Prosthetic-joint InfectionPROTHEE-PILOTENCT05551572
Physiopathology of Prosthetic Joint Infections
An observational study of Prosthetic-joint Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic-joint Infection
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2022to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients eligible for lower limb revision surgery for infected or non-infected prosthesis. Primary care clinic.
Who may be able to join
- 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
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Lariboisière
Paris, 75010
Anne-Claude CREMIEUX, Md, PhD, +33(0) 1 42 49 40 15, anne-claude.cremieux@aphp.fr
About this study
Official title: Physiopathology of Prosthetic Joint Infections : a Pilot Study
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.
Read the 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.
- Conditions
- Prosthetic-joint Infection
- Keywords
- prosthetic joint infection, prosthesis loosening, Staphylococcus, osteoblast, immune system, microenvironment
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| septic samples | patients undergoing revision surgery for prosthetic joint infection | |
| aseptic samples | patients undergoing revision surgery for prosthetic replacement without infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
markers of bone loss
Immunohistochemistry detection of Tartrate-resistant acid phosphatase cells (TRAP); cathepsin K; Matrix Metalloproteinase 9 (MMP9); sclerostin
Measured: 12 months
Secondary outcomes (4)
markers of cellular activity in the bone microenvironment
immunohistochemistry detection of nuclear factor-activated T cells c1 (NFATc1); Matrix Metalloproteinase 9 (MMP9); Fibroblast growth factor 23 (FGF23)
Measured: 12 months
immune-profiling of bone microenvironment
mapping lymphoid and myeloid cells by spectral flow cytometry assay
Measured: 12 months
inflammatory mediators in the bone microenvironment
flow cytometry quantification of cytokine producing cells
Measured: 12 months
differentiation between osteoclasts from mononuclear phagocytes
enzyme-linked immunosorbent (ELISA) and/or flow cytometry assays using specific antibodies
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic-joint InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine COHEN-SOLAL, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551572
- Sponsor's protocol ID
- APHP220417
- Acronym
- PROTHEE-PILOTE
- Status last verified
- Sep 2022
- First submitted
- 10 Jun 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiopathology of Prosthetic Joint Infections : a Pilot Study
- ClinicalTrials.gov ID
- NCT05551572
- Acronym / sponsor ID
- PROTHEE-PILOTE / APHP220417
- Conditions
- Prosthetic-joint Infection
- Keywords
- prosthetic joint infection, prosthesis loosening, Staphylococcus, osteoblast, immune system, microenvironment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| septic samples | – | –patients undergoing revision surgery for prosthetic joint infection |
| aseptic samples | – | –patients undergoing revision surgery for prosthetic replacement without infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for lower limb revision surgery for infected or non-infected prosthesis. Primary care clinic.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
markers of bone loss
Time frame: 12 months
Immunohistochemistry detection of Tartrate-resistant acid phosphatase cells (TRAP); cathepsin K; Matrix Metalloproteinase 9 (MMP9); sclerostin
4 secondary outcomes
markers of cellular activity in the bone microenvironment
Time frame: 12 months
immune-profiling of bone microenvironment
Time frame: 12 months
inflammatory mediators in the bone microenvironment
Time frame: 12 months
differentiation between osteoclasts from mononuclear phagocytes
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine COHEN-SOLAL, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthetic-joint Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martine COHEN-SOLAL, MD, PhD (+33(0)1 49 95 63 58, martine.cohen-solal@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
markers of bone loss (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.