Search Results (86)

Background: The company Ethnocare has developed the Overlay, a new pneumatic solution for managing volumetric variations (VVs) of the residual limb (RL) in transtibial amputees (TTAs), which improves socket fitting. However, the impact of the Overlay during functional tasks and on the comfort and pain felt in the RL is unknown. Methods: 8 TTAs participated in two evaluations, separated by two weeks. We measured compensatory strategies (CS) using spatio-temporal parameters and three-dimensional lower limb kinematics and kinetics during gait and sit-to-stand (STS) tasks. During each visit, the participant carried out our protocol while wearing the Overlay and prosthetic folds (PFs), the most common solution to VV. Between each task, comfort and pain felt were assessed using visual analog scales. Results: While walking, the cadence with the Overlay was 105 steps/min, while it was 101 steps/min with PFs (p = 0.021). During 35% and 55% of the STS cycle, less hip flexion was observed while wearing the Overlay compared to PFs (p = 0.004). We found asymmetry coefficients of 13.9% with the Overlay and 17% with PFs during the STS (p = 0.016) task. Pain (p = 0.031), comfort (p = 0.017), and satisfaction (p = 0.041) were better with the Overlay during the second visit. Conclusion: The Overlay’s impact is similar to PFs’ but provides less pain and better comfort. Full article

The ankle joint is pivotal in prosthetic feet, especially in Energy-Storing-and-Releasing feet, favoured by individuals with moderate to high mobility (K3/K4) due to their energy efficiency and simple construction. ESR feet, mainly designed for sagittal-plane motion, often exhibit high stiffness in other planes, leading to difficulties in adapting to varied ground conditions, potentially causing discomfort or pain. This study aims to present a systematic methodology for modifying the ankle joint’s stiffness properties across its three motion planes, tailored to individual user preferences, and to decouple the sagittal-plane behaviour from the frontal and transverse ones. To integrate the multi-axial ankle inside the MyFlex-η, the designing of experiments using finite element analysis was conducted to explore the impact of geometric parameters on the joint’s properties with respect to design constraints and to reach the defined stiffness targets on the three ankle’s motion planes. A prototype of the multi-axial ankle joint was then manufactured and tested under FEA-derived load conditions to validate the final configuration chosen. Composite elastic elements and complementary parts of the MyFlex-η, incorporating the multi-axial ankle joint, were developed, and the prosthesis was biomechanically tested according to lower limb prosthesis ISO standards and guidelines from literature and the American Orthotic and Prosthetic Association (AOPA). Experimental tests showed strong alignment with numerical predictions. Moreover, implementing the multi-axial ankle significantly increased frontal-plane compliance by 414% with respect to the same prosthesis with only one degree of freedom on the sagittal plane without affecting the main plane of locomotion performance. Full article

Background: In recent years, there has been considerable interest in prosthetic alignment techniques for total knee arthroplasty (TKA), particularly in the so-called kinematic alignment, which aims to restore the knee’s native alignment. However, implementing this technique requires specialized instruments and procedural steps that can be laborious. This study introduces the bisector of the trochlear groove as a reliable landmark for performing the distal femoral cut while maintaining parallelism with the native femoral joint line. Methods: Three orthopedic specialists assessed 110 X-ray images of full-leg, weight-bearing lower limbs obtained from healthy individuals between January 2021 and December 2022. The bisector of the trochlear groove was identified on the X-ray images, and the angle between this bisector and the femoral joint line was measured. The consistency of these measurements across repeated assessments and different examiners was evaluated. Results: The bisector of the trochlear groove was found to be perpendicular to the femoral joint line, with a mean angle of 89.4°. The inter-rater reliability was 68% within ±1.3° from the mean, while the intra-rater reliability was 82% within ±1.5° from the mean. Conclusions: These results suggest that by performing a femoral cut perpendicular to the bisector of the trochlear groove, surgeons can inherently restore the femoral joint line of the native knee in patients where the native joint line is no longer identifiable due to the effect of osteoarthritis. This method may offer a viable and straightforward alternative to the standard surgical technique currently practiced for kinematic alignment in TKA. Full article

