Development and experimental validation of a finite element model of total ankle replacement

Total ankle replacement remains a less satisfactory solution compared to other joint replacements. The goal of this study was to develop and validate a finite element model of total ankle replacement, for future testing of hypotheses related to clinical issues. To validate the finite element model, an experimental setup was specifically developed and applied on 8 cadaveric tibias. A non-cemented press fit tibial component of a mobile bearing prosthesis was inserted into the tibias. Two extreme anterior and posterior positions of the mobile bearing insert were considered, as well as a centered one. An axial force of 2 kN was applied for each insert position. Strains were measured on the bone surface using digital image correlation. Tibias were CT scanned before implantation, after implantation, and after mechanical tests and removal of the prosthesis. The finite element model replicated the experimental setup. The first CT was used to build the geometry and evaluate the mechanical properties of the tibias. The second CT was used to set the implant position. The third CT was used to assess the bone-implant interface conditions. The coefficient of determination (R-squared) between the measured and predicted strains was 0.91. Predicted bone strains were maximal around the implant keel, especially at the anterior and posterior ends. The finite element model presented here is validated for future tests using more physiological loading conditions.     

The role of patient, surgical, and implant design variation in total knee replacement performance

Clinical studies demonstrate substantial variation in kinematic and functional performance within the total knee replacement (TKR) patient population. Some of this variation is due to differences in implant design, surgical technique and component alignment, while some is due to subject-specific differences in joint loading and anatomy that are inherently present within the population. Combined finite element and probabilistic methods were employed to assess the relative contributions of implant design, surgical, and subject-specific factors to overall tibiofemoral (TF) and patellofemoral (PF) joint mechanics, including kinematics, contact mechanics, joint loads, and ligament and quadriceps force during simulated squat, stance-phase gait and stepdown activities. The most influential design, surgical and subject-specific factors were femoral condyle sagittal plane radii, tibial insert superior-inferior (joint line) position and coronal plane alignment, and vertical hip load, respectively. Design factors were the primary contributors to condylar contact mechanics and TF anterior-posterior kinematics; TF ligament forces were dependent on surgical factors; and joint loads and quadriceps force were dependent on subject-specific factors. Understanding which design and surgical factors are most influential to TKR mechanics during activities of daily living, and how robust implant designs and surgical techniques must be in order to adequately accommodate subject-specific variation, will aid in directing design and surgical decisions towards optimal TKR mechanics for the population as a whole.     

Meniscal wear at a three-component total ankle prosthesis by a knee joint simulator

Despite the fundamental value of wear simulation studies to assess wear resistance of total joint replacements, neither specialised simulators nor established external conditions are available for the human ankle joint. The aim of the present study was to verify the suitability of a knee wear simulator to assess wear rates in ankle prostheses, and to report preliminary this rate for a novel three-component total ankle replacement design. Four intact 'small' size specimens of the Box ankle were analysed in a four-station knee wear simulator. Special component-to-actuator holders were manufactured and starting spatial alignment of the three-components was sought. Consistent load and motion cycles representing conditions at the ankle joint replaced exactly with the prosthesis design under analysis were taken from a corresponding mechanical model of the stance phase of walking. The weight loss for the three specimens, after two million cycles, was 32.68, 14.78, and 62.28mg which correspond to a linear penetration of 0.018, 0.008, and 0.034mm per million-cycle, respectively for the specimens #1, #2, and #3. The knee wear simulator was able to reproduce load-motion patterns typical of a replaced ankle. Motion of the meniscal bearing in between the tibial and talar components was smooth, this component remaining in place and in complete congruence with the metal components throughout the test.     

In vivo kinematics of two-component total ankle arthroplasty during non-weightbearing and weightbearing dorsiflexion/plantarflexion

