Although much is known about total joint replacement, research has had little success in elucidating the genesis of prosthetic stem loosening. The adopted methods of stem fixation include positioning the stem’s shaft inside the bone’s medullary canal and rely on ossification inside the canal in the inward radial direction. His special communication is to note that the medcanal's normal physiology contains obstacles for reliable fixation. The reason is that the ossification of bone walls in the inward radial direction is naturally restricted to protect the needed space for bone marrow. Also, human development and exercise result in a continued increase in the medullary canal’s diameter, which diminishes the reliability of the bond between the canal’s inner walls and the stem with or without cement.

Background/Objectives: A comparative study of silver (Ag), titanium nitride (TiN), zirconium nitride (ZrN), and copper (Cu) coatings on titanium (Ti) disks, considering the specifications of a microporous skin- and bone-integrated titanium pylon (SBIP), was performed to assess their biocompatibility, osseointegration, and mechanical properties. Methods: To assess cytotoxicity and biocompatibility, Ti disks with various metal coatings were co-cultured with FetMSCs and MG-63 cells for 1, 3, 7, and 14 days and subsequently evaluated using a cell viability assay, as supported by SEM and confocal microscopy studies. The antimicrobial activity of the selected four materials coating the implants was tested against S. aureus by mounting Ti disks onto the surface of LB agar dishes spread with a bacterial suspension and measuring the diameter of the growth inhibition zones. Quantitative Real-Time Polymerase Chain Reaction (RT-PCR) analysis of the relative gene expression of biomarkers that are associated with extracellular matrix components (fibronectin, vitronectin, type I collagen) and cell adhesion (α2, α5, αV integrins), as well as of osteogenic markers (osteopontin, osteonectin, TGF-β1, SMAD), was performed during the 14-day follow-up period. Additionally, the activity of matrix metalloproteinases (MMP-1, -2, -8, -9) was assessed. Results: All samples with metal coatings, except the copper coating, demonstrated a good cytotoxicity profile, as evidenced by the presence of a cellular monolayer on the sample surface on the 14th day of the follow-up period (as shown by SEM and inverted confocal microscopy). All metal coatings enhanced MMP activity, as well as cellular adhesion and osteogenic marker expression; however, TiN showed the highest values of these parameters. Significant inhibition of bacterial growth was observed only in the Ag-coated Ti disks, and it persisted for over 35 days. Conclusions: The silver-based coating, due to its high antibacterial activity, low cytotoxicity, and biointegrative capacity, can be recommended as the coating of choice for microporous titanium implants for further preclinical studies.

Research into methods for regulating the biocorrosion rate of biodegradable magnesium implants is one of the most urgent tasks in the field of biomedical materials science. Atomic layer deposition (ALD) is a highly effective method for the preparation of nanocoatings, which can be used to regulate the biodegradation rate. The present paper presents the findings of a research study in which the most commonly used simple oxide ALD coatings (Al2O3, TiO2, and ZnO) were examined, in addition to mixed coatings obtained by alternating ALD cycles of the application of ZnO-TiO2 (ZTO) and Al2O3-TiO2 (ATO). The coating thicknesses exhibited a variation within the most typical range for ALD coatings, measuring between 20 and 80 nanometres. The biocorrosion testing was conducted in Ringer's physiological solution through the measurement of potentiodynamic polarisation curves and impedance spectroscopy. The findings demonstrated that, for Al2O3 coatings, the protective properties exhibited an increase with increasing thickness, while for TiO2, the trend was found to be dependent on the type of precursor utilised. The protective properties of titanium tetraisopropoxide (TTIP) have been observed to increase with increasing thickness. Conversely, the protective properties of titanium tetrachloride (TiCl4) have been observed to decrease. The application of mixed ZTO oxides with a thickness of 40 nm has been demonstrated to reduce the corrosion current by 1.7 and 3.4 times, depending on the use of TiCl4 or TTIP. Furthermore, the effectiveness of ATO coatings of similar thicknesses has been shown to be higher, with a reduction in corrosion currents of 54 and 24 times for samples obtained using TiCl4 and TTIP, respectively. A thorough analysis of the collected data unequivocally demonstrates the superior efficacy of mixed oxides in comparison to their pure oxide counterparts.

