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

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).

Study Overview

• Status: Completed
• Conditions: Periprosthetic Joint Infection (PJI)
• Intervention / Treatment: Other: data collection to classify infection status

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 Type: Observational
• Enrollment (Actual): 1554

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto, Porto, Portugal
• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel, Orthopedics and Traumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
revision total hip or knee arthroplasties; THA/TKA patients that underwent revision surgery between 01.01.2013 until 31.12.2018	Other: data 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Ricardo Jorge Gomes de Sousa, Prof. Dr. med., Centro Hospitalar Universitario do Porto, Orthopedics Department

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2021
• Primary Completion (Actual): August 16, 2021
• Study Completion (Actual): October 19, 2021

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Infection Likely group; Infection Unlikely group; European Bone and Joint Infection Society (EBJIS); revision total hip arthroplasty (THA); revision total knee arthroplasty (TKA)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Infections; Communicable Diseases; Arthritis, Infectious
• Other Study ID Numbers: 2021-00133; mu21Clauss

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No