State-of-the-Art of Non-Radiative, Non-Visual Spine Sensing with a Focus on Sensing Forces, Vibrations and Bioelectrical Properties: A Systematic Review.

In the research field of robotic spine surgery, there is a big upcoming momentum for surgeon-like autonomous behaviour and surgical accuracy in robotics which goes beyond the standard engineering notions such as geometric precision. The objective of this review is to present an overview of the state of the art in non-visual, non-radiative spine sensing for the enhancement of surgical techniques in robotic automation. It provides a vantage point that facilitates experimentation and guides new research projects to what has not been investigated or integrated in surgical robotics. Studies were identified, selected and processed according to the PRISMA guidelines. Relevant study characteristics that were searched for include the sensor type and measured feature, the surgical action, the tested sample, the method for data analysis and the system's accuracy of state identification. The 6DOF f/t sensor, the microphone and the electromyography probe were the most commonly used sensors in each category, respectively. The performance of the electromyography probe is unsatisfactory in terms of preventing nerve damage as it can only signal after the nerve is disturbed. Feature thresholding and artificial neural networks were the most common decision algorithms for state identification. The fusion of different sensor data in the decision algorithm improved the accuracy of state identification.

Mid-Activity and At-Home Wearable Bioimpedance Elucidates an Interpretable Digital Biomarker of Muscle Fatigue.

OBJECTIVE: Muscle health and decreased muscle performance (fatigue) quantification has proven to be an invaluable tool for both athletic performance assessment and injury prevention. However, existing methods estimating muscle fatigue are infeasible for everyday use. Wearable technologies are feasible for everyday use and can enable discovery of digital biomarkers of muscle fatigue. Unfortunately, the current state-of-the-art wearable systems for muscle fatigue tracking suffer from either low specificity or poor usability. METHODS: We propose using dual-frequency bioimpedance analysis (DFBIA) to non-invasively assess intramuscular fluid dynamics and thereby muscle fatigue. A wearable DFBIA system was developed to measure leg muscle fatigue of 11 individuals during a 13-day protocol consisting of exercise and unsupervised at-home portions. RESULTS: We derived a digital biomarker of muscle fatigue, fatigue score, from the DFBIA signals that was able to estimate the percent reduction in muscle force during exercise with repeated-measures Pearson's r = 0.90 and mean absolute error (MAE) of 3.6%. This fatigue score also estimated delayed onset muscle soreness with repeated-measures Pearson's r = 0.83 and MAE = 0.83. Using at-home data, DFBIA was strongly associated with absolute muscle force of participants (n = 198, p < 0.001). CONCLUSION: These results demonstrate the utility of wearable DFBIA for non-invasively estimating muscle force and pain through the changes in intramuscular fluid dynamics. SIGNIFICANCE: The presented approach may inform development of future wearable systems for quantifying muscle health and provide a novel framework for athletic performance optimization and injury prevention.

Knee acoustic emissions as a noninvasive biomarker of articular health in patients with juvenile idiopathic arthritis: a clinical validation in an extended study population.

BACKGROUND: Joint acoustic emissions from knees have been evaluated as a convenient, non-invasive digital biomarker of inflammatory knee involvement in a small cohort of children with Juvenile Idiopathic Arthritis (JIA). The objective of the present study was to validate this in a larger cohort. FINDINGS: A total of 116 subjects (86 JIA and 30 healthy controls) participated in this study. Of the 86 subjects with JIA, 43 subjects had active knee involvement at the time of study. Joint acoustic emissions were bilaterally recorded, and corresponding signal features were used to train a machine learning algorithm (XGBoost) to classify JIA and healthy knees. All active JIA knees and 80% of the controls were used as training data set, while the remaining knees were used as testing data set. Leave-one-leg-out cross-validation was used for validation on the training data set. Validation on the training and testing set of the classifier resulted in an accuracy of 81.1% and 87.7% respectively. Sensitivity / specificity for the training and testing validation was 88.6% / 72.3% and 88.1% / 83.3%, respectively. The area under the curve of the receiver operating characteristic curve was 0.81 for the developed classifier. The distributions of the joint scores of the active and inactive knees were significantly different. CONCLUSION: Joint acoustic emissions can serve as an inexpensive and easy-to-use digital biomarker to distinguish JIA from healthy controls. Utilizing serial joint acoustic emission recordings can potentially help monitor disease activity in JIA affected joints to enable timely changes in therapy.

