Comparison of computational analysis with clinical measurement of stresses on below-knee residual limb in a prosthetic socket

Interface pressures and shear stresses between a below-knee residual limb and prosthetic socket predicted using finite element analyses were compared with experimental measurements. A three-dimensional nonlinear finite element model, based on actual residual geometry and incorporating PTB socket rectification and interfacial friction/slip conditions, was developed to predict the stress distribution. A system for measuring pressures and bi-axial shear stresses was used to measure the stresses in the PTB socket of a trans-tibial amputee. The FE-predicted results indicated that the peak pressure of 226 kPa occurred at the patellar tendon area and the peak shear stress of 50 kPa at the anterolateral tibia area. Quantitatively, FE-predicted pressures were 11%, on average, lower than those measured by triaxial transducers placed at all the measurement sites. Because friction/slip conditions between the residual limb and socket liner were taken into consideration by using interface elements in the FE model, the directions and magnitudes of shear stresses match well between the FE prediction and clinical measurements. The results suggest that the nonlinear mechanical properties of soft tissues and dynamic effects during gait should be addressed in future work.     

Finite element modeling of the contact interface between trans-tibial residual limb and prosthetic socket

Finite element method has been identified as a useful tool to understand the load transfer mechanics between a residual limb and its prosthetic socket. This paper proposed a new practical approach in modeling the contact interface with consideration of the friction/slip conditions and pre-stresses applied on the limb within a rectified socket. The residual limb and socket were modeled as two separate structures and their interactions were simulated using automated contact methods. Some regions of the limb penetrated into the socket because of socket modification. In the first step of the simulation, the penetrated limb surface was moved onto the inner surface of the socket and the pre-stresses were predicted. In the subsequent loading step, pre-stresses were kept and loadings were applied at the knee joint to simulate the loading during the stance phase of gait. Comparisons were made between the model using the proposed approach and the model having an assumption that the shape of the limb and the socket were the same which ignored pre-stress. It was found that peak normal and shear stresses over the regions where socket undercuts were made reduced and the stress values over other regions raised in the model having the simplifying assumption.     

Interface mechanics in external prosthetics: review of interface stress measurement techniques

Instrumentation to measure accurately the stresses at the interface of a residual limb and prosthetic socket has a strong potential for use in prosthetic treatment. As a tool in the clinical setting, the device would allow a clinician to identify sites of excessive loading, information which could then be combined with clinical assessment of skin quality to determine regions of potential skin breakdown. Stress distributions for different prosthetic designs could be compared, facilitating a clinician’s judgement to determine the optimal design for a patient. The instrumentation would have additional use in research as an evaluation tool for computer-based finite-element (FE) models. Stump-socket FE models predict stress distributions for proposed socket designs, thus offering advantages over interface stress measurement because evaluation can be conducted before a prosthesis is fabricated or put on an amputee patient. However, FE models must first be proven valid against experimental measurements before they can be considered accurate predictors of interface stresses. Current interface stress measurement techniques are described, with a concentration on a physical explanation of the advantages and limitations with each technique. New emerging technologies are discussed which are instruments that have been described but for which no data collected on amputees have been reported in the literature. The important new features of those technologies are also discussed.     

Development of a non-linear finite element modelling of the below-knee prosthetic socket interface

A non-linear finite element model has been established to predict the pressure and shear stress distribution at the limb-socket interface in below-knee amputees with consideration of the skin-liner interface friction and slip. In this model, the limb tissue and socket liner were respectively meshed into 954 and 450 three-dimensional eight-node isoparametric brick elements, based on measurements of an individual's amputated limb surface; the bone was meshed into three-dimensional six-node triangular prism elements, based on radiographic measurements of the individual's residual limb. The socket shell was assumed to be a rigid boundary. An important feature of this model is the use of 450 interface elements (ABAQUS INTER4) which mimic the interface friction condition. The results indicate that a maximum pressure of 226 kPa, shear stress of 53 kPa and less than 4 mm slip exist at the skin-liner interface when the full body weight of 800 N is applied to the limb. The results also show that the coefficient of friction is a very sensitive parameter in determining the interface pressures, shear stresses and slip. With the growth of coefficient of friction, the shear stresses will increase, while the pressure and slip will decrease.     

