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Pre-clinical assessment of the in vivo behaviour of non-articulating Interfaces between implant components concerning the consequences of micro motion or corrosion processes : test methodology, and requirements for testing and characterization of implant modularities
Publikationstyp
Research Report
Date Issued
2023-05
Sprache
English
Author(s)
Mayer, Richard T.
Start Page
104
End Page
111
Citation
1st EFORT European Consensus Medical & Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices (2023)
Publisher
EFORT
Question: Modularities / interfaces
How can the in vivo behaviour of interfaces between implant components (e.g. head-conus-connection, not articulation partners) be
assessed pre-clinically, for example concerning the consequences of micro motion or corrosion processes?
1. Which test methods concerning modularities / corrosion / performance in vivo/in vitro do exist?
2. Which aspects cannot be covered by the current test methods?
3. Which are the requirements for the testing / the characterization of implant modularities and what needs to be considered?
Summary / Recommendation:
Test methods concerning modular interfaces are available (e.g. ASTM F1875) and they are frequently used in short- or long-term
applications. By mechanically loading the interfaces, several outcome variables like electrochemical parameters or the amount of lost
material are assessed. Furthermore, some studies focus on the analysis of interface micro motions. Nevertheless, in the past, clinically
relevant failure modes regarding modular connections were not completely predictable by these testing methods. Current research has
pointed out the importance of an appropriate test fluid and the addition of pH lowering additives or corrosion enhancing supplements such
as H2O2, FeCl3 or HCl are of interest and should be considered in pre-clinical testing. To evaluate the fretting and fatigue performance of
modular connections the addition of bovine calf serum to the test fluid should be considered.
Furthermore it appears to be advisable to perform long-term tests and to gain quantitative information about the amount and
composition of the degraded material.
How can the in vivo behaviour of interfaces between implant components (e.g. head-conus-connection, not articulation partners) be
assessed pre-clinically, for example concerning the consequences of micro motion or corrosion processes?
1. Which test methods concerning modularities / corrosion / performance in vivo/in vitro do exist?
2. Which aspects cannot be covered by the current test methods?
3. Which are the requirements for the testing / the characterization of implant modularities and what needs to be considered?
Summary / Recommendation:
Test methods concerning modular interfaces are available (e.g. ASTM F1875) and they are frequently used in short- or long-term
applications. By mechanically loading the interfaces, several outcome variables like electrochemical parameters or the amount of lost
material are assessed. Furthermore, some studies focus on the analysis of interface micro motions. Nevertheless, in the past, clinically
relevant failure modes regarding modular connections were not completely predictable by these testing methods. Current research has
pointed out the importance of an appropriate test fluid and the addition of pH lowering additives or corrosion enhancing supplements such
as H2O2, FeCl3 or HCl are of interest and should be considered in pre-clinical testing. To evaluate the fretting and fatigue performance of
modular connections the addition of bovine calf serum to the test fluid should be considered.
Furthermore it appears to be advisable to perform long-term tests and to gain quantitative information about the amount and
composition of the degraded material.
DDC Class
610: Medicine, Health
620: Engineering