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临床试验/NCT04027231
NCT04027231已完成不适用

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

Brigitte Jolles, MD1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Changes in electrochemical impedance spectrum

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • indication to knee joint puncture
  • Written consent

排除标准

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

结局指标

主要结局

Changes in electrochemical impedance spectrum

时间窗: only one serie of measurements after collection, every 60 minutes, during 1 day

through electrochemical impedance spectroscopy

Open circuit potential

时间窗: only 1 measurement immediatly after collection, the day of collection (1 day)

through a potentiostat device

Changes in Corrosion speed

时间窗: only 1 serie of measurements immediatly after collection, every 10 minutes, during 1 day

through polarisation resistance

次要结局

未报告次要终点

研究者

发起方
Brigitte Jolles, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Brigitte Jolles, MD

Professor

University of Lausanne Hospitals

研究点 (1)

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