Electrochemical Behavior of Biomedical Alloys Exposed to Human Synovial Fluid
Comportement Electrochimique D'alliages Biomedicaux Dans Des Liquides Synoviaux En Fonction De L'etat Pathologique
1 other identifier
observational
150
1 country
1
Brief Summary
Biomedical implant metals are reactive when in contact with body fluids. Some reactions may adverse the biocompatibility character of the material and should be studied. This can be achieved by direct measurement through electrochemical, gravimetric, spectrophotometric and surface analysis of reaction occurring at the interface between functionalized metal samples and body fluids (synovia) directly extracted from patients. The general aim of this project is to contribute to develop a comprehensive vision of interfacial reactions occurring on biomedical alloy surfaces exposed to human synovial fluid and to link them to clinical data
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2019
CompletedFirst Posted
Study publicly available on registry
July 19, 2019
CompletedStudy Start
First participant enrolled
October 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMarch 30, 2025
December 1, 2024
4 years
May 24, 2019
March 25, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Open circuit potential
through a potentiostat device
only 1 measurement immediatly after collection, the day of collection (1 day)
Changes in Corrosion speed
through polarisation resistance
only 1 serie of measurements immediatly after collection, every 10 minutes, during 1 day
Changes in electrochemical impedance spectrum
through electrochemical impedance spectroscopy
only one serie of measurements after collection, every 60 minutes, during 1 day
Study Arms (5)
Ahlback I
Ahlback II
Ahlback III
1 year following TKA
TKA revision
Interventions
Electrochemical cell analysing the patients' synovial fluid whenever an invasive intervention is medically prescribed
Eligibility Criteria
Human adults presenting either a knee osteoarthritis, a knee joint replacement at 1-year follow-up or an indication for TKA revision surgery
You may qualify if:
- indication to knee joint puncture
- Written consent
You may not qualify if:
- refusing to sign written consent
- patient unabled to have a follow-up by their own surgeon/doctor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHUV - Site HO
Lausanne, CH, 1011, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 24, 2019
First Posted
July 19, 2019
Study Start
October 15, 2019
Primary Completion
October 30, 2023
Study Completion
December 31, 2024
Last Updated
March 30, 2025
Record last verified: 2024-12