3D-printed microporous titanium scaffolds enjoy good biointegration with the residuum’s soft and bone tissues, and they promote excellent biomechanical properties in attached prostheses. Implant-associated infection, however, remains a major clinical challenge. Silver-based implant coatings can potentially reduce bacterial growth and inhibit biofilm formation, thereby reducing the risk of periprosthetic infections. In the current study, a 1-µm thick silver coating was prepared on the surface of a 3D-printed microporous titanium alloy with physical vapor deposition (PVD), with a final silver content of 1.00 ± 02 mg/cm2. Cell viability was evaluated with an MTT assay of MC3T3-E1 osteoblasts and human dermal fibroblasts cultured on the surface of the implants, and showed low cytotoxicity for cells during the 14-day follow-up period. Quantitative real-time polymerase chain reaction (RT-PCR) analysis of the relative gene expression of the extracellular matrix components (fibronectin, vitronectin, type I collagen) and cell adhesion markers (α2, α5, αV, β1 integrins) in dermal fibroblasts showed that cell adhesion was not reduced by the silver coating of the microporous implants. An RT-PCR analysis of gene expression related to osteogenic differentiation, including TGF-β1, SMAD4, osteocalcin, osteopontin, and osteonectin in MC3T3-E1 osteoblasts, demonstrated that silver coating did not reduce the osteogenic activity of cells and, to the contrary, enhanced the activity of the TGF-β signaling pathway. For representative sample S5 on day 14, the gene expression levels were 7.15 ± 0.29 (osteonectin), 6.08 ± 0.12 (osteocalcin), and 11.19 ± 0.77 (osteopontin). In conclusion, the data indicate that the silver coating of the microporous titanium implants did not reduce the biointegrative or osteoinductive properties of the titanium scaffold, a finding that argues in favor of applying this coating in designing personalized osseointegrated implants.

Introduction Approximately 89% of all service members with amputations do not return to duty. Restoring intuitive neural control with somatosensory sensation is a key to improving the safety and efficacy of prosthetic locomotion. However, natural somatosensory feedback from lower-limb prostheses has not yet been incorporated into any commercial prosthesesMaterials and Methods We developed a neuroprosthesis with intuitive bidirectional control and somatosensation and evoking phase-dependent locomotor reflexes, we aspire to significantly improve the prosthetic rehabilitation and long-term functional outcomes of U.S. amputees. We implanted the skin and bone integrated pylon with peripheral neural interface pylon into the cat distal tibia, electromyographic electrodes into the residual gastrocnemius muscle, and nerve cuff electrodes on the distal tibial and sciatic nerves. Results. The bidirectional neural interface that was developed was integrated into the existing passive Free-Flow Foot and Ankle prosthesis, WillowWood, Mount Sterling, OH. The Free-Flow Foot was chosen because it had the highest Index of Anthropomorphicity among lower-limb prostheses and was the first anthropomorphic prosthesis brought to market. Conclusion. The cats walked on a treadmill with no cutaneous feedback from the foot in the control condition and with their residual distal tibial nerve stimulated during the stance phase of walking

Chronic overloading of the cartilage can lead to its irreversible destruction, as observed in people with osteoarthritis. The floating skeleton model previously introduced postulates that overloading begins and progresses when a joint is isolated from the hydrostatical connection with other joints. Such a connection occurs via the interstitial fluid in subperiosteal space and allows for pressure transmission between synovial capsules modulating intra-articular pressure. In the current study, a simple experiment was performed to model an obstruction in the subperiosteal hydrostatic pressure conductivity between joints to illustrate the effect of that obstruction on loads borne by the joint. When the obstruction was removed, the load experienced by the joint was reduced as it was redistributed throughout the model structure. The experiment demonstrated that contact pressures can be redistributed when the conditions of Pascal’s Law are met.

