Enhanced stratified pre-clinical simulation of the natural knee

自然膝关节的增强型分层临床前模拟

• 批准号: 1958770
• 金额: --
• 依托单位: University of Leeds
• 依托单位国家: 英国
• 项目类别: Studentship
• 财政年份: 2017
• 资助国家: 英国
• 起止时间: 2017 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=studentship-1958770
• 关键词: Enhanced; stratified; pre; clinical; simulation

The clinical need for this project is in the ability to develop and translate safe and reliable medical device technology in the tibio-femoral joint for treatment of degenerative joint disease. Current options for young and active patients with degenerative joint disease - such as mosaicplasty or MACI - are limited, with very limited success, and can be costly. Further, such interventions have not been pre-clinically tested. Surgeons are reluctant to carry out total joint replacement in younger patients, leaving them in pain and for the condition to worsen before any intervention takes place. There is a clinical need both for improved interventions, and for stratified pre-clinical simulation methods to assess the intervention before it is offered to the patient. Such pre-clinical simulation methods will ultimately be adopted by companies developing tissue repair interventions to support their product development process and to reduce risk of costly failures both to them and patients.The research challenge is to develop experimental simulation methods that can be used to pre-clinically assess and predict biomechanical and tribological function of tissue repair interventions in the natural tibio-femoral joint.The specific research questions are as follows:1. Can knee experimental simulation models be developed that mimic knee conditions from patients with different knee diseases and pathology (e.g. cartilage defect, ligament defect, meniscus defect, bone defect)?2. Can enhanced pre-clinical experimental simulation methods be developed that can evaluate different knee therapies and interventions? And differentiate between different interventions (of the same type)?Addressing these questions will guide the stratification and development of enhanced experimental simulation methods for biomechanical/tribological function. Currently scaffolds or other tissue repair interventions move directly into animal studies without functional tribological or biomechanical studies, which can lead to costly failures in animals as well as in the clinic. Projects to commercially develop and get CE mark for early repair interventions such as scaffolds cost of the order of £1 to 3m, followed by similar investments to support clinical trials and post market activity. Pre-clinical simulation will support this activity and reduce the risk of unsuccessful outcomes in clinical studies.

本项目的临床需求是能够开发和转化安全可靠的胫股关节医疗器械技术，以治疗退行性关节疾病。目前，年轻和活跃的退行性关节疾病患者的选择-如镶嵌成形术或MACI -是有限的，成功率非常有限，而且可能是昂贵的。此外，这些干预措施尚未进行临床前测试。外科医生不愿意对年轻患者进行全关节置换术，这会让他们感到疼痛，并在进行任何干预之前使病情恶化。临床上既需要改进的干预措施，也需要分层的临床前模拟方法，以便在向患者提供干预措施之前对其进行评估。这种临床前模拟方法最终将被开发组织修复干预措施的公司所采用，以支持其产品开发过程，并降低对他们和患者代价高昂的失败风险。研究挑战是开发实验模拟方法，可用于临床前评估和预测自然胫骨中组织修复干预措施的生物力学和摩擦学功能。具体研究问题如下：1.是否可以开发膝关节实验模拟模型，以模拟患有不同膝关节疾病和病理（例如软骨缺损、韧带缺损、半月板缺损、骨缺损）的患者的膝关节状况？2.能否开发出能够评价不同膝关节治疗和干预的增强临床前实验模拟方法？并区分不同的干预措施（同一类型）？解决这些问题将指导生物力学/摩擦学功能的增强实验模拟方法的分层和发展。目前，支架或其他组织修复干预措施直接进入动物研究，而没有功能摩擦学或生物力学研究，这可能导致动物和临床上代价高昂的失败。商业化开发并获得CE认证的早期修复干预项目（如支架）的成本约为100万至300万英镑，其次是类似的投资，以支持临床试验和上市后活动。临床前模拟将支持这一活动，并降低临床研究中不成功结局的风险。