Sigal Portnoy

Stress relaxation of porcine gluteus muscle subjected to sudden transverse deformation as related to pressure sore modeling.

Computational studies of deep pressure sores (DPS) in skeletal muscles require information on viscoelastic constitutive behavior of muscles, particularly when muscles are loaded transversally as during bone-muscle interaction in sitting and lying immobilized patients. In this study, we measured transient shear moduli G(t) of fresh porcine muscles in vitro using the indentation method. We employed a custom-made pneumatic device that allowed rapid (2000 mms) 4 mm indentations. We tested 8 gluteus muscles, harvested from 5 adult pigs. Each muscle was indented transversally (perpendicularly to the direction of fibers) at 3 different sites, 7 times per site, to obtain nonpreconditioned (NPC) and preconditioned (PC) G(t) data. Short-term (GS) and long-term (GL) shear moduli were obtained directly from experiments. We further fitted measured G(t) data to a biexponential equation G(t) = G1 x exp(-t/tau1)+ G2 x exp(-t/tau2) + Ginfinity, which provided good fit, visually and in terms of the correlation coefficients. Typically, plateau of the stress relaxation curves (defined as 10% difference from final GL) was evident approximately 20 s after indentation. Short-term shear moduli GS (mean NPC: 8509 Pa, PC: 5711 Pa) were greater than long-term moduli GL (NPC: 609 Pa, PC: 807 Pa) by about an order of magnitude. Statistical analysis of parameters showed that only G2 was affected by preconditioning, while GL, GS, Ginfinity, tau1, tau2, and G1 properties were unaffected. Since DPS develop over time scales of minutes to hours, but most stress relaxation occurs within approximately 20 s, the most relevant property for computational modeling is GL (mean approximately 700 Pa), which is, conveniently, unaffected by preconditioning.

Internal mechanical conditions in the soft tissues of a residual limb of a trans-tibial amputee

Most trans-tibial amputation (TTA) patients use a prosthesis to retain upright mobility capabilities. Unfortunately, interaction between the residual limb and the prosthetic socket causes elevated internal strains and stresses in the muscle and fat tissues in the residual limb, which may lead to deep tissue injury (DTI) and other complications. Presently, there is paucity of information on the mechanical conditions in the TTA residual limb during load-bearing. Accordingly, our aim was to characterize the mechanical conditions in the muscle flap of the residual limb of a TTA patient after donning the prosthetic socket and during load-bearing. Knowledge of internal mechanical conditions in the muscle flap can be used to identify the risk for DTI and improve the fitting of the prosthesis. We used a patient-specific modelling approach which involved an MRI scan, interface pressure measurements between the residual limb and the socket of the prosthesis and three-dimensional non-linear large-deformation finite-element (FE) modelling to quantify internal soft tissue strains and stresses in a female TTA patient during static load-bearing. Movement of the truncated tibia and fibula during load-bearing was measured by means of MRI and used as displacement boundary conditions for the FE model. Subsequently, we calculated the internal strains, strain energy density (SED) and stresses in the muscle flap under the truncated bones. Internal strains under the tibia peaked at 85%, 129% and 106% for compression, tension and shear strains, respectively. Internal strains under the fibula peaked at substantially lower values, that is, 19%, 22% and 19% for compression, tension and shear strains, respectively. Strain energy density peaked at the tibial end (104kJ/m(3)). The von Mises stresses peaked at 215kPa around the distal end of the tibia. Stresses under the fibula were at least one order of magnitude lower than the stresses under the tibia. We surmise that our present patient-specific modelling method is an important tool in understanding the etiology of DTI in the residual limbs of TTA patients.

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.

Design of a Free-Floating Polycarbonate-Urethane Meniscal Implant Using Finite Element Modeling and Experimental Validation

The development of a synthetic meniscal implant that does not require surgical attachment but still provides the biomechanical function necessary for joint preservation would have important advantages. We present a computational-experimental approach for the design optimization of a free-floating polycarbonate-urethane (PCU) meniscal implant. Validated 3D finite element (FE) models of the knee and PCU-based implant were analyzed under physiological loads. The model was validated by comparing calculated pressures, determined from FE analysis to tibial plateau contact pressures measured in a cadaveric knee in vitro. Several models of the implant, some including embedded reinforcement fibers, were tested. An optimal implant configuration was then selected based on the ability to restore pressure distribution in the knee, manufacturability, and long-term safety. The optimal implant design entailed a PCU meniscus embedded with circumferential reinforcement made of polyethylene fibers. This selected design can be manufactured in various sizes, without risking its integrity under joint loads. Importantly, it produces an optimal pressure distribution, similar in shape and values to that of natural meniscus. We have shown that a fiber-reinforced, free-floating PCU meniscal implant can redistribute joint loads in a similar pattern to natural meniscus, without risking the integrity of the implant materials.