Percutaneous implants osseointegrated into the residuum of a person with limb amputation need to provide mechanical stability and protection against infections. Although significant progress has been made in the biointegration of percutaneous implants, the problem of forming a reliable natural barrier at the level of the surface of the implant and the skin and bone tissues remains unresolved. The use of a microporous implant structure incorporated into the Skin and Bone Integrated Pylon (SBIP) should address the issue by allowing soft and bone tissues to grow directly into the implant structure itself, which, in turn, should form a reliable barrier to infections and support strong osseointegration. To evaluate biological interactions between dermal fibroblasts and MC3T3-E1 osteoblasts in vitro, small titanium discs (with varying pore sizes and volume fractions to achieve deep porosity) were fabricated via 3D printing and sintering. The cell viability MTT assay demonstrated low cytotoxicity for cells co-cultured in the pores of the 3D-printed and sintered Ti samples during the 14-day follow-up period. A subsequent Quantitative Real-Time Polymerase Chain Reaction (RT-PCR) analysis of the relative gene expression of biomarkers that are associated with cell adhesion (α2, α5, αV, and β1 integrins) and extracellular matrix components (fibronectin, vitronectin, type I collagen) demonstrated that micropore sizes ranging from 200 to 500 µm of the 3D printed and sintered Ti discs were favorable for dermal fibroblast adhesion. For example, for representative 3D-printed Ti sample S6 at 72 h the values were 4.71 ± 0.08 (α2 integrin), 4.96 ± 0.08 (α5 integrin), 4.71 ± 0.08 (αV integrin), and 1.87 ± 0.12 (β1 integrin). In contrast, Ti discs with pore sizes ranging from 400 to 800 µm demonstrated the best results (in terms of marker expression related to osteogenic differentiation, including osteopontin, osteonectin, osteocalcin, TGF-β1, and SMAD4) for MC3T3-E1 cells. For example, for the representative 3D sample S4 on day 14, the marker levels were 11.19 ± 0.77 (osteopontin), 7.15 ± 0.29 (osteonectin), and 6.08 ± 0.12 (osteocalcin), while for sintered samples the levels of markers constituted 5.85 ± 0.4 (osteopontin), 4.45 ± 0.36 (osteonectin), and 4.46 ± 0.3 (osteocalcin). In conclusion, the data obtained show the high biointegrative properties of porous titanium structures, while the ability to implement several pore options in one structure using 3D printing makes it possible to create personalized implants for the best one-time integration with both skin and bone tissues.

The purpose of this paper is to discuss a new quantitative mechanical parameter of prosthetic feet called the Index of Anthropomorphicity (IA), which has the potential to be adopted as an objective predictor of their functionality. The objectives are to present the research findings supporting the introduction of IA and unify previous results into a coherent theory. The IA is founded on the moment criterion of the anthropomorphicity of prosthetic feet. The term "anthropomorphicity" is defined for this application. Studies with a small number of human subjects and prostheses have shown that the value of the parameter is positively correlated with patient comfort and with the restoration of certain normal gait characteristics. Confirmatory studies with controlled human trials and mechanical tests with a wider selection of prosthesis types can give prosthesis manufacturers a new criterion to follow in the design process, and prosthetists may use the IA for selecting more suitable prostheses for a patient's comfort and health.

Cutaneous feedback from feet is involved in regulation of muscle activity during locomotion, and the lack of this feedback results in motor deficits. We tested the hypothesis that locomotor changes caused by local unilateral anesthesia of paw pads in the cat could be reduced/reversed by electrical stimulation of cutaneous and proprioceptive afferents in the distal tibial nerve during stance. Several split-belt conditions were investigated in four adult female cats. In addition, we investigated the effects of similar distal tibial nerve stimulation on overground walking of one male cat that had a transtibial, bone-anchored prosthesis for 29 months and, thus, had no cutaneous/proprioceptive feedback from the foot. In all treadmill conditions, cats walked with intact cutaneous feedback (control), with right fore- and hindpaw pads anesthetized by lidocaine injections, and with a combination of anesthesia and electrical stimulation of the ipsilateral distal tibial nerve during the stance phase at 1.2× threshold of afferent activation. Electrical stimulation of the distal tibial nerve during the stance phase of walking with anesthetized ipsilateral paw pads reversed or significantly reduced the effects of paw pad anesthesia on several kinematic variables, including lateral center of mass shift, cycle and swing durations, and duty factor. We also found that stimulation of the residual distal tibial nerve in the prosthetic hindlimb often had different effects on kinematics compared with stimulation of the intact hindlimb with paw anesthetized. We suggest that stimulation of cutaneous and proprioceptive afferents in the distal tibial nerve provides functionally meaningful motion-dependent sensory feedback, and stimulation responses depend on limb conditions.

