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

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: Completed
• Conditions: Osteoarthritis, Knee; Arthroplasty, Replacement, Knee
• Intervention / Treatment: Other: analysis of the synovial fluid

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: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Brigitte Jolles, MD

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID 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