An interventional study of Blood, urine, hair, synovial fluid and peri-prosthetic tissue collections and Autopsy in Biomarker and Systemic Inflammation, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2022-04-21.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
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.
As secondary objectives, the study aims:
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This study's enrollment of 159 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.
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Exclusion Criteria:
Re-intervention surgery: blood, urine, hair, synovial fluid and peri-prosthetic tissue collections. 50 patients for re-intervention of hip prosthesis with friction couples of: ceramic-on-ceramic or metal-on-metal (25 patients by group)
Other: Blood, urine, hair, synovial fluid and peri-prosthetic tissue collections
Re-intervention surgery: blood, urine, hair, synovial fluid and peri-prosthetic tissue collections. 50 patients for re-intervention of hip prosthesis of stainless steel ball.
Other: Blood, urine, hair, synovial fluid and peri-prosthetic tissue collections
Re-intervention surgery: blood, urine, hair, synovial fluid and peri-prosthetic tissue collections. 50 inpatient subjects for re-intervention of knee prosthesis polyethylene-on-metal.
Other: Blood, urine, hair, synovial fluid and peri-prosthetic tissue collections
Autopsy: 80 dead patients IMD holders will be autopsied.
Other: Autopsy
Autopsy: dead patients non-IMD holders autopsied, 30 subjects in this arm.
Other: Autopsy
Before the initial prosthesis surgery: 30 patients Blood, urine, hair, synovial fluid and peri-prosthetic tissue collections will be done
Other: Blood, urine, hair, synovial fluid and peri-prosthetic tissue collections
All inpatient subjects: following samples will be collected during hospitalization: Twice blood and urine collections: 1. at the beginning of hospitalization: 10 ml of blood + 5 ml of urine; 2. at the end of hospitalization: 5 ml of blood + 5 ml of urine. Synovial fluid collection: 1 ml Peri-prosthetic tissue collection: about 1 cm3 Hair collection: a single hair of 0.5 cm diameter
Dead patients will be autopsied: hair, urine, blood, peri-prosthetic tissue and viscera (liver, kidney, spleen, brain, heart, lung) sampling for each autopsy.
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.
Time frame: through study completion, an average of 2 years
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
Time frame: through study completion, an average of 2 years
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
Time frame: through study completion, an average of 2 years
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
Time frame: through study completion, an average of 2 years
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.
Time frame: through study completion, an average of 2 years
Comparison of concentrations of 40 analyzed trace elements
Comparison of concentrations of 40 analyzed trace elements in different materials, depending on the groups.
Time frame: through study completion, an average of 2 years
Plan to share: No
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Assistance Publique - Hôpitaux de Paris