PEEK-OPTIMA as a Platform for Natural Total Knee Replacement

根据国家关节登记处，全膝关节置换术（TKR）通常是一种成功的择期手术，仅在英格兰和威尔士每年就有超过10万例初次TKR手术。然而，5-10%的患者在初次手术后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，高达30%的接受者报告症状改善很少或没有改善和/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，以及人口老龄化，患者期望的变化和人口BMI的增加，创造了机会。PEEK膝关节产品可以用6分钟的一次成型工艺制造，与需要6周制造的现有材料相比，成本显著降低，为供应链改进提供了机会。已开发出PEEK股骨膝关节部件的第一代产品，并在上市前全球可行性研究中植入少数患者体内，旨在评估安全性和有效性。该器械包括与全聚乙烯胫骨和髌骨置换物结合使用的骨水泥型股骨部件。为了优化不同患者组的临床结局，需要该TKR的其他变体，例如组配式胫骨部件和非骨水泥固定选项。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，开发出一种经济实惠的全聚合物膝关节置换术，可牢固地固定在骨骼中，并最大限度地减少磨损。该研究将创建一个平台，从中可以开发进一步的医疗方案，以满足其他目前未满足的需求（例如，长期软组织修复，面部重建，金属敏感骨科患者）。

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).