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

Completed

• Conditions: Periprosthetic Joint Infection (PJI)
• Interventions: Other: data collection to classify infection status

• Registration Number: NCT05117671
• Lead Sponsor: University Hospital, Basel, Switzerland

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).

Study Timeline

• Study Start: 2021-04-16
• Primary Completion: 2021-08-16
• Study Completion: 2021-10-19
• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1554

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
revision total hip or knee arthroplasties	data collection to classify infection status	THA/TKA patients that underwent revision surgery between 01.01.2013 until 31.12.2018

Primary Outcome Measures

Name	Time	Method
Prosthetic Joint Infections (with or without the need for further surgery)	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	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	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	since 01.01.2013 with a minimum of two years follow up	Survival rates between different classifications (EBJIS, MSIS/ICM 2013, ICM 2018).

Trial Locations

Locations (2)

University Hospital Basel, Orthopedics and Traumatology; 🇨🇭 Basel, Switzerland

Centro Hospitalar do Porto, Porto, Portugal; 🇵🇹 Porto, Portugal