Patient-specific analyses of deep tissue loads post transtibial amputation in residual limbs of multiple prosthetic users

Active transtibial amputation (TTA) patients are at risk for developing pressure ulcers (PU) and deep tissue injury (DTI) while using their prosthesis. It is therefore important to obtain knowledge of the mechanical state in the internal soft tissues of the residuum, as well as knowledge of the mechanical state upon its surface. Our aim was to apply patient-specific MRI-based non-linear finite element (FE) models to quantify internal strains in TTA prosthetic users (n=5) during load-bearing. By further employing a strain injury threshold for skeletal muscle, we identified patients susceptible to DTI. The geometrical characteristics of the residuum of the TTA participants varied substantially between patients, e.g. the residuum lengths were 7.6, 8.1, 9.2, 11.5 and 13.3cm. We generally found that internal strains were higher in the bone proximity than in the muscle flap periphery. The highest strains, which in some patients exceeded 50% (engineering strain) for compressive, tensile and shear strains, were found in the shortest residual limbs, i.e. the 7.6 and 8.1cm-long limbs. Correspondingly, the lowest strains were found in the 13.3cm-long residuum, which had the bulkiest muscle flap. Yet, even in the case of a long residuum, about a third of the soft tissue volume at the distal tibial proximity area was occupied by large (>5%) internal compressive, tensile and shear strains. For both patients with shorter residual limbs, the internal principal compressive strains above 5% occupied almost the entire distal tibial proximity area. For a patient whose distal tibial end was flat (non-beveled), internal strains were more uniformly distributed, compared to the strain distributions in the other models, where focal elevated strains accumulated in the bone proximity. We found no muscle strains above the immediate injury threshold, indicating that all patients were not at immediate risk for DTI. Two patients whose residuum fat padding was minimal to none, were the only ones identified as theoretically prone to DTI at long (>3h) continuous weight-bearing periods. We conclude that there is a wide variability in internal mechanical conditions between residual limbs across subjects, which necessitates patient-specific quantitative analyses of internal mechanical states in TTA patients, to assess the mechanical performance of the reconstructed limb and in particular, the individual risk for deep PU or DTI.

Real-time subject-specific analyses of dynamic internal tissue loads in the residual limb of transtibial amputees

Transtibial amputation (TTA) prosthetic-users may risk the integrity of their residuum while trying to maintain everyday activities. Compression of the muscle flap between the truncated bones and the prosthetic socket may cause pressure ulcers and deep tissue injury (DTI). We hypothesize that mechanical stresses in the muscle flap are higher when walking over complex terrains than during plane gait, and so, the residuum could be at risk for DTI when walking over these terrains. Accordingly, we evaluated internal soft tissue stresses in the residuum at the vicinity of the tibia in 18 prosthetic-users (7 vascular, 11 traumatic). For this purpose, we developed a portable monitor that calculated subject-specific internal stresses in the residuum in real-time. Each subject was studied while walking on plane floor, grass, stairs and slope. We found that internal stresses were the highest while subjects descended a slope, during which internal peak and root mean square (RMS) stresses were approximately 40% and 50% greater than in plane gait, respectively. Peak and RMS stresses calculated while descending a slope were approximately 2 times higher for the sub-group of vascular subjects compared to traumatic, but were similar between the two sub-groups for other ambulation tasks. Overall, the present internal stress monitor is a practical tool for real-time evaluation of internal stresses in the residuum of TTA prosthetic-users in the clinical setting or outdoors. Pending integration of appropriate dynamic tissue injury thresholds, the device can be utilized for alerting to the danger of DTI.

Outdoor dynamic subject-specific evaluation of internal stresses in the residual limb: Hydraulic energy-stored prosthetic foot compared to conventional energy-stored prosthetic feet

The prosthetic foot plays an important role in propelling, breaking, balancing and supporting body loads while the amputee ambulates on different grounds. It is therefore important to quantify the effect of the prosthetic foot mechanism on biomechanical parameters, in order to prevent pressure ulcers and deep tissue injury. Our aim was to monitor the internal stresses in the residuum of transtibial amputation (TTA) prosthetic-users ambulating on different terrains, which the amputees encounter during their daily activities, i.e. paved floor, grass, ascending and descending stairs and slope. We specifically aimed to compare between the internal stresses in the TTA residuum of amputees ambulating with a novel hydraulic prosthetic foot compared to conventional energy storage and return (ESR) prosthetic feet. Monitoring of internal stresses was accomplished using a portable subject-specific real-time internal stress monitor. We found significant decrease (p<0.01) in peak internal stresses and in the loading rate of the amputated limb, while walking with the hydraulic foot, compared to walking with ESR feet. The loading rate calculated while ambulating with the hydraulic foot was at least three times lower than the loading rate calculated while ambulating with the ESR foot. Although the average decrease in internal stresses was ≈ 2-fold larger when replacing single-toe ESR feet with the hydraulic foot than when replacing split-toed ESR feet with the hydraulic foot, the differences were statistically insignificant. Our findings suggest that using a hydraulic prosthetic foot may protect the distal tibial end of the TTA residuum from high stresses, therefore preventing pressure-related injury and pain.

