# itemDataValues

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  The principal goal of the FEBio project is to provide an advanced finite element tool for the biomechanics and biophysics communities that allows researchers to model mechanics, transport, and electrokinetic phenomena for biological systems accurately and efficiently. In addition, because FEBio is geared toward the research community, the code is designed such that new features can be added easily, thus making it an ideal tool for testing novel computational methods. Finally, because the success of a code is determined by its user base, integral goals of the FEBio project have been to offer support and outreach to our community; to provide mechanisms for dissemination of results, models, and data; and to encourage interaction between users. This review presents the history of the FEBio project, from its initial developments through its current funding period. We also present a glimpse into the future of FEBio.


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  Movement is fundamental to human and animal life, emerging through interaction of complex neural, muscular, and skeletal systems. Study of movement draws from and contributes to diverse fields, including biology, neuroscience, mechanics, and robotics. OpenSim unites methods from these fields to create fast and accurate simulations of movement, enabling two fundamental tasks. First, the software can calculate variables that are difficult to measure experimentally, such as the forces generated by muscles and the stretch and recoil of tendons during movement. Second, OpenSim can predict novel movements from models of motor control, such as kinematic adaptations of human gait during loaded or inclined walking. Changes in musculoskeletal dynamics following surgery or due to human-device interaction can also be simulated; these simulations have played a vital role in several applications, including the design of implantable mechanical devices to improve human grasping in individuals with paralysis. OpenSim is an extensible and user-friendly software package built on decades of knowledge about computational modeling and simulation of biomechanical systems. OpenSim's design enables computational scientists to create new state-of-the-art software tools and empowers others to use these tools in research and clinical applications. OpenSim supports a large and growing community of biomechanics and rehabilitation researchers, facilitating exchange of models and simulations for reproducing and extending discoveries. Examples, tutorials, documentation, and an active user forum support this community. The OpenSim software is covered by the Apache License 2.0, which permits its use for any purpose including both nonprofit and commercial applications. The source code is freely and anonymously accessible on GitHub, where the community is welcomed to make contributions. Platform-specific installers of OpenSim include a GUI and are available on simtk.org.


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  OpenSim: Simulating musculoskeletal dynamics and neuromuscular control to study human and animal movement


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  Computational mechanics has been advanced in every area of orthopedic biomechanics. The objective of this paper is to provide a general review of the computational models used in the analysis of the mechanical function of the knee joint in different loading and pathological conditions. Major review articles published in related areas are summarized first. The constitutive models for soft tissues of the knee are briefly discussed to facilitate understanding the joint modeling. A detailed review of the tibiofemoral joint models is presented thereafter. The geometry reconstruction procedures as well as some critical issues in finite element modeling are also discussed. Computational modeling can be a reliable and effective method for the study of mechanical behavior of the knee joint, if the model is constructed correctly. Single-phase material models have been used to predict the instantaneous load response for the healthy knees and repaired joints, such as total and partial meniscectomies, ACL and PCL reconstructions, and joint replacements. Recently, poromechanical models accounting for fluid pressurization in soft tissues have been proposed to study the viscoelastic response of the healthy and impaired knee joints. While the constitutive modeling has been considerably advanced at the tissue level, many challenges still exist in applying a good material model to three-dimensional joint simulations. A complete model validation at the joint level seems impossible presently, because only simple data can be obtained experimentally. Therefore, model validation may be concentrated on the constitutive laws using multiple mechanical tests of the tissues. Extensive model verifications at the joint level are still crucial for the accuracy of the modeling.


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  Understanding how structural and functional alterations of individual tissues impact on whole-joint function is challenging, particularly in humans where direct invasive experimentation is difficult. Finite element (FE) computational models produce quantitative predictions of the mechanical and physiological behaviour of multiple tissues simultaneously, thereby providing a means to study changes that occur through healthy ageing and disease such as osteoarthritis (OA). As a result, significant research investment has been placed in developing such models of the human knee. Previous work has highlighted that model predictions are highly sensitive to the various inputs used to build them, particularly the mathematical definition of material properties of biological tissues. The goal of this systematic review is two-fold. First, we provide a comprehensive summation and evaluation of existing linear elastic material property data for human tibiofemoral joint tissues, tabulating numerical values as a reference resource for future studies. Second, we review efforts to model tibiofemoral joint mechanical behaviour through FE modelling with particular focus on how studies have sourced tissue material properties. The last decade has seen a renaissance in material testing fuelled by development of a variety of new engineering techniques that allow the mechanical behaviour of both soft and hard tissues to be characterised at a spectrum of scales from nano- to bulk tissue level. As a result, there now exists an extremely broad range of published values for human tibiofemoral joint tissues. However, our systematic review highlights gaps and ambiguities that mean quantitative understanding of how tissue material properties alter with age and OA is limited. It is therefore currently challenging to construct FE models of the knee that are truly representative of a specific age or disease-state. Consequently, recent tibiofemoral joint FE models have been highly generic in terms of material properties even relying on non-human data from multiple species. We highlight this by critically evaluating current ability to quantitatively compare and model (1) young and old and (2) healthy and OA human tibiofemoral joints. We suggest that future research into both healthy and diseased knee function will benefit greatly from a subject- or cohort-specific approach in which FE models are constructed using material properties, medical imagery and loading data from cohorts with consistent demographics and/or disease states.


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  Tissue material properties and computational modelling of the human tibiofemoral joint: a critical review


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  Finite element has been used for more than four decades to study and evaluate the mechanical behaviour total joint replacements. In Huiskes seminal paper "Failed innovation in total hip replacement: diagnosis and proposals for a cure", finite element modelling was one of the potential cures to avoid poorly performing designs reaching the market place. The size and sophistication of models has increased significantly since that paper and a range of techniques are available from predicting the initial mechanical environment through to advanced adaptive simulations including bone adaptation, tissue differentiation, damage accumulation and wear. However, are we any closer to FE becoming an effective screening tool for new devices? This review contains a critical analysis of currently available finite element modelling techniques including (i) development of the basic model, the application of appropriate material properties, loading and boundary conditions, (ii) describing the initial mechanical environment of the bone-implant system, (iii) capturing the time dependent behaviour in adaptive simulations, (iv) the design and implementation of computer based experiments and (v) determining suitable performance metrics. The development of the underlying tools and techniques appears to have plateaued and further advances appear to be limited either by a lack of data to populate the models or the need to better understand the fundamentals of the mechanical and biological processes. There has been progress in the design of computer based experiments. Historically, FE has been used in a similar way to in vitro tests, by running only a limited set of analyses, typically of a single bone segment or joint under idealised conditions. The power of finite element is the ability to run multiple simulations and explore the performance of a device under a variety of conditions. There has been increasing usage of design of experiments, probabilistic techniques and more recently population based modelling to account for patient and surgical variability. In order to have effective screening methods, we need to continue to develop these approaches to examine the behaviour and performance of total joint replacements and benchmark them for devices with known clinical performance. Finite element will increasingly be used in the design, development and pre-clinical testing of total joint replacements. However, simulations must include holistic, closely corroborated, multi-domain analyses which account for real world variability.


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  Four decades of finite element analysis of orthopaedic devices: where are we now and what are the opportunities?


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  Simulation-based medicine and the development of complex computer models of biological structures is becoming ubiquitous for advancing biomedical engineering and clinical research. Finite element analysis (FEA) has been widely used in the last few decades to understand and predict biomechanical phenomena. Modeling and simulation approaches in biomechanics are highly interdisciplinary, involving novice and skilled developers in all areas of biomedical engineering and biology. While recent advances in model development and simulation platforms offer a wide range of tools to investigators, the decision making process during modeling and simulation has become more opaque. Hence, reliability of such models used for medical decision making and for driving multiscale analysis comes into question. Establishing guidelines for model development and dissemination is a daunting task, particularly with the complex and convoluted models used in FEA. Nonetheless, if better reporting can be established, researchers will have a better understanding of a model's value and the potential for reusability through sharing will be bolstered. Thus, the goal of this document is to identify resources and considerate reporting parameters for FEA studies in biomechanics. These entail various levels of reporting parameters for model identification, model structure, simulation structure, verification, validation, and availability. While we recognize that it may not be possible to provide and detail all of the reporting considerations presented, it is possible to establish a level of confidence with selective use of these parameters. More detailed reporting, however, can establish an explicit outline of the decision-making process in simulation-based analysis for enhanced reproducibility, reusability, and sharing.


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  Conducting large-scale complex modeling and simulation (M&S) projects continues to pose significant challenges for M&S engineers, project managers, and sponsoring organizations. This paper presents a M&S life cycle to alleviate the challenges. The M&S life cycle describes a framework for organization of the processes, work products, quality assurance activities, and project management activities required to develop, use, maintain, and reuse a M&S application from birth to retirement. It provides guidance to a M&S developer (engineer), manager, organization, and community of interest. The M&S life cycle specifies the work products to be created by executing the corresponding processes, together with the integrated verification, validation, and quality assurance activities. The M&S life cycle is critically needed to modularize and structure a M&S application development, and to provide valuable guidance for conducting a M&S project successfully.


