Physiopathology of Prosthetic Joint Infections

Not yet recruiting

• Conditions: Prosthetic-joint Infection

• Registration Number: NCT05551572
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2022-06-10
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-20
• Last Update Submitted: 2022-09-20
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-22
• Study Start: 2022-10
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
markers of bone loss	12 months	Immunohistochemistry detection of Tartrate-resistant acid phosphatase cells (TRAP); cathepsin K; Matrix Metalloproteinase 9 (MMP9); sclerostin

Secondary Outcome Measures

Name	Time	Method
markers of cellular activity in the bone microenvironment	12 months	immunohistochemistry detection of nuclear factor-activated T cells c1 (NFATc1); Matrix Metalloproteinase 9 (MMP9); Fibroblast growth factor 23 (FGF23)
immune-profiling of bone microenvironment	12 months	mapping lymphoid and myeloid cells by spectral flow cytometry assay
inflammatory mediators in the bone microenvironment	12 months	flow cytometry quantification of cytokine producing cells
differentiation between osteoclasts from mononuclear phagocytes	12 months	enzyme-linked immunosorbent (ELISA) and/or flow cytometry assays using specific antibodies

Trial Locations

Locations (1)

Hôpital Lariboisière; 🇫🇷 Paris, France