Novel design analysis tools to increase precision and reduce variation in hip replacement performance

全世界有超过6000万患者患有髋关节骨关节炎，越来越多的患者需要全髋关节置换手术。尽管手术非常成功，但活跃人口的老龄化和肥胖的增加对髋关节置换术提出了额外的要求：现在的设备必须承受更高的负荷，并在体内存活更长的时间。更换磨损或损坏部件的翻修手术数量正在增加，需要开发更坚固的髋关节置换装置，以承受所有患者群体日益增长的需求。髋关节置换术失败的主要原因之一是由于设备部件的磨损和疲劳。这些损伤过程可能会急剧增加，如果组件没有很好地排列相对于彼此，或相对于他们在体内所经历的负载的方向。影响对齐的因素有很多，包括器械设计和手术程序，以及患者的解剖结构和生物力学。在本提案中，我们将开发计算机模型来模拟不同失位条件下的髋关节置换术表现。我们将把病人和手术的变化纳入模型中，这样我们就可以准确地定义特定设备需要什么样的对齐水平才能充分运作。这将使我们能够为个体患者提供更好的器械选择指导，以减少错位的可能性。这也将有助于告知外科医生不同患者特征的组件定位。我们将与一家大型骨科公司（DePuy Synthes）合作，将计算机模型整合到他们的新产品开发过程中，以便下一代设备可以设计得更坚固，以适应校准变化，并且可以开发手术工具来帮助在最关键的方向上以更好的精度校准设备。我们还将与监管机构和标准机构合作，制定新的测试要求，考虑到患者和手术的变化，以便所有新产品在推向市场之前都必须经过更严格的测试。从长远来看，我们开发的方法将有助于延长下一代髋关节置换术的使用寿命和可靠性，并使这些设备能够满足我们日益老龄化的活跃人口日益增长的需求。

Over 60 million patients worldwide suffer from hip osteoarthritis, and increasing numbers of patients are requiring total hip replacement surgery. Although the surgery is highly successful, the ageing active population and rise in obesity are placing extra demands on hip replacements: devices must now withstand higher loads and survive for longer durations in the body. The number of revision surgery procedures to replace worn out or damaged components is rising, and there is a need to develop more robust hip replacement devices that can withstand these increasing demands across all patient groups. One of the major causes of failure of hip replacements is due to wear and fatigue of the device components. These damage processes can increase dramatically if the components are not well aligned relative to each another, or relative to the direction of the loads they experience in the body. There can be many factors which affect the alignment, including the device design and surgical procedure as well as the patient anatomy and biomechanics. In this proposal, we will develop computer models to simulate hip replacement performance under different misalignment conditions. We will incorporate patient and surgical variations into the model so that we can define exactly what levels of alignment are required for specific devices to operate adequately. This will enable us to provide better guidance on the choice of device for individual patients to reduce the likelihood of misalignment. It will also help inform surgeons on the positioning of the components for different patient characteristics. We will work with a major orthopaedic company (DePuy Synthes) to integrate the computer models into their new product development process, so that the next generation of devices can be designed to be more robust to alignment variations, and surgical tools can be developed to help align devices with better precision in the most critical directions. We will also work with regulators and standards agencies to develop new testing requirements that take account of the variations in patients and surgery, so that all new products will have to undergo more robust testing before they are introduced onto the market. In the longer term, the methods we develop will help extend the lifetime and reliability of the next generation of hip replacements and enable these devices to meet the increasing demands of our ageing active population.