Enhancing soft tissue balance: Evaluating robotic-assisted functional positioning in varus knees across flexion and extension with quantitative sensor-guided technology.

PURPOSE: Functional implant positioning (FIP) for total knee arthroplasty (TKA) is an evolution of kinematic alignment based on preoperative CT scan and robotic-assisted technology. This study aimed to assess the ligament balancing of image-based robotic-assisted TKA in extension, mid-flexion and flexion with an FIP using intraoperative sensor-guided technology. The hypothesis was that image-based robotic-assisted TKA performed by FIP would achieve ligament balancing all along the arc of knee flexion. METHODS: This prospective monocentric study included 47 consecutive patients with varus knees undergoing image-based robotic-assisted TKA performed with FIP. After robotic-assisted bone cuts, trial components were inserted, and soft tissue balance was assessed using sensor-guided technology at 10°, 45° and 90° of knee flexion. A mediolateral balanced knee was defined by an intercompartmental pressure difference (ICPD) ≤ 15 lbf and medial and lateral compartment pressure ≤60 lbf. The mean age was 71.6 years old ±6.7, the mean BMI was 29.0 kg/m2 ± 4.9 and the mean preoperative HKA was 174° ± 5 [159; 183]. RESULTS: The mean postoperative knee alignment was 177.0° ± 2.2° [172; 181]. There were 93.6% of balanced knees (n = 44) at 10 and 90° of knee flexion versus 76.6% (n = 36) at 45° of knee flexion with a significant difference (p = 0.014). Median ICPD at 10, 45 and 90° of knee flexion were, respectively, 7.0 (interquartile range [IQR]: 9), 11.0 (IQR: 9.5) and 8.0 (IQR: 9.0). Pairwise analyses revealed differences for ICPD at 45° versus ICPD at 10° (p = 0.003) and ICPD at 90° versus ICPD at 45° (p = 0.007). CONCLUSION: FIP with an image-based robotic-assisted system allowed the restoration of a well-balanced knee at 10° and 90° of flexion in varus knees. Nevertheless, some discrepancies occurred in midflexion, and more work is needed to understand ligament behaviour all along the arc of knee flexion. LEVEL OF EVIDENCE: Level II.

Collateral Ligament Tension and Balance Alone Does Not Ensure Improved Outcome After Total Knee Arthroplasty.

BACKGROUND: It is hypothesized that suboptimal soft tissue and collateral ligament balance is a cause of patient dissatisfaction following total knee arthroplasty (TKA). This analysis examined the association between compartment pressures during TKA and patient-reported outcome measurements (PROMs). METHODS: This single-institution, retrospective cohort study of prospectively collected compartment pressure data measured during TKA comprised 145 patients who underwent surgery between 2015 and 2021 and completed 1-year follow-up PROMs. The primary outcome included pressures, in pounds (lbs), of the medial and lateral compartments in extension (5°), mid-flexion (45°), and flexion (90°), and associated PROMs. The difference been the 1-year and preoperative PROMs was used to separate the top 25% from the bottom 75% performers. Pressures were compared using Student's T-tests and multivariate linear regressions, while controlling for preoperative deformity. A subgroup analysis of the most popular implant was performed. RESULTS: Higher medial compartment pressures were seen in our total cohort (Knee Society Score (KSS) mid-flexion 24 versus 18 lbs, P = .03, flexion 24 versus 17 lbs P = .01) and within our subgroup analysis (Short form- Mental (SF-M) extension 32 versus 21 lbs P = .01, KSS mid-flexion 27 versus 16 lbs P = .005, extension 31 versus 20 lbs P = .003). This trend persisted in the subgroup analysis when controlling for preoperative deformity (KSS extension +16.22 lbs P ≤ .001, mid-flexion +17.6 lbs. P = .001, and flexion +9.2 lbs, P = .005). CONCLUSION: Several groups demonstrated higher medial versus lateral pressures. However, this pattern was not consistent across PROMs, suggesting that compartment pressures at the time of TKA are an important factor but not the sole predictor of patient satisfaction.

Intraoperative Load Sensing in Total Knee Arthroplasty Leads to a Functional but Not Clinical Difference: A Comparative, Gait Analysis Evaluation.