Chronic overloading of cartilages may lead to their irreversible destruction, as seen in people with osteoarthritis. We hypothesize that overloading begins and progressing when one or more joints become isolated from the newly discovered physiological system - Floating Skeleton (FS), devoted to keeping the loads in a safe range. To demonstrate in a model experiment how subperiosteal hydrostatic pressure conductivity between joints decreases contact loads on cartilages we constructed a physical model from a commercial Ziploc bag, which walls have been glued together in its center with a small caramel plug. After pouring water in the bag, we put a standardized weight on the upper wall of the bag over the caramel plug and recorded the load transmitted to the measuring plate directly under the plug. Then, the caramel plug was dissolved so that an unobstructed water layer between the bag’s walls was restored. The same weight was placed at the same spot and the load on the measuring plate was recorded. Restoration of the water layer between the bag’s walls caused a reduction of the load. The experiments conclusively demonstrated that contact pressures can be redistributed when the conditions of the Pascal Law are met.

Enhancing the technology of bone-anchored limb prosthetics, we present a modified porcine model for developing an infection-free integration between the skin and a percutaneous bone implant. The deeply porous Skin and Bone Integrated Pylon (SBIP) presented an infection-free skin-implant interface both after implantation into the dorsum and after implantation into the residuum after below-knee amputation. However, deep ingrowth of skin into the porous cladding of the SBIP was achieved better in the dorsal procedure, while implantation to the residuum sometimes developed a stoma, probably due to the high mobility of the skin and soft tissues in the pig's thigh. Uncontrolled high skin mobility during the first week after implantation constituted a limitation for the porcine animal model, which we tried to address in the current study. As our previous studies showed that casting of the leg residuum did not sufficiently limit the skin's movement around the implant, we tested a modified protocol of the implantation, which included injection of botulinum toxin into the thigh muscles. During the course of the study, we identified proper botulinum toxin componentry, dosage, and the period after injections to achieve a maximal effect of immobilization of the muscles affecting skin movements. To verify the immobilization, we used kinetic data on the asymmetry of loading during gait with the Strideway System, Tekscan, Inc., Boston, MA, USA. We found that injections in the four muscles of the distal thigh of the left hind leg with MYOBLOC® (rimabotulinumtoxinB; 5,000 units/muscle) were sufficient to provide noticeable immobilization by the fourth week after the procedure. This conclusion was made based on the analysis of the dynamics of asymmetry in vertical ground reactions on the injected (left hind) and uninvolved (right hind) legs during gait over an instrumented walkway.

BACKGROUND:A new training and rehabilitation methodology called Sanomechanics® is presented based on a recent discovery of the anatomical system called Floating Skeleton System (FSS) responsible for redistributing contact pressures in the joint capsules and thus minimizing the loads on joint cartilages.MATERIALS AND METHODS:The main idea behind the Sanomechanics® methodology (SMM) is that when this system of subperiosteal pressure transmission is disrupted, the overloading of cartilages may occur leading to trauma, osteoarthritis and other related pathologies. Conversely, if functioning of the FSS is adequately restored and continuously maintained, the pathological developments can be effectively stopped.RESULTS:Analysis of existing training systems using mind-body approach revealed that they are lacking the understanding of a physiological mechanism of their success or failure in training. It is postulated that maintaining/restoration of transmission of pressure between the joint capsules is necessary component of preventing overloading of joint cartilages occurring in military training and operations and in civilian life. Visualization of this concept has been suggested as a key element to the SMM training system.CONCLUSIONS:The FSS provides for a guidance for development of scientific approaches to the training and rehabilitation techniques. The SMM is balanced mind-body training system, which can help U.S. Servicemen and Servicewomen be better prepared for extreme load during their service.

