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Clinical Trials/NCT05551572
NCT05551572
Not yet recruiting
Not Applicable

Physiopathology of Prosthetic Joint Infections : a Pilot Study

Assistance Publique - Hôpitaux de Paris1 site in 1 country20 target enrollmentOctober 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prosthetic-joint Infection
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
20
Locations
1
Primary Endpoint
markers of bone loss
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2022
End Date
October 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

  • Not provided

Outcomes

Primary Outcomes

markers of bone loss

Time Frame: 12 months

Immunohistochemistry detection of Tartrate-resistant acid phosphatase cells (TRAP); cathepsin K; Matrix Metalloproteinase 9 (MMP9); sclerostin

Secondary Outcomes

  • markers of cellular activity in the bone microenvironment(12 months)
  • immune-profiling of bone microenvironment(12 months)
  • inflammatory mediators in the bone microenvironment(12 months)
  • differentiation between osteoclasts from mononuclear phagocytes(12 months)

Study Sites (1)

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