Electrochemical Behavior of Biomedical Alloys Exposed to Human Synovial Fluid

March 25, 2025 updated by: Brigitte Jolles, MD

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • CH
      • Lausanne, CH, Switzerland, 1011
        • CHUV - Site HO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Human adults presenting either a knee osteoarthritis, a knee joint replacement at 1-year follow-up or an indication for TKA revision surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Ahlback I
Other: analysis of the synovial fluid
Electrochemical cell analysing the patients' synovial fluid whenever an invasive intervention is medically prescribed
Ahlback II
Other: analysis of the synovial fluid
Electrochemical cell analysing the patients' synovial fluid whenever an invasive intervention is medically prescribed
Ahlback III
Other: analysis of the synovial fluid
Electrochemical cell analysing the patients' synovial fluid whenever an invasive intervention is medically prescribed
1 year following TKA
Other: analysis of the synovial fluid
Electrochemical cell analysing the patients' synovial fluid whenever an invasive intervention is medically prescribed
TKA revision
Other: analysis of the synovial fluid
Electrochemical cell analysing the patients' synovial fluid whenever an invasive intervention is medically prescribed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Open circuit potential
Time Frame: only 1 measurement immediatly after collection, the day of collection (1 day)
through a potentiostat device
only 1 measurement immediatly after collection, the day of collection (1 day)
Changes in Corrosion speed
Time Frame: only 1 serie of measurements immediatly after collection, every 10 minutes, during 1 day
through polarisation resistance
only 1 serie of measurements immediatly after collection, every 10 minutes, during 1 day
Changes in electrochemical impedance spectrum
Time Frame: only one serie of measurements after collection, every 60 minutes, during 1 day
through electrochemical impedance spectroscopy
only one serie of measurements after collection, every 60 minutes, during 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigitte Jolles, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 208/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

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