Status:
COMPLETED
Study of Systemic Impact of Trace Elements Release by Implantable Medical Devices. Identification of Biomarkers of Systemic Inflammation
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Biomarker
Systemic Inflammation
Eligibility:
All Genders
Phase:
NA
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 res...
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, ...
Eligibility Criteria
Inclusion
- 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
- Infection caused by prosthesis resumption;
- Professional exposure to metals;
- Patient under guardianship.
Key Trial Info
Start Date :
June 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2021
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT03812627
Start Date
June 24 2019
End Date
March 19 2021
Last Update
April 21 2022
Active Locations (1)
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1
Service de Chirurgie orthopédique, Hôpital Raymond Poincaré
Garches, Hauts-des-Seine, France, 92380