost of 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: NCT03612076
• Other study ID #: 17-089
• Status: Completed
• Start date: December 1, 2016
• Est. completion date: July 1, 2018

Study information

• Verified date: December 2020
• 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 of this study is to determine the global cost of management of prosthetic joint infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: July 1, 2018
• Est. primary completion date: July 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 and managed at the CRIOAc from at least the reimplantation (between 2013 and 2015)

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infection
• Prosthetic Joint Infection

Intervention

Other:
• Global cost of management of PJI
estimation of the global cost to manage PJI with 2-step exchange over 3 years

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	Heraeus Medical GmbH

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)