Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Re-intervention of hip prosthesis made of ceramic or metal | Experimental | 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) |
|
| Re-intervention of hip prosthesis of stainless steel ball | Experimental | 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. |
|
| Re-intervention of knee prosthesis | Experimental | 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. |
|
| Dead patients IMD holders autopsied | Experimental | Autopsy: 80 dead patients IMD holders will be autopsied. |
|
| Dead patients non-IMD holders autopsied |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood, urine, hair, synovial fluid and peri-prosthetic tissue collections | Other | All inpatient subjects: following samples will be collected during hospitalization: Twice blood and urine collections:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean-Claude Alvarez, MD, PhD | Laboratoire de Pharmacologie-Toxicologie, Hôpital Raymond Poincaré, Garches | Principal Investigator |
| Thomas BAUER, MD, PhD | Orthopédie et traumatologie, Hôpital Ambroise Paré, Boulogne-Billancourt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie orthopédique, Hôpital Raymond Poincaré | Garches | Hauts-des-Seine | 92380 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Autopsy: dead patients non-IMD holders autopsied, 30 subjects in this arm. |
|
| patients before first prosthesis surgery | Active Comparator | Before the initial prosthesis surgery: 30 patients Blood, urine, hair, synovial fluid and peri-prosthetic tissue collections will be done |
|
|
| Autopsy | Other | Dead patients will be autopsied: hair, urine, blood, peri-prosthetic tissue and viscera (liver, kidney, spleen, brain, heart, lung) sampling for each autopsy. |
|
| 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. | through study completion, an average of 2 years |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D014554 | Urination |
| D001344 | Autopsy |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D014553 | Urinary Tract Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
Not provided
Not provided