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Completed

NCT Number: NCT04027231

Electrochemical Behavior of Biomedical Alloys Exposed to Human Synovial Fluid

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHUV - Site HO

Lausanne, CH, 1011, Switzerland

About this study

Most widely used biomedical materials are polymeric, ceramics and metals. Among these materials, metals exhibit a unique combination of mechanical strength, toughness, wear resistance and forming easiness. Metals are chemically reactive when in contact with body fluids. While some of the reactions are welcome, such as the surface oxidation providing corrosion protection, other reactions may adverse the biocompatibility character of the material.The understanding of these reactions is the object of several studies. Corrosion scientists try to characterise the corrosion response of metals when in contact with simulated body fluids in order to verify the occurrence of hypothetical mechanisms. Biologists look at specific reaction products expected to be released by cells when set in contact with structured or functionalized surfaces. These approaches are necessary but also time consuming due to the complexity of possible reaction mechanisms. As complement to these deductive approaches we propose here an inductive one based on 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. This will be achieved through a collaboration between surgeons and corrosion scientists. The synovial fluid will be extracted form patients using an established procedure and transferred to a portable sterile corrosion laboratory located close to the surgery room. There, surface reaction will be characterized using electrochemical methods already successfully applied in recent studies carried out by the same team. We will be integrating in-situ quartz crystal microgravimetry and in-situ Raman spectroscopy as well as ex-situ methods. Further, metal surfaces will be chemically functionalized (wettability, oxidation, surface charge) in order to selectively influence specific reactions of body fluid components (i.e. adsorption depends on surface energy and wettability while Redox reactions are influenced by the oxidation state of the surface. The acquired information will be compared to the clinical state of the patient in order to establish possible correlations between interface reactivity and patient state.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • indication to knee joint puncture
  • Written consent

Exclusion criteria

  • refusing to sign written consent
  • patient unabled to have a follow-up by their own surgeon/doctor

Treatment and study plan

analysis of the synovial fluid

Other

Electrochemical cell analysing the patients' synovial fluid whenever an invasive intervention is medically prescribed

Primary outcomes

  1. Open circuit potential

    Time frame: only 1 measurement immediatly after collection, the day of collection (1 day)

    through a potentiostat device

  2. Changes in Corrosion speed

    Time frame: only 1 serie of measurements immediatly after collection, every 10 minutes, during 1 day

    through polarisation resistance

  3. Changes in electrochemical impedance spectrum

    Time frame: only one serie of measurements after collection, every 60 minutes, during 1 day

    through electrochemical impedance spectroscopy

Sponsors and collaborators

Lead sponsor

Brigitte Jolles, MD

Other

Registry information

Official study title

Comportement Electrochimique D'alliages Biomedicaux Dans Des Liquides Synoviaux En Fonction De L'etat Pathologique

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Jul 19, 2019
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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