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OpenTrials
Completed

NCT Number: NCT03473392

One-stage Exchange Arthroplasty for Chronic Prosthetic Joint Infections

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.

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Key information

Conditions

Exchange of Prosthetic Joint One-step Exchange Prosthetic Joint Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. bacterial epidemiology

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

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

Secondary outcomes

  1. Treatment failure

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

    Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 22, 2018
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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