NCT05551572

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

Same day

First QC Date

June 10, 2022

Last Update Submit

September 20, 2022

Conditions

Prosthetic-joint Infection

Keywords

prosthetic joint infectionprosthesis looseningStaphylococcusosteoblastimmune systemmicroenvironment

Outcome Measures

Primary Outcomes (1)

  • markers of bone loss

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

    12 months

Secondary Outcomes (4)

  • 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 Arms (2)

septic samples

patients undergoing revision surgery for prosthetic joint infection

aseptic samples

patients undergoing revision surgery for prosthetic replacement without infection

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients eligible for lower limb revision surgery for infected or non-infected prosthesis. Primary care clinic.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lariboisière

Paris, 75010, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human tissue samples collected during surgery for prosthetic joint infection

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martine COHEN-SOLAL, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martine COHEN-SOLAL, MD, PhD

CONTACT

+33(0)1 49 95 63 58martine.cohen-solal@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2022

First Posted

September 22, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

September 22, 2022

Record last verified: 2022-09

Locations

FR(1)