Prosthetic socket manufacturing is experiencing a revolutionary shift towards using digital methods, such as 3D scanning and 3D printing. However, using digital methods requires the clinician to transfer their skills from making sockets by hand to making sockets with a computer. This shift in practice may change the socket geometry and fit; however, to what extent is unknown. Thus, the aim of this study was to explore the feasibility of analyzing geometric and clinical differences between digitally- and manually-designed sockets. Nine adult inpatients with below-knee amputation were recruited. Two sockets were 3D printed for each participant from 3D socket models that were developed from: (1) 3D scanning a manually-modified hand-casted positive mold of the residuum; and (2) a digitally-modified 3D scan of the residuum. Manual and digital procedures were compared for three measures: final socket geometry, the Socket Comfort Score, and a patient experience survey. Feasibility data were collected to measure protocol implementation fidelity to inform a future larger study. These data revealed that 89% of participants followed the intended protocol, no participants dropped out, and only one adverse event was report. As no significant geometric differences were found and participants experienced similar comfort scores between manually- and digitally-designed sockets, study feasibility was determined to be successful. Thus, a randomized control trial study will be conducted to draw statistically relevant conclusions from these outcome measures that may provide meaningful information for improving digital design procedures. Full article

This paper presents a comprehensive review of natural fiber-reinforced composites (NFRCs) for lower-limb prosthetic designs. It covers the characteristics, types, and properties of natural fiber-reinforced composites as well as their advantages and drawbacks in prosthetic designs. This review also discusses successful prosthetic designs that incorporate NFRCs and the factors that make them effective. Additionally, this study explores the use of computational biomechanical models to evaluate the effectiveness of prosthetic devices and the key factors that are considered. Overall, this document provides a valuable resource for anyone interested in using NFRCs for lower-limb prosthetic designs. Full article

The demand for affordable prostheses, particularly in low- and middle-income countries (LMICs), is significant. Currently, the majority of prosthetic sockets are manufactured using monolithic thermoplastic polymers such as PP (polypropylene), which lack durability, strength, and exhibit creep. Alternatively, they are reinforced with consumptive thermoset resin and expensive composite fillers such as carbon, glass, or Kevlar fibres. However, there are unmet needs that amputees face in obtaining affordable prosthetic sockets, demanding a solution. This study utilises self-reinforced PET (polyethylene terephthalate), an affordable and sustainable composite material, to produce custom-made sockets. Advancing the development of a unique socket manufacturing technique employing a reusable vacuum bag and a purpose-built curing oven, we tested fabricated sockets for maximum strength. Subsequently, a prosthetic device was created and assessed for its performance during ambulation. The mechanical and structural strength of PET materials for sockets reached a maximum strength of 132 MPa and 5686 N. Findings indicate that the material has the potential to serve as a viable substitute for manufacturing functional sockets. Additionally, TOPSIS analysis was conducted to compare the performance index of sockets, considering decision criteria such as material cost, socket weight, and strength. The results showed that PET sockets outperformed other materials in affordability, durability, and strength. The methodology successfully fabricated complex-shaped patient sockets in under two hours. Additionally, walking tests demonstrated that amputees could perform daily activities without interruptions. This research makes significant progress towards realising affordable prostheses for LMICs, aiming to provide patient-specific affordable prostheses tailored for LMICs. Full article