INTRODUCTION: Although Total Knee Arthroplasty (TKA) is a successful procedure, a significant number of patients are still unsatisfied, reporting instability at the mid-flexion range (Mid-Flexion Instability-MFI). To avoid this complication, many innovations, including load sensors (LS), have been introduced. The intraoperative use of LS may facilitate the balance of the knee during the entire range of motion to avoid MFI postoperatively. The objective of this study was to perform a Gait Analysis (GA) evaluation of a series of patients who underwent primary TKA using a single LS technology. METHODS: The authors matched and compared two groups of patients treated with the same posterior stabilized TKA design. In Group A, 10 knees were intraoperatively balanced with LS technology, while 10 knees (Group B) underwent standard TKA. The correct TKA alignment was preoperatively determined aiming for a mechanical alignment. Clinical evaluation was performed according to the WOMAC, Knee Society Score (KSS) and Forgotten Joint Score, while functional evaluation was performed using a state-of-the-art GA platform. RESULTS: We reported excellent clinical results in both groups without any statistical difference in patient reported outcome measurements (PROMs); from a functional standpoint, several GA space-time parameters were closer to normal in the sensor group when compared to the standard group, but a statistically significant difference was not reached. CONCLUSIONS: Gait Analysis represents a valid method to evaluate TKA kinematics. This study, with its limitations, showed that pressure sensitive technology represents a valid aid for surgeons aiming to improve the postoperative stability of TKA; however, other factors (i.e., level of intra-articular constraint and alignment) may play a major role in reproducing the normal knee biomechanics.

Combining load sensor and robotic technologies for ligament balance in total knee arthroplasty.

Good ligament balance in total knee arthroplasty (TKA) is thought to improve clinical results, but is highly surgeon-dependent when performed without technological assistance. We therefore describe a TKA technique using the Mako robotic arm (Stryker, Kalamazoo, Michigan, USA) as sole means of balancing ligament tension by bone recuts associated to control by the VERASENSE load sensor (Orthosensor, Inc, Dania Beach, Florida, USA). In this preliminary series of 29 patients, 27 (93%) showed a well-balanced knee in extension at end of procedure, and 23 (79%) showed a well-balanced knee in flexion and extension, without any periarticular soft-tissue release. The load sensor analyzes ligament balance after the initial bone cuts, and guides possible further femoral or tibial recuts. This technique enables quantifiable alignment and control of ligament tension. Collecting objective intraoperative data should improve knowledge in placing TKA prostheses.

Tibiofemoral dynamic stressed gap laxities correlate with compartment load measurements in robotic arm-assisted total knee arthroplasty.

AIMS: It is unknown whether gap laxities measured in robotic arm-assisted total knee arthroplasty (TKA) correlate to load sensor measurements. The aim of this study was to determine whether symmetry of the maximum medial and lateral gaps in extension and flexion was predictive of knee balance in extension and flexion respectively using different maximum thresholds of intercompartmental load difference (ICLD) to define balance. METHODS: A prospective cohort study of 165 patients undergoing functionally-aligned TKA was performed (176 TKAs). With trial components in situ, medial and lateral extension and flexion gaps were measured using robotic navigation while applying valgus and varus forces. The ICLD between medial and lateral compartments was measured in extension and flexion with the load sensor. The null hypothesis was that stressed gap symmetry would not correlate directly with sensor-defined soft tissue balance. RESULTS: In TKAs with a stressed medial-lateral gap difference of ≤1 mm, 147 (89%) had an ICLD of ≤15 lb in extension, and 112 (84%) had an ICLD of ≤ 15 lb in flexion; 157 (95%) had an ICLD ≤ 30 lb in extension, and 126 (94%) had an ICLD ≤ 30 lb in flexion; and 165 (100%) had an ICLD ≤ 60 lb in extension, and 133 (99%) had an ICLD ≤ 60 lb in flexion. With a 0 mm difference between the medial and lateral stressed gaps, 103 (91%) of TKA had an ICLD ≤ 15 lb in extension, decreasing to 155 (88%) when the difference between the medial and lateral stressed extension gaps increased to ± 3 mm. In flexion, 47 (77%) had an ICLD ≤ 15 lb with a medial-lateral gap difference of 0 mm, increasing to 147 (84%) at ± 3 mm. CONCLUSION: This study found a strong relationship between intercompartmental loads and gap symmetry in extension and flexion measured with prostheses in situ. The results suggest that ICLD and medial-lateral gap difference provide similar assessment of soft-tissue balance in robotic arm-assisted TKA. Cite this article: Bone Jt Open 2021;2(11):974-980.

