PEEK-OPTIMA as a Platform for Natural Total Knee Replacement

根据国家联合登记处的数据，全膝关节置换术（TKR）通常是一种成功的选择性手术，仅在英格兰和威尔士，每年就有超过10万例初级TKR手术。然而，5-10%的患者在10年内需要再次手术和更换，一些手术的费用达到每位患者75,000英镑。此外，多达30%的接受者报告很少或没有症状改善和/或对结果不满意。当前产品材料成本的增加和全球市场价格的下降，加上人口老龄化、患者期望的变化和人口体重指数的增加，创造了机会。PEEK膝部产品可以在6分钟内一次成型，与现有材料相比，成本显著降低，可能需要6周的时间来制造，为供应链改善提供了机会。PEEK股骨膝关节假体的第一次迭代已经开发出来，并已在上市前的全球可行性研究中植入少量患者，旨在评估安全性和有效性。该装置包括与全聚乙烯胫骨和髌骨替代物一起使用的骨水泥股骨假体。为了优化不同患者群体的临床结果，需要这种TKR的其他变体，例如模块化胫骨组件和无骨水泥固定选项。这项研究计划旨在彻底改变膝关节置换术，使用先进的材料技术结合增强的临床前评估模拟方法，开发一种经济实惠的全聚合物膝关节置换术，可以安全地固定在骨骼中并最大限度地减少磨损。这项研究将为进一步的医疗选择提供一个平台，以满足其他目前尚未满足的需求（例如，长期软组织修复、面部重建、金属敏感矫形患者）。

According to the National Joint Registry, Total Knee Replacement (TKR) is generally a successful elective operation, with more than 100,000 primary TKR procedures performed every year in England and Wales alone. However 5-10% require reoperation and replacement within 10 years of initial surgery, with the cost of some procedures reaching £75,000 per patient. Additionally, up to 30% of recipients report little or no symptom improvement and/or dissatisfaction with the results. The increasing cost of current product materials and globally decreasing market prices, together with an ageing population, changing patient expectations and increasing population BMI, creates the opportunity. A PEEK knee product can be manufactured with a 6 minute, one shot moulding process at a significant cost reduction over incumbent materials that can take 6 weeks to manufacture, offering opportunities for supply chain improvements. A first iteration of a PEEK femoral knee component has been developed and has been implanted into a small number of patients in a pre-market, global feasibility study designed to assess safety and efficacy. This device comprises a cemented femoral component used in conjunction with an all polyethylene tibia and patellar replacement. To optimise clinical outcomes for different groups of patients, additional variants of this TKR will be required, such as modular tibial components and cementless fixation options. This research programme is set to revolutionise knee replacement, using advanced materials technology combined with enhanced preclinical evaluation simulation methods to develop an affordable all polymer knee replacement that fixes securely into bone and minimises wear. The research will create a platform from which further medical treatment options could be developed, to meet other currently unmet needs (for example, long term soft tissue repair, facial reconstruction, metal sensitive orthopaedic patients).