The aim of this work was to assess the accuracy, repeatability, and reproducibility of a hand-held, structured-light 3D scanner (EINScan Pro 2X Plus with High Definition Prime Pack, SHINING 3D Tech. Co., Ltd., Hangzhou, China), to support its potential use in multi-site settings on lower limb prosthetics. Four limb models with different shapes were fabricated and scanned with a metrological 3D scanner (EINScan Laser FreeScan 5X, SHINING 3D Tech. Co., Ltd., Hangzhou, China) by a professional operator (OP0). Limb models were then mailed to three sites where two operators (OP1, OP2) scanned them using their own structured-light 3D scanner (same model). OP1 scanned limb models twice (OP1-A, OP1-B). OP0, OP1-A, and OP2 scans were compared for accuracy, OP1-A and OP1-B for repeatability, and OP1-A and OP2 for reproducibility. Among all comparisons, the mean radial error was <0.25 mm, mean angular error was <4°, and root mean square error of the radial distance was <1 mm. Moreover, limits of agreement were <3.5% for perimeters and volumes. By comparing these results with respect to clinically-relevant thresholds and to the literature available on other 3D scanners, we conclude that the EINScan Pro 2X Plus 3D Scanner with High Definition Prime Pack has good accuracy, repeatability, and reproducibility, supporting its use in multi-site settings. Full article

Lower limb knee–ankle prostheses can effectively assist above-knee amputees in completing their basic daily activities. This study explored methods for estimating the joint kinematics of intelligent lower limb prostheses to better adapt them to the walking requirements of amputees. A method of estimating the knee and ankle joint trajectories under different speeds and slopes was raised. The joints of a prosthetic need to have a movement trajectory similar to that of the joints of healthy individuals, taking into account the person’s motion intentions and complying with the law of movement. In this study, a prosthetic kinematics estimation method was studied to realize continuous speed and slope adaptation through key points. The iterative Douglas–Peucker algorithm automatically found the key points of the kinematic trajectory curve, and an invariant basis function-fitting model with key points constraints was constructed. Finally, the radial basis function neural network was used to estimate the adaptive task function of the parts affected by the speed and slope, resulting in an overall kinematics estimation model. Our experiments verified the effectiveness of the proposed method, which accurately estimated the kinematic trajectory; the knee and ankle joint estimation errors were greatly reduced compared to those obtained with previous methods, facilitating further research on individual algorithms. Full article

Increased pressure and shear stress distributions at the limb–socket interface are hypothesised to result from changes in the residual limb shape and volume, which can cause socket fit difficulties. Accurate residual limb volume measurements may aid clinicians in developing strategies to accommodate volume fluctuations. This review primarily aims to analyse the techniques available for measuring the residual lower limb volume that may be used in clinical settings, as documented in the works published over the previous four decades. A comprehensive search of articles in PubMed, ScienceDirect, Web of Science, and Google Scholar identified 904 articles, and further analysis resulted in only 39 articles being chosen to be analysed. Based on the findings, there are nine techniques available to measure the residual limb volume: water displacement, anthropometric measurement, contact probes, optical scanning, spiral X-ray computed tomography (SXCT), magnetic resonance imaging (MRI), ultrasound, laser scanning, and bioimpedance. Considering the variety of techniques for determining residual limb volume, it is critical to choose the ones that best suit clinicians’ objectives, and each technique has potential sources of error that should be avoided by taking precautionary action. A comprehensive study of the measurement techniques is needed since researchers have developed and extensively utilised many new measuring devices, especially handheld 3D laser scanners. Full article

An intelligent lower-limb prosthesis can provide walking support and convenience for lower-limb amputees. Trajectory planning of prosthesis joints plays an important role in the intelligent prosthetic control system, which directly determines the performance and helps improve comfort when wearing the prosthesis. Due to the differences in physiology and walking habits, humans have their own walking mode that requires the prosthesis to consider the individual’s demands when planning the prosthesis joint trajectories. The human is an integral part of the control loop, whose subjective feeling is important feedback information, as humans can evaluate many indicators that are difficult to quantify and model. In this study, trajectories were built using the phase variable method by normalizing the gait curve to a unified range. The deviations between the optimal trajectory and current were represented using Fourier series expansion. A gait dataset that contains multi-subject kinematics data is used in the experiments to prove the feasibility and effectiveness of this method. In the experiments, we optimized the subjects’ gait trajectories from an average to an individual gait trajectory. By using the individual trajectory planning algorithm, the average gait trajectory can be effectively optimized into a personalized trajectory, which is beneficial for improving walking comfort and safety and bringing the prosthesis closer to intelligence. Full article

