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

Periprosthetic Joint Infection (PJI) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05117671
• Other study ID #: 2021-00133; mu21Clauss
• Status: Completed
• Start date: April 16, 2021
• Est. completion date: October 19, 2021

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1554
• Est. completion date: October 19, 2021
• Est. primary completion date: August 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infections
• Periprosthetic Joint Infection (PJI)

Intervention

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).

Locations

Country	Name	City	State
Portugal	Centro Hospitalar do Porto, Porto, Portugal	Porto
Switzerland	University Hospital Basel, Orthopedics and Traumatology	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Countries where clinical trial is conducted

Portugal,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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