Feasibility study of a novel calcium phosphate-based composition for orthopaedic device applications

SIRAKOSS开发并生产了一种用于脊柱和创伤手术的新型磷酸钙基骨移植替代品，第一种产品最近获得了CE认证。这种材料在这些手术的临床前模型中表现出优异的性能，但这种材料的性质具有缺点，因为它不能使用传统磷酸钙材料可以使用的高温（>1000°C）进行加工。这意味着它不能烧结形成大孔陶瓷，因此不能利用3D打印方法制造复杂/定制的植入物设计，并且不能使用行业标准方法将其涂覆到医疗器械上。我们已经确定了一种改进现有技术的工艺，以生产一种新的组合物，初步研究表明，该组合物在制造此类陶瓷和涂层所需的高温下具有热稳定性。该项目旨在充分利用这种新组合物，测试其形成大孔陶瓷的能力，并在临床前研究中筛选这些样品以评估骨愈合反应。这一概念验证将使SIRAKOSS能够在未来开发利用这种新配方的新产品，其中可能包括利用3D打印和脊柱融合器和其他骨科医疗器械中的生物活性涂层的定制植入物。

SIRAKOSS developed and manufacture a novel calcium phosphate-based bone graft substitute for use in spinal and trauma surgery and the first product was recently CE-marked. This material has shown excellent performance in pre-clinical models of these surgeries but the nature of this material has a disadvantage in that it cannot be processed using high temperatures (\>1000°C) that traditional calcium phosphate materials can be. This means it cannot be sintered to form a macroporous ceramic, so can't utilise 3D printing approaches to manufacture complex/custom implant designs, and it cannot be coated onto medical devices using industry standard approaches. We have identified a process to modify our existing technology to produce a new composition that initial studies have shown is thermally stable at the high temperatures required to manufacture such ceramics and coatings. This project aims to characterise fully this new composition, test its ability to be formed into a macroporous ceramic, and screen these samples in a pre-clinical study to evaluate the bone healing response. This proof of concept would allow SIRAKOSS to be able to develop new products in the future that utilise this new formulation, which could include customised implants utilised 3D printing and bioactive coatings in spinal cages and other orthopaedic medical devices.