Facing above-knee amputation poses a significant hurdle due to its profound impact on walking ability. To overcome this challenge, a complex adaptation strategy is necessary at the neuromuscular level to facilitate safe movement with a prosthesis. Prior research conducted on lower-limb amputees has shown a comparable amount of intricacy exhibited by the neurological system, regardless of the level of amputation and state of walking. This research investigated the differences in muscle synergies among individuals with unilateral transfemoral amputations during walking at three different speeds of transient-state gait. Surface electromyography was recorded from eleven male transfemoral amputees’ intact limbs (TFA), and the concatenated non-negative matrix factorization technique was used to identify muscle synergy components, synergy vectors (S), and activation coefficient profiles (C). Results showed varying levels of correlation across paired-speed comparisons in TFA, categorized as poor (S1), moderate (S3 and S4), and strong (S2). Statistically significant differences were observed in all activation coefficients except C3, particularly during the stance phase. This study can assist therapists in understanding muscle coordination in TFA during unsteady gait, contributing to rehabilitation programs for balance and mobility improvement, and designing myoelectric prosthetic systems to enhance their responsiveness to trips or falls. Full article

Despite recent advancements in prosthetic technology, lower-limb amputees often remain limited to passive prostheses, which leads to an asymmetric gait and increased energy expenditure. Developing active prostheses with effective control systems is important to improve mobility for these individuals. This study presents a machine-learning-based approach to classify five distinct locomotion tasks: ground-level walking (GWL), ramp ascent (RPA), ramp descent (RPD), stairs ascent (SSA), and stairs descent (SSD). The dataset comprises fused electromyographic (EMG) and inertial measurement unit (IMU) signals from twenty non-amputated and five transtibial amputated participants. EMG sensors were strategically positioned on the thigh muscles, while IMU sensors were placed on various leg segments. The performance of two classification algorithms, support vector machine (SVM) and long short-term memory (LSTM), were evaluated on segmented data. The results indicate that SVM models outperform LSTM models in accuracy, precision, and F1 score in the individual evaluation of amputee and non-amputee datasets for 80–20 and 50–50 data distributions. In the 80–20 distribution, an accuracy of 95.46% and 95.35% was obtained with SVM for non-amputees and amputees, respectively. An accuracy of 93.33% and 93.30% was obtained for non-amputees and amputees by using LSTM, respectively. LSTM models show more robustness and inter-population generalizability than SVM models when applying domain-adaptation techniques. Furthermore, the average classification latency for SVM and LSTM models was 19.84 ms and 37.07 ms, respectively, within acceptable limits for real-time applications. This study contributes to the field by comprehensively comparing SVM and LSTM classifiers for locomotion tasks, laying the foundation for the future development of real-time control systems for active transtibial prostheses. Full article

In recent years, significant improvements in the design of leg blade prosthetics have been carried out. After several advances in material and topological optimisations, sport-purpose feet prosthetics have reached high-level performances, allowing athletes with limb loss to participate in various sport activities at a competitive level. Since the knowledge of prosthetic mechanical behaviour is crucial for its optimal design, specific studies are required to meet the anthropometric characteristics of the athlete. This research work is focused on investigating the dynamic behaviour of a running blade prosthetic and developing a validated prosthetic model, placing particular emphasis on the definition of suitable material properties. An experimental modal analysis is performed on the Cheetah Xcel, Össur lower limb prosthetic. In contrast with what has already been presented in the literature, a roving hummer test under free–free conditions is proposed here to avoid the uncertainties due to constraint conditions. For the first time, blade prosthetic dynamic characteristics in free–free conditions are presented. Additionally, a novel Finite Element model of the prosthetic is developed and tuned on the basis of the experimental results. The modal assurance criterion index is exploited to compare experimental and numerical mode shapes. Starting from frequency response functions, the first six mode shapes are experimentally identified in the frequency range up to 750 Hz, including both bending and torsion. As expected, the bending in the vertical plane constitutes the primary mode shape: this kind of flexion enhances energy storage, enabling athletes to achieve an optimal running gait. This study shows the dynamic modal behaviour of a lower limb prosthetic in free–free conditions and demonstrates that a traditional isotropic material is not suitable in describing its dynamic features. The development of a model that exploits orthotropic material properties improves the alignment between experimental and numerical outcomes. This result is in agreement with the material composition of the prosthetic, which consists of carbon fibre layers. Full article

