Biomarker Clinical Trial
— PROMETOXOfficial title:
Study of Systemic Impact of Trace Elements Release by Implantable Medical Devices. Identification of Biomarkers of Systemic Inflammation
NCT number | NCT03812627 |
Other study ID # | APHP180539 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 24, 2019 |
Est. completion date | March 19, 2021 |
Verified date | April 2022 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main objective of this study is to evaluate the systemic impact of salting out of trace elements (TE) by metallic and nonmetallic implantable medical devices (IMD) and in particular the immune response of the organism to these trace elements and of their target organs, and to identify circulating protein biomarkers which might indicate an evolution of inflammation caused by an IMD.
Status | Completed |
Enrollment | 159 |
Est. completion date | March 19, 2021 |
Est. primary completion date | March 19, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Inpatient subjects for re-intervention of: hip prosthesis made by ceramic-on-ceramic or metal-on-metal, hip prosthesis made by stainless steel ball and knee prosthesis made by polyethylene-on-metal; - Autopsied patients with and without IMD; - Covered by a health insurance. Exclusion Criteria: - Infection caused by prosthesis resumption; - Professional exposure to metals; - Patient under guardianship. |
Country | Name | City | State |
---|---|---|---|
France | Service de Chirurgie orthopédique, Hôpital Raymond Poincaré | Garches | Hauts-des-Seine |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immunophenotyping of inflammatory cells activated in contact with trace element nanoparticles | Demonstration of systemic inflammation induced by the trace elements existing in IMD with blood and tissue criteria:
1/ A measure by flow cytometry to identify hyperactivated circulating mononuclear cells (macrophages, dendritic cells, T and B lymphocytes), in contact with trace element nanoparticles and thus, to highlight an immunophenotype of this inflammation. |
through study completion, an average of 2 years | |
Primary | Identification of specific circulating proteins (biomarkers) of inflammation related to trace element release | Demonstration of systemic inflammation induced by the trace elements existing in IMD with blood and tissue criteria:
2/ A measure by multiplex LuminexTM (Bio-plex ProTM human inflammation panel, Bio-rad) to identify specific circulating proteins such as TNF, IFN, cytokines, chemokines, metalloproteins, related to activation of the cells of inflammation throughout release of particles and salting out of trace elements by IMD |
through study completion, an average of 2 years | |
Primary | Macroscopic characterization of tissue inflammation of autopsied patients | Demonstration of systemic inflammation induced by the trace elements existing in IMD with blood and tissue criteria:
- 3/ A macroscopic study of organs to determine the possible presence of tumor foci |
through study completion, an average of 2 years | |
Primary | Microscopic characterization of tissue inflammation of autopsied patients | Demonstration of systemic inflammation induced by the trace elements existing in IMD with blood and tissue criteria:
- 4/ Cytopathological analysis on slides, after sampling, fixation, inclusion and staining with hematoxylin-eosin-saffron to evaluate semi-quantitatively the type of inflammation (chronic if mononuclear cells or acute if neutrophils) and degree according to the number of inflammatory cells |
through study completion, an average of 2 years | |
Secondary | Trace elements dosing in liquids and tissues | Trace elements dosing in liquids and tissue by high resolution ICP mass spectrometry in studied sub-population (autopsied IMD holder and non-holder dead subjects, IMD holder living patients with inflammatory reaction and will undergo re-intervention) and in each analyzed material in non-mineralized form, in order to determinate concentrations of free trace elements and after full mineralization to determinate the concentrations of trace elements in nanoparticle form. | through study completion, an average of 2 years | |
Secondary | Comparison of concentrations of 40 analyzed trace elements | Comparison of concentrations of 40 analyzed trace elements in different materials, depending on the groups. | through study completion, an average of 2 years |
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