Study of Systemic Impact of Trace Elements Release by Implantable Medical Devices. Identification of Biomarkers of Systemic Inflammation (PROMETOX)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Systemic Inflammation

Biomarker

Treatments

Other: Autopsy

Other: Blood, urine, hair, synovial fluid and peri-prosthetic tissue collections

Study type

Interventional

Funder types

Other

Identifiers

NCT03812627

APHP180539

Details and patient eligibility

About

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.

Full 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.

Enrollment

159 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

159 participants in 6 patient groups

Re-intervention of hip prosthesis made of ceramic or metal

Experimental group

Description:

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)

Treatment:

Other: Blood, urine, hair, synovial fluid and peri-prosthetic tissue collections

Re-intervention of hip prosthesis of stainless steel ball

Experimental group

Description:

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.

Treatment:

Other: Blood, urine, hair, synovial fluid and peri-prosthetic tissue collections

Re-intervention of knee prosthesis

Experimental group

Description:

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.

Treatment:

Other: Blood, urine, hair, synovial fluid and peri-prosthetic tissue collections

Dead patients IMD holders autopsied

Experimental group

Description:

Autopsy: 80 dead patients IMD holders will be autopsied.

Treatment:

Other: Autopsy

Dead patients non-IMD holders autopsied

Active Comparator group

Description:

Autopsy: dead patients non-IMD holders autopsied, 30 subjects in this arm.