大腿残肢步态过程的非线性有限元分析

目的利用三维有限元分析方法研究大腿截肢患者在行走过程中3个不同时相下残肢的生物力学特性,为建立完整的大腿接受腔测量、设计与评估系统提供研究基础。方法首先根据CT图像三维重建大腿截肢患者的骨骼、肌肉软组织和接受腔的三维几何模型;定义软组织为超弹性和线弹性材料属性,并相应建立两个有限元仿真模型;定义残端与接受腔之间的接触关系,约束残肢近端,对模型的远端施加膝关节载荷,模拟步态周期中足跟着地时期、站立相中期、脚尖离地3个时相下大腿残肢-接受腔系统所受载荷;计算分析接触界面上的应力,并对比分析超弹性和线弹性软组织力学特性对接触界面力学行为特性的影响。结果无论线弹性还是超弹性模型,3个时相下大腿残肢-接受腔界面的最大接触压力均在残肢末端达到最大值。超弹性模型3个时相下接触压力峰值分别为55.80、47.63和50.44 kPa;而线弹性模型接触压力的最大值都增加2倍以上,其值分别为149.86、118.55和139.68 kPa。同时通过分析接触面间的径向剪切应力和轴向剪切应力发现,3个时相下接触界面间的应力在残肢末端较集中,在足跟着地到脚尖离地过程中,有部分力通过接受腔后侧缘传递转向接受腔前缘传递。结论不同时相下残肢与接受腔接触界面的压力和剪切应力分布情况不同,在设计接受腔时需要充分考虑其受力特点。     

一体化小腿假肢的三维有限元应力分析

建立一体化小腿假肢和残肢的三维模型，应用有限元分析方法，计算此模型在模拟Mid—Stance步态时相的载荷作用下各节点的应力，从而得到此模型内外表面的应力分布，为一体化假肢设计的CAD＼CAM系统提供理论依据。计算结果表明，接受腔的应力值较小，假腿的应力值较大，高应力区出现在假腿下端及接受腔与假腿的交界区域。     

Finite Element Analysis of Donning Procedure of a Prosthetic Transfemoral Socket

Lower limb amputation is a severe psychological and physical event in a patient. A prosthetic solution can be provided but should respond to a patient-specific need to accommodate for the geometrical and biomechanical specificities. A new approach to calculate the stress–strain state at the interaction between the socket and the stump of five transfemoral amputees is presented. In this study the socket donning procedure is modeled using an explicit finite element method based on the patient-specific geometry obtained from CT and laser scan data. Over stumps the mean maximum pressure is 4 kPa (SD 1.7) and the mean maximum shear stresses are 1.4 kPa (SD 0.6) and 0.6 kPa (SD 0.3) in longitudinal and circumferential directions, respectively. Locations of the maximum values are according to pressure zones at the sockets. The stress–strain states obtained in this study can be considered more reliable than others, since there are normal and tangential stresses associated to the socket donning procedure.     

Finite element analysis for the evaluation of the structural behaviour,of a prosthesis for trans-tibial amputees

The finite element analysis (FEA) has been identified as a useful tool for the stress and strain behaviour determination in lower limb prosthetics. The residual limb and prosthetic socket interface was the main subject of interest in previous studies. This paper focuses on the finite element analysis for the evaluation of structural behaviour of the Sure-flex? prosthetic foot and other load-bearing components. A prosthetic socket was not included in the FEA. An approach for the finite element modelling including foot analysis, reverse engineering and material property testing was used. The foot analysis incorporated ground reaction forces measurement, motion analysis and strain gauge analysis. For the material model determination, non-destructive laboratory testing and its FE simulation was used. A new, realistic way of load application is presented along with a detailed investigation of stress distribution in the load-bearing components of the prosthesis. A novel approach for numerical and experimental agreement determination was introduced. This showed differences in the strain on the pylon between the experimental and the numerical model within 30% for the anteroposterior bending and up to 25% for the compression. The highest von Mises stresses were found on the foot–pylon connecting component at toe off. Peak stress of 216 MPa occurred on the posterior adjusting screw and maximum stress of 156 MPa was found at the neck of the male pyramid.     