Relatively high rates of loosening and implant failure have been reported after total ankle arthroplasty, especially in first and second generation implants. Abnormal kinematics and incongruency of the articular surface may cause increased loads applied to the implant with concomitant polyethylene wear, resulting in loosening and implant failure. The purpose of this study was to measure three-dimensional kinematics of two-component total ankle arthroplasty during non-weightbearing and weightbearing activities, and to investigate incongruency of the articular surfaces during these activities. Forty-seven patients with a mean age of 71 years were enrolled. Radiographs were taken at non-weightbearing maximal dorsiflexion and plantarflexion, and weightbearing maximal dorsiflexion, plantarflexion, and neutral position. 3D-2D model-image registration was performed using the radiographs and the three-dimensional implant models, and three-dimensional joint angles were determined. The implanted ankles showed 18.1±8.6° (mean±standard deviation) of plantarflexion, 0.1±0.7° of inversion, 1.2±2.0° of internal rotation, and 0.8±0.6mm of posterior translation of the talar component in the non-weightbearing activity, and 17.8±7.5° of plantarflexion, 0.4±0.5° of inversion, 1.8±2.0° of internal rotation, and 0.7±0.5mm of posterior translation in the weightbearing activity. There were no significant differences between the non-weightbearing and weightbearing kinematics except for the plantarflexion angle. Incongruency of the articular surface occurred in more than 75% of the ankles. Our observations will provide useful data against which kinematics of other implant designs, such as three-component total ankle arthroplasty, can be compared.     

Bone remodelling around the tibia due to total ankle replacement: effects of implant material and implant–bone interfacial conditions

Abstract

One of the major causes of implant loosening is due to excessive bone resorption surrounding the implant due to bone remodelling. The objective of the study is to investigate the effects of implant material and implant–bone interface conditions on bone remodelling around tibia bone due to total ankle replacement. Finite element models of intact and implanted ankles were developed using CT scan data sets. Bone remodelling algorithm was used in combination with FE analysis to predict the bone density changes around the ankle joint. Dorsiflexion, neutral, and plantar flexion positions were considered, along with muscle force and ligaments. Implant–bone interfacial conditions were assumed as debonded and bonded to represent non-osseointegration and fully osseointegration at the porous coated surface of the implant. To investigate the effect of implant material, three finite element models having different material combinations of the implant were developed. For model 1, tibial and talar components were made of Co–Cr–Mo, and meniscal bearing was made of UHMWPE. For model 2, tibial and talar components were made of ceramic and meniscal bearing was made of UHMWPE. For model 3, tibial and talar components were made of ceramic and meniscal bearing was made of CFR-PEEK. Changes in implant material showed no significant changes in bone density due to bone remodelling. Therefore, ceramic appears to be a viable alternative to metal and CFR-PEEK can be used in place of UHMWPE. This study also indicates that proper bonding between implant and bone is essential for long-term survival of the prosthetic components.     

Elbow joint biomechanics for preclinical evaluation of total elbow prostheses

Total elbow arthroplasty is a clinically successful procedure, yet long-term implant survival rates have historically lagged behind those reported for total hips and knees. Clinical complications associated with implant wear, osteolysis, stem loosening and device fracture have been implicated as reasons for limited long-term survivorship. Unfortunately, there is little published information on the biomechanics and method(s) for preclinical evaluation of total elbow prostheses that could provide insight into the mechanisms of failure. Additionally, there are no consensus testing standards or summaries of loading profiles of the humero-ulnar joint associated with a range of activities of daily living. Such data would facilitate the standardized preclinical assessment of total elbow devices such is commonplace for other large joints. The objective of the work here is therefore to provide a comprehensive review of elbow joint biomechanics as it relates to preclinical evaluation of total elbow implants. This summary includes a review of elbow joint forces, kinematics, the types and frequency of humero-ulnar joint motions associated with activities of daily living and clinical outcomes, as well as proposing a methodology for deriving humero-ulnar joint reaction force magnitudes and vector orientations as a function of a known mass/force at the hand. From these data, a scalable, bi-axial loading profile is proposed as a foundation for the development of clinically relevant, laboratory simulations for assessment of total elbow prostheses performance.     

