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NCT Number: NCT07107685

Prosthetic Joint Infection : Lessons From Deceased Patients in Critical Care.

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.

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Key information

Conditions

Osteoarticular Infections Infections Inflammation Intensive Care Patients Pathologic Processes Pathological Conditions, Signs and Symptoms Prosthetic Joint Infection Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Lariboisière

Paris, France, 75010

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Global cohort

Other

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

Primary outcomes

  1. Epidemiological description of deceased patients

    Time frame: 2 years

    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).

Secondary outcomes

  1. Composite endpoint reflecting poor clinical outcome

    Time frame: 2 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.

  2. Mortality at 2 years

    Time frame: 2 years

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

    Time frame: 2 years

    Special focus on: Gram-positive bacteria (Staphylococcus, Streptococcus, Enterococcus), Gram-negative bacteria (Enterobacteriacea, Pseudmononas), slow-growing bacteria (Cutibacterium, Corynenbacteria), yeasts; resistance mechanisms (meticillin, rifampicin, quinolone, glycopeptide, ESBL, carbapenem).

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin CHOUSTERMAN, MD, PhD

CONTACT

[email protected]

Benjamin SOYER, MD, Msc

CONTACT

[email protected]

+33 1 49 95 85 15

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Osteoarticular Sepsis In Intensive Care Units : a Retrospective Study About Deceased Patients.

Acronym: OASIS²

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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