Development of an Instrument to Assess the Stability of Cementless Femoral Implants Using Vibration Analysis During Total Hip Arthroplasty.

OBJECTIVE: The level of primary implant fixation in cementless total hip arthroplasty is a key factor for the longevity of the implant. Vibration-based methods show promise for providing quantitative information to help surgeons monitor implant fixation intraoperatively. A thorough understanding of what is driving these changes in vibrational behavior is important for further development and improvement of these methods. Additionally, an instrument must be designed to enable surgeons to leverage these methods. This study addresses both of these issues. METHOD: An augmented system approach was used to develop an instrument that improves the sensitivity of the vibrational method and enables the implementation of the necessary excitation and measurement equipment. The augmented system approach took into account the dynamics of the existing bone-implant system and its interaction with the added instrument. RESULTS: Two instrument designs are proposed, accompanied by a convergence-based method to determine the insertion endpoint. The modal strain energy density distribution was shown to affect the vibrational sensitivity to contact changes in certain areas. CONCLUSION: The augmented system approach led to an instrument design that improved the sensitivity to changes in the proximal region of the combined bone-implant-instrument system. This fact was confirmed both in silico and in vitro. Clinical Impact: The presented method and instruments address practical intraoperative challenges and provide perspective to objectively support the surgeon's decision-making process, which will ensure optimal patient treatment.

Acoustic analysis to monitor implant seating and early detect fractures in cementless THA: An in vivo study.

The initial stability of cementless total hip arthroplasty (THA) implants is obtained by an interference fit that allows osseointegration for a long term secondary stability of the implant. Yet, finding the insertion endpoint that corresponds to an appropriate initial stability is currently often based on a number of subjective experiences of the orthopedic surgeon, which can be challenging. In order to assist the orthopedic surgeons in their pursuit to find this optimal initial stability, this study aims to determine whether the analysis of sound that results from the implant insertion hammer blows can be used to objectively monitor the insertion process of cementless THA implants. An in vivo study was conducted. The experimental results revealed vibro-acoustic behavior sensitive to implant seating, related to the low frequency content of the response spectra. This sensitive low-frequency behavior was quantified by a set of specific vibro-acoustic features and metrics that reflected the power and similarity of the low-frequency response. These features and metrics allowed monitoring the implant seating and their convergence agreed well with the endpoint of insertion as determined by the orthopedic surgeon. Intraoperative fractures caused an abrupt and opposite change of the vibro-acoustic behavior prior to the notification of the fracture by the orthopedic surgeon. The observation of such an abrupt change in the vibro-acoustic behavior can be an important early warning for loss of implant stability. The presented vibro-acoustic measurement method shows potential to serve as a decision supporting source of information as it showed to reflect the implant seating.

The Use of a Vibro-Acoustic Based Method to Determine the Composite Material Properties of a Replicate Clavicle Bone Model.

Replicate bones are widely used as an alternative for cadaveric bones for in vitro testing. These composite bone models are more easily available and show low inter-specimen variability compared to cadaveric bone models. The combination of in vitro testing with in silico models can provide further insights in the evaluation of the mechanical behavior of orthopedic implants. An accurate numerical representation of the experimental model is important to draw meaningful conclusions from the numerical predictions. This study aims to determine the elastic material constants of a commonly used composite clavicle model by combining acoustic experimental and numerical modal analysis. The difference between the experimental and finite element (FE) predicted natural frequencies was minimized by updating the elastic material constants of the transversely isotropic cortical bone analogue that are provided by the manufacturer. The longitudinal Young's modulus was reduced from 16.00 GPa to 12.88 GPa and the shear modulus was increased from 3.30 GPa to 4.53 GPa. These updated material properties resulted in an average natural frequency difference of 0.49% and a maximum difference of 1.73% between the FE predictions and the experimental results. The presented updated model aims to improve future research that focuses on mechanical simulations with clavicle composite bone models.

Two Different Methods to Measure the Stability of Acetabular Implants: A Comparison Using Artificial Acetabular Models.

