Polymer-based capacitive strain gauges are a novel and promising concept for measuring large displacements and strains in various applications. These novel sensors allow for high strain, well above the maximum values achieved with state-of-the-art strain gauges (Typ. 1%). In recent years, a lot of interest in this technology has existed in orthopedics, where the sensors have been used to measure knee laxity caused by a tear of the anterior cruciate ligament (ACL), and for other ligament injuries. The validation of this technology in the field has a very low level of maturity, as no fast, reproducible, and reliable manufacturing process which allows mass production of sensors with low cost exists. For this reason, in this paper, a new approach for the fabrication of polymer-based capacitive strain gauges is proposed, using polydimethylsiloxane (PDMS) as base material. It allows (1) the fast manufacturing of sensor batches with reproducible geometry, (2) includes a fabrication step for embedding rigid electrical contacts on the sensors, and (3) is designed to produce sensor batches in which the size, the number, and the position of the sensors can be adapted to the patient’s anatomy. In the paper, the process repeatability and the robustness of the design are successfully proven. After 1000 large-strain elongation cycles, in the form of accelerated testing caused much higher strains than in the above-mentioned clinical scenario, the sensor’s electrical contacts remained in place and the functionalities were unaltered. Moreover, the prototype of a patient customizable patch, embedding multiple sensors, was produced.

Purpose: The ambition of the research group was to develop a sensor-based system that allowed the transfer of results with strain sensors applied to the knee joint. This system was to be validated in comparison to the current static mechanical measurement system. For this purpose, the internal rotation laxity of the knee joint was measured, as it is relevant for anterolateral knee laxity and anterior cruciate ligament (ACL) injury. Methods: This is a noninvasive measurement method using strain sensors which are applied to the skin in the course of the anterolateral ligament. The subjects were placed in supine position. First the left and then the right leg were clinically examined sequentially and documented by means of an examination form. 11 subjects aged 21 to 45 years, 5 women and 6 men were examined. Internal rotation of the lower leg was performed with a torque of 2 Nm at a knee flexion angle of 30°. Results: Comparison of correlation between length change and internal knee rotation angle showed a strong positive correlation (r = 1, p < 0.01). Whereas females showed a significant higher laxity vs. males (p = 0.003). Conclusions: The present study showed that the capacitive strain sensors can be used for reproducible measurement of anterolateral knee laxity. In contrast to the previous static systems, a dynamic measurement will be possible by this method in the future.

With the conventional mechanical rotation measurement of joints, only static measurements are possible with the patient at rest. In the future, it would be interesting to carry out dynamic rotation measurements, for example, when walking or participating in sports. Therefore, a measurement method with an elastic polymer-based capacitive measuring system was developed and validated. In our system, the measurement setup was comprised of a capacitive strain gauge made from a polymer, which was connected to a flexible printed circuit board. The electronics integrated into the printed circuit board allowed data acquisition and transmission. As the sensor strip was elongated, it caused a change in the spacing between the strain gauge’s electrodes, leading to a modification in capacitance. Consequently, this alteration in capacitance enabled the measurement of strain. The measurement system was affixed to the knee by adhering the sensor to the skin in alignment with the anterolateral ligament (ALL), allowing the lower part of the sensor (made of silicone) and the circuit board to be in direct contact with the knee’s surface. It is important to note that the sensor should be attached without any prior stretching. To validate the system, an in vivo test was conducted on 10 healthy volunteers. The dorsiflexion of the ankle was set at 2 Nm using a torque meter to eliminate any rotational laxity in the ankle. A strain gauge sensor was affixed to the Gerdii’s tubercle along the course of the anterolateral ligament, just beneath the lateral epicondyle of the thigh. In three successive measurements, the internal rotation of the foot and, consequently, the lower leg was quantified with a 2 Nm torque. The alteration in the stretch mark’s length was then compared to the measured internal rotation angle using the static measuring device. A statistically significant difference between genders emerged in the internal rotation range of the knee (p = 0.003), with female participants displaying a greater range of rotation compared to their male counterparts. The polymer-based capacitive strain gauge exhibited consistent linearity across all measurements, remaining within the sensor’s initial 20% strain range. The comparison between length change and the knee’s internal rotation angle revealed a positive correlation (r = 1, p < 0.01). The current study shows that elastic polymer-based capacitive strain gauges are a reliable instrument for the internal rotation measurement of the knee. This will allow dynamic measurements in the future under many different settings. In addition, significant gender differences in the internal rotation angle were seen.

Introduction and Problem: With conventional mechanical rotation measurement of joints, only static measurements are possible with the patient at rest. In the future, however, it would be interesting to carry out dynamic rotation measurements, for example when walking or doing sports. Therefore, a measurement method with an elastic capacitive measuring system was developed and validated. Material and Methods: The measurement system consists of a capacitive strain gauge connected to a flexible printed circuit board. The electronics on the printed circuit board are used for data acquisition and transmission. When the sensor strip is stretched, the distance between the fingers of the strain gauge changes and with it the capacitance. Consequently, the strain can be measured via the change in capacitance. The measurement system is taped to the knee with the sensor on the skin in the direction of the anterolateral ligament (ALL). The bottom of the sensor (silicone) and the bottom of the circuit board are in contact with the knee surface. The sensor must be attached to the knee without pre-stretching The system is validated with an in vivo test on 11 patients. For this purpose, the internal rotational laxity of the knee was tested on healthy volunteers and the results compared with the measurements on the static measuring device (Laxitester). The subjects are placed in the supine position. First the left and then the right leg is clinically examined one after the other and documented using an examination form. Exclusion criteria are the presence of a pathological ligament findings in the area of the collateral/cruciate ligaments, previous knee operations or limitations in the range of motion. The distal thigh rests on a support bench on which a knee joint flexion of 30° is set by height adjustment. The femoral condyles are secured against rotation in the positioning aid by posts. This also prevents internal rotation and displacement of the thigh. The foot is strapped into the holding device without shoes. The second toe beam is centered using an adjustable side clamp on the medial and lateral edge of the foot. Dorsiflexion is set at 2 Nm with a torque meter, in accordance with previous studies, to rule out rotational laxity in the ankle. The strain gauge sensor is taped to Gerdii’s tubercle in the course of the antero-lateral ligament below the lateral epicondyle of the thigh. Then, in three repeated measurements, the internal rotation of the foot and thus the lower leg is measured with a torque of 2 Nm. The change in length of the stretch mark is compared with the measured internal rotation angle in the static measuring device (Laxitester). Results: A significant difference between the sexes was found in the internal rotation range of the knee (p=0.003). The range of rotation was greater for female participants than for male participants. Regarding the measured length change values, the measurements presented showed an individual result for each participant, which tended to decrease with increasing internal rotation angle, with no age or gender differences being observed. The stiffness of the strain gauge was in the linear range for all measurements, within the first 20% strain of the sensor. The differences determined do not result from a different stretching of the sensor, but from individual differences between the test persons. The comparison between length change and internal rotation angle of the knee showed a strong positive correlation (r=1, p<0.01). Conclusion: Elastic capacitive strain gauges can be used to reliably measure the internal rotation angle of the knee joint. This will allow dynamic measurements in the future.