Arthroplasty, Replacement, KneeNCT04027231
Electrochemical Behavior of Biomedical Alloys Exposed to Human Synovial Fluid
An observational study of Arthroplasty, Replacement, Knee and Osteoarthritis, Knee, run by Brigitte Jolles, MD at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Osteoarthritis, Knee
- What is being tested?
- analysis of the synovial fluid
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Oct 2019to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- indication to knee joint puncture
- Written consent
Who cannot join
- refusing to sign written consent
- patient unabled to have a follow-up by their own surgeon/doctor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- analysis of the synovial fluid
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis of the synovial fluidOther
Electrochemical cell analysing the patients' synovial fluid whenever an invasive intervention is medically prescribed
| Study group | Role | What they receive |
|---|---|---|
| Ahlback I | Not described Receives: Other: analysis of the synovial fluid | |
| Ahlback II | Not described Receives: Other: analysis of the synovial fluid | |
| Ahlback III | Not described Receives: Other: analysis of the synovial fluid | |
| 1 year following TKA | Not described Receives: Other: analysis of the synovial fluid | |
| TKA revision | Not described Receives: Other: analysis of the synovial fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Open circuit potential
through a potentiostat device
Measured: only 1 measurement immediatly after collection, the day of collection (1 day)
Changes in Corrosion speed
through polarisation resistance
Measured: only 1 serie of measurements immediatly after collection, every 10 minutes, during 1 day
Changes in electrochemical impedance spectrum
through electrochemical impedance spectroscopy
Measured: only one serie of measurements after collection, every 60 minutes, during 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start15 Oct 2019
- Primary completion30 Oct 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigitte Jolles, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brigitte Jolles, MD, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027231
- Sponsor's protocol ID
- 208/13
- Status last verified
- Dec 2024
- First submitted
- 24 May 2019
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comportement Electrochimique D'alliages Biomedicaux Dans Des Liquides Synoviaux En Fonction De L'etat Pathologique
- ClinicalTrials.gov ID
- NCT04027231
- Acronym / sponsor ID
- 208/13
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Brigitte Jolles, MDUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ahlback I | – | Other: analysis of the synovial fluid |
| Ahlback II | – | Other: analysis of the synovial fluid |
| Ahlback III | – | Other: analysis of the synovial fluid |
| 1 year following TKA | – | Other: analysis of the synovial fluid |
| TKA revision | – | Other: analysis of the synovial fluid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- indication to knee joint puncture
- Written consent
Key exclusion criteria (2 listed)
- refusing to sign written consent
- patient unabled to have a follow-up by their own surgeon/doctor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analysis of the synovial fluidElectrochemical cell analysing the patients' synovial fluid whenever an invasive intervention is medically prescribed | Other | 1 year following TKA, Ahlback I, Ahlback II, Ahlback III, TKA revision |
Primary outcome
Open circuit potential
Time frame: only 1 measurement immediatly after collection, the day of collection (1 day)
through a potentiostat device
Changes in Corrosion speed
Time frame: only 1 serie of measurements immediatly after collection, every 10 minutes, during 1 day
through polarisation resistance
Changes in electrochemical impedance spectrum
Time frame: only one serie of measurements after collection, every 60 minutes, during 1 day
through electrochemical impedance spectroscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Knee and Osteoarthritis, Knee, run by Brigitte Jolles, MD at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Open circuit potential (time frame: only 1 measurement immediatly after collection, the day of collection (1 day)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.