Development of a statistical shape-function model of the implanted knee for real-time prediction of joint mechanics

Outcomes of total knee arthroplasty (TKA) are dependent on surgical technique, patient variability, and implant design. Non-optimal design or alignment choices may result in undesirable contact mechanics and joint kinematics, including poor joint alignment, instability, and reduced range of motion. Implant design and surgical alignment are modifiable factors with potential to improve patient outcomes, and there is a need for robust implant designs that can accommodate patient variability. Our objective was to develop a statistical shape-function model (SFM) of a posterior stabilized implanted knee to instantaneously predict joint mechanics in an efficient manner. Finite element methods were combined with Latin hypercube sampling and regression analyses to produce modeling equations relating nine implant design and six surgical alignment parameters to tibiofemoral (TF) joint mechanics outcomes during a deep knee bend. A SFM was developed and TF contact mechanics, kinematics, and soft tissue loads were instantaneously predicted from the model. Average normalized root-mean-square error predictions were between 2.79% and 9.42%, depending on the number of parameters included in the model. The statistical shape-function model generated instantaneous joint mechanics predictions using a maximum of 130 training simulations, making it ideally suited for integration into a patient-specific design and alignment optimization pipeline. Such a tool may be used to optimize kinematic function to achieve more natural motion or minimize implant wear, and may aid the engineering and clinical communities in improving patient satisfaction and surgical outcomes.     

Analysis of surface-to-surface distance mapping during three-dimensional motion at the ankle and subtalar joints

Joint surface interaction and ligament constraints determine the kinematic characteristics of the ankle and subtalar joints. Joint surface interaction is characterized by joint contact mechanics and by relative joint surface position potentially characterized by distance mapping. While ankle contact mechanics was investigated, limited information is available on joint distance mapping and its changes during motion. The purpose of this study was to use image-based distance mapping to quantify this interaction at the ankle and subtalar joints during tri-planar rotations of the ankle complex. Five cadaveric legs were scanned using Computed Tomography and the images were processed to produce 3D bone models of the tibia, fibula, talus and calcaneus. Each leg was tested on a special linkage through which the ankle complex was loaded in dorsiflexion/plantarflexion, inversion/eversion, and internal/external rotation and the resulting bone movements were recorded. Fiduciary bone markers data and 3D bone models were combined to generate color-coded distance maps for the ankle and subtalar joints. The results were processed focusing on the changes in surface-to-surface distance maps between the extremes of the range of motion and neutral. The results provided detailed insight into the three-dimensional highly coupled nature of these joints showing significant and unique changes in distance mapping from neutral to extremes of the range of motion. The non-invasive nature of the image-based distance mapping technique could result, after proper modifications, in an effective diagnostic and clinical evaluation technique for application such as ligament injuries and quantifying the effect of arthrodesis or total ankle replacement surgery.     

A Novel Approach for Dynamic Testing of Total Hip Dislocation under Physiological Conditions

Constant high rates of dislocation-related complications of total hip replacements (THRs) show that contributing factors like implant position and design, soft tissue condition and dynamics of physiological motions have not yet been fully understood. As in vivo measurements of excessive motions are not possible due to ethical objections, a comprehensive approach is proposed which is capable of testing THR stability under dynamic, reproducible and physiological conditions. The approach is based on a hardware-in-the-loop (HiL) simulation where a robotic physical setup interacts with a computational musculoskeletal model based on inverse dynamics. A major objective of this work was the validation of the HiL test system against in vivo data derived from patients with instrumented THRs. Moreover, the impact of certain test conditions, such as joint lubrication, implant position, load level in terms of body mass and removal of muscle structures, was evaluated within several HiL simulations. The outcomes for a normal sitting down and standing up maneuver revealed good agreement in trend and magnitude compared with in vivo measured hip joint forces. For a deep maneuver with femoral adduction, lubrication was shown to cause less friction torques than under dry conditions. Similarly, it could be demonstrated that less cup anteversion and inclination lead to earlier impingement in flexion motion including pelvic tilt for selected combinations of cup and stem positions. Reducing body mass did not influence impingement-free range of motion and dislocation behavior; however, higher resisting torques were observed under higher loads. Muscle removal emulating a posterior surgical approach indicated alterations in THR loading and the instability process in contrast to a reference case with intact musculature. Based on the presented data, it can be concluded that the HiL test system is able to reproduce comparable joint dynamics as present in THR patients.     

