CERAMIC TIBIA FOR MOBILE BEARING KNEE

航空航天/工程应用中的最新发展和经验已经确立了层状复合氧化锆/钢偶作为超低磨损的明显优势。 这在实际上消除磨损颗粒介导的骨质溶解和随后的植入物失效方面具有很大的植入物应用潜力。 磨损率与陶瓷/陶瓷偶件相当，磨损量比最佳陶瓷/PE偶件低2-3个数量级。 然而，与陶瓷/陶瓷偶件相比，所提出的复合陶瓷/金属偶件消除了脆性断裂引起的主要临床问题。 在一种消除PE磨屑和降低脆性失效风险的新型替代方法中，提出了一种与钴铬股骨部件接合的复合陶瓷胫骨部件。 建议将工程领域的发展和经验应用于生物医学植入物应用，并预计将产生上级的耐磨性（与最佳陶瓷/陶瓷组合相当），同时消除PE胫骨部件。 与传统陶瓷相比，韧性提高了2倍，显著降低了胫骨失效的风险。 这与移动的磨损膝关节设计特别相关，其中观察到增加的运动范围和由此产生的磨损。 第1阶段将确立上级材料性能，并证明磨损率显著降低。 在第2阶段，将沿着设计和制造过程优化进行磨损模拟器测试。拟议的商业应用超韧性复合陶瓷胫骨部件与钴铬股骨部件接合的新型组合将导致可忽略的磨损碎屑和植入物失效。 将已建立的工程陶瓷与已建立的钴铬髁部件进行适配和增强，将大大提高商业应用。

Recent developments and experience in aerospace/engineering applications has established a clear superiority of layered composite zirconia/steel couples as ultra low wear. This has a great potential for implant applications in virtually eliminating wear particle mediated osteolysis and consequent implant failures. Wear rates comparable to ceramic/ceramic couples with demonstrated 2-3 orders lower wear volume than the best ceramic/PE couples can be expected. In contrast to the ceramic/ceramic couples however, the proposed composite ceramic/metal couple alleviates the major clinical concern stemming from brittle fracture. In a novel alternative approach to eliminating PE wear debris and lowering risk of brittle failure, a composite ceramic tibial component articulating against a Co-Cr femoral component is proposed. Developments and experience from the engineering fields is proposed to be applied to biomedical implant applications and is expected to lead to both superior wear resistance (comparable to the best ceramic/ceramic couples), with elimination of the PE tibial component. Toughness, enhancement of 2x over conventional ceramics significantly reduces risk of tibial failure. This is particularly relevant to mobile wearing knee designs where increased range of motion and resultant wear is observed. Phase 1 will establish the superior materials properties and demonstrate significantly reduced wear rates. In Phase 2, wear simulator tests will be conducted along with design and manufacturing process optimization. PROPOSED COMMERCIAL APPLICATION The novel combination of an ultra-tough composite ceramic tibial components articulating against Co-Cr femoral components will lead to negligible wear debris and implant failures. Adaptation and enhancement of an established engineering ceramic for articulation with the established Co-Cr condylar components will greatly enhance commercial applications.