The total number of total hip arthroplasties is increasing every year, and approximately 10% of these surgeries are revisions. New implant design and surgical techniques are evolving quickly and demand accurate preclinical evaluation. The initial stability of cementless implants is one of the main concerns of these preclinical evaluations. A broad range of initial stability test methods is currently used, which can be categorized into two main groups: Load-to-failure tests and relative micromotion measurements. Measuring relative micromotion between implant and bone is recognized as the golden standard for implant stability testing as this micromotion is directly linked to the long-term fixation of cementless implants. However, specific custom-made set-ups are required to measure this micromotion, with the result that numerous studies opt to perform more straightforward load-to-failure tests. A custom-made micromotion test set-up for artificial acetabular bone models was developed and used to compare load-to-failure (implant push-out test) with micromotion and to assess the influence of bone material properties and press-fit on the implant stability. The results showed a high degree of correlation between micromotion and load-to-failure stability metrics, which indicates that load-to-failure stability tests can be an appropriate estimator of the primary stability of acetabular implants. Nevertheless, micromotions still apply as the golden standard and are preferred when high accuracy is necessary. Higher bone density resulted in an increase in implant stability. An increase of press-fit from 0.7 mm to 1.2 mm did not significantly increase implant stability.

Modal frequency and shape curvature as a measure of implant fixation: A computer study on the acetabular cup.

Modal parameters are often investigated in order to assess the initial fixation of an implant. Most of studies are focused on the natural frequencies and frequency response function. Usually the femoral stem is tested although the acetabular cup fixation is important as well. The results of implant stability assessment are inconsistent and seem to suggest that frequency as a stability indicator is not sufficiently sensitive. In this study the sensitivity of the modal properties to changes in the bone-implant interface was investigated with the help of the finite element method (FEM). A novel fixation index based on modal shape curvature was investigated as a potential measure of the implant fixation. Modal frequencies are sensitive to interface changes in some manner, but suffer from insensitivity to local changes at bone-implant interface. The sensitivity up to 44% of natural frequencies to stiffness change due insertion steps was observed. The tested damage indicators are able to detect localized small changes in peripheral stiffness (5% stiffness reduction) with 95% confidence under the noise up to 1%. The modal shapes and their curvatures have a great potential to be a robust fixation indicator.

Vibration-based fixation assessment of tibial knee implants: A combined in vitro and in silico feasibility study.

The preoperative diagnosis of loosening of cemented tibial knee implants is challenging. This feasibility study explored the basic potential of a vibration-based method as an alternative diagnostic technique to assess the fixation state of a cemented tibia implant and establish the method's sensitivity limits. A combined in vitro and in silico approach was pursued. Several loosening cases were simulated. The largest changes in the vibrational behavior were obtained in the frequency range above 1500 Hz. The vibrational behavior was described with two features; the frequency response function and the power spectral density band power. Using both features, all experimentally simulated loosening cases could clearly be distinguished from the fully cemented cases. By complementing the experimental work with an in silico study, it was shown that loosening of approximately 14% of the implant surface on the lateral and medial side was detectable with a vibration-based method. Proximal lateral and medial locations on the tibia or locations toward the edge of the implant surface measured in the longitudinal direction were the most sensitive measurement and excitation locations to assess implant fixation. These results contribute to the development of vibration-based methods as an alternative follow-up method to detect loosened tibia implants.

Development of an acoustic measurement protocol to monitor acetabular implant fixation in cementless total hip Arthroplasty: A preliminary study.

In cementless total hip arthroplasty (THA), the initial stability is obtained by press-fitting the implant in the bone to allow osseointegration for a long term secondary stability. However, finding the insertion endpoint that corresponds to a proper initial stability is currently based on the tactile and auditory experiences of the orthopedic surgeon, which can be challenging. This study presents a novel real-time method based on acoustic signals to monitor the acetabular implant fixation in cementless total hip arthroplasty. Twelve acoustic in vitro experiments were performed on three types of bone models; a simple bone block model, an artificial pelvic model and a cadaveric model. A custom made beam was screwed onto the implant which functioned as a sound enhancer and insertor. At each insertion step an acoustic measurement was performed. A significant acoustic resonance frequency shift was observed during the insertion process for the different bone models; 250 Hz (35%, second bending mode) to 180 Hz (13%, fourth bending mode) for the artificial bone block models and 120 Hz (11%, eighth bending mode) for the artificial pelvis model. No significant frequency shift was observed during the cadaveric experiment due to a lack of implant fixation in this model. This novel diagnostic method shows the potential of using acoustic signals to monitor the implant seating during insertion.

