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

NCT ID: NCT03612076

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prosthetic Joint Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

prosthetic joint infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Global cost of management of PJI

Global cost of management of PJI

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Global cost of management of PJI

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Heraeus Medical GmbH

UNKNOWN

Sponsor Role collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tristan Ferry, Md,PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon - Hôpital de la Croix-Rousse

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospices Civils de Lyon

Lyon, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17-089

Identifier Type: -

Identifier Source: org_study_id