A computational model for stress reduction at the skin-implant interface of osseointegrated prostheses

Osseointegrated implants (OI)s for transfemoral prosthetic attachment offer amputees an alternative to the traditional socket attachment. Potential benefits include a natural transfer of loads directly to the skeleton via the percutaneous abutment, relief of pain and discomfort of residual limb soft tissues by eliminating sockets, increased sensory feedback, and improved function. Despite the benefits, the skin-implant interface remains a critical limitation, as it is highly prone to bacterial infection. One approach to improve clinical outcomes is to minimize stress concentrations at the skin-implant interface due to shear loading, reducing soft tissue breakdown and subsequent risk of infection. We hypothesized that broadening the bone base at the distal end of the femur would provide added surface area for skin adhesion and reduce stresses at the skin-implant interface. We tested this hypothesis using finite element models of an OI in a residual limb. Results showed a dramatic decrease in stress reduction, with up to ~90% decrease in stresses at the skin-implant interface as cortical bone thickness increased from 2 to 8 mm. The findings in this study suggests that surgical techniques could stabilize the skin-implant interface, thus enhancing a skin-to-bone seal around the percutaneous device and minimizing infection.     

Static and dynamic pressure prediction for prosthetic socket fitting assessment utilising an inverse problem approach

Objective

It has been recognised in a review of the developments of lower-limb prosthetic socket fitting processes that the future demands new tools to aid in socket fitting. This paper presents the results of research to design and clinically test an artificial intelligence approach, specifically inverse problem analysis, for the determination of the pressures at the limb/prosthetic socket interface during stance and ambulation.

Methods

Inverse problem analysis is based on accurately calculating the external loads or boundary conditions that can generate a known amount of strain, stresses or displacements at pre-determined locations on a structure. In this study a backpropagation artificial neural network (ANN) is designed and validated to predict the interfacial pressures at the residual limb/socket interface from strain data collected from the socket surface. The subject of this investigation was a 45-year-old male unilateral trans-tibial (below-knee) traumatic amputee who had been using a prosthesis for 22 years.

Results

When comparing the ANN predicted interfacial pressure on 16 patches within the socket with actual pressures applied to the socket there is shown to be 8.7% difference, validating the methodology. Investigation of varying axial load through the subject's prosthesis, alignment of the subject's prosthesis, and pressure at the limb/socket interface during walking demonstrates that the validated ANN is able to give an accurate full-field study of the static and dynamic interfacial pressure distribution.

Conclusions

To conclude, a methodology has been developed that enables a prosthetist to quantitatively analyse the distribution of pressures within the prosthetic socket in a clinical environment. This will aid in facilitating the “right first time” approach to socket fitting which will benefit both the patient in terms of comfort and the prosthetist, by reducing the time and associated costs of providing a high level of socket fit.     

Effects of liner stiffness for trans-tibial prosthesis: a finite element contact model

The socket liner plays a crucial role in redistribution of the interface stresses between the stump and the socket, so that the peak interface stress could be reduced. However, how the peak stress is affected by various liner stiffnesses is still unknown, especially when the phenomenon of the stump slide within the socket is considered. This study employed nonlinear contact finite element analyses to study the biomechanical reaction of the stump sliding with particular attention to the liner stiffness effects of the trans-tibial prosthesis. To validate the finite element outcomes, experimental measurements of the interface stresses and sliding distance were further executed. The results showed that the biomechanical response of the stump sliding are highly nonlinear. With a less stiff liner, the slide distance of the stump would increase with a larger contact area. However, this increase in the contact area would not ensure a reduction in the peak interface stress and this is due to the combined effects of the non-uniform shape of the socket and the various sliding distances generated by the different liner stiffnesses.     

