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Completed

NCT Number: NCT05117671

Is the EBJIS Definition of Prosthetic Joint Infection Meaningful in Our Clinical Practice?

This retrospective multi-center, multi-national cohort study is to validate the European Bone and Joint Infection Society (EBJIS) Definition of Prosthetic Joint Infection. Specifically, it is to analyze the outcome of the Infection Likely group and compare it to the Infection Unlikely group as well as other subgroups within previous validated definitions (Musculoskeletal Infection Society (MSIS)/International Consensus on Musculoskeletal Infection (ICM) 2013 and ICM 2018).

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Key information

Conditions

Periprosthetic Joint Infection (PJI)

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Hospitalar do Porto, Porto, Portugal, Porto, Portugal

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About this study

Periprosthetic joint infection (PJI) is a major burden for healthcare systems. The European Bone and Joint Infection Society (EBJIS) proposed a new set of criteria introducing a three level 'traffic light' distinction: Infection Unlikely, Infection Confirmed but also an intermediate group called Infection Likely (but nor confirmed). This retrospective multi-center, multi-national cohort study is to validate the EBJIS Definition of Prosthetic Joint Infection. Specifically, it is to analyze the outcome of the Infection Likely group and compare it to the Infection Unlikely group as well as other subgroups within previous validated definitions (Musculoskeletal Infection Society (MSIS)/International Consensus on Musculoskeletal Infection (ICM) 2013 and ICM 2018).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • THA/TKA patients that underwent revision surgery regardless of final aseptic vs. infected diagnosis between 01.01.2013 until 31.12.2018

Exclusion criteria

  • less than two years follow up
  • less than four intraoperative microbiology samples (synovial fluid, tissue samples, implant sonication)
  • no preoperative/intraoperative synovial fluid differential leukocyte count

Treatment and study plan

data collection to classify infection status

Other

Review of medical records of all selected cases (TKA/THA patients) to classify infection status according to different classifications (EBJIS, MSIS/ICM 2013, ICM 2018).

Primary outcomes

  1. Prosthetic Joint Infections (with or without the need for further surgery)

    Time frame: since 01.01.2013 with a minimum of two years follow up

    Number of Prosthetic Joint Infections (with or without the need for further surgery) among each PJI definition ("Infection Unlikely", "Infection Confirmed", "Infection Likely (but nor confirmed)"

  2. Prosthetic Joint Infections (with or without the need for further surgery)

    Time frame: since 01.01.2013 with a minimum of two years follow up

    Number of Prosthetic Joint Infections (with or without the need for further surgery) according to different classifications (EBJIS, MSIS/ICM 2013, ICM 2018).

  3. Need for Revision Surgery

    Time frame: since 01.01.2013 with a minimum of two years follow up

    Number of Revision Surgeries (for all causes, PJI and aseptic failure) among each PJI definition ("Infection Unlikely", "Infection Confirmed", "Infection Likely (but nor confirmed)"

  4. Need for Revision Surgery

    Time frame: since 01.01.2013 with a minimum of two years follow up

    Number of Revision Surgeries (for all causes, PJI and aseptic failure) according to different classifications (EBJIS, MSIS/ICM 2013, ICM 2018).

  5. Survival rates of different subgroups among each PJI definition

    Time frame: since 01.01.2013 with a minimum of two years follow up

    Survival rates of different subgroups among each PJI definition ("Infection Unlikely", "Infection Confirmed", "Infection Likely (but nor confirmed)"

  6. Survival rates between different definitions

    Time frame: since 01.01.2013 with a minimum of two years follow up

    Survival rates between different classifications (EBJIS, MSIS/ICM 2013, ICM 2018).

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Is the EBJIS Definition of Prosthetic Joint Infection Meaningful in Our Clinical Practice? - a Multicentric Validation Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 11, 2021
Registry last updated
Feb 28, 2024

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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