Implant-associated soft tissue infections at the skin-implant interface represent the most frequent complications in reconstructive surgery and lead to implant failures and revisions. Titanium implants with deep porosity, called skin-and-bone-integrated-pylons (SBIP), allow for skin ingrowth in the morphologically natural direction, thus restoring a reliable dermal barrier and reducing the risk of infection. Silver coating of the SBIP implant surface using physical vapor deposition technique offers the possibility of preventing biofilm formation and exerting a direct antimicrobial effect during the wound healing phase. In vivo studies employing pig and rabbit dorsum models for assessment of skin ingrowth into the pores of the pylon demonstrated the safety of transcutaneous implantation of the SBIP system. No postoperative complications were reported at the end of the follow-up period of 6 months. Histological analysis proved skin ingrowth in the minipig model without signs of silver toxicity. Analysis of silver release (using energy dispersive X-ray spectroscopy) in the model of intramedullary-inserted silver-coated SBIP in New Zealand rabbits demonstrated trace amounts of silver after 3 months of in-bone implantation. In conclusion, selected temporary silver coating of the SBIP implant surface is powerful at preventing the periprosthetic infections without imparing skin ingrowth and can be considered for clinical application.

Introduction: Osseointegrated implants for direct skeletal attachment of transtibial prosthesis carry risks that are yet to be fully resolved, such as early loosening, mechanical failure of percutaneous and medullar parts of implant, periprosthetic issues, and infections. Underloading could lead to early loosening and infection. Overloading might compromise the bone-implant interface. Therefore, Goldilocks loading regimen applied by transtibial bone-anchored prostheses is critical for safe and efficient development of osseointegration around the implant during rehabilitation and beyond. We hypothesized that Goldilocks loading could be achieved when ambulating with a so-called anthropomorphic prosthetic ankle showing moment-angle relationship similar to a sound ankle. Materials and Methods: Quantitative characteristics of the moment-angle curve of the sound ankle during dorsiflexion phase of a free-pace walking were extracted for 4 able-bodied participants (experiment 1). A slope of the moment-angle curve (stiffness) was calculated twice: for the first half and for the second half of the moment-angle curve. The difference of stiffnesses (those at the second half minus at the first half) was called the index of anthropomorphicity (IA). By definition, positive IA is associated with concave shape of the moment-angle curve, and the negative IA is associated with convex shape. In experiment 2, the same recordings and calculations were performed for 3 participants fitted with transtibial osseointegrated fixation during walking with their usual feet and the Free-Flow Foot (Ohio Willow Wood). The Free-Flow Foot was selected for its anthropomorphicity demonstrated in the previous studies with amputees using traditional socket attachment. Results: The IA was 5.88 +/- 0.93 for the able-bodied participants, indicating that the stiffness during the first part of the dorsiflexion phase was substantially fewer than during the second parts, as the calf muscles resisted to angulation in ankle substantially less than during the second part of dorsiflexion phase. For amputees fitted with Free-Flow Foot, IA was 2.68 +/- 1.09 and -2.97 +/- 2.37 for the same amputees fitted with their usual feet. Conclusions: Indexes of anthropomorphicity, while of different magnitude, were positive in control able-bodied group and in the amputee group wearing Free-Flow Foot, which was qualitatively associated with concave shape of their moment-angle curves. The 3 usual feet worn by the participants were classified as nonanthropomorphic as their individual moment-angle curves were convex and the corresponding IAs were negative. Furthermore, this study showed that a foot with anthropomorphic characteristics tends to decrease maximal loads at the bone-implant interface as compared to the nonanthropomorphic feet and possibly may minimize the risks to compromise the integrity of this interface.

INTRODUCTION:The three major unresolved problems in bone-anchored limb prosthetics are stable, infection-free integration of skin with a percutaneous bone implant, robust skeletal fixation between the implant and host bone, and a secure interface of sensory nerves and muscles with a prosthesis for the intuitive bidirectional prosthetic control. Here we review results of our completed work and report on recent progress. MATERIALS AND METHODS:Eight female adult cats received skin- and bone-integrated pylon (SBIP) and eight male adult cats received SBIP-peripheral neural interface (PNI) pylon into the right distal tibia. The latter pylons provided PNI for connection between a powered sensing transtibial prosthesis and electrodes in residual soleus muscle and on residual distal tibial nerve. If signs of infection were absent 28-70 days after implantation, cats started wearing a passive prosthesis. We recorded and analyzed full-body mechanics of level and slope locomotion in five cats with passive prostheses and in one cat with a powered sensing prosthesis. We also performed histological analyses of tissue integration with the implants in nine cats. Four pigs received SBIPs into the left hindlimb and two pigs-into the left forelimb. We recorded vertical ground reