OsteoArticular Sepsis in Intensive Care unitS (OASIS)

OSTEOARTICULAR SEPSIS ON EQUIPMENT in Intensive Care and Continuing Care Units in France

This is an ambispective observational study of patients admitted to intensive care with a diagnosis of joint prosthesis infection (mainly knee and hip prostheses). The main objective of the study is to describe the profile, care trajectories during the stay (before or after surgery) and prognosis of patients admitted to critical care with such an infection. We also aim to compare prognosis between different groups of patients sharing the same profile and care trajectory, and to assess independent risk factors associated with 2-year mortality among the study population. Finally, we will describe the microbiological and resistance profile of severe osteoarticular device infections requiring critical care admission in France.

This is a descriptive and analytical observational study open to all French public and private hospitals.

Patient data will be retrieved prospectively from patient source files. Only 2-year data (vital status, functional data) will be collected specifically for the study, by telephone contact with the patient or his or her support person.

Study Overview

• Status: Suspended
• Conditions: Prosthetic Joint Infection; Osteoarticular Infection; Intensive Care Patients

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• France
  • France
    • Paris, France, France, 75010
      • Hôpital Lariboisiere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Critical care patients (intensive care and continuing care), admitted between 2018 and 2022 with a principal or associated diagnosis of prosthetic joint infection.

Description

Inclusion Criteria:

• Patient at least 18 years old.
• Hospitalization in critical care (intensive care unit or continuing care unit) between 2018 and 2022 of at least 48 hours, with prosthetic joint infection (hip, knee or shoulder prosthesis infection) as the main or associated diagnosis.

Exclusion Criteria:

• Infection on osteosynthesis material
• Infection on spinal equipment
• Patient with several infected prostheses
• Recurrence of infection on prosthesis with the same microorganism
• Patient opposing data collection
• Patient under legal protection.
• Pregnant or breast-feeding patient.
• Patient deprived of liberty.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Global cohort; All patients admitted to intensive care during the study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The profile, trajectories of care during the stay (before or after surgery) and the prognosis of patients admitted to intensive care for joint prosthesis infection over a 2-year period after admission to intensive care.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite endpoint reflecting poor clinical outcome	Mortality, measured in critical care, at 30 days, 1 year and 2 years; Therapeutic failure at 2 years, defined as mechanical or septic failure.; Functional failure at 2 years, defined as failure to resume walking and usual activities, to return home, or to regain autonomy.	2 years
Mortality at 2 years		2 years
Description of pathogens found in intraoperative samples, and their resistance spectrum		2 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Carine Paré, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: critical care; intensive care; sepsis; prosthetic joint infection; Osteoarticular sepsis; osteoarticular prothetis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis
• Other Study ID Numbers: APHP241174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No