NCT07107685

Brief Summary

This is an observational, retrospective, multicenter study based on the use of demographic, clinical and biological data from deceased patients admitted between 2018 and 2022 to critical care with a principal or associated diagnosis of joint prosthesis infection. Data from this study will be combined with that from the OASIS study (APHP241174/ ID-RCB: 2024-A01769-38) concerning osteoarticular sepsis on prosthetic material in critical care of living patients. The aim of this study is to improve our knowledge of the profile, care trajectories and outcomes of patients hospitalized in critical care in the context of osteoarticular material sepsis. The results of the study could help identify at-risk populations and improve management strategies for patients with osteoarticular sepsis.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 24, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2026

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

July 9, 2025

Last Update Submit

September 25, 2025

Conditions

Keywords

Osteoarticular sepsissepsisosteoarticular prothetisintensive carecritical careprosthetic joint infection

Outcome Measures

Primary Outcomes (1)

  • Epidemiological description of deceased patients

    Demographic data, medical history, history of Periprosthetic Joint Infection (timing, diagnosis, surgery, antibiotics), data in intensive care unit (leng of stay, organ failure, drugs and mechanical support, biological data) and outcome (time of death within 2 years after admission to Intensive Care Units).

    2 years

Secondary Outcomes (3)

  • Composite endpoint reflecting poor clinical outcome

    2 years

  • Mortality at 2 years

    2 years

  • Epidemiological description based on the number (n) and proportion (%) of bacterial strains found in samples collected during the operation.

    2 years

Interventions

All deceased patients admitted to intensive care during the study period and satisfying the eligibility criteria.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critical care patients (intensive care and continuing care), admitted between 2018 and 2022 with a principal or associated diagnosis of joint prosthesis infection, who have since died.

You may qualify if:

  • Patient aged 18 years or older.
  • Hospitalization in critical care (intensive care unit or continuing care unit) between 2018 and 2022, lasting at least 48 hours, with a prosthetic joint infection (hip, knee, or shoulder prosthesis infection) as the primary or associated diagnosis.
  • Deceased patient who had not refused data processing.

You may not qualify if:

  • Infection involving osteosynthesis material
  • Infection involving spinal instrumentation
  • Patient with multiple infected prostheses
  • Recurrence of prosthetic infection with the same microorganism as a previous episode
  • Patient under legal protection
  • Pregnant or breastfeeding patient
  • Patient deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lariboisière

Paris, France, 75010, France

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Carine PARE

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Central Study Contacts

Benjamin SOYER, MD, Msc

CONTACT

Benjamin CHOUSTERMAN, MD, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 9, 2025

First Posted

August 6, 2025

Study Start

September 24, 2025

Primary Completion

March 24, 2026

Study Completion

March 24, 2026

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations