Accelerating pre-clinical development and translation of a novel total meniscus replacement towards first in human studies

在英国，每年有超过400万人受到膝关节半月板缺陷引起的疼痛和行动不便的影响，花费相当于国民生产总值的1%。这包括那些患有与年龄有关的骨关节炎的人，以及因事故或运动损伤而造成的半月板损伤的人。治疗选择受到开发具有合适表面特征的承重材料和固定方法以形成替代半月板的挑战的限制。在没有替代装置的情况下，不可修复半月板（占所有半月板撕裂的85%）的标准治疗是部分或完全切除（半月板切除术），全世界每年有200万例此类手术。其结果是降低患者的生活质量和早期不可修复的半月板损伤和晚期退行性疾病的治疗差距，这通常需要膝关节置换术。作为回应，从伦敦帝国理工学院（Imperial College London）衍生出来的中小企业Orthonika开发了一种用于手术植入的医疗设备，可以替代整个半月板。独特的材料和专利设计被整合到植入物中，通过可靠和成熟的方法直接固定在骨头上。在先前工作的基础上，Orthonika现在必须解决将临床前羊模型转化为人类的技术挑战，为项目后的首次人体临床研究做准备。

Public descriptionOver 4 million people annually in the UK are affected by pain and immobility caused by a deficient meniscus in the knee, costing the equivalent of 1% GNP. This includes those suffering from age-related osteoarthritis as well as meniscal damage from accidents or sports injuries.Treatment options have been limited by challenges in developing load-bearing materials with suitable surface characteristics and fixation methods to form a replacement meniscus. In the absence of replacement devices, the standard of care for an irreparable meniscus (85% of all meniscal tears) is partial or complete removal (meniscectomy), with 2 million/year such procedures worldwide. The consequence is reduced patient quality of life and a treatment gap for both early-stage irreparable meniscal injury and later stage degenerative disease, that often necessitate knee replacement.In response Orthonika, an SME spin-out from Imperial College London, has developed a medical device for surgical implantation as a total meniscus replacement. Unique materials and a patented design are incorporated into an implant that is fixed directly to the bone via a reliable and established method.Building on previous work, Orthonika must now address technical challenges in translating the pre-clinical ovine model to humans, in preparation for first-in-human clinical studies post-project.