Comportement Electrochimique d'Alliages Biomedicaux Dans Des Liquides Synoviaux en Fonction de l'Etat Pathologique
Electrochemical Behavior of Biomedical Alloys Exposed to Human Synovial Fluid
Sponsors
Source
University of Lausanne Hospitals
Oversight Info
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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
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.
Overall Status
Not yet recruiting
Start Date
2019-07-15
Completion Date
2020-12-31
Primary Completion Date
2020-07-15
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
Open circuit potential |
only 1 measurement immediatly after collection, the day of collection (1 day) |
|
Changes in Corrosion speed |
only 1 serie of measurements immediatly after collection, every 10 minutes, during 1 day |
|
Changes in electrochemical impedance spectrum |
only one serie of measurements after collection, every 60 minutes, during 1 day |
Number Of Groups
5
Enrollment
150
Conditions
Intervention
Intervention Type
Other
Intervention Name
Description
Electrochemical cell analysing the patients' synovial fluid whenever an invasive intervention is medically prescribed
Arm Group Label
Ahlback I
Ahlback II
Ahlback III
1 year following TKA
TKA revision
Eligibility
Study Pop
Human adults presenting either a knee osteoarthritis, a knee joint replacement at 1-year
follow-up or an indication for TKA revision surgery
Sampling Method
Non-Probability Sample
Criteria
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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Location
Facility |
|
CHUV - Site HO Lausanne CH 1011 Switzerland |
Location Countries
Country
Switzerland
Verification Date
2019-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor-Investigator
Investigator Affiliation
University of Lausanne Hospitals
Investigator Full Name
Brigitte Jolles, MD
Investigator Title
Professor
Has Expanded Access
No
Condition Browse
Arm Group
Arm Group Label
Ahlback I
Arm Group Label
Ahlback II
Arm Group Label
Ahlback III
Arm Group Label
1 year following TKA
Arm Group Label
TKA revision
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
Undecided
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Case-Only
Time Perspective
Cross-Sectional
Study First Submitted
May 24, 2019
Study First Submitted Qc
July 18, 2019
Study First Posted
July 19, 2019
Last Update Submitted
July 18, 2019
Last Update Submitted Qc
July 18, 2019
Last Update Posted
July 19, 2019
ClinicalTrials.gov processed this data on December 12, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.