Using computational simulation to aid in the prediction of socket fit: a preliminary study

This study illustrates the use of computational analysis to predict prosthetic socket fit. A simple indentation test is performed by applying force to the residual limb of a trans-tibial amputee through an indenter until the subject perceives the onset of pain. Computational finite element (FE) analysis is then applied to evaluate the magnitude of pressure underlying the indenter that initiates pain (pain threshold pressure), and the pressure at the prosthetic socket-residual limb interface. The assessment of socket fit is examined by studying whether or not the socket-limb interface pressure exceeds the pain threshold pressure of the limb. Based on the computer-aided assessment, a new prosthetic socket is then fabricated and fitted to the amputee subject. Successful socket fit is achieved at the end of this process. The approach of using computational analysis to aid in assessing socket fit allows a more efficient evaluation and re-design of the socket even before the actual fabrication and fitting of the prosthetic socket. However, more thorough investigations are required before this approach can be widely used. A subsequent part of this paper discusses the limitations and suggests future research directions in this area.     

Real-Time Patient-Specific Finite Element Analysis of Internal Stresses in the Soft Tissues of a Residual Limb: A New Tool for Prosthetic Fitting

Fitting of a prosthetic socket is a critical stage in the process of rehabilitation of a trans-tibial amputation (TTA) patient, since a misfit may cause pressure ulcers or a deep tissue injury (DTI: necrosis of the muscle flap under intact skin) in the residual limb. To date, prosthetic fitting typically depends on the subjective skills of the prosthetist, and is not supported by biomedical instrumentation that allows evaluation of the quality of fitting. Specifically, no technology is presently available to provide real-time continuous information on the internal distribution of mechanical stresses in the residual limb during fitting of the prosthesis, or while using it and this severely limits patient evaluations. In this study, a simplified yet clinically oriented patient-specific finite element (FE) model of the residual limb was developed for real-time stress analysis. For this purpose we employed a custom-made FE code that continuously calculates internal stresses in the residual limb, based on boundary conditions acquired in real-time from force sensors, located at the limb-prosthesis interface. Validation of the modeling system was accomplished by means of a synthetic phantom of the residual limb, which allowed simultaneous measurements of interface pressures and internal stresses. Human studies were conducted subsequently in five TTA patients. The dimensions of bones and soft tissues were obtained from X-rays of the residual limb of each patient. An indentation test was performed in order to obtain the effective elastic modulus of the soft tissues of the residual limb. Seven force sensors were placed between the residual limb and the prosthetic liner, and subjects walked on a treadmill during analysis. Generally, stresses under the shinbones were ∼threefold higher than stresses at the soft tissues behind the bones. Usage of a thigh corset decreased the stresses in the residual limb during gait by approximately 80%. Also, the stresses calculated during the trial of a subject who complained about pain and discomfort were the highest, confirming that his socket was not adequately fitted. We conclude that real-time patient-specific FE analysis of internal stresses in deep soft tissues of the residual limb in TTA patients is feasible. This method is promising for improving the fitting of prostheses in the clinical setting and for protecting the residual limb from pressure ulcers and DTI.     

A finite element model to assess transtibial prosthetic sockets with elastomeric liners

People with transtibial amputation often experience skin breakdown due to the pressures and shear stresses that occur at the limb-socket interface. The purpose of this research was to create a transtibial finite element model (FEM) of a contemporary prosthesis that included complete socket geometry, two frictional interactions (limb-liner and liner-socket), and an elastomeric liner. Magnetic resonance imaging scans from three people with characteristic transtibial limb shapes (i.e., short-conical, long-conical, and cylindrical) were acquired and used to develop the models. Each model was evaluated with two loading profiles to identify locations of focused stresses during stance phase. The models identified five locations on the participants’ residual limbs where peak stresses matched locations of mechanically induced skin issues they experienced in the 9 months prior to being scanned. The peak contact pressure across all simulations was 98 kPa and the maximum resultant shear stress was 50 kPa, showing reasonable agreement with interface stress measurements reported in the literature. Future research could take advantage of the developed FEM to assess the influence of changes in limb volume or liner material properties on interface stress distributions.

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Graphical abstract Residual limb finite element model. Left: model components. Right: interface pressures during stance phase

     

Shear stress related blood damage along the cusp of a tri-leaflet prosthetic valve.

