Abstract
For evaluation of orthopaedic biomaterials the closest hostile-like in vitro environments are desirable with relevant control of chemical, biological, mechanical etc. parameters. For faster screening and reduction of time and costs, combination of different critical key parameters in minimal tests is needed. New trends also favour minimisation of in vivo (2010/63/EC, towards replacement technology) and clinical tests (2001/20/EC, 2005/28/EC) for new products yet not compromising risks. Biomaterials manufacturers also are interested in shortening of the time-to-market keeping conformity to essential requirements and withstanding the simulated “worst case” conditions (2003/94/EC). Here we show the new approach of the creation of conditions closest to real life and applications, based on scientifically designed and optimised models, aiming on predictive outputs. With new device and designed protocols, several biomaterials for orthopaedic applications were analysed: titanium, biodegradable fibrous scaffolds and hydrogels. Creation of several favourable conditions for different tissues type formation took place on the surface of the porous titanium specimen. Such conditions could be designed for measurement of the cells proliferation and e.g. simultaneous bacterial adhesion with rather high precision. The method has been compared in independent laboratories for hydrogels with other measuring techniques and shown the benefits of the method especially in more precise control of biomechanical cues. It was observed that significant amount of data are containing in the recorded signals which underlines the importance of correct and holistic data post-processing. The protocols can be furthermore tailored to simulate different conditions, such as for specific positions in tibia, or humeral etc., and combined with patient-specific biomechanics (soft tissues) for customised implant design. The financial support from the Finnish Agency of Innovation (Tekes) is gratefully acknowledged.
Author has no competing financial or conflicting interests.
