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

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

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

Conditions
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Periprosthetic Joint Infection (PJI)

Intervention / Treatment
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* Other: data collection to classify infection status


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| revision total hip or knee arthroplasties<br>THA/TKA patients that underwent revision surgery between 01.01.2013 until 31.12.2018 | Other: data collection to classify infection status<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prosthetic Joint Infections (with or without the need for further surgery) | 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) | since 01.01.2013 with a minimum of two years follow up | 
| Prosthetic Joint Infections (with or without the need for further surgery) | Number of Prosthetic Joint Infections (with or without the need for further surgery) according to different classifications (EBJIS, MSIS/ICM 2013, ICM 2018). | since 01.01.2013 with a minimum of two years follow up | 
| Need for Revision Surgery | Number of Revision Surgeries (for all causes, PJI and aseptic failure) among each PJI definition (Infection Unlikely, Infection Confirmed, Infection Likely (but nor confirmed) | since 01.01.2013 with a minimum of two years follow up | 
| Need for Revision Surgery | Number of Revision Surgeries (for all causes, PJI and aseptic failure) according to different classifications (EBJIS, MSIS/ICM 2013, ICM 2018). | since 01.01.2013 with a minimum of two years follow up | 
| Survival rates of different subgroups among each PJI definition | Survival rates of different subgroups among each PJI definition (Infection Unlikely, Infection Confirmed, Infection Likely (but nor confirmed) | since 01.01.2013 with a minimum of two years follow up | 
| Survival rates between different definitions | Survival rates between different classifications (EBJIS, MSIS/ICM 2013, ICM 2018). | since 01.01.2013 with a minimum of two years follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infection Likely group, Infection Unlikely group, European Bone and Joint Infection Society (EBJIS), revision total hip arthroplasty (THA), revision total knee arthroplasty (TKA)