Rugged and Compact Three-Axis Force/Torque Sensor for Wearable Robots.

In the field of robotics, sensors are crucial in enabling the interaction between robots and their users. To ensure this interaction, sensors mainly measure the user's strength, and based on this, wearable robots are controlled. In this paper, we propose a novel three-axis force/torque sensor for wearable robots that is compact and has a high load capacity. The bolt and nut combination of the proposed sensor is designed to measure high-load weights, and the simple structure of this combination allows the sensor to be compact and light. Additionally, to measure the three-axis force/torque, we design three capacitance-sensing cells. These cells are arranged in parallel to measure the difference in capacitance between the positive and negative electrodes. From the capacitance change measured by these sensing cells, force/torque information is converted through deep neural network calibration. The sensing point can also be confirmed using the geometric and kinematic relation of the sensor. The proposed sensor is manufactured through a simple and inexpensive process using cheap and simply structured components. The performance of the sensor, such as its repeatability and capacity, is evaluated using several experimental setups. In addition, the sensor is applied to a wearable robot to measure the force of an artificial muscle.

Design and analysis of a compliant 3D printed energy harvester housing for knee implants.

Instrumented implants have the potential to detect abnormal loading patterns which could be deleterious to implant longevity, indicating a need for intervention which could reduce the need for more complicated revision surgeries. Reliably powering such devices has been one obstacle preventing widespread usage of instrumented implants in clinical populations. This study presents a 3D-printed titanium interpositional device designed to integrate triboelectric generators (TEGs) into a commercially available total knee replacement (TKR). The device's stiffness, durability, and efficacy as a TEG housing were determined. Surprisingly, the stiffness of the 3D printed prototype was 73% less than what was calculated in a corresponding computational model, and under long-term durability testing failed after approximately 30,000 cycles of simulated gait loading. Under cyclical compressive loading, TEGs embedded in the device were able to generate 10.05 µW of power which is sufficient to run the frontend electronics for a load measurement system. The stiffness discrepancy between the computational and experimental models and the premature fatigue failure are suspected to be a result of internal porosity, unfused material and surface roughness of the 3D printed metal. Further refinements in design and manufacturing of the compliant device are required to improve its durability and TEG power output.

Development of a Wireless Telemetry Sensor Device to Measure Load and Deformation in Orthopaedic Applications.

Due to sensor size and supporting circuitry, in-vivo load and deformation measurements are currently restricted to applications within larger orthopaedic implants. The objective of this study is to repurpose a commercially available low-power, miniature, wireless, telemetric, tire-pressure sensor (FXTH87) to measure load and deformation for future use in orthopaedic and biomedical applications. The capacitive transducer membrane was modified, and compressive deformation was applied to the transducer to determine the sensor signal value and the internal resistive force. The sensor package was embedded within a deformable enclosure to illustrate potential applications of the sensor for monitoring load. To reach the maximum output signal value, sensors required compressive deformation of 350 ± 24 µm. The output signal value of the sensor was an effective predictor of the applied load on a calibrated plastic strain member, over a range of 35 N. The FXTH87 sensor can effectively sense and transmit load-induced deformations. The sensor does not have a limit on loads it can measure, as long as deformation resulting from the applied load does not exceed 350 µm. The proposed device presents a sensitive and precise means to monitor deformation and load within small-scale, deformable enclosures.

Real-Time Wireless Platform for In Vivo Monitoring of Bone Regeneration.

For the monitoring of bone regeneration processes, the instrumentation of the fixation is an increasingly common technique to indirectly measure the evolution of bone formation instead of ex vivo measurements or traditional in vivo techniques, such as X-ray or visual review. A versatile instrumented external fixator capable of adapting to multiple bone regeneration processes was designed, as well as a wireless acquisition system for the data collection. The design and implementation of the overall architecture of such a system is described in this work, including the hardware, firmware, and mechanical components. The measurements are conditioned and subsequently sent to a PC via wireless communication to be in vivo displayed and analyzed using a developed real-time monitoring application. Moreover, a model for the in vivo estimation of the bone callus stiffness from collected data was defined. This model was validated in vitro using elastic springs, reporting promising results with respect to previous equipment, with average errors and uncertainties below 6.7% and 14.04%. The devices were also validated in vivo performing a bone lengthening treatment on a sheep metatarsus. The resulting system allowed the in vivo mechanical characterization of the bone callus during experimentation, providing a low-cost, simple, and highly reliable solution.

