CERAMIC TIBIA FOR MOBILE BEARING KNEE - DESCRIPTION (provided by applicant): Mobile bearing TKA implants are preferred owing to their potential to better restore natural knee kinematics, and could find increased acceptance if the important clinical concern related to increased wear is addressed. Equally, overcoming the materials fatigue related failures of polyethlylene (PE) tibial inserts over the long term would be a significant step forward in extending the life, range of motion and function of the more popular fixed bearing TKA implants. In Phase I, we successfully demonstrated the feasibility of a novel, ultra-low wear bearing for TKA implants by developing and wear testing of a new ceramic optimized for low friction articulation against established CoCr alloys. The novel ceramic material was shown in standard tests to possess the highest combination of strength, toughness and Weibull modulus, with a significant enhancement over current state of the art Biolox Delta. We have also demonstrated in pin on disc tests a 10 fold reduction in multidirectional wear compared to CoCr-PE bearings, under a 3X higher contact stress. This success points to the clinical potential of a novel alternate TKA implant bearing with ultra-low wear and high safety characteristics: a CoCr femoral condyle/ with a ceramic tibia insert. If successful, this novel TKA bearing offers the potential to eliminate PE material failure and promises to increase the life of TKA implants by a factor of 2 - 3X. Indeed, this bearing has the potential to introduce a unique, safe and effective alternative bearing for the first time, for TKA implants. In Phase II, we aim to extend these results by developing and demonstrating the wear performance, mechanical and biological safety of actual TKA implant components in a physiologically / clinically more relevant geometry. In Phase II, we propose to extend these promising results by developing, optimizing and demonstrating in vitro, the wear performance, mechanical safety and function in a set of comprehensive, statistically rigorous experimental designs. We also propose to conduct wear tests to 10 million cycles in a knee simulator on actual TKA bearing components of both mobile and fixed bearing designs, using physiologically relevant test parameters, to confirm the superiority of the novel proposed bearings. Major orthopedic implant manufacturers have expressed interest in our technology and collaborating on the evaluation of the novel TKA bearings.
