NCT04722926

Brief Summary

Bone and joint infections (BJI), although infrequent (prevalence of 70 per 100,000 in France), have a significant economic and clinical impact. Between 2008 and 2013, the prevalence of BJI increased and infections involving joint prosthesis (PJI) represent a third of BJI in France. They are most often post-operative and more expensive than native IOAs. This study aims to describe PJI and understand the failure mechanisms of PJI in order to improve their management.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 15, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

January 10, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

10 months

First QC Date

January 15, 2021

Last Update Submit

January 19, 2022

Conditions

Bone and Joint Infection

Keywords

prosthesis joint infectionrelapse

Outcome Measures

Primary Outcomes (9)

  • rate of PJI

    proportion of PJI among all BJI

    between 2018 and 2020

  • Description of PJI

    acute/chronic

    between 2018 and 2020

  • Description of type of prosthesis PJI

    number of prosthesis

    between 2018 and 2020

  • Description of patients having had a PJI

    type of patients: age

    between 2018 and 2020

  • Description of comorbidities of patients having had a PJI

    type of comorbidities..

    between 2018 and 2020

  • rate of bacteria

    epidemiologic description of PJI

    between 2018 and 2020

  • description of antibiotic used

    type of antibiotic : name

    between 2018 and 2020

  • description of antibiotic treatment

    duration of antibiotic treatment

    between 2018 and 2020

  • description of surgical treatment

    type of surgery: 1-step exchange, 2- step exchange, DAIR

    between 2018 and 2020

Secondary Outcomes (2)

  • rate of failure

    between 2018 and 2020

  • description of the failure

    between 2018 and 2020

Study Arms (1)

PJI

Patients having had a PJI

Other: PJI

Interventions

PJIOTHER

patients having had a PJI managed at the CRIOAc Lyon, with or without relapse

PJI

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients having had a PJI between 2018 and 2020 managed at the CRIOAc Lyon

You may qualify if:

  • patients having had a PJI between 2018 and 2020

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

RECRUITING

Related Links

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Eugenie Mabrut, CRA

CONTACT

. 04 26 73 29 38eugenie.mabrut@chu-lyon.fr

Tristan Ferry, MD,PhD

CONTACT

. 04 26 73 29 38tristan.ferry@chu-lyon.fr

Study Design

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

Study Record Dates

First Submitted

January 15, 2021

First Posted

January 25, 2021

Study Start

January 10, 2022

Primary Completion

November 1, 2022

Study Completion

March 1, 2024

Last Updated

January 20, 2022

Record last verified: 2022-01

Locations

FR(1)