Breast augmentation: choosing the optimal incision, implant, and pocket plane

A retrospective study of 220 patients was performed to review surgical design in breast augmentation. Three specific issues were studied: incision site, implant variables, and pocket plane selection. The influence of these three factors on aesthetic results in both primary and secondary cases was the focus of the analysis. No attempt was made to address long-term issues such as capsular contracture or saline implant deflation rates. In 77 primary augmentation patients and 80 unilateral augmentations for symmetry in breast reconstruction, there were the following untoward results: 11 revisions for unilateral malposition, change to a different implant shape, or change to a larger implant size; four deflations of saline implants requiring replacement; and four conversions of saline to silicone gel implants. In 63 secondary cases, there were two hematomas and two infections requiring implant removal and subsequent replacement. Operative technique in breast augmentation is described, as are recommendations for each of the options associated with the three variables studied.     

利用神经网络构建超声多普勒栓子信号自动检测系统

对血液中栓子的早期检测有着重要的临床诊断意义。超声多普勒技术使栓子的无损检测成为可能,但是目前的检测尚依赖于医生的手动操作和临床经验,仍缺乏可靠的自动检测系统。本文基于小波包变换和主元分析提取对栓子敏感的特征参数,并利用神经网络构建超声多普勒栓子信号的自动检测系统。仿真研究和临床实验表明:该系统有效提高了栓子检测的准确性,有望应用于临床诊断。     

In vivo determination of the anatomical axes of the ankle joint complex: An optimization approach

This study investigates the feasibility of a subject-specific three-dimensional model of the ankle joint complex for kinematic and dynamic analysis of movement. The ankle joint complex was modelled as a three-segment system, connected by two ideal highe joints: the talocrural and the subtalar joint. A mathematical formulation was developed to express the three-dimensional translation and rotation between the foot and shank segments as a function of the two joint angles, and 12 model parameters describing the locations of the joint axes. An optimization method was used to fit the model parameters to three-dimensional kinematic data of foot and shank markers, obtained during test movements throughout the entire physiological range of motion of the ankle joint. The movement of the talus segment, which cannot be measured non-invasively, is not necessary for the analysis.

This optimization method was used to determine the position and orientation of the joint axes in 14 normal subjects. After optimization, the discrepancy between the best fitting model and actual marker kinematics was between 1 and 3 mm for all subjects. The predicted inclination of the subtalar joint axis from the horizontal plane was 37.4±2.7°, and the medial deviation was 18.0±16.2°. The lateral side of the talucrural axis was directed slightly posteriorly (6.8±8.1°), and inclined downward by 7.0±5.4°. These results are similar to previously reported typical results from anatomical, in vitro, studies. Reproducibility was evaluated by repeated testing of one subject, which resulted in variations of about one-fifth of the standard deviation within the group, the inclination of the subtalar joint axis was significantly correlated to the arch height and a radiographic ‘tarsal index’. It is concluded that this optimization method provides the opportunity to incorporate inter-individual anatomical differences into kinematic and dynamic analysis of the ankle joint complex. This allows a more functional interpretation of kinematic data, and more realistic estimates of internal forces.     

Influence of the method of TM joint total replacement implantation on the loading of the joint on the opposite side

The temporomandibular (TM) joint is one of the most used joints in the human body, and any defect in this joint has a significant influence on quality of life. The objective of this study was to create a parametric numerical finite element (FE) analysis to compare the effect of surgical techniques used for total TM joint replacement implantation on loading the TM joint on the other side. Our hypothesis is that for the optimal function of all total TM joint replacements used in clinical practice it is crucial to devise a minimally invasive surgical technique, whereby there is minimum resection of masticatory muscles. This factor is more important than the design of the usually used total TM joint replacements. The extent of muscle resection influences the mechanical loading of the whole system. In the parametric FE analyses, the magnitude of the TM joint loading was compared for four different ranges of muscle resections during bite, using an anatomical model. The results obtained from all FE analyses support our hypothesis that an increasing extent of the muscle resection increased the magnitude of the TM joint overloading on the opposite side. The magnitude of the TM joint overloading increased depending on the muscle resection to 235% for bite on an incisor and up to 491% for bite on molars. Our study leads to a recommendation that muscle resection be minimised during replacement implantation and to a proposal that the attachment of the condylar part of the TM joint replacement be modified.     