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  Advances in computational mechanics, constitutive modeling, and techniques for subject-specific modeling have opened the door to patient-specific simulation of the relationships between joint mechanics and osteoarthritis (OA), as well as patient-specific preoperative planning. This article reviews the application of computational biomechanics to the simulation of joint contact mechanics as relevant to the study of OA. This review begins with background regarding OA and the mechanical causes of OA in the context of simulations of joint mechanics. The broad range of technical considerations in creating validated subject-specific whole joint models is discussed. The types of computational models available for the study of joint mechanics are reviewed. The types of constitutive models that are available for articular cartilage are reviewed, with special attention to choosing an appropriate constitutive model for the application at hand. Issues related to model generation are discussed, including acquisition of model geometry from volumetric image data and specific considerations for acquisition of computed tomography and magnetic resonance imaging data. Approaches to model validation are reviewed. The areas of parametric analysis, factorial design, and probabilistic analysis are reviewed in the context of simulations of joint contact mechanics. Following the review of technical considerations, the article details insights that have been obtained from computational models of joint mechanics for normal joints; patient populations; the study of specific aspects of joint mechanics relevant to OA, such as congruency and instability; and preoperative planning. Finally, future directions for research and application are summarized.


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  Subject-specific analysis of joint contact mechanics: application to the study of osteoarthritis and surgical planning


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  In vitro testing of the human knee provides valuable insight that contributes to further understanding knee biomechanics. Cadaveric testing correlates well with clinical trials because the tissue has similar properties to that of live subjects. In addition, in vitro testing allows studies to be performed that would otherwise be unethical to evaluate in vivo. Due to their many advantages, cadaveric testing has been utilized to evaluate many of medical devices and surgical techniques that have been developed in recent decades. This article aims to review the current technologies and methodologies utilized in experimental in vitro testing of the human knee. The article provides a summary of the different rigs and machines that are currently used to examine the biomechanics of the knee. It also highlights the variable experimental techniques and measurement systems that are used to collect the kinematics and kinetics of the knee joint. As technologies advance so do the measurement systems and equipment in the experimental biomechanics field. The influence of improvements to these testing equipment and measurement devices on in vitro testing of the knee will also be discussed in this review.


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  Most X-ray fluoroscopy systems are stationary and impose restrictions on the measurement of dynamic joint motion; for example, knee-joint kinematics during gait is usually measured with the subject ambulating on a treadmill. We developed a computer-controlled, mobile, biplane, X-ray fluoroscopy system to track human body movement for high-speed imaging of 3D joint motion during overground gait. A robotic gantry mechanism translates the two X-ray units alongside the subject, tracking and imaging the joint of interest as the subject moves. The main aim of the present study was to determine the accuracy with which the mobile imaging system measures 3D knee-joint kinematics during walking. In vitro experiments were performed to measure the relative positions of the tibia and femur in an intact human cadaver knee and of the tibial and femoral components of a total knee arthroplasty (TKA) implant during simulated overground gait. Accuracy was determined by calculating mean, standard deviation and root-mean-squared errors from differences between kinematic measurements obtained using volumetric models of the bones and TKA components and reference measurements obtained from metal beads embedded in the bones. Measurement accuracy was enhanced by the ability to track and image the joint concurrently. Maximum root-mean-squared errors were 0.33 mm and 0.65° for translations and rotations of the TKA knee and 0.78 mm and 0.77° for translations and rotations of the intact knee, which are comparable to results reported for treadmill walking using stationary biplane systems. System capability for in vivo joint motion measurement was also demonstrated for overground gait.


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  Manual segmentation of articular cartilage from knee joint 3D magnetic resonance images (MRI) is a time consuming and laborious task. Thus, automatic methods are needed for faster and reproducible segmentations. In the present study, we developed a semi-automatic segmentation method based on radial intensity profiles to generate 3D geometries of knee joint cartilage which were then used in computational biomechanical models of the knee joint. Six healthy volunteers were imaged with a 3T MRI device and their knee cartilages were segmented both manually and semi-automatically. The values of cartilage thicknesses and volumes produced by these two methods were compared. Furthermore, the influences of possible geometrical differences on cartilage stresses and strains in the knee were evaluated with finite element modeling. The semi-automatic segmentation and 3D geometry construction of one knee joint (menisci, femoral and tibial cartilages) was approximately two times faster than with manual segmentation. Differences in cartilage thicknesses, volumes, contact pressures, stresses, and strains between segmentation methods in femoral and tibial cartilage were mostly insignificant (p > 0.05) and random, i.e. there were no systematic differences between the methods. In conclusion, the devised semi-automatic segmentation method is a quick and accurate way to determine cartilage geometries; it may become a valuable tool for biomechanical modeling applications with large patient groups.


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  Application of a semi-automatic cartilage segmentation method for biomechanical modeling of the knee joint


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  Estimation of individual muscle forces during human movement can provide insight into neural control and tissue loading and can thus contribute to improved diagnosis and management of both neurological and orthopaedic conditions. Direct measurement of muscle forces is generally not feasible in a clinical setting, and non-invasive methods based on musculoskeletal modeling should therefore be considered. The current state of the art in clinical movement analysis is that resultant joint torques can be reliably estimated from motion data and external forces (inverse dynamic analysis). Static optimization methods to transform joint torques into estimates of individual muscle forces using musculoskeletal models, have been known for several decades. To date however, none of these methods have been successfully translated into clinical practice. The main obstacles are the lack of studies reporting successful validation of muscle force estimates, and the lack of user-friendly and efficient computer software. Recent advances in forward dynamics methods have opened up new opportunities. Forward dynamic optimization can be performed such that solutions are less dependent on measured kinematics and ground reaction forces, and are consistent with additional knowledge, such as the force-length-velocity-activation relationships of the muscles, and with observed electromyography signals during movement. We conclude that clinical applications of current research should be encouraged, supported by further development of computational tools and research into new algorithms for muscle force estimation and their validation.


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  Quantitative computed tomography-based finite-element analysis (QCT/FEA) has become increasingly popular in an attempt to understand and possibly reduce vertebral fracture risk. It is known that scanning acquisition settings affect Hounsfield units (HU) of the CT voxels. Material properties assignments in QCT/FEA, relating HU to Young's modulus, are performed by applying empirical equations. The purpose of this study was to evaluate the effect of QCT scanning protocols on predicted stiffness values from finite-element models. One fresh frozen cadaveric torso and a QCT calibration phantom were scanned six times varying voltage and current and reconstructed to obtain a total of 12 sets of images. Five vertebrae from the torso were experimentally tested to obtain stiffness values. QCT/FEA models of the five vertebrae were developed for the 12 image data resulting in a total of 60 models. Predicted stiffness was compared to the experimental values. The highest percent difference in stiffness was approximately 480% (80 kVp, 110 mAs, U70), while the lowest outcome was ∼1% (80 kVp, 110 mAs, U30). There was a clear distinction between reconstruction kernels in predicted outcomes, whereas voltage did not present a clear influence on results. The potential of QCT/FEA as an improvement to conventional fracture risk prediction tools is well established. However, it is important to establish research protocols that can lead to results that can be translated to the clinical setting.


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  Quantitative Computed Tomography Protocols Affect Material Mapping and Quantitative Computed Tomography-Based Finite-Element Analysis Predicted Stiffness


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  A custom knee loading apparatus (KLA), when used in conjunction with magnetic resonance imaging, enables in vivo measurement of the gross anterior laxity of the knee joint. A numerical model was applied to the KLA to understand the contribution of the individual joint structures and to estimate the stiffness of the anterior-cruciate ligament (ACL). The model was evaluated with a cadaveric study using an in situ knee loading apparatus and an ElectroForce test system. A constrained optimization solution technique was able to predict the restraining forces within the soft-tissue structures and joint contact. The numerical model presented here allowed in vivo prediction of the material stiffness parameters of the ACL in response to applied anterior loading. Promising results were obtained for in vivo load sharing within the structures. The numerical model overestimated the ACL forces by 27.61-92.71%. This study presents a novel approach to estimate ligament stiffness and provides the basis to develop a robust and accurate measure of in vivo knee joint laxity.


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  Virtual representations of the knee joint can provide clinicians, scientists, and engineers the tools to explore mechanical functions of the knee and its tissue structures in health and disease. Modeling and simulation approaches such as finite element analysis also provide the possibility to understand the influence of surgical procedures and implants on joint stresses and tissue deformations. A large number of knee joint models are described in the biomechanics literature. However, freely accessible, customizable, and easy-to-use models are scarce. Availability of such models can accelerate clinical translation of simulations, where labor-intensive reproduction of model development steps can be avoided. Interested parties can immediately utilize readily available models for scientific discovery and clinical care. Motivated by this gap, this study aims to describe an open source and freely available finite element representation of the tibiofemoral joint, namely Open Knee, which includes the detailed anatomical representation of the joint's major tissue structures and their nonlinear mechanical properties and interactions. Three use cases illustrate customization potential of the model, its predictive capacity, and its scientific and clinical utility: prediction of joint movements during passive flexion, examining the role of meniscectomy on contact mechanics and joint movements, and understanding anterior cruciate ligament mechanics. A summary of scientific and clinically directed studies conducted by other investigators are also provided. The utilization of this open source model by groups other than its developers emphasizes the premise of model sharing as an accelerator of simulation-based medicine. Finally, the imminent need to develop next-generation knee models is noted. These are anticipated to incorporate individualized anatomy and tissue properties supported by specimen-specific joint mechanics data for evaluation, all acquired in vitro from varying age groups and pathological states.


