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

NCT03812627 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2022-04-21

No results posted yet for this study

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.

Conditions

  • Biomarker
  • Systemic 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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jean-Claude Alvarez, MD, PhD · Laboratoire de Pharmacologie-Toxicologie, Hôpital Raymond Poincaré, Garches

  • Thomas BAUER, MD, PhD · Orthopédie et traumatologie, Hôpital Ambroise Paré, Boulogne-Billancourt

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2021-03-19
Completion
2021-03-19

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03812627 on ClinicalTrials.gov