Clinical trial NCT05551572: Physiopathology of Prosthetic Joint Infections
Official title: Physiopathology of Prosthetic Joint Infections : a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prosthetic-joint Infection
Keywords: prosthetic joint infection
prosthesis loosening
Staphylococcus
osteoblast
immune system
microenvironment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for lower limb revision surgery for infected or non-infected prosthesis. Primary care clinic.

Brief summary: This study aim to explore cellular responses of bone and immune cells to bacterial infections observed in patients with prosthetic joint infections. The investigators will analyze clinical data and tissue samples collected from patients undergoing surgery as part of their usual care for prosthetic joint infections. These research will be conducted on three different hospitals in Paris: Lariboisière (AP-HP), Cochin (AP-HP) and Croix Saint-Simon.

Detailed description: The number of prosthetic joint infections (PJI) new cases in France is estimated at 2000/2500 cases per year. PJI, mainly caused by staphylococci, are serious infections responsible for significant morbidity result of inflammation and bone destruction (osteomyelitis). Despite optimal medical and surgical management, a risk of failure and recurrence exists, which varies depending on the situation.

In addition to the deterioration in patients' quality of life, the economic cost for the health care system is very high, in particular because of prolonged hospitalizations, complex treatments, and frequent readmissions. Thus, the adequate management of PJI is a major public health issue.

In this context, new therapeutic approaches are urgent medical needs for the management of patients with PJI.

Thus, the identification of the biological mechanisms (immunology, microbiology, bone physiology) underlying these infections is essential. Indeed, the impact of bacterial infections on bone homeostasis is poorly documented. Although several biological mechanisms have been suggested the host-pathogen interaction and the close links between bacterial infection and biological response of bone cells to microorganisms and their environment warrant to be explored.

Eligibility criteria: Inclusion Criteria:

* 18 years-old and older
* Patient eligible for lower limb revision surgery (revision surgery for infected or non-infected prosthesis)
* Patient affiliated to a social security system
* Oral consent to the research

Exclusion Criteria:

* NA

Primary outcomes:
measure: markers of bone loss
timeFrame: 12 months
Secondary outcomes:
measure: markers of cellular activity in the bone microenvironment
timeFrame: 12 months
measure: immune-profiling of bone microenvironment
timeFrame: 12 months
measure: inflammatory mediators in the bone microenvironment
timeFrame: 12 months
measure: differentiation between osteoclasts from mononuclear phagocytes
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Martine COHEN-SOLAL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: