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

NACompletedINTERVENTIONAL
Enrollment

159

Participants

Timeline

Start Date

June 24, 2019

Primary Completion Date

March 19, 2021

Study Completion Date

March 19, 2021

Conditions
BiomarkerSystemic Inflammation
Interventions
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"

OTHER

Autopsy

Dead patients will be autopsied: hair, urine, blood, peri-prosthetic tissue and viscera (liver, kidney, spleen, brain, heart, lung) sampling for each autopsy.

Trial Locations (1)

92380

Service de Chirurgie orthopédique, Hôpital Raymond Poincaré, Garches

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT03812627 - Study of Systemic Impact of Trace Elements Release by Implantable Medical Devices. Identification of Biomarkers of Systemic Inflammation | Biotech Hunter | Biotech Hunter