LifeLongJoints project structure
WP1: Synthesis and characterisation of silicon nitride coatings (Lead: University of Uppsala)
The overall objective of WP1 is to provide a high adhesion, damage resistant and high wear resistance Silicon Nitride coating from which the wear debris are soluble, hence reducing the potential adverse reaction to metallic debris (ARMD) in metal on metal articulations. The coating will also be assessed in articulations against UHMWPE to assess whether or not the possible improvement in lubricity will reduce the generation of polymer debris from the softer counter face. The coating should also be composed of ions present in humans, i.e. no foreign elements.
WP2: In vitro simulation and biological assessment of wear in silicon nitride coatings (Lead: University of Leeds)
The aim of WP2 is to assess the tribological properties of Silicon Nitride coatings within the given applications, using novel advanced, more realistic, as well as standard-prescribed, simulation methodologies. This series of stratified assessments will deliver more clinically relevant functional outcomes. These investigations include both (i) assessment of the coatings tribo-corrosive performance and (ii) characterisation of the debris released due to wear using newly developed debris isolation techniques and cell response assays.
WP3: Computational modelling and simulation of hip joint mechanics and wear (Lead: ETH)
The goal of WP3 is to provide predictions of the performance potential of silicon nitride coated implants in the proposed applications, employing multi-scale computational modelling. Overall objectives are to develop and validate (1) biomechanical models of the articulating joint systems, (2) surface wear models and (3) simulations of interfacial behaviour between the substrate and coating within the articulating system, to assess coating performance. Simulation models will incorporate population modelling and a validation framework will be developed for their future maintenance and extension. The developed models will provide the inputs for the physical simulations and also for new software tools to be broadly distributed within the industry.
WP4: Device prototyping and manufacturing scale-up of silicon nitride coatings (Lead: Ionbond)
Work in WP4 will identify, evaluate and address the challenges in applying the preferred coating, as defined in WP1, to real implants under commercially relevant conditions whilst demonstrating compliance with relevant regulatory requirements. This will be achieved through the construction of an industrial scale equipment able to meet the coating specification (or better) as defined in WP1. This equipment will be used to provide industrial scale sampling, medical device prototypes (coated) and validation of the coating, the coating process and the coating equipment.
WP5: Assessment of silicon nitride coating performance in vivo (Lead: University of Zurich)
In WP5 relevant in vivo animal models will be developed and also conducted to assess i) biocompatibility, resorption of generated wear particles within synovial joints, ii) overall performance of wear of the new implants in rabbits and a large animal model which allows longer-term assessment of implant performance iii) the cellular responses of the local tissue in a diarthrodial joint (bone, synovial membrane, periarticular structures).
WP6: Medical device regulation, exploitation and dissemination (Lead: Tutech Innovation)
The objective of WP6 is to ensure the timely organisation and execution of those activities necessary to deliver functional coatings for the desired applications with improved biocompatibility and long term stability. This entails on the one hand ensuring dissemination of results to stakeholders in including establishing relations to key clinical opinion leaders, and on the other ensuring the necessary groundwork for product developed is addressed for exploitation which means addresses issues relating to regulatory approval including standards.
WP7: Project management and coordination (University of Leeds)
WP7 covers the management and coordination activities of the project to ensure the efficient project and technical coordination of the LifeLongJoints project according to the work plan.
