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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05117671
Enrollment
1554
Registered
2021-11-11
Start date
2021-04-16
Completion date
2021-10-19
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periprosthetic Joint Infection (PJI)

Keywords

Infection Likely group, Infection Unlikely group, European Bone and Joint Infection Society (EBJIS), revision total hip arthroplasty (THA), revision total knee arthroplasty (TKA)

Brief summary

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

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).

Interventions

OTHERdata collection to classify infection status

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).

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prosthetic Joint Infections (with or without the need for further surgery)since 01.01.2013 with a minimum of two years follow upNumber 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)
Need for Revision Surgerysince 01.01.2013 with a minimum of two years follow upNumber of Revision Surgeries (for all causes, PJI and aseptic failure) among each PJI definition (Infection Unlikely, Infection Confirmed, Infection Likely (but nor confirmed)
Survival rates of different subgroups among each PJI definitionsince 01.01.2013 with a minimum of two years follow upSurvival rates of different subgroups among each PJI definition (Infection Unlikely, Infection Confirmed, Infection Likely (but nor confirmed)
Survival rates between different definitionssince 01.01.2013 with a minimum of two years follow upSurvival rates between different classifications (EBJIS, MSIS/ICM 2013, ICM 2018).

Countries

Portugal, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026