Kretzer, Jan PhilippeJan PhilippeKretzerGrupp, Thomas M.Thomas M.GruppKaddick, ChristianChristianKaddickMayer, Richard T.Richard T.MayerMorlock, MichaelMichaelMorlock2024-01-042024-01-042023-051st EFORT European Consensus Medical & Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices (2023)https://hdl.handle.net/11420/44906Question: 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.enMedicine, HealthEngineering and Applied OperationsResearch Reporthttps://www.efort.org/wp-content/uploads/2023/05/EFORT_Consensus.pdfResearch Report