Clinical trial NCT05117671: Is the EBJIS Definition of Prosthetic Joint Infection Meaningful in Our Clinical Practice?
Official title: Is the EBJIS Definition of Prosthetic Joint Infection Meaningful in Our Clinical Practice? - a Multicentric Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 1554
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: THA/TKA patients that underwent revision surgery regardless of final aseptic vs. infected diagnosis between 1st of January 2013 until 31.12.2018. All data coming from everyday clinical work. The average patient operated with revision arthroplasty is normally aged above 70 years.

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).

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

Primary outcomes:
measure: Prosthetic Joint Infections (with or without the need for further surgery)
timeFrame: since 01.01.2013 with a minimum of two years follow up
measure: Prosthetic Joint Infections (with or without the need for further surgery)
timeFrame: since 01.01.2013 with a minimum of two years follow up
measure: Need for Revision Surgery
timeFrame: since 01.01.2013 with a minimum of two years follow up
measure: Need for Revision Surgery
timeFrame: since 01.01.2013 with a minimum of two years follow up
measure: Survival rates of different subgroups among each PJI definition
timeFrame: since 01.01.2013 with a minimum of two years follow up
measure: Survival rates between different definitions
timeFrame: since 01.01.2013 with a minimum of two years follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto, Porto, Portugal
city: Basel
country: Switzerland
facility: University Hospital Basel, Orthopedics and Traumatology
Study officials:
affiliation: Centro Hospitalar Universitario do Porto, Orthopedics Department
name: Ricardo Jorge Gomes de Sousa, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: