AM Porous Layer Implant Design with Bioactive Layer of Glass Coating – APLID BioLOGIC

骨关节炎(OA)，特别是髋关节和膝盖的骨关节炎，是全世界导致残疾的主要原因之一。每年有超过300万例关节置换手术，其中英国有超过25万例。这一数字一直在增长，原因有两个：1)关节炎因年龄和体重的增加而恶化，世界人口日益老龄化和肥胖；2)在中国等国家，越来越多的人能够负担得起这种手术。该联盟正专注于关节置换领域的下一个重大增强，通过一种新的和改进的涂层制造工艺，以加速植入物与宿主骨的整合。该财团由JRI牵头，这是一家领先的英国制造商，在制造和销售涂层矫形植入物方面拥有30多年的经验。他们已经通过Innovate UK资助的一项可行性研究，与项目合作伙伴之一GTS一起展示了制造一种将3D打印与生物活性玻璃相结合的新型植入物组合的可能性。在那项研究中，他们表明，与现有涂层相比，这种组合提高了骨骼的响应性。他们还证实，新的制造工艺应该以商业上可行的成本运行。此外，生物活性玻璃具有天然的抗微生物特性，这将有助于对抗感染。在该项目中，另外两家中小企业加入了现有的合作伙伴(Vitritech和Metron)，通过新的表面工程技术优化制造工艺。中小企业还将形成强大的供应链，以确保对未来生产的信心。这一涂层过程将通过剑桥大学的研究进行验证，剑桥大学还将确认和评估生物活性玻璃的抗感染性能。该项目的结果将是开发一种准备扩大到全球市场的制造工艺，并生成支持法规的文件。这将导致一项首次的人体研究，随后不久将在全球推出--合作伙伴的目标是：欧洲、美国和中国市场，JRI已经在这些市场拥有重要的业务和多年的监管流程经验。

Osteoarthritis (OA), especially of the hip and knee, is one of the leading causes of disability across the world. Every year there are over 3 million surgical replacements of joints -- with over 0.25 million in the UK. This number is growing all the time for two reasons: 1) arthritis is exacerbated by age and body weight and the world population is getting older and more obese, and 2) in countries such as China more of the population are being able to afford this surgery.This consortium are focussing on the next big enhancement in joint replacement through a new and improved manufacturing process for a coating to accelerate the integration of the implant into the host bone. The consortium is led by JRI an SME that is a leading UK manufacturer with over 30 years' experience in making and selling coated orthopaedic implants. They have already shown with GTS, one of the project partners, through a feasibility study funded by Innovate UK that it is possible to manufacture a new combination of implants that combine 3D printing with bio-active glass. In that study they showed that this combination had improved response from bone over existing coatings. They also confirmed that the new manufacturing process should be run at a cost that is commercially viable. In addition bioactive glasses are known to have natural anti-microbial properties, which will help fight infection.In this project two other SMEs join the existing partners (Vitritech and Metron) to optimise the manufacturing processes through novel surface engineering techniques. The SMEs will also form a robust supply chain to ensure confidence for future production. This coating process will then be validated through studies by the University of Cambridge, who will also confirm and evaluate the anti-infective properties of the bio-active glass. The outcome of this project will be the development of a manufacturing process that is ready to be scaled up for the global market as well as generating the supporting regulatory documents. This will lead to a first-in-human study, followed shortly by a global launch -- the partners are targeting: European, American and Chinese markets where JRI already has a significant presence and many years' experience of their regulatory processes.