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

NCT ID: NCT05117671

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1554 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-16

Study Completion Date

2021-10-19

Brief Summary

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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

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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

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Periprosthetic Joint Infection (PJI)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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revision total hip or knee arthroplasties

THA/TKA patients that underwent revision surgery between 01.01.2013 until 31.12.2018

data collection to classify infection status

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricardo Jorge Gomes de Sousa, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar Universitario do Porto, Orthopedics Department

Locations

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Centro Hospitalar do Porto, Porto, Portugal

Porto, , Portugal

Site Status

University Hospital Basel, Orthopedics and Traumatology

Basel, , Switzerland

Site Status

Countries

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Portugal Switzerland

Other Identifiers

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2021-00133; mu21Clauss

Identifier Type: -

Identifier Source: org_study_id

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