Garcia-Rey, EduardoEduardoGarcia-ReyCordero-Ampuero, JoséJoséCordero-AmpueroBabis, GeorgeGeorgeBabisBenazzo, FrancescoFrancescoBenazzoMorlock, 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/11420/44901Question: Biotribology (wear simulation, wear debris release and biological response) How can we detect wear/debris complications at an early follow-up? 1. Which complementary tests can improve “silent bone loss” detection like blood samples or advanced imaging in risky patients? 2. How to detect wear/debris from non-articulating interfaces in risky modular implants? Summary / Recommendation: Currently, there are different tools and protocols that have demonstrated to be useful to detect “silent bone loss” secondary to wear/ debris in patients undergoing total joint replacement. Previous international consensus regarding on the use of risky implants like metalon- metal total hip replacements (THRs) on the European level with a multidisciplinary approach did provide important information to facilitate this difficult topic. Although most experts agreed that annual clinical and conventional radiological evaluation is recommended, additional imaging with ultrasound, computed tomography (CT)-scan and magnetic resonance imaging (MRI) with metal artifaction sequence (MARS) clearly show significant information. Despite ion analysis is more controversial, cobalt levels in the whole blood can be more practical particularly for risky implants. Metallic femoral heads with a diameter of 36 mm or more, previously recalled resurfacing types and modular-neck THRs can be considered as risky implants. Further investigations have also reported that wear and debris have been clearly associated with blood metal ion levels and periarticular tissue damage in large-friction THR. More evidence is needed in TKR. Although risky modular implants are usually easy to define, these imaging techniques and blood samples are very useful to assess pain or other complications like bone loss or mechanical loosening in patients with total joint replacement.enMedicine, HealthEngineering and Applied OperationsDetection of wear/debris complications in total hip and knee arthroplasty at an early follow-up with regard to complementary tests for “silent bone loss” detection and risky modular implantsResearch Reporthttps://www.efort.org/wp-content/uploads/2023/05/EFORT_Consensus.pdfResearch Report