Influence of the method of TM joint total replacement implantation on the loading of the joint on the opposite side

The temporomandibular (TM) joint is one of the most used joints in the human body, and any defect in this joint has a significant influence on quality of life. The objective of this study was to create a parametric numerical finite element (FE) analysis to compare the effect of surgical techniques used for total TM joint replacement implantation on loading the TM joint on the other side. Our hypothesis is that for the optimal function of all total TM joint replacements used in clinical practice it is crucial to devise a minimally invasive surgical technique, whereby there is minimum resection of masticatory muscles. This factor is more important than the design of the usually used total TM joint replacements. The extent of muscle resection influences the mechanical loading of the whole system. In the parametric FE analyses, the magnitude of the TM joint loading was compared for four different ranges of muscle resections during bite, using an anatomical model. The results obtained from all FE analyses support our hypothesis that an increasing extent of the muscle resection increased the magnitude of the TM joint overloading on the opposite side. The magnitude of the TM joint overloading increased depending on the muscle resection to 235% for bite on an incisor and up to 491% for bite on molars. Our study leads to a recommendation that muscle resection be minimised during replacement implantation and to a proposal that the attachment of the condylar part of the TM joint replacement be modified.     

In vivo kinematics and articular surface congruency of total ankle arthroplasty during gait

Relatively high rates of loosening and implant failure have been reported after total ankle arthroplasty. Abnormal kinematics and incongruency of the articular surface may cause increased contact pressure and rotational torque applied to the implant, leading to loosening and implant failure. We measured in vivo kinematics of two-component total ankle arthroplasty (TNK ankle), and assessed congruency of the articular surface during the stance phase of gait. Eighteen ankles of 15 patients with a mean age of 75±6 years (mean±standard deviation) and follow-up of 44±38 months were enrolled. Lateral fluoroscopic images were taken during the stance phase of gait. 3D-2D model-image registration was performed using the fluoroscopic image and the implant models, and three-dimensional kinematics of the implant and incongruency of the articular surface were determined. The mean ranges of motion were 11.1±4.6°, 0.8±0.4°, and 2.6±1.5° for dorsi-/plantarflexion, inversion/eversion, and internal/external rotation, respectively. At least one type of incongruency of the articular surface occurred in eight of 18 ankles, including anterior hinging in one ankle, medial or lateral lift off in four ankles, and excessive axial rotation in five ankles. Among the four ankles in which lift off occurred during gait, only one ankle showed lift off in the static weightbearing radiograph. Our observations will provide useful data against which kinematics of other implant designs, such as three-component total ankle arthroplasty, can be compared. Our results also showed that evaluation of lift off in the standard weightbearing radiograph may not predict its occurrence during gait.     

Partial hemi-resurfacing of the hip joint--a new approach to treat local osteochondral defects?

There is currently renewed interest in articular resurfacing for the treatment of damaged hip-joint cartilage. In contrast to these implants, which involve endoprosthetic replacement of both articulating surfaces, we present a new joint-preserving technique that allows treatment of local osteochondral defects of the femoral head by partial hemi-resurfacing. In this study we describe the operative and technical aspects and problems for partial hemi-resurfacing of the hip joint and critically discuss indications for this procedure in one case. To guarantee an adequate view of the situs, we recommend a surgical approach involving trochanter flip osteotomy, followed by surgical dislocation of the hip joint. Besides partial hemi-resurfacing of the osteochondral defect, this approach allows treatment of associated labral tears and cartilage defects of the hip joint at the same time. For adequate implant fixation, good bone quality is required. Furthermore, osteochondral defects of limited extent and excellent patient compliance are essential for clinical success. In particular, prominence of the implant has to be avoided, which can lead to an irregular joint surface and may induce further cartilage destruction. Long-term studies on statistical populations will show if partial articular hemi-resurfacing is a bone-preserving and useful therapeutic alternative to hemi-resurfacing caps in the treatment of osteochondral hip-joint defects, especially in young patients.     

