CompletedNot Applicable

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

Portugal, Switzerland1,554 participantsStarted 2021-04-16

Plain-language 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).

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prosthetic Joint Infections (with or without the need for further surgery)

Timeframe: since 01.01.2013 with a minimum of two years follow up

Prosthetic Joint Infections (with or without the need for further surgery)

Timeframe: since 01.01.2013 with a minimum of two years follow up

Need for Revision Surgery

Timeframe: since 01.01.2013 with a minimum of two years follow up

Need for Revision Surgery

Timeframe: since 01.01.2013 with a minimum of two years follow up

Survival rates of different subgroups among each PJI definition

Timeframe: since 01.01.2013 with a minimum of two years follow up

Survival rates between different definitions

Timeframe: since 01.01.2013 with a minimum of two years follow up

Trial details

NCT IDNCT05117671

SponsorUniversity Hospital, Basel, Switzerland

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-08-16

View on ClinicalTrials.gov More Periprosthetic Joint Infection (PJI) trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Prosthetic Joint Infections (with or without the need for further surgery)

Timeframe: since 01.01.2013 with a minimum of two years follow up

Prosthetic Joint Infections (with or without the need for further surgery)

Timeframe: since 01.01.2013 with a minimum of two years follow up

Need for Revision Surgery

Timeframe: since 01.01.2013 with a minimum of two years follow up

Need for Revision Surgery

Timeframe: since 01.01.2013 with a minimum of two years follow up

Survival rates of different subgroups among each PJI definition

Timeframe: since 01.01.2013 with a minimum of two years follow up

Survival rates between different definitions

Timeframe: since 01.01.2013 with a minimum of two years follow up