A biomechanical testing system to determine micromotion between hip implant and femur accounting for deformation of the hip implant: Assessment of the influence of rigid body assumptions on micromotions measurements.

BACKGROUND: Accurate pre-clinical evaluation of the initial stability of new cementless hip stems using in vitro micromotion measurements is an important step in the design process to assess the new stem's potential. Several measuring systems, linear variable displacement transducer-based and other, require assuming bone or implant to be rigid to obtain micromotion values or to calculate derived quantities such as relative implant tilting. METHODS: An alternative linear variable displacement transducer-based measuring system not requiring a rigid body assumption was developed in this study. The system combined advantages of local unidirectional and frame-and-bracket micromotion measuring concepts. The influence and possible errors that would be made by adopting a rigid body assumption were quantified. Furthermore, as the system allowed emulating local unidirectional and frame-and-bracket systems, the influence of adopting rigid body assumptions were also analyzed for both concepts. Synthetic and embalmed bone models were tested in combination with primary and revision implants. Single-legged stance phase loading was applied to the implant - bone constructs. FINDINGS: Adopting a rigid body assumption resulted in an overestimation of mediolateral micromotion of up to 49.7µm at more distal measuring locations. Maximal average relative rotational motion was overestimated by 0.12° around the anteroposterior axis. Frontal and sagittal tilting calculations based on a unidirectional measuring concept underestimated the true tilting by an order of magnitude. INTERPRETATION: Non-rigid behavior is a factor that should not be dismissed in micromotion stability evaluations of primary and revision femoral implants.

Determination of replicate composite bone material properties using modal analysis.

Replicate composite bones are used extensively for in vitro testing of new orthopedic devices. Contrary to tests with cadaveric bone material, which inherently exhibits large variability, they offer a standardized alternative with limited variability. Accurate knowledge of the composite's material properties is important when interpreting in vitro test results and when using them in FE models of biomechanical constructs. The cortical bone analogue material properties of three different fourth-generation composite bone models were determined by updating FE bone models using experimental and numerical modal analyses results. The influence of the cortical bone analogue material model (isotropic or transversely isotropic) and the inter- and intra-specimen variability were assessed. Isotropic cortical bone analogue material models failed to represent the experimental behavior in a satisfactory way even after updating the elastic material constants. When transversely isotropic material models were used, the updating procedure resulted in a reduction of the longitudinal Young's modulus from 16.00GPa before updating to an average of 13.96 GPa after updating. The shear modulus was increased from 3.30GPa to an average value of 3.92GPa. The transverse Young's modulus was lowered from an initial value of 10.00GPa to 9.89GPa. Low inter- and intra-specimen variability was found.

A nondestructive method to verify the glenosphere-baseplate assembly in reverse shoulder arthroplasty.

BACKGROUND: Glenoid dissociation is a rare postoperative complication in reverse shoulder arthroplasty that has severe consequences for the patient and requires revision in most cases. A mechanically compromised Morse taper is hypothesized to be the main cause of this complication, with bony impingements and soft tissue interpositioning being cited as the most important problems. Intraoperative assessment of the taper assembly is challenging. Current methods require applying considerable torque to the glenosphere or relying on radiographs. MATERIALS AND METHODS: This in vitro study demonstrates how the assembly quality can be accurately determined in a nondestructive way by exploiting the implant-specific relation between screw and Morse taper characteristics by measuring the angular rotation-torque curve. RESULTS: The feasibility of the method is demonstrated on 2 reverse implant models. Several data features that can statistically discriminate between optimal and suboptimal assemblies are proposed. CONCLUSION: Suboptimal assemblies can be detected using the method presented, which could easily be integrated in the current surgical workflow. Clinical recommendations based on the method's rationale are also presented, allowing detection of the most severe defect cases with surgical instruments currently in use.