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  Computational models that predict in vivo joint loading and muscle forces can potentially enhance and augment our knowledge of both typical and pathological gaits. To adopt such models into clinical applications, studies validating modeling predictions are essential. This study created a full-body musculoskeletal model using data from the "Sixth Grand Challenge Competition to Predict in vivo Knee Loads." This model incorporates subject-specific geometries of the right leg in order to concurrently predict knee contact forces, ligament forces, muscle forces, and ground contact forces. The objectives of this paper are twofold: (1) to describe an electromyography (EMG)-driven modeling methodology to predict knee contact forces and (2) to validate model predictions by evaluating the model predictions against known values for a patient with an instrumented total knee replacement (TKR) for three distinctly different gait styles (normal, smooth, and bouncy gaits). The model integrates a subject-specific knee model onto a previously validated generic full-body musculoskeletal model. The combined model included six degrees-of-freedom (6DOF) patellofemoral and tibiofemoral joints, ligament forces, and deformable contact forces with viscous damping. The foot/shoe/floor interactions were modeled by incorporating shoe geometries to the feet. Contact between shoe segments and the floor surface was used to constrain the shoe segments. A novel EMG-driven feedforward with feedback trim motor control strategy was used to concurrently estimate muscle forces and knee contact forces from standard motion capture data collected on the individual subject. The predicted medial, lateral, and total tibiofemoral forces represented the overall measured magnitude and temporal patterns with good root-mean-squared errors (RMSEs) and Pearson's correlation (p2). The model accuracy was high: medial, lateral, and total tibiofemoral contact force RMSEs = 0.15, 0.14, 0.21 body weight (BW), and (0.92 < p2 < 0.96) for normal gait; RMSEs = 0.18 BW, 0.21 BW, 0.29 BW, and (0.81 < p2 < 0.93) for smooth gait; and RMSEs = 0.21 BW, 0.22 BW, 0.33 BW, and (0.86 < p2 < 0.95) for bouncy gait, respectively. Overall, the model captured the general shape, magnitude, and temporal patterns of the contact force profiles accurately. Potential applications of this proposed model include predictive biomechanics simulations, design of TKR components, soft tissue balancing, and surgical simulation.


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  Electromyography-Driven Forward Dynamics Simulation to Estimate In Vivo Joint Contact Forces During Normal, Smooth, and Bouncy Gaits


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  BACKGROUND: Pivot-shift injury commonly results in combined anterior cruciate ligament (ACL)/medial collateral ligament (MCL) injury, yet the contribution of the components of the MCL complex to restraining multiplanar rotatory loads forming critical subcomponents of the pivot shift is not well understood.
  PURPOSE: To quantify the role of the MCL complex in restraining multiplanar rotatory loads.
  STUDY DESIGN: Controlled laboratory study.
  METHODS: A robotic manipulator was used to apply combined valgus and internal rotation torques in a simplified model of the pivot-shift examination in 12 cadaveric knees (49 ± 11 years). Tibiofemoral kinematics were recorded with the ACL intact. Loads borne by the superficial MCL (sMCL), posterior oblique ligament (POL), deep MCL (dMCL), and ACL were determined via the principle of superposition.
  RESULTS: The POL bore about 50% of the load carried by the ACL in response to the combined torques at 5° and 15° of flexion. The POL bore load during the internal rotation component of the combined torques, while the sMCL carried load during the valgus and internal rotation phases of the simulated pivot. Load in the dMCL was always <10% of the ACL in response to combined valgus and internal rotation torques.
  CONCLUSION: The POL provides complementary load bearing to the ACL near extension in response to combined torques, which capture key components of the pivot-shift examination. The sMCL resists the valgus component of the maneuver alone, a loading pattern unique from those of the POL and ACL. The dMCL is not loaded during clinical tests of rotational knee stability in the ACL-competent knee.
  CLINICAL RELEVANCE: Both the sMCL and POL work together with the ACL to resist combined moments, which form key components of the pivot-shift examination.


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  Distribution of Force in the Medial Collateral Ligament Complex During Simulated Clinical Tests of Knee Stability


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  BACKGROUND: Anterior cruciate ligament (ACL) injuries are catastrophic events that affect athletic careers and lead to long-term degenerative knee changes. As injuries are believed to occur within the first 50 milliseconds after initial contact during a rapid deceleration task, impact simulators that rapidly deliver impulse loads to cadaveric specimens have been developed. However, no impactor has reproducibly and reliably created ACL injures in a distribution that mimics clinical observation.
  PURPOSE: To better understand ACL injury patterns through a cadaveric investigation that applied in vivo-measured external loads to the knee during simulated landings.
  STUDY DESIGN: Controlled laboratory study.
  METHODS: A novel mechanical impact simulator reproduced kinetics from in vivo-recorded drop landing tasks on 45 cadaveric knees. Specimens were exposed to a randomized order of variable knee abduction moment, anterior tibial shear, and internal tibial rotation loads before the introduction of an impulse load at the foot. This process was repeated until a hard or soft tissue injury was induced on the joint. Injuries were assessed by an orthopaedic surgeon, and ligament strain was recorded by implanted strain gauges.
  RESULTS: The mechanical impact simulator induced ACL injuries in 87% of specimens, with medial collateral ligament (MCL) injuries in 31%. ACL tear locations were 71% femoral side, 21% midsubstance, and 9% tibial side. Peak strain before failure for ACL-injured specimens was 15.3% ± 8.7% for the ACL and 5.1% ± 5.6% for the MCL ( P < .001).
  CONCLUSION: The ACL injuries induced by the mechanical impact simulator in the present study have provided clinically relevant in vitro representations of in vivo ACL injury patterns as cited in the literature. Additionally, current ligament strains corroborate the literature to support disproportionate loading of the ACL relative to the MCL during athletic tasks.
  CLINICAL RELEVANCE: These findings indicate that the mechanical impact simulator is an appropriate model for examining independent mechanical variables, treatment techniques, and preventive interventions during athletic tasks leading up to and including an ACL injury. Accordingly, this system can be utilized to further parse out contributing factors to an ACL injury as well as assess the shortcomings of ACL reconstruction techniques in a dynamic, simulated environment that is better representative of in vivo injury scenarios.


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  Validation of Noncontact Anterior Cruciate Ligament Tears Produced by a Mechanical Impact Simulator Against the Clinical Presentation of Injury


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  Modeling complex knee biomechanics is a continual challenge, which has resulted in many models of varying levels of quality, complexity, and validation. Beyond modeling healthy knees, accurately mimicking pathologic knee mechanics, such as after cruciate rupture or meniscectomy, is difficult. Experimental tests of knee laxity can provide important information about ligament engagement and overall contributions to knee stability for development of subject-specific models to accurately simulate knee motion and loading. Our objective was to provide combined experimental tests and finite-element (FE) models of natural knee laxity that are subject-specific, have one-to-one experiment to model calibration, simulate ligament engagement in agreement with literature, and are adaptable for a variety of biomechanical investigations (e.g., cartilage contact, ligament strain, in vivo kinematics). Calibration involved perturbing ligament stiffness, initial ligament strain, and attachment location until model-predicted kinematics and ligament engagement matched experimental reports. Errors between model-predicted and experimental kinematics averaged <2 deg during varus-valgus (VV) rotations, <6 deg during internal-external (IE) rotations, and <3 mm of translation during anterior-posterior (AP) displacements. Engagement of the individual ligaments agreed with literature descriptions. These results demonstrate the ability of our constraint models to be customized for multiple individuals and simultaneously call attention to the need to verify that ligament engagement is in good general agreement with literature. To facilitate further investigations of subject-specific or population based knee joint biomechanics, data collected during the experimental and modeling phases of this study are available for download by the research community.


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  A Combined Experimental and Computational Approach to Subject-Specific Analysis of Knee Joint Laxity


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  Surgical technique is one factor that has been identified as critical to success of total knee arthroplasty. Researchers have shown that computer simulations can aid in determining how decisions in the operating room generally affect post-operative outcomes. However, to use simulations to make clinically relevant predictions about knee forces and motions for a specific total knee patient, patient-specific models are needed. This study introduces a methodology for estimating knee soft-tissue properties of an individual total knee patient. A custom surgical navigation system and stability device were used to measure the force-displacement relationship of the knee. Soft-tissue properties were estimated using a parameter optimization that matched simulated tibiofemoral kinematics with experimental tibiofemoral kinematics. Simulations using optimized ligament properties had an average root mean square error of 3.5° across all tests while simulations using generic ligament properties taken from literature had an average root mean square error of 8.4°. Specimens showed large variability among ligament properties regardless of similarities in prosthetic component alignment and measured knee laxity. These results demonstrate the importance of soft-tissue properties in determining knee stability, and suggest that to make clinically relevant predictions of post-operative knee motions and forces using computer simulations, patient-specific soft-tissue properties are needed.