Clinically oriented real-time monitoring of the individual’s risk for deep tissue injury

Spinal cord injury patients are under daily risk for developing deep tissue injury which is a severe pressure ulcer that initiates in soft tissues at the bones’ proximity. We aimed to formulate a patient-specific biomechanical model that can continuously monitor internal tissue stresses in real time. We adopted a formulation solving an axisymmetric contact problem of a finite-thickness, elastic layer (soft tissue), and a rigid spherical indentor (ischial tuberosity). We utilized finite element analyses to expand the formulation for large deformations. Sensitivity analyses showed that the soft tissue mechanical properties are the most influential factors in this modeling. We then used synthetic surface pressure data and actual surface pressures recorded under the buttocks of five paraplegic wheelchair users to demonstrate clinical feasibility. Output parameters were designed to be simple so that they can be easily interpreted by the user. Specifically, we calculated peak and average internal von Mises stress and stress dose, under each buttock, and also a time-dependent stress asymmetry index, to account for frequency of posture adjustments. Inter-subject variability was higher than the intra-subject variability. The heaviest subject had the highest maximal and average peak internal soft tissue stress. We believe that this method holds a high potential for clinical applications.

Effects of sitting postures on risks for deep tissue injury in the residuum of a transtibial prosthetic-user: a biomechanical case study.

Transtibial amputation prosthetic-users are at risk of developing deep tissue injury (DTI) while donning their prosthesis for prolonged periods; however, no study addresses the mechanical loading of the residuum during sitting with a prosthesis. We combined MRI-based 3D finite element modelling of a residuum with an injury threshold and a muscle damage law to study risks for DTI in one sitting subject in two postures: 30°-knee-flexion vs. 90°-knee-flexion. We recorded skin-socket pressures, used as model boundary conditions. During the 90°-knee-flexion simulations, major internal muscle injuries were predicted (>1000 mm3). In contrast, the 30°-knee-flexion simulations only produced minor injury ( < 14 mm3). Predicted injury rates at 90°-knee-flexion were over one order of magnitude higher than those at 30°-knee-flexion. We concluded that in this particular subject, prolonged 90°-knee-flexion sitting theoretically endangers muscle viability in the residuum. By expanding the studies to large subject groups, this research approach can support development of guidelines for DTI prevention in prosthetic-users.

Gait characteristics of post-poliomyelitis patients: Standardization of quantitative data reporting

OBJECTIVES To evaluate the differences in gait characteristics and gait symmetry of post-polio syndrome (PPS) patients ambulating with or without shoes and between subgroups walking with different walking aids and orthoses, study the correlation of these data with personal data, illness condition, physical health, frequency of using aids and orthotics and frequency of falls, and derive recommendations for standardization of reporting these data. METHOD Twenty-six PPS subjects ambulated with their own walking devices. We calculated spatio-temporal parameters and symmetry indices (SI) of gait using a data acquired by a motion capture system. We compared inter-subject differences in gait pattern for PPS groups that differed by questionnaire-obtained data of demographics, physical activity, polio history, falls and walking aids. Additional inter-subject comparisons were performed between normal subjects (n=16), PPS patients walking with shoes with/without an ankle-foot-orthosis (n=11), PPS patients walking with knee-ankle-foot-orthosis (n=5), and PPS patients walking with a walker/crutches (n=10). We also compared intra-subject variability in PPS subjects who were able to repeat the trials barefoot. RESULTS Our main results show that subjects who reported participating in physical activity twice a week or more had significantly better step time and double support symmetry. Subjects who use walking aids on a daily basis had significantly higher gait cadence and shorter stride time. Also, subjects that do not require knee-ankle-foot orthoses and/or walking aids walked with a smaller base width and better symmetry in stance and swing durations than PPS subjects who require these aids. CONCLUSIONS The gait pattern of PPS patients is related to numerous intrinsic and extrinsic factors. Standardization of the reporting protocol of gait-related data of PPS patients is crucial for patient evaluation and treatment design.