Latif Ahmed M H, Mehats Aude, Elcocks Martyn, Rushton Neil, Field Richard E, Jones Eric
Clinical Fellow in Orthopaedics, South West London Elective Orthopaedic Centre, Dorking Road, Surrey, London KT18 7EG, UK.
J Mater Sci Mater Med. 2008 Apr;19(4):1729-36. doi: 10.1007/s10856-007-3256-6. Epub 2007 Nov 8.
A previous clinical study was undertaken to evaluate the safety and efficacy of an anatomically shaped, flexible acetabular cup. Clinical results achieved were satisfactory, although some deficiencies in the model were identified. Design changes to the original model have been implemented to improve both initial stability and long term biological fixation. This was achieved through modifications made to both the anchoring mechanism and by the application of an appropriate backing surface layer promoting bone on-growth. In addition, changes to the articulation couple have also been introduced to improve implant durability and bearing performance, utilising a carbon fibre reinforced polyetheretherketone--alumina couple. Simulated loading, in both models, was performed using Finite Element Analysis. Mechanical and tribological tests were also performed to ensure the robustness of the new optimised design. Bio-compatibility of the articulation couple was demonstrated using an animal model. Implantation of the device has been extensively tested and re-validated in vitro to achieve a favourable polar contact between cup and femoral head and establish a reproducible operative technique. This preliminary work is undertaken prior to commencing a post market surveillance study of the CE marked implant.
之前进行了一项临床研究，以评估一种解剖形状的柔性髋臼杯的安全性和有效性。尽管发现该模型存在一些缺陷，但取得的临床结果令人满意。已对原始模型进行了设计更改，以提高初始稳定性和长期生物固定性。这是通过对锚固机制进行修改以及应用促进骨生长的合适背衬表面层来实现的。此外，还引入了关节组件的更改，以利用碳纤维增强聚醚醚酮 - 氧化铝组件提高植入物的耐用性和承载性能。在两个模型中，均使用有限元分析进行模拟加载。还进行了机械和摩擦学测试，以确保新优化设计的稳健性。使用动物模型证明了关节组件的生物相容性。该装置的植入已在体外进行了广泛测试和重新验证，以实现髋臼杯与股骨头之间良好的极性接触，并建立可重复的手术技术。这项初步工作是在开始对带有CE标志的植入物进行上市后监测研究之前进行的。
