Periprosthetic Joint Infection (PJI)NCT05117671
Is the EBJIS Definition of Prosthetic Joint Infection Meaningful in Our Clinical Practice?
An observational study of Periprosthetic Joint Infection (PJI), run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periprosthetic Joint Infection (PJI)
- What is being tested?
- data collection to classify infection status
- How many people
- 1,554 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Apr 2021to 19 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- THA/TKA patients that underwent revision surgery regardless of final aseptic vs. infected diagnosis between 01.01.2013 until 31.12.2018
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Switzerland1 site
University Hospital Basel, Orthopedics and Traumatology
Basel, 4031
About this study
Official title: 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).
Read the 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).
- Conditions
- Periprosthetic Joint Infection (PJI)
- Being tested
- data collection to classify infection status
- Keywords
- Infection Likely group, Infection Unlikely group, European Bone and Joint Infection Society (EBJIS), revision total hip arthroplasty (THA), revision total knee arthroplasty (TKA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collection to classify infection statusOther
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).
| Study group | Role | What they receive |
|---|---|---|
| revision total hip or knee arthroplasties | THA/TKA patients that underwent revision surgery between 01.01.2013 until 31.12.2018 Receives: Other: data collection to classify infection status |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)"
Measured: 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).
Measured: 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)"
Measured: 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).
Measured: 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)"
Measured: 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).
Measured: since 01.01.2013 with a minimum of two years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start16 Apr 2021
- Primary completion16 Aug 2021
- Study completion19 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic Joint Infection (PJI)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,554 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Jorge Gomes de Sousa, Prof. Dr. med., Principal investigator, Centro Hospitalar Universitario do Porto, Orthopedics Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117671
- Sponsor's protocol ID
- 2021-00133; mu21Clauss
- Status last verified
- Feb 2024
- First submitted
- 10 Nov 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the EBJIS Definition of Prosthetic Joint Infection Meaningful in Our Clinical Practice? - a Multicentric Validation Study
- ClinicalTrials.gov ID
- NCT05117671
- Acronym / sponsor ID
- 2021-00133; mu21Clauss
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,554 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| revision total hip or knee arthroplasties | – | Other: data collection to classify infection statusTHA/TKA patients that underwent revision surgery between 01.01.2013 until 31.12.2018 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- THA/TKA patients that underwent revision surgery regardless of final aseptic vs. infected diagnosis between 01.01.2013 until 31.12.2018
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collection to classify infection statusReview of medical records of all selected cases (TKA/THA patients) to classify infection status according to different classifications (EBJIS, MSIS/ICM 2013, ICM 2018). | Other | revision total hip or knee arthroplasties |
Primary outcome
Prosthetic Joint Infections (with or without the need for further surgery)
Time frame: 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) among each PJI definition ("Infection Unlikely", "Infection Confirmed", "Infection Likely (but nor confirmed)"
Prosthetic Joint Infections (with or without the need for further surgery)
Time frame: 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
Time frame: since 01.01.2013 with a minimum of two years follow up
Number of Revision Surgeries (for all causes, PJI and aseptic failure) among each PJI definition ("Infection Unlikely", "Infection Confirmed", "Infection Likely (but nor confirmed)"
Need for Revision Surgery
Time frame: 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
Time frame: 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
Time frame: since 01.01.2013 with a minimum of two years follow up
Survival rates between different classifications (EBJIS, MSIS/ICM 2013, ICM 2018).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Jorge Gomes de Sousa, Prof. Dr. med. principal investigator
Centro Hospitalar Universitario do Porto, Orthopedics Department
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periprosthetic Joint Infection (PJI), run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthetic Joint Infections (with or without the need for further surgery) (time frame: since 01.01.2013 with a minimum of two years follow up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.