NILAX Sensor system for the determination of knee laxities

该项目的目的是开发和测试一种通用的、易于使用的诊断系统，该系统基于高弹性应变仪，用于客观评估交叉韧带损伤及其愈合过程。该项目的结果是一个传感器系统，可以穿在病人的形式，可拉伸袜子，这允许动态测量。该器械预期用于支持日常临床实践中膝关节手术或治疗的决策过程。简单的适用性还使得在患者的家庭环境中进行测量以控制治疗结果成为可能。该项目建立在DFG先前的高弹性聚合物应变计开发预研究的经验基础上。在该研究中，建立了用于从模拟膝关节获得测量值的应变计和读出电子器件的构造过程。这为今后的临床研究奠定了基础。该项目的第一阶段是调整现有的传感器系统，用于交叉韧带的临床研究。该系统的开发是基于前期工作，包括先证者和患者的测量结果，并考虑到已经开发的传感器系统的特性。最终的传感器设计在已经建立的体外测试台上进行优化。最初，在先证者的帮助下，使用简单的测量条进行静态比较测量。这些结果被用于传感器系统的优化。传感器系统的第一功能模式用于在健康先证者中进行进一步的测试。在第二个项目阶段，将使用优化的传感器系统进行临床研究。在真实的生理动态条件下结合膝关节的旋转松弛（旋转滑动）来测量适应性松弛。此外，正在开展工作，以提高测量系统的特异性和灵敏度，并使传感器生产自动化。与传统方法相比，该系统的优势在于可以同时监测膝关节松弛的三个组成部分（前-后、侧-内侧、旋转和滑动），而传统方法一次只能单独确定一个。此外，矫形器能够在正常运动期间进行监测。该项目将在弗赖堡大学医学中心微系统工程系和矫形外科和创伤科密切合作下实施。

The aim of this project is the development and testing of a universal, easy-to-use diagnostic system, based on highly elastic strain gauges, for the objective assessment of cruciate ligament injuries and their healing process. The project result is a sensor system which can be worn on the patient in the form of a stretchable sock, which allows dynamic measurements. The device is intended to support the decision process for an operation or therapy of the knee in everyday clinical practice. The simple applicability also makes measurements in the patient's home environment possible for the control of the treatment outcome. This project builds upon the experiences of a prior DFG pre-study into the development of a highly elastic polymer strain gauge. In that study, a process was established for the construction of strain gauges and read-out electronics for use in obtaining measurements from a simulated knee. This lays the groundwork for future clinical studies. The first phase of the project is to adapt the existing sensor system for a clinical study on cruciate ligament. The development of the system is carried out based on the preliminary work, including the results of measurements on probands and patients, and taking into account the characteristics of the sensor system already developed. The final sensor design is optimized at the already established in vitro test stand. Initially, static comparative measurements are performed with simple measuring strips with the help of probands. These results were used for optimization of the sensor system. The first functional patterns of the sensor system are used to carry out further tests in healthy probands. In the second project phase, a clinical study will be carried out with the optimized sensor system. The ap-laxity is measured in combination with the rotational laxity (rotational slide) of the knee joint under physiologically dynamic conditions in real time. In addition, work is being carried out to increase the specificity and sensitivity of the measuring system and to automate sensor production. The system holds an advantage over conventional methods in that the three components of knee laxity (anterior-posterior, lateral-medial, rotation and slipping) can be simultaneously monitored, whereas the conventional methods can only individually determine one at a time. Additionally, the orthosis enables monitoring during normal motion. The project will be carried out in close cooperation between the Department of Microsystems Engineering (IMTEK) and the Department for Orthopedics and Traumatic Injuries at the University Medical Center Freiburg.