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Physiopathology of Prosthetic Joint Infections

Physiopathology of Prosthetic Joint Infections : a Pilot Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05551572
Acronym
PROTHEE-PILOTE
Enrollment
20
Registered
2022-09-22
Start date
2022-10-31
Completion date
2022-10-31
Last updated
2022-09-22

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

Conditions

Prosthetic-joint Infection

Keywords

prosthetic joint infection, prosthesis loosening, Staphylococcus, osteoblast, immune system, microenvironment

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
markers of bone loss12 monthsImmunohistochemistry detection of Tartrate-resistant acid phosphatase cells (TRAP); cathepsin K; Matrix Metalloproteinase 9 (MMP9); sclerostin

Secondary

MeasureTime frameDescription
differentiation between osteoclasts from mononuclear phagocytes12 monthsenzyme-linked immunosorbent (ELISA) and/or flow cytometry assays using specific antibodies
markers of cellular activity in the bone microenvironment12 monthsimmunohistochemistry detection of nuclear factor-activated T cells c1 (NFATc1); Matrix Metalloproteinase 9 (MMP9); Fibroblast growth factor 23 (FGF23)
immune-profiling of bone microenvironment12 monthsmapping lymphoid and myeloid cells by spectral flow cytometry assay
inflammatory mediators in the bone microenvironment12 monthsflow cytometry quantification of cytokine producing cells

Countries

France

Contacts

Primary ContactMartine COHEN-SOLAL, MD, PhD
martine.cohen-solal@aphp.fr+33(0)1 49 95 63 58

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026