Blood flowing through a prosthetic heart valve can be damaged by flow-induced shear forces. Fluid dynamics variables and geometric factors play an important role in the evaluation of shear-stress-related blood damage. Central-flow prosthetic valves have been considered as an optimal replacement for mechanical and biological valves. Recently it was shown that shear stress distribution along the surface of a polyurethane cusp reaches values that can damage the blood elements. A mathematical model correlating the effects of shear stresses on blood corpuscles with clinical findings was employed in vitro. The model can be applied to the effects of blood-surface interaction and is of clinical relevance.     

The influence of geometry on the stress distribution in joints — a finite element analysis

The incongruity of human joints is a phenomenon which has long been recognized, and recent CT-osteoabsorptiometric findings suggest that this incongruity influences the distribution of stress in joints during their normal physiological use. The finite element method (FEM) was therefore applied to five different geometric configurations consistent with the anatomy of articular surfaces, and a program with variable contact areas (Marc) was used to calculate the stress distribution for loads of 100 to 6 900 N. The assumption of congruity between head and socket results in a “bell-shaped” distribution of stress with a maximum value of 61.5 N/mm² in the depths of the socket, decreasing towards zero at its edges. In the model with a flatter socket the von Mises stresses are higher (max. 101.3 N/mm²); with a deeper socket, lower (max. 53.0 N/mm²). If the diameter of the head is greater, the stresses build up from the periphery of the socket and move towards its depths as the load increases. The combination of an oversized head and a deeper socket results in the most satisfactory stress distribution (max. 43.2 N/mm²). These results extend previous photoelastic findings with incongruous joint surfaces. The calculated mechanical conditions show a relationship to the location of osteoarthritic changes, and are reflected by the distribution pattern of subchondral bone density. A more satisfactory stress distribution is found with functionally advantageous, incongruous joint surfaces (oversized head and deepened socket) than in the congruous joint, and a better nutritive situation for the articular cartilage seems likely. The geometry of the joint is therefore a physiologically important and quantifiable factor contributing to an optimized transmission of forces in joints.     

小腿假肢接受腔的三维有限元分析

通过建立三维非线性有限元模型来分析小腿假肢接受腔与残肢之间的载荷分布。此模型基于残肢,骨头,软套和接受腔的三维几何形状,考虑界面摩擦滑动条件和软组织的大变形等非线性因素。模型可以预测不同外载下残肢和接受腔之间的压力,剪切力和相对滑动情况。并分析了不同的接受腔形状对载荷分布的影响。     

Interface load analysis for computer-aided design of below-knee prosthetic sockets

A finite-element analysis is made for the compression of soft tissues of the residual lower limb contained in a prosthetic socket. The analysis is relevant to static loading during stance in a patellar-tendon-bearing, below-knee design of socket. Values of Young's modulus are obtained experimentally for use in the model. One of the main objectives is to study the sensitivity of the loading to these values and also to other assumed conditions. Using direct pressure at the limb/socket interface and vertical stiffness as indicators, changes in material properties, socket alignment and socket rectification are investigated; assumptions about the frictional characteristic at the interface are seen to be critical in determination of load distribution. This type of analysis may provide the next stage of refinement for computeraided socket design systems.     

A pressure and shear sensor system for stress measurement at lower limb residuum/socket interface

A sensor system for measurement of pressure and shear at the lower limb residuum/socket interface is described. The system comprises of a flexible sensor unit and a data acquisition unit with wireless data transmission capability. Static and dynamic performance of the sensor system was characterised using a mechanical test machine. The static calibration results suggest that the developed sensor system presents high linearity (linearity error ≤ 3.8%) and resolution (0.9 kPa for pressure and 0.2 kPa for shear). Dynamic characterisation of the sensor system shows hysteresis error of approximately 15% for pressure and 8% for shear. Subsequently, a pilot amputee walking test was conducted. Three sensors were placed at the residuum/socket interface of a knee disarticulation amputee and simultaneous measurements were obtained during pilot amputee walking test. The pressure and shear peak values as well as their temporal profiles are presented and discussed. In particular, peak pressure and shear of approximately 58 kPa and 27 kPa, respectively, were recorded. Their temporal profiles also provide dynamic coupling information at this critical residuum/socket interface. These preliminary amputee test results suggest strong potential of the developed sensor system for exploitation as an assistive technology to facilitate socket design, socket fit and effective monitoring of lower limb residuum health.