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  Multiple computational models have been developed to study knee biomechanics. However, the majority of these models are mainly validated against a limited range of loading conditions and/or do not include sufficient details of the critical anatomical structures within the joint. Due to the multifactorial dynamic nature of knee injuries, anatomic finite element (FE) models validated against multiple factors under a broad range of loading conditions are necessary. This study presents a validated FE model of the lower extremity with an anatomically accurate representation of the knee joint. The model was validated against tibiofemoral kinematics, ligaments strain/force, and articular cartilage pressure data measured directly from static, quasi-static, and dynamic cadaveric experiments. Strong correlations were observed between model predictions and experimental data (r &gt; 0.8 and p &lt; 0.0005 for all comparisons). FE predictions showed low deviations (root-mean-square (RMS) error) from average experimental data under all modes of static and quasi-static loading, falling within 2.5 deg of tibiofemoral rotation, 1% of anterior cruciate ligament (ACL) and medial collateral ligament (MCL) strains, 17 N of ACL load, and 1 mm of tibiofemoral center of pressure. Similarly, the FE model was able to accurately predict tibiofemoral kinematics and ACL and MCL strains during simulated bipedal landings (dynamic loading). In addition to minimal deviation from direct cadaveric measurements, all model predictions fell within 95% confidence intervals of the average experimental data. Agreement between model predictions and experimental data demonstrates the ability of the developed model to predict the kinematics of the human knee joint as well as the complex, nonuniform stress and strain fields that occur in biological soft tissue. Such a model will facilitate the in-depth understanding of a multitude of potential knee injury mechanisms with special emphasis on ACL injury.


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  Although variability in connective tissue parameters is widely reported and recognized, systematic examination of the effect of such parametric uncertainties on predictions derived from a full anatomical joint model is lacking. As such, a sensitivity analysis was performed to consider the behavior of a three-dimensional, non-linear, finite element knee model with connective tissue material parameters that varied within a given interval. The model included the coupled mechanics of the tibio-femoral and patello-femoral degrees of freedom. Seven primary connective tissues modeled as non-linear continua, articular cartilages described by a linear elastic model, and menisci modeled as transverse isotropic elastic materials were included. In this study, a multi-factorial global sensitivity analysis is proposed, which can detect the contribution of influential material parameters while maintaining the potential effect of parametric interactions. To illustrate the effect of material uncertainties on model predictions, exemplar loading conditions reported in a number of isolated experimental paradigms were used. Our findings illustrated that the inclusion of material uncertainties in a coupled tibio-femoral and patello-femoral model reveals biomechanical interactions that otherwise would remain unknown. For example, our analysis revealed that the effect of anterior cruciate ligament parameter variations on the patello-femoral kinematic and kinetic response sensitivities was significantly larger, over a range of flexion angles, when compared to variations associated with material parameters of tissues intrinsic to the patello-femoral joint. We argue that the systematic sensitivity framework presented herein will help identify key material uncertainties that merit further research and provide insight on those uncertainties that may not be as relative to a given response.


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  The effect of connective tissue material uncertainties on knee joint mechanics under isolated loading conditions


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  As one of the most complex and vulnerable structures of body, the human knee joint should maintain dynamic equilibrium and stability in occupational and recreational activities. The evaluation of its stability and factors affecting it is vital in performance evaluation/enhancement, injury prevention and treatment managements. Knee stability often manifests itself by pain, hypermobility and giving-way sensations and is usually assessed by the passive joint laxity tests. Mechanical stability of both the human knee joint and the lower extremity at early stance periods of gait (0% and 5%) were quantified here for the first time using a hybrid musculoskeletal model of the lower extremity. The roles of muscle coactivity, simulated by setting minimum muscle activation at 0-10% levels and ACL deficiency, simulated by reducing ACL resistance by up to 85%, on the stability margin as well as joint biomechanics (contact/muscle/ligament forces) were investigated. Dynamic stability was analyzed using both linear buckling and perturbation approaches at the final deformed configurations in gait. The knee joint was much more stable at 0% stance than at 5% due to smaller ground reaction and contact forces. Muscle coactivity, when at lower intensities (<3% of its maximum active force), increased dynamic stability margin. Greater minimum activation levels, however, acted asan ineffective strategy to enhance stability. Coactivation also substantially increased muscle forces, joint loads and ACL force and hence the risk of further injury and degeneration. A deficiency in ACL decreases total ACL force (by 31% at 85% reduced stiffness) and the stability margin of the knee joint at the heel strike. It also markedly diminishes forces in lateral hamstrings (by up to 39%) and contact forces on the lateral plateau (by up to 17%). Current work emphasizes the need for quantification of the lower extremity stability margin in gait.


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  Computational stability of human knee joint at early stance in Gait: Effects of muscle coactivity and anterior cruciate ligament deficiency


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  Quantifying the mechanical environment at the knee is crucial for developing successful rehabilitation and surgical protocols. Computational models have been developed to complement in vitro studies, but are typically created to represent healthy conditions, and may not be useful in modeling pathology and repair. Thus, the objective of this study was to create finite element (FE) models of the natural knee, including specimen-specific tibiofemoral (TF) and patellofemoral (PF) soft tissue structures, and to evaluate joint mechanics in intact and ACL-deficient conditions. Simulated gait in a whole joint knee simulator was performed on two cadaveric specimens in an intact state and subsequently repeated following ACL resection. Simulated gait was performed using motor-actuated quadriceps, and loads at the hip and ankle. Specimen-specific FE models of these experiments were developed in both intact and ACL-deficient states. Model simulations compared kinematics and loading of the experimental TF and PF joints, with average RMS differences [max] of 3.0° [8.2°] and 2.1° [8.4°] in rotations, and 1.7 [3.0] and 2.5 [5.1] mm in translations, for intact and ACL-deficient states, respectively. The timing of peak quadriceps force during stance and swing phase of gait was accurately replicated within 2° of knee flexion and with an average error of 16.7% across specimens and pathology. Ligament recruitment patterns were unique in each specimen; recruitment variability was likely influenced by variations in ligament attachment locations. ACL resections demonstrated contrasting joint mechanics in the two specimens with altered knee motion shown in one specimen (up to 5mm anterior tibial translation) while increased TF joint loading was shown in the other (up to 400N).


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  Combined measurement and modeling of specimen-specific knee mechanics for healthy and ACL-deficient conditions


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  The role of computational modeling for biomechanics research and related clinical care will be increasingly prominent. The biomechanics community has been developing computational models routinely for exploration of the mechanics and mechanobiology of diverse biological structures. As a result, a large array of models, data, and discipline-specific simulation software has emerged to support endeavors in computational biomechanics. Sharing computational models and related data and simulation software has first become a utilitarian interest, and now, it is a necessity. Exchange of models, in support of knowledge exchange provided by scholarly publishing, has important implications. Specifically, model sharing can facilitate assessment of reproducibility in computational biomechanics and can provide an opportunity for repurposing and reuse, and a venue for medical training. The community's desire to investigate biological and biomechanical phenomena crossing multiple systems, scales, and physical domains, also motivates sharing of modeling resources as blending of models developed by domain experts will be a required step for comprehensive simulation studies as well as the enhancement of their rigor and reproducibility. The goal of this paper is to understand current perspectives in the biomechanics community for the sharing of computational models and related resources. Opinions on opportunities, challenges, and pathways to model sharing, particularly as part of the scholarly publishing workflow, were sought. A group of journal editors and a handful of investigators active in computational biomechanics were approached to collect short opinion pieces as a part of a larger effort of the IEEE EMBS Computational Biology and the Physiome Technical Committee to address model reproducibility through publications. A synthesis of these opinion pieces indicates that the community recognizes the necessity and usefulness of model sharing. There is a strong will to facilitate model sharing, and there are corresponding initiatives by the scientific journals. Outside the publishing enterprise, infrastructure to facilitate model sharing in biomechanics exists, and simulation software developers are interested in accommodating the community's needs for sharing of modeling resources. Encouragement for the use of standardized markups, concerns related to quality assurance, acknowledgement of increased burden, and importance of stewardship of resources are noted. In the short-term, it is advisable that the community builds upon recent strategies and experiments with new pathways for continued demonstration of model sharing, its promotion, and its utility. Nonetheless, the need for a long-term strategy to unify approaches in sharing computational models and related resources is acknowledged. Development of a sustainable platform supported by a culture of open model sharing will likely evolve through continued and inclusive discussions bringing all stakeholders at the table, e.g., by possibly establishing a consortium.


