NCT03473392

Brief Summary

The results found in the literature do not allow to define objectively the indications respective for a one-step or a two-step exchange of prosthetic joint. Some criteria could help to decide for one-step exchange or two-step exchange: bacteria is/are identified, profile of the bacteria, anesthetic difficulties,.. A puncture could allow to identify the bacteria involved in the prosthetic joint infection (PJI) and an antibiotherapy for a few days can be given to the patient in order to decrease the inoculum. Then, a one-step exchange can be performed. The purpose of this study is to describe the management of patients who had a pre-treatment before a one-step exchange of their prosthetic joint.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2016

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

1.8 years

First QC Date

March 15, 2018

Last Update Submit

March 15, 2018

Conditions

Exchange of Prosthetic JointProsthetic Joint InfectionOne-step Exchange

Keywords

pre-treatmentantibiotherapyprosthetic joint infectiontreatment failure

Outcome Measures

Primary Outcomes (1)

  • bacterial epidemiology

    This outcome will describe the bacterial epidemiology identified with a punction, the antibiotherapy used for pre-treatment, the characteristics of patients and the PJI.

    at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

Secondary Outcomes (1)

  • Treatment failure

    at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

Eligibility Criteria

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

patients having had puncture which allowed to identify bacteria responsible for the IPA and having had a pre-treatment for a few days against those bacteria before a one-step exchange of prosthetic joint

You may qualify if:

  • patient with prosthetic joint infection and having had a pre-treatment, managed at the Croix-Rousse Hospital
  • \> 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Tristan FERRY

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 15, 2018

First Posted

March 22, 2018

Study Start

April 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 22, 2018

Record last verified: 2018-03