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Clinical Trials/NCT05117671
NCT05117671
Completed
Not Applicable

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

University Hospital, Basel, Switzerland2 sites in 2 countries1,554 target enrollmentApril 16, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periprosthetic Joint Infection (PJI)
Sponsor
University Hospital, Basel, Switzerland
Enrollment
1554
Locations
2
Primary Endpoint
Prosthetic Joint Infections (with or without the need for further surgery)
Status
Completed
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 16, 2021
End Date
October 19, 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

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).

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)"

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).

Study Sites (2)

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