A novel flexible capacitive load sensor for use in a mobile unicompartmental knee replacement bearing: An in vitro proof of concept study.

Instrumented knee replacements can provide in vivo data quantifying physiological loads acting on the knee. To date instrumented mobile unicompartmental knee replacements (UKR) have not been realised. Ideally instrumentation would be embedded within the polyethylene bearing. This study investigated the feasibility of an embedded flexible capacitive load sensor. A novel flexible capacitive load sensor was developed which could be incorporated into standard manufacturing of compression moulded polyethylene bearings. Dynamic experiments were performed to determine the characteristics of the sensor on a uniaxial servo-hydraulic material testing machine. The instrumented bearing was measured at sinusoidal frequencies between 0.1 and 10Hz, allowing for measurement of typical gait load magnitudes and frequencies. These correspond to frequencies of interest in physiological loading. The loads that were applied were a static load of 390N, corresponding to an equivalent body weight load for UKR, and a dynamic load of ±293N. The frequency transfer response of the sensor suggests a low pass filter response with a -3dB frequency of 10Hz. The proposed embedded capacitive load sensor was shown to be applicable for measuring in vivo loads within a polyethylene mobile UKR bearing.

Improvement of the Measurement Range and Temperature Characteristics of a Load Sensor Using a Quartz Crystal Resonator with All Crystal Layer Components.

Monitoring multiple biosignals, such as heart rate, respiration cycle, and weight transitions, contributes to the health management of individuals. Specifically, it is possible to measure multiple biosignals using load information obtained through contact with the environment, such as a chair and bed, in daily use. A wide-range load sensor is essential since load information contains multiple biosignals with various load ranges. In this study, a load sensor is presented by using a quartz crystal resonator (QCR) with a wide measurement range of 1.5 × 106 (0.4 mN to 600 N), and its temperature characteristic of load is improved to -7 Hz/°C (-18 mN/°C). In order to improve the measurement range of the load, a design method of this sensor is proposed by restraining the buckling of QCR and by using a thinner QCR. The proposed sensor allows a higher allowable load with high sensitivity. The load sensor mainly consists of three layers, namely a QCR layer and two holding layers. As opposed to the conventional holding layer composed of silicon, quartz crystal is utilized for the holding layers to improve the temperature characteristic of the load sensor. In the study, multiple biosignals, such as weight and pulse, are detected by using a fabricated sensor.

Intraoperative Load-Sensing Variability During Cemented, Posterior-Stabilized Total Knee Arthroplasty.

BACKGROUND: Load-sensing technology during total knee arthroplasty (TKA) provides objective measurements of ligamentous balance. The purpose of this study is to assess its intraoperative validity and reliability during TKA. METHODS: Fifty-four patients underwent TKA using the OrthoSensor VERASENSE tibial insert to assist with ligament balance. The transepicondylar axis (TEA) was used to determine femoral component rotation, and the posterior condylar angle (PCA) was measured. Load measurements were documented at 10°, 45°, and 90° of flexion with the trial (TRIAL) components and with the definitive (FINAL) cemented implants. Adequate balance was defined as a load differential ≤15 pounds between compartments. RESULTS: Adequate balanced with TRIAL and FINAL implants was observed in 89% TKAs. There was a significant linear correlation of the TRIAL and FINAL loads in the medial compartment throughout range of motion. No correlation between the TRIAL and FINAL loads was identified in the lateral compartment. There was no relationship between an increasing PCA and medial compartment loads at 45° (R2 = 0.0006, Y = -0.10X + 7.3 ± 2.3; P = .86) and 90° (R2 = 0.004, Y = -0.25X + 6.3 ± 2.1; P = .62) of flexion, suggesting that the compartment loads were not significantly altered with femoral rotation parallel to the TEA. A similar finding was observed in the lateral compartment at all poses. CONCLUSION: Variability between the TRIAL and FINAL implant measurements was higher in the lateral compartment as compared to the medial compartment. Using the TEA and not the posterior condylar line as a landmark to guide femoral component rotation, the flexion gap is frequently balanced without the need for additional ligament releases.