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  Cells of the musculoskeletal system are known to respond to mechanical loading and chondrocytes within the cartilage are not an exception. However, understanding how joint level loads relate to cell level deformations, e.g. in the cartilage, is not a straightforward task. In this study, a multi-scale analysis pipeline was implemented to post-process the results of a macro-scale finite element (FE) tibiofemoral joint model to provide joint mechanics based displacement boundary conditions to micro-scale cellular FE models of the cartilage, for the purpose of characterizing chondrocyte deformations in relation to tibiofemoral joint loading. It was possible to identify the load distribution within the knee among its tissue structures and ultimately within the cartilage among its extracellular matrix, pericellular environment and resident chondrocytes. Various cellular deformation metrics (aspect ratio change, volumetric strain, cellular effective strain and maximum shear strain) were calculated. To illustrate further utility of this multi-scale modeling pipeline, two micro-scale cartilage constructs were considered: an idealized single cell at the centroid of a 100×100×100 μm block commonly used in past research studies, and an anatomically based (11 cell model of the same volume) representation of the middle zone of tibiofemoral cartilage. In both cases, chondrocytes experienced amplified deformations compared to those at the macro-scale, predicted by simulating one body weight compressive loading on the tibiofemoral joint. In the 11 cell case, all cells experienced less deformation than the single cell case, and also exhibited a larger variance in deformation compared to other cells residing in the same block. The coupling method proved to be highly scalable due to micro-scale model independence that allowed for exploitation of distributed memory computing architecture. The method's generalized nature also allows for substitution of any macro-scale and/or micro-scale model providing application for other multi-scale continuum mechanics problems.


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  Chondrocyte deformations as a function of tibiofemoral joint loading predicted by a generalized high-throughput pipeline of multi-scale simulations


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  The effects of changes in cruciate ligament material and prestrain on knee joint biomechanics following ligament reconstruction surgery by a tendon are not adequately known. A 3D nonlinear finite element model of the entire knee joint was used to investigate the joint response at different flexion angles under a quadriceps force while varying ACL and PCL initial strains or material properties. The ACL and PCL forces as well as tibiofemoral contact forces/areas substantially increased with greater ACL or PCL initial strains or stiffness. The patellofemoral contact force slightly increased whereas the tibial extensor moment slightly decreased with tenser or stiffer ACL. Reverse trends were predicted with slacker ACL. Results confirm the hypotheses that changes in the prestrain of one cruciate ligament substantially influence the force in the other cruciate ligament and the entire joint and that the use of the patellar tendon (PT) as a replacement for cruciate ligaments markedly alters the joint biomechanics with trends similar to those predicted when increasing prestrains. Forces in both ACL and PCL ligaments increased as one of them became tenser or stiffer and diminished as it became slacker. These results have important consequences in joint biomechanics following ligament injuries or replacement and tend to recommend the use of grafts with smaller prestrains (i.e. slacker than intact) when using the PT as the replacement material with stiffness greater than that of replaced ligament itself.


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  Biomechanics of changes in ACL and PCL material properties or prestrains in flexion under muscle force-implications in ligament reconstruction


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  BACKGROUND: Despite partial meniscectomies and ligament reconstructions as treatments of choice for meniscal and ligament injuries, respectively, the knee joint osteoarthritis persists.
  METHODS: A detailed nonlinear finite element model of the knee joint was developed to evaluate biomechanics of the tibiofemoral joint under 200 N drawer load with and without 1500 N compression preload. The model incorporated composite structure of cartilage and meniscus. The effects on joint response and articular contact pressure of unilateral partial meniscectomy, of changes in prestrain or material properties of the anterior cruciate ligament and of their combination were investigated.
  FINDINGS: Compressive preload further increases anterior cruciate ligament strains/forces in drawer loading. Partial meniscectomy and perturbations in anterior cruciate ligament prestrain/material properties, alone or combined, substantially alter the load transfer via covered and uncovered areas of cartilage as well as contact pressure distribution on cartilage. Partial meniscectomy especially when combined with a slacker anterior cruciate ligament diminish the load via affected meniscus generating unloaded regions on the cartilage.
  INTERPRETATION: Partial meniscectomy concurrent with a slack anterior cruciate ligament substantially alter cartilage contact pressures. These alterations further intensify in the event of greater external forces, larger meniscal resections and total anterior cruciate ligament rupture, thus suggesting a higher risk of joint degeneration.


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  Analysis of partial meniscectomy and ACL reconstruction in knee joint biomechanics under a combined loading


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  Limb asymmetry is a known factor for increased ACL injury risk. These asymmetries are normally observed during in vivo testing. Prior studies have developed in vitro testing methodologies driven by in vivo kinematics to investigate knee mechanics relative to ACL injury. The objective of this study was to determine if mechanical side-to-side asymmetries persist in contralateral pairs during in vitro simulation testing. In vivo kinematics were recorded for male and female drop vertical jump and sidestep cutting tasks. The recorded kinematics were used to robotically simulate the motions on 7 contralateral pairs of cadaveric lower extremities specimens. ACL and MCL force, torque, and strains were recorded and analyzed for differences between contralateral pairs. There was a general lack of mechanical differences between limb sides. Adduction peak torque for the male sidestep cut movement was significantly different between limb sides (p=0.04). However, this is consistent with ACL injury mechanics in that movement in the frontal plane (abduction/adduction) increases injury risk and it is possible loading differences in this plane may have resulted from tolerances within the setup process. The findings of this study indicate that contralateral knee joints were representative of each other during biomechanical in vitro tests. In future cadaveric robotic simulations, contralateral limbs can be used interchangeably. In addition, direct comparisons of the structural behaviors of isolated conditions for contralateral knee joints can be performed.


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  Robotic simulation of identical athletic-task kinematics on cadaveric limbs exhibits a lack of differences in knee mechanics between contralateral pairs


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  By characterizing anatomical differences in size and shape between subjects, statistical shape models enable population-based evaluations in biomechanics. Statistical models have largely focused on individual bones with application to implant sizing, bone fracture and osteoarthritis; however, in joint mechanics applications, the statistical models must consider the geometry of multiple structures of a joint and their relative position. Accordingly, the objectives of this study were to develop a statistical shape and alignment modeling (SSAM) approach to characterize the intersubject variability in bone morphology and alignment for the structures of the knee, to demonstrate the statistical model's ability to describe variability in a training set and to generate realistic instances for use in finite element evaluation of joint mechanics. The statistical model included representations of the bone and cartilage for the femur, tibia and patella from magnetic resonance images and relative alignment of the structures at a known, loaded position in an experimental knee simulator for a training set of 20 specimens. The statistical model described relationships or modes of variation in shape and relative alignment of the knee structures. By generating new 'virtual subjects' with physiologically realistic knee anatomy, the modeling approach can efficiently perform investigations into joint mechanics and implant design which benefit from population-based considerations.


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  Measurements of the sagittal profiles of the articular surfaces of 24 femoral condyles were performed using a laser range finder. An algebraic algorithm was developed to reconstruct the measured sagittal profiles with simple geometry. In particular, it has been shown that a two-circular-arc model provides a very accurate reconstruction of the actual profiles in the femorotibial contact region. The average sagittal profile was used for a femorotibial contact analysis of TKA implants. The contact analysis was performed by using a rigid-body-spring model extended to the case of nonlinear force-deformation behavior of the tibial polyethylene component.


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  Little is known about knee-specific factors that influence contact mechanics. Finite Element (FE) models offer a powerful tool to study contact mechanics, but there often exists ambiguity in the exact values of the inputs (e.g., tissue properties), which can result in a range of output values. Our objective was to quantify the reduction in the range of output values (defined herein as "uncertainty") from FE models of the human knee joint when known pre-defined values are used for clinically measurable inputs. To achieve this goal, we applied a statistically augmented FE approach to three human cadaveric knees for which full geometric and kinematic data were available. Two sets of conditions were simulated: All model inputs, clinically measurable or not, were varied to represent a "normal" patient population (Condition 1); subsets of clinically measurable variable inputs were fixed at specific values (called "patient derived inputs," or PDIs) while the other variables were varied over "normal" values (Condition 2). We found that by fixing body mass index and the anterior-posterior position of the meniscal-bony insertion points, model output uncertainty was reduced by one- to three-fifths. The magnitude of uncertainty reduction was strongly influenced by the individual knee. It was observed that knees with great anterior-posterior translation during gait had greater reductions in uncertainty when PDIs were used. This study represents the first step in developing FE models of the human knee joint based on inputs that can be derived from patients in a clinical setting. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:2233-2242, 2017.


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  Reducing uncertainty when using knee-specific finite element models by assessing the effect of input parameters


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  Knee ligaments are elastic bands of soft tissue with a complex microstructure and biomechanics, which are critical to determine the kinematics as well as the stress bearing behavior of the knee joint. Their correct implementation in terms of material models and properties is therefore necessary in the development of finite element models of the knee, which has been performed for decades for the investigation of both its basic biomechanics and the development of replacement implants and repair strategies for degenerative and traumatic pathologies. Indeed, a wide range of element types and material models has been used to represent knee ligaments, ranging from elastic unidimensional elements to complex hyperelastic three-dimensional structures with anatomically realistic shapes. This paper systematically reviews literature studies, which described finite element models of the knee, and summarizes the approaches, which have been used to model the ligaments highlighting their strengths and weaknesses.


