NCT05117671

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,554

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2021

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

November 10, 2021

Last Update Submit

February 26, 2024

Conditions

Periprosthetic Joint Infection (PJI)

Keywords

Infection Likely groupInfection Unlikely groupEuropean Bone and Joint Infection Society (EBJIS)revision total hip arthroplasty (THA)revision total knee arthroplasty (TKA)

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (1)

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

Interventions

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).

revision total hip or knee arthroplasties

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • THA/TKA patients that underwent revision surgery regardless of final aseptic vs. infected diagnosis between 01.01.2013 until 31.12.2018

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro Hospitalar do Porto, Porto, Portugal

Porto, 4099-001, Portugal

Location

University Hospital Basel, Orthopedics and Traumatology

Basel, 4031, Switzerland

Location

Study Officials

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

    Centro Hospitalar Universitario do Porto, Orthopedics Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2021

First Posted

November 11, 2021

Study Start

April 16, 2021

Primary Completion

August 16, 2021

Study Completion

October 19, 2021

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations

PT(1)CH(1)