Prosthetic reconstruction can serve as a feasible alternative, delivering both functional and aesthetic benefits to individuals with hand and finger injuries, frequent causes of emergency room visits. Implant-related infections pose significant challenges in arthroplasty and osteosynthesis procedures, contributing to surgical failures. As a potential solution to this challenge, this study developed a new class of silver (Ag)-doped chitosan (CS) coatings via electrophoretic deposition (EPD) on osseointegrated prostheses for infection therapy. These coatings were successfully applied to additively manufactured Ti₆Al₄V ELI samples. In the initial phase, the feasibility of the composite coating was assessed using the Thermogravimetric Analysis (TGA) and Attenuated Total Reflection (ATR) techniques. The optimized structures exhibited impressive water uptake in the range of 300–360%. Codeposition with an antibacterial agent proved effective, and scanning electron microscopy (SEM) was used to examine the coating morphology. Biologically, CS coatings demonstrated cytocompatibility when in direct contact with a fibroblast cell line (L929) after 72 h. When exposed to the Staphylococcus epidermidis strain (ATCC 12228), these coatings inhibited bacterial growth and biofilm formation within 24 h. These findings underscore the significant potential of this approach for various applications, including endoprostheses like hip implants, internal medical devices, and transcutaneous prostheses such as osseointegrated limb prosthetics for upper and lower extremities. Full article

Aim: Complex atherosclerotic femoro-popliteal lesions have traditionally been treated with bypass surgery. A prosthetic graft is used to save the vein graft for more distal revascularisations or when a vein graft is unavailable. The endovascular approach has gained popularity and is offered as a first-line strategy for complex lesions. This study aimed to evaluate whether endovascular procedures can be used as a first-line treatment strategy for complex native femoro-popliteal lesions over open surgery with prosthetic bypass in patients with peripheral arterial disease (PAD). Methods: This single-centre retrospective observational study was conducted between 2013 and 2021; it included patients with symptomatic PAD who required limb revascularisation at the femoro-popliteal segment and who had complex lesions. The primary endpoints analysed were technical success, primary patency, freedom from clinically driven target lesion revascularisation (cdTLR), freedom from major adverse limb and cardiovascular events (MALE and MACE, respectively), freedom from limb loss, and survival. The secondary endpoints were length of in-hospital stay, and duration and costs of the procedure. Results: We identified 185 limbs among 174 suitable candidates for comparison, wherein 105 were treated with an endovascular procedure and 80 with a femoro-popliteal prosthetic bypass. Most patients in both groups presented with chronic limb-threatening ischaemia, and >90% of them had an American Society of Anesthesiologists (ASA) physical status classification of >3. The endovascular group had more octogenarians (p = 0.02) and patients with coronary disease (p = 0.004). The median follow-up was 30 months. The technical failure rate for endovascular procedures was 4.7%, versus 0% in the open group (p = 0.047). Freedom from MACE was similar in both groups. The endovascular group showed superior primary patency (p < 0.0001), cdTLR (p < 0.0001), MALE (p < 0.0001), and freedom from limb loss (p = 0.0018) at 24 and 48 months. Further analysis performed for the open above-the-knee sub-group showed that the aforementioned endpoints were similar between the groups at 12 months and were better in the endovascular group at 24 and 48 months. Procedural time and in-hospital stay were longer in the open group than in the endovascular group (p < 0.0001 and p < 0.001, respectively). The procedural cost in the endovascular group was 10-fold lower than that in the prosthetic bypass group. Conclusions: Endovascular procedures are safe for treating complex femoro-popliteal lesions in patients at a high risk for surgery and show better outcomes at 24 months than prosthetic bypasses do. The latter may be considered as an alternative should endovascular treatment fail. Full article