An image-based kinematic model of the tibiotalar and subtalar joints and its application to gait analysis in children with Juvenile Idiopathic Arthritis

In vivo estimates of tibiotalar and the subtalar joint kinematics can unveil unique information about gait biomechanics, especially in the presence of musculoskeletal disorders affecting the foot and ankle complex. Previous literature investigated the ankle kinematics on ex vivo data sets, but little has been reported for natural walking, and even less for pathological and juvenile populations. This paper proposes an MRI-based morphological fitting methodology for the personalised definition of the tibiotalar and the subtalar joint axes during gait, and investigated its application to characterise the ankle kinematics in twenty patients affected by Juvenile Idiopathic Arthritis (JIA). The estimated joint axes were in line with in vivo and ex vivo literature data and joint kinematics variation subsequent to inter-operator variability was in the order of 1°. The model allowed to investigate, for the first time in patients with JIA, the functional response to joint impairment. The joint kinematics highlighted changes over time that were consistent with changes in the patient’s clinical pattern and notably varied from patient to patient. The heterogeneous and patient-specific nature of the effects of JIA was confirmed by the absence of a correlation between a semi-quantitative MRI-based impairment score and a variety of investigated joint kinematics indexes. In conclusion, this study showed the feasibility of using MRI and morphological fitting to identify the tibiotalar and subtalar joint axes in a non-invasive patient-specific manner. The proposed methodology represents an innovative and reliable approach to the analysis of the ankle joint kinematics in pathological juvenile populations.     

A rolling-gliding wear simulator for the investigation of tribological material pairings for application in total knee arthroplasty

Background  

Material wear testing is an important technique in the development and evaluation of materials for use in implant for total knee arthroplasty. Since a knee joint induces a complex rolling-gliding movement, standardised material wear testing devices such as Pin-on-Disc or Ring-on-Disc testers are suitable to only a limited extent because they generate pure gliding motion only.     

Measuring the sensitivity of total knee replacement kinematics and laxity to soft tissue imbalances

Ligament balancing during total knee replacement (TKR) is receiving increased attention due to its influence on resulting joint kinematics and laxity. We employed a novel in vitro technique to measure the kinematics and laxity of TKR implants during gait, and measured how these characteristics are influenced by implant shape and soft tissue balancing, simulated using virtual ligaments. Compared with virtual ligaments that were equally balanced in flexion and extension, the largest changes in stance-phase tibiofemoral AP and IE kinematics occurred when the virtual ligaments were simulated to be tighter in extension (tibia offset 1.0 ± 0.1 mm posterior and 3.6 ± 0.1° externally rotated). Virtual ligaments which were tight in flexion caused the largest swing-phase changes in AP kinematics (tibia offset 2.3 ± 0.2 mm), whereas ligaments which were tight in extension caused the largest swing-phase changes in IE kinematics (4.2 ± 0.1° externally rotated). When AP and IE loads were superimposed upon normal gait loads, incremental changes in AP and IE kinematics occurred (similar to laxity testing); and these incremental changes were smallest for joints with virtual ligaments that were tight in extension (in both the stance and swing phases). Two different implant designs (symmetric versus medially congruent) exhibited different kinematics and sensitivities to superimposed loads, but demonstrated similar responses to changes in ligament balancing. Our results demonstrate the potential for pre-clinical testing of implants using joint motion simulators with virtual soft tissues to better understand how ligament balancing affects implant motion.     

Activity intensity,assistive devices and joint replacement influence predicted remodelling in the proximal femur

Bone morphology and density changes are commonly observed following joint replacement, may contribute to the risks of implant loosening and periprosthetic fracture and reduce the available bone stock for revision surgery. This study was presented in the ‘Bone and Cartilage Mechanobiology across the scales’ WCCM symposium to review the development of remodelling prediction methods and to demonstrate simulation of adaptive bone remodelling around hip replacement femoral components, incorporating intrinsic (prosthesis) and extrinsic (activity and loading) factors. An iterative bone remodelling process was applied to finite element models of a femur implanted with a cementless total hip replacement (THR) and a hip resurfacing implant. Previously developed for a cemented THR implant, this modified process enabled the influence of pre- to post-operative changes in patient activity and joint loading to be evaluated. A control algorithm used identical pre- and post-operative conditions, and the predicted extents and temporal trends of remodelling were measured by generating virtual X-rays and DXA scans. The modified process improved qualitative and quantitative remodelling predictions for both the cementless THR and resurfacing implants, but demonstrated the sensitivity to DXA scan region definition and appropriate implant–bone position and sizing. Predicted remodelling in the intact femur in response to changed activity and loading demonstrated that in this simplified model, although the influence of the extrinsic effects were important, the mechanics of implantation were dominant. This study supports the application of predictive bone remodelling as one element in the range of physical and computational studies, which should be conducted in the preclinical evaluation of new prostheses.