Clinical trial NCT03812627: Study of Systemic Impact of Trace Elements Release by Implantable Medical Devices. Identification of Biomarkers of Systemic Inflammation
Official title: Study of Systemic Impact of Trace Elements Release by Implantable Medical Devices. Identification of Biomarkers of Systemic Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biomarker
Systemic Inflammation
Keywords: Implantable medical devices
Biomarker
Systemic inflammation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 159
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: As secondary objectives, the study aims:

* to establish the norms of concentrations of free TE and nanoparticles for some forty of elements (in particular Chrome, Cobalt, Nickel, Titanium, Tantalum, Zirconium, Tungsten, Gold, Silver, Mercury, Molybdenum, Strontium ...) in different materials (blood, urine, hair and the viscera), with non-IMD holder subjects, before and after mineralization of these materials (dead patients and autopsied non-IMD holder subjects and subjects before placement of IMD.
* to evaluate the distribution of concentrations of metals in the same materials and in peri-prothetic environment with IMD holder subjects (dead autopsied patients), more often with no inflammatory sign, with possibility of some probably inflammatory IMD.
* to evaluate the parameters of distributions of concentrations of metals in same materials (with the exception of the viscera) with living IMD holder patients, with inflammatory reaction (during revision surgery).
* to define the most suitable material (accessibility, concentrations, absence of contamination) for follow-up and evolution of inflammation in order to determinate norms of studied metals concentration.
* to determinate proportion between different forms of circulation: particulate form (analysis after full mineralization) or free form (analysis without mineralization, permitting measurement of free forms), trace elements in organism.

Eligibility criteria: 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.

Primary outcomes:
measure: Immunophenotyping of inflammatory cells activated in contact with trace element nanoparticles
timeFrame: through study completion, an average of 2 years
measure: Identification of specific circulating proteins (biomarkers) of inflammation related to trace element release
timeFrame: through study completion, an average of 2 years
measure: Macroscopic characterization of tissue inflammation of autopsied patients
timeFrame: through study completion, an average of 2 years
measure: Microscopic characterization of tissue inflammation of autopsied patients
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Trace elements dosing in liquids and tissues
timeFrame: through study completion, an average of 2 years
measure: Comparison of concentrations of 40 analyzed trace elements
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Garches
country: France
facility: Service de Chirurgie orthopédique, Hôpital Raymond Poincaré
state: Hauts-des-Seine
Study officials:
affiliation: Laboratoire de Pharmacologie-Toxicologie, Hôpital Raymond Poincaré, Garches
name: Jean-Claude Alvarez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopédie et traumatologie, Hôpital Ambroise Paré, Boulogne-Billancourt
name: Thomas BAUER, MD, PhD
role: STUDY_DIRECTOR
References: