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OsteoArticular Sepsis in Intensive Care unitS

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

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06627842
Acronym
OASIS
Enrollment
150
Registered
2024-10-04
Start date
2025-03-31
Completion date
2026-10-01
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Patients, Osteoarticular Infection, Prosthetic Joint Infection

Keywords

Osteoarticular sepsis, sepsis, osteoarticular prothetis, intensive care, critical care, prosthetic joint infection

Brief summary

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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

MeasureTime frameDescription
Composite endpoint reflecting poor clinical outcome2 years* 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.
Mortality at 2 years2 years
Description of pathogens found in intraoperative samples, and their resistance spectrum2 years

Countries

France

Contacts

STUDY_DIRECTORCarine PARE

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026