NCT03612076

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

1.6 years

First QC Date

July 27, 2018

Last Update Submit

December 11, 2020

Conditions

Prosthetic Joint Infection

Keywords

prosthetic joint infection

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Global cost of management of PJI

Other: Global cost of management of PJI

Interventions

Global cost of management of PJIOTHER

estimation of the global cost to manage PJI with 2-step exchange over 3 years

Global cost of management of PJI

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with prosthetic joint infection having had a 2-step exchange.

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

Location

Study Officials

  • Tristan Ferry, Md,PhD

    Hospices Civils de Lyon - Hôpital de la Croix-Rousse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2018

First Posted

August 2, 2018

Study Start

December 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

December 16, 2020

Record last verified: 2020-12

Locations

FR(1)