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  Material models and properties in the finite element analysis of knee ligaments: a literature review


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  In this study, we evaluated the intra- and inter-observer variability when determining the insertion and origin sites of knee ligaments on MRI scan images. We collected data of five observers with different backgrounds, who determined the ligament attachment sites in an MRI scan of a right knee of a 66-year-old male cadaver donor. We evaluated the intra- and inter-observer differences between the ligament attachment center points, and also determined the differences relative to a physical measurement performed on the same cadaver. The largest mean intra- and inter-observer differences were 4.30mm (ACL origin) and 16.81mm (superficial MCL insertion), respectively. Relative to the physical measurement, the largest intra- and inter-observer differences were 31.84mm (superficial MCL insertion) and 23.39mm (deep MCL insertion), respectively. The results indicate that, dependent on the location, a significant variation can occur when identifying the attachment site of the knee ligaments. This finding is of particular importance when creating computational models based on MRI data, as the variations in attachment sites may have a considerable effect on the biomechanical behavior of the human knee joint.


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  Generating finite element models of the knee: How accurately can we determine ligament attachment sites from MRI scans?


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  As a step towards developing a finite element model of the knee that can be used to study how the variables associated with a meniscal replacement affect tibio-femoral contact, the goals of this study were 1) to develop a geometrically accurate three-dimensional solid model of the knee joint with special attention given to the menisci and articular cartilage, 2) to determine to what extent bony deformations affect contact behavior, and 3) to determine whether constraining rotations other than flexion/extension affects the contact behavior of the joint during compressive loading. The model included both the cortical and trabecular bone of the femur and tibia, articular cartilage of the femoral condyles and tibial plateau, both the medial and lateral menisci with their horn attachments, the transverse ligament, the anterior cruciate ligament, and the medial collateral ligament. The solid models for the menisci and articular cartilage were created from surface scans provided by a noncontacting, laser-based, three-dimensional coordinate digitizing system with an root mean squared error (RMSE) of less than 8 microns. Solid models of both the tibia and femur were created from CT images, except for the most proximal surface of the tibia and most distal surface of the femur which were created with the three-dimensional coordinate digitizing system. The constitutive relation of the menisci treated the tissue as transversely isotropic and linearly elastic. Under the application of an 800 N compressive load at 0 degrees of flexion, six contact variables in each compartment (ie., medial and lateral) were computed including maximum pressure, mean pressure, contact area, total contact force, and coordinates of the center of pressure. Convergence of the finite element solution was studied using three mesh sizes ranging from an average element size of 5 mm by 5 mm to 1 mm by 1 mm. The solution was considered converged for an average element size of 2 mm by 2 mm. Using this mesh size, finite element solutions for rigid versus deformable bones indicated that none of the contact variables changed by more than 2% when the femur and tibia were treated as rigid. However, differences in contact variables as large as 19% occurred when rotations other than flexion/extension were constrained. The largest difference was in the maximum pressure. Among the principal conclusions of the study are that accurate finite element solutions of tibio-femoral contact behavior can be obtained by treating the bones as rigid. However, unrealistic constraints on rotations other than flexion/extension can result in relatively large errors in contact variables.


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  Joint kinematics and contact mechanics dictate the success of current total knee replacement (TKR) devices. Efficient computer models present an effective way of evaluating these characteristics. Predicted contact stress and area due to articulations at the tibio-femoral and patello-femoral interfaces indicate potential clinical performance. Previous finite element (FE) knee models have generally been used to predict contact stresses and/or areas during static or quasi-static loading conditions. Explicit dynamic FE analyses have recently been used to efficiently predict TKR kinematics and contact mechanics during dynamic loading conditions. The objective of this study was to develop and experimentally validate an explicit FE TKR model that incorporates tibio-femoral and patello-femoral articulations. For computational efficiency, we developed rigid body analyses that can reasonably reproduce the kinematics, contact pressure distribution, and contact area of a fully deformable system. Results from the deformable model showed that the patello-femoral and tibio-femoral kinematics were in good agreement with experimental knee simulator measurements. Kinematic results from the rigid body analyses were nearly identical to those from the fully deformable model, and the contact pressure and contact area correlation was acceptable given the great reduction in analysis time. Component mesh density studied had little effect on the predicted kinematics, particularly for the patellar component, and small effects on the predicted contact pressure and area. These analyses have shown that, at low computational cost, a force-control dynamic simulation of a gait cycle can yield useful and predictable results.


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  This paper presents a three-dimensional finite element tibio-femoral joint model of a human knee that was validated using experimental data. The geometry of the joint model was obtained from magnetic resonance (MR) images of a cadaveric knee specimen. The same specimen was biomechanically tested using a robotic/universal force-moment sensor (UFS) system and knee kinematic data under anterior-posterior tibial loads (up to 100 N) were obtained. In the finite element model (FEM), cartilage was modeled as an elastic material, ligaments were represented as nonlinear elastic springs, and menisci were simulated by equivalent-resistance springs. Reference lengths (zero-load lengths) of the ligaments and stiffness of the meniscus springs were estimated using an optimization procedure that involved the minimization of the differences between the kinematics predicted by the model and those obtained experimentally. The joint kinematics and in-situ forces in the ligaments in response to axial tibial moments of up to 10 Nm were calculated using the model and were compared with published experimental data on knee specimens. It was also demonstrated that the equivalent-resistance springs representing the menisci are important for accurate calculation of knee kinematics. Thus, the methodology developed in this study can be a valuable tool for further analysis of knee joint function and could serve as a step toward the development of more advanced computational knee models.


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  Ten “not so” simple rules for credible practice of modeling and simulation in healthcare: a multidisciplinary committee perspective


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  2015 Biomedical Engineering Society / Food and Drug Administration Frontiers in Medical Devices Conference: Innovations in Modeling and Simulation


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  Computational techniques and software for the analysis of problems in mechanics have naturally moved from their origins in the traditional engineering disciplines to the study of cell, tissue and organ biomechanics. Increasingly complex models have been developed to describe and predict the mechanical behavior of such biological systems. While the availability of advanced computational tools has led to exciting research advances in the field, the utility of these models is often the subject of criticism due to inadequate model verification and validation (V&V). The objective of this review is to present the concepts of verification, validation and sensitivity studies with regard to the construction, analysis and interpretation of models in computational biomechanics. Specific examples from the field are discussed. It is hoped that this review will serve as a guide to the use of V&V principles in the field of computational biomechanics, thereby improving the peer acceptance of studies that use computational modeling techniques.


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  Impairment of the human neuromusculoskeletal system can lead to significant mobility limitations and decreased quality of life. Computational models that accurately represent the musculoskeletal systems of individual patients could be used to explore different treatment options and optimize clinical outcome. The most significant barrier to model-based treatment design is validation of model-based estimates of in vivo contact and muscle forces. This paper introduces an annual "Grand Challenge Competition to Predict In Vivo Knee Loads" based on a series of comprehensive publicly available in vivo data sets for evaluating musculoskeletal model predictions of contact and muscle forces in the knee. The data sets come from patients implanted with force-measuring tibial prostheses. Following a historical review of musculoskeletal modeling methods used for estimating knee muscle and contact forces, we describe the first two data sets used for the first two competitions and summarize four subsequent data sets to be used for future competitions. These data sets include tibial contact force, video motion, ground reaction, muscle EMG, muscle strength, static and dynamic imaging, and implant geometry data. Competition participants create musculoskeletal models to predict tibial contact forces without having access to the corresponding in vivo measurements. These blinded predictions provide an unbiased evaluation of the capabilities and limitations of musculoskeletal modeling methods. The paper concludes with a discussion of how these unique data sets can be used by the musculoskeletal modeling research community to improve the estimation of in vivo muscle and contact forces and ultimately to help make musculoskeletal models clinically useful.


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  Project Information - NIH RePORTER - NIH Research Portfolio Online Reporting Tools Expenditures and Results


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  Healthy patellofemoral (PF) joint mechanics are critical to optimal function of the knee joint. Patellar maltracking may lead to large joint reaction loads and high stresses on the articular cartilage, increasing the risk of cartilage wear and the onset of osteoarthritis. While the mechanical sources of PF joint dysfunction are not well understood, links have been established between PF tracking and abnormal kinematics of the tibiofemoral (TF) joint, specifically following cruciate ligament injury and repair. The objective of this study was to create a validated finite element (FE) representation of the PF joint in order to predict PF kinematics and quadriceps force across healthy and pathological specimens. Measurements from a series of dynamic in-vitro cadaveric experiments were used to develop finite element models of the knee for three specimens. Specimens were loaded under intact, ACL-resected and both ACL and PCL-resected conditions. Finite element models of each specimen were constructed and calibrated to the outputs of the intact knee condition, and subsequently used to predict PF kinematics, contact mechanics, quadriceps force, patellar tendon moment arm and patellar tendon angle of the cruciate resected conditions. Model results for the intact and cruciate resected trials successfully matched experimental kinematics (avg. RMSE 4.0°, 3.1mm) and peak quadriceps forces (avg. difference 5.6%). Cruciate resections demonstrated either increased patellar tendon loads or increased joint reaction forces. The current study advances the standard for evaluation of PF mechanics through direct validation of cruciate-resected conditions including specimen-specific representations of PF anatomy.


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  Validation of predicted patellofemoral mechanics in a finite element model of the healthy and cruciate-deficient knee


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  The topics of verification and validation have increasingly been discussed in the field of computational biomechanics, and many recent articles have applied these concepts in an attempt to build credibility for models of complex biological systems. Verification and validation are evolving techniques that, if used improperly, can lead to false conclusions about a system under study. In basic science, these erroneous conclusions may lead to failure of a subsequent hypothesis, but they can have more profound effects if the model is designed to predict patient outcomes. While several authors have reviewed verification and validation as they pertain to traditional solid and fluid mechanics, it is the intent of this paper to present them in the context of computational biomechanics. Specifically, the task of model validation will be discussed, with a focus on current techniques. It is hoped that this review will encourage investigators to engage and adopt the verification and validation process in an effort to increase peer acceptance of computational biomechanics models.


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  Movement of the unloaded knee has been described in several studies by an "envelope of passive flexion", a description that does not describe or explain the widely reported coupling of internal tibial rotation to flexion. The objective of the current study was to show that the envelope of passive knee flexion can be reduced to a coupled path. Two hypotheses were tested: (1) in normal knees flexed passively, internal/external rotation, abduction/adduction and all three components of translation are coupled to flexion angle, and (2) the tibia rotates internally as the knee is flexed passively. Fifteen cadaver knees were flexed in a rig designed to apply minimal resistance to knee movement while three-dimensional kinematics of the femur relative to the tibia were measured with an electromagnetic tracking system. Each specimen displayed internal tibial rotation and posterior, proximal and medial displacement of a reference point with flexion, while a range of ab/adduction behaviour was observed. Mean absolute differences between the flexing and extending paths in normal specimens were under 2 and 0.2 degrees for internal/external tibial rotation and ab/adduction, respectively. Deviation from the movement path was resisted: when released after being displaced, the femur of each normal joint sprang back to its original position on the motion path. It was concluded that passive knee flexion can be described by a coupled path. Although the exact shape of the path is very sensitive to load and varies between knees, knee rotations and translations were always coupled to flexion, and internal tibial rotation with flexion was always observed.


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  Arthroscopy: The Journal of Arthroscopic & Related Surgery: Official Publication of the Arthroscopy Association of North America and the International Arthroscopy Association


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  PURPOSE: To conduct a systematic review to identify and summarize the various techniques that have been used to simulate the pivot-shift test in vitro.
  METHODS: Medline, Embase, and the Cochrane Library were screened for studies involving the simulated pivot-shift test in human cadaveric knees published between 1946 and May 2014. Study parameters including sample size, study location, simulated pivot-shift technique, loads applied, knee flexion angles at which simulated pivot shift was tested, and kinematic evaluation tools were extracted and analyzed.
  RESULTS: Forty-eight studies reporting simulated pivot-shift testing on 627 cadaveric knees fulfilled the criteria. Reviewer inter-rater agreement for study selection showed a κ score of 0.960 (full-text review). Twenty-seven studies described the use of internal rotation torque, with a mean of 5.3 Nm (range, 1 to 18 Nm). Forty-seven studies described the use of valgus torque, with a mean of 8.8 Nm (range, 1 to 25 Nm). Four studies described the use of iliotibial tract tension, ranging from 10 to 88 N. Regarding static simulated pivot-shift test techniques, 100% of the studies performed testing at 30° of knee flexion, and the most tested range of motion in the continuous tests was 0° to 90°. Anterior tibial translation was the most analyzed parameter during the simulated pivot-shift test, being used in 45 studies. In 22% of the studies, a robotic system was used to simulate the pivot-shift test. Robotic systems were shown to have better control of the loading system and higher tracking system accuracy.
  CONCLUSIONS: This study provides a reference for investigators who desire to apply simulated pivot shift in their in vitro studies. It is recommended to simulate the pivot-shift test using a 10-Nm valgus torque and 5-Nm internal rotation torque. Knee flexion of 30° is mandatory for testing.
  LEVEL OF EVIDENCE: Level IV, systematic review of basic science studies.


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  OBJECTIVE: Progression of knee osteoarthritis (OA) has typically been assessed in the medial tibiofemoral (TF) compartment on the anteroposterior (AP) or posteroanterior (PA) view. We propose a new approach using multiple views and compartments that is likely to be more sensitive to change and reveals progression throughout the knee.
  METHODS: We tested our approach in the Multicenter Osteoarthritis Study, a study of persons with OA or at high risk of disease. At baseline and 30 months, subjects provided PA (fixed flexion without fluoro) and lateral weight-bearing knee radiographs. Paired radiographs were read by 2 readers who scored joint space (JS) using a 0-3 atlas-based scale. When JS narrowed but narrowing did not reach a full grade on the scale, readers used half-grades. Change was scored in medial and lateral TF compartments on both PA and lateral views and in the patellofemoral (PF) joint on lateral view. A knee showed progression when there was at least a half-grade worsening in JS width in any compartment at followup. Disagreements were adjudicated by a panel of 3 readers. To validate progression, we tested definitions for TF progression to see if malalignment on long-limb radiographs at baseline (>or=3 degrees malaligned in any direction with nonmalaligned knees being reference) increased risk of progression. A valid definition of progression would show that malalignment strongly predicted progression.
  RESULTS: We studied 842 knees with either Kellgren-Lawrence grade>or=2 or PF OA at baseline in 606 subjects (age range 50-79 yrs, mean 63.9 yrs; 66.6% women). Mean body mass index was 31.9, and 32.8% of knees had frequent knee pain at baseline. Of these, 500 knees (59.4%) showed progression. Of the 500, 75 (15%) had progression only in the PF joint, while the remainder had progression in the TF joint. Malalignment increased the risk of overall progression in TF joint and increased the risk of half-grade progression, suggesting that half-grade progression had validity.
  CONCLUSION: PA and lateral views obtained in persons at high risk of OA progression can produce a cumulative incidence of progression above 50% at 30 months. Keys to increasing the yield include imaging PF and lateral compartments, using semiquantitative scales designed to detect change, and examining more than one radiographic view.


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  Sit-to-stand transfer is a common task that is challenging for older adults and others with musculoskeletal impairments. Associated joint torques and muscle activations have been analyzed two-dimensionally, neglecting possible three-dimensional (3D) compensatory movements in those who struggle with sit-to-stand transfer. Furthermore, how muscles accelerate an individual up and off the chair remains unclear; such knowledge could inform rehabilitation strategies. We examined muscle forces, muscleinduced accelerations, and interlimb muscle force differences during sit-to-stand transfer in young, healthy adults. Dynamic simulations were created using a custom 3D musculoskeletal model; static optimization and induced acceleration analysis were used to determine muscle forces and their induced accelerations, respectively. The gluteus maximus generated the largest force (2009.07 ± 277.31 N) and was a main contributor to forward acceleration of the center of mass (COM) (0.62 ± 0.18 m/s(2)), while the quadriceps opposed it. The soleus was a main contributor to upward (2.56 ± 0.74 m/s(2)) and forward acceleration of the COM (0.62 ± 0.33 m/s(2)). Interlimb muscle force differences were observed, demonstrating lower limb symmetry cannot be assumed during this task, even in healthy adults. These findings establish a baseline from which deficits and compensatory strategies in relevant populations (eg, elderly, osteoarthritis) can be identified.


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  Muscle Forces and Their Contributions to Vertical and Horizontal Acceleration of the Center of Mass During Sit-to-Stand Transfer in Young, Healthy Adults


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  Limits of agreement provide a straightforward and intuitive approach to agreement between different methods for measuring the same quantity. When pairs of observations using the two methods are independent, i.e., on different subjects, the calculations are very simple and straightforward. Some authors collect repeated data, either as repeated pairs of measurements on the same subject, whose true value of the measured quantity may be changing, or more than one measurement by one or both methods of an unchanging underlying quantity. In this paper we describe methods for analysing such clustered observations, both when the underlying quantity is assumed to be changing and when it is not.


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  The Hausdorff distance (HD) between two point sets is a commonly used dissimilarity measure for comparing point sets and image segmentations. Especially when very large point sets are compared using the HD, for example when evaluating magnetic resonance volume segmentations, or when the underlying applications are based on time critical tasks, like motion detection, then the computational complexity of HD algorithms becomes an important issue. In this paper we propose a novel efficient algorithm for computing the exact Hausdorff distance. In a runtime analysis, the proposed algorithm is demonstrated to have nearly-linear complexity. Furthermore, it has efficient performance for large point set sizes as well as for large grid size; performs equally for sparse and dense point sets; and finally it is general without restrictions on the characteristics of the point set. The proposed algorithm is tested against the HD algorithm of the widely used national library of medicine insight segmentation and registration toolkit (ITK) using magnetic resonance volumes with extremely large size. The proposed algorithm outperforms the ITK HD algorithm both in speed and memory required. In an experiment using trajectories from a road network, the proposed algorithm significantly outperforms an HD algorithm based on R-Trees.


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  Reporting of Computational Modeling Studies in Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff


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  https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM381813.pdf


value:
  Finite element (FE) model studies have made important contributions to our understanding of functional biomechanics of the lumbar spine. However, if a model is used to answer clinical and biomechanical questions over a certain population, their inherently large inter-subject variability has to be considered. Current FE model studies, however, generally account only for a single distinct spinal geometry with one set of material properties. This raises questions concerning their predictive power, their range of results and on their agreement with in vitro and in vivo values. Eight well-established FE models of the lumbar spine (L1-5) of different research centers around the globe were subjected to pure and combined loading modes and compared to in vitro and in vivo measurements for intervertebral rotations, disc pressures and facet joint forces. Under pure moment loading, the predicted L1-5 rotations of almost all models fell within the reported in vitro ranges, and their median values differed on average by only 2° for flexion-extension, 1° for lateral bending and 5° for axial rotation. Predicted median facet joint forces and disc pressures were also in good agreement with published median in vitro values. However, the ranges of predictions were larger and exceeded those reported in vitro, especially for the facet joint forces. For all combined loading modes, except for flexion, predicted median segmental intervertebral rotations and disc pressures were in good agreement with measured in vivo values. In light of high inter-subject variability, the generalization of results of a single model to a population remains a concern. This study demonstrated that the pooled median of individual model results, similar to a probabilistic approach, can be used as an improved predictive tool in order to estimate the response of the lumbar spine.


value:
  Comparison of eight published static finite element models of the intact lumbar spine: predictive power of models improves when combined together


value:
  The FieldML project has made significant progress towards the goal of addressing the need to have open standards and open source software for representing finite element method (FEM) models and, more generally, multivariate field models, such as many of the models that are core to the euHeart project and the Physiome project. FieldML version 0.5 is the most recently released format from the FieldML project. It is an XML format that already has sufficient capability to represent the majority of euHeart's explicit models such as the anatomical FEM models and simulation solution fields. The details of FieldML version 0.5 are presented, as well as its limitations and some discussion of the progress being made to address these limitations.


value:
  Articular cartilage plays an important role in the function of diarthrodial joints. Computational methods have been used to study the biphasic mechanics of cartilage, and Abaqus has been one of the most widely used commercial software packages for this purpose. A newly developed open-source finite element solver, FEBio, has been developed specifically for biomechanical applications. The aim of this study was to undertake a direct comparison between FEBio and Abaqus for some practical contact problems involving cartilage. Three model types, representing a porous flat-ended indentation test, a spherical-ended indentation test, and a conceptual natural joint contact model, were compared. In addition, a parameter sensitivity study was also performed for the spherical-ended indentation test to investigate the effects of changes in the input material properties on the model outputs, using both FEBio and Abaqus. Excellent agreement was found between FEBio and Abaqus for all of the model types and across the range of material properties that were investigated.


value:
  OBJECTIVE: The overall goal of this paper is to demonstrate that dissemination of models and analyses for assessing the reproducibility of simulation results can be incorporated in the scientific review process in biomechanics.
  METHODS: As part of a special issue on model sharing and reproducibility in the IEEE Transactions on Biomedical Engineering, two manuscripts on computational biomechanics were submitted: Rajagopal et al., IEEE Trans. Biomed. Eng., 2016 and Schmitz and Piovesan, IEEE Trans. Biomed. Eng., 2016. Models used in these studies were shared with the scientific reviewers and the public. In addition to the standard review of the manuscripts, the reviewers downloaded the models and performed simulations that reproduced results reported in the studies.
  RESULTS: There was general agreement between simulation results of the authors and those of the reviewers. Discrepancies were resolved during the necessary revisions. The manuscripts and instructions for download and simulation were updated in response to the reviewers' feedback; changes that may otherwise have been missed if explicit model sharing and simulation reproducibility analysis was not conducted in the review process. Increased burden on the authors and the reviewers, to facilitate model sharing and to repeat simulations, were noted.
  CONCLUSION: When the authors of computational biomechanics studies provide access to models and data, the scientific reviewers can download and thoroughly explore the model, perform simulations, and evaluate simulation reproducibility beyond the traditional manuscript-only review process.
  SIGNIFICANCE: Model sharing and reproducibility analysis in scholarly publishing will result in a more rigorous review process, which will enhance the quality of modeling and simulation studies and inform future users of computational models.


value:
  Commentary on the integration of model sharing and reproducibility analysis to scholarly publishing workflow in computational biomechanics


value:
  Protecting and promoting public health is the mission of the U.S. Food and Drug Administration (FDA). FDA's Center for Devices and Radiological Health (CDRH), which regulates medical devices marketed in the U.S., envisions itself as the world's leader in medical device innovation and regulatory science-the development of new methods, standards, and approaches to assess the safety, efficacy, quality, and performance of medical devices. Traditionally, bench testing, animal studies, and clinical trials have been the main sources of evidence for getting medical devices on the market in the U.S. In recent years, however, computational modeling has become an increasingly powerful tool for evaluating medical devices, complementing bench, animal and clinical methods. Moreover, computational modeling methods are increasingly being used within software platforms, serving as clinical decision support tools, and are being embedded in medical devices. Because of its reach and huge potential, computational modeling has been identified as a priority by CDRH, and indeed by FDA's leadership. Therefore, the Office of Science and Engineering Laboratories (OSEL)-the research arm of CDRH-has committed significant resources to transforming computational modeling from a valuable scientific tool to a valuable regulatory tool, and developing mechanisms to rely more on digital evidence in place of other evidence. This article introduces the role of computational modeling for medical devices, describes OSEL's ongoing research, and overviews how evidence from computational modeling (i.e., digital evidence) has been used in regulatory submissions by industry to CDRH in recent years. It concludes by discussing the potential future role for computational modeling and digital evidence in medical devices.


value:
  Advancing Regulatory Science With Computational Modeling for Medical Devices at the FDA's Office of Science and Engineering Laboratories


value:
  This Standard provides a framework for assessing the relevance and adequacy of completed V&V activities that establish credibility of a computational model. The credibility should be commensurate with the degree to which the computational model is relied on as evidence of device performance, functional characteristic, and/or safety to support a decision, and the consequences of that decision being incorrect. This Standard will help users communicate the value of the completed V&V activities and establish the associated credibility of the computational model to support a decision. It also augments other standards that present V&V methodologies, such as ASME V&V 10 and ASME V&V 20. Therefore, it is intended for the practitioner who is familiar with V&V terminology. It does not present a method for incorporating user expertise or modeler pedigree, nor does it describe the specific V&V activities and rigor that are needed to establish credibility for a particular application and/or device. Instead, this Standard presents a framework for the practitioner to make that assessment using sound engineering judgment. It is not a step-by-step guide, nor is it intended to present a quantitative method for establishing model credibility. While the framework was developed specifically for medical devices, the V&V 40 Subcommittee considers this Standard to be general enough to be applied to other disciplines.


value:
  ASME - STANDARDS - Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices


value:
  ASME - STANDARDS - Assessing Credibility of Computational Modeling through Verification and Validation


value:
  A multibody model of the knee was developed and the predicted ligament forces and kinematics during passive flexion corroborated subject-specific measurements obtained from a human cadaveric knee that was tested using a robotic manipulator. The model incorporated a novel strategy to estimate the slack length of ligament fibers based on experimentally measured ligament forces at full extension and included multifiber representations for the cruciates. The model captured experimentally measured ligament forces (≤ 5.7 N root mean square (RMS) difference), coupled internal rotation (≤ 1.6 deg RMS difference), and coupled anterior translation (≤ 0.4 mm RMS difference) through 130 deg of passive flexion. This integrated framework of model and experiment improves our understanding of how passive structures, such as ligaments and articular geometries, interact to generate knee kinematics and ligament forces.


value:
  A Multibody Knee Model Corroborates Subject-Specific Experimental Measurements of Low Ligament Forces and Kinematic Coupling During Passive Flexion


value:
  2015 Biomedical Engineering Society / Food and Drug Administration Frontiers in Medical Devices Conference: Innovations in Modeling and Simulation, May 18-20, 2015


value:
  In finite element (FE) models knee ligaments can represented either by a group of one-dimensional springs, or by three-dimensional continuum elements based on segmentations. Continuum models closer approximate the anatomy, and facilitate ligament wrapping, while spring models are computationally less expensive. The mechanical properties of ligaments can be based on literature, or adjusted specifically for the subject. In the current study we investigated the effect of ligament modelling strategy on the predictive capability of FE models of the human knee joint. The effect of literature-based versus specimen-specific optimized material parameters was evaluated. Experiments were performed on three human cadaver knees, which were modelled in FE models with ligaments represented either using springs, or using continuum representations. In spring representation collateral ligaments were each modelled with three and cruciate ligaments with two single-element bundles. Stiffness parameters and pre-strains were optimized based on laxity tests for both approaches. Validation experiments were conducted to evaluate the outcomes of the FE models. Models (both spring and continuum) with subject-specific properties improved the predicted kinematics and contact outcome parameters. Models incorporating literature-based parameters, and particularly the spring models (with the representations implemented in this study), led to relatively high errors in kinematics and contact pressures. Using a continuum modelling approach resulted in more accurate contact outcome variables than the spring representation with two (cruciate ligaments) and three (collateral ligaments) single-element-bundle representations. However, when the prediction of joint kinematics is of main interest, spring ligament models provide a faster option with acceptable outcome.


value:
  The influence of ligament modelling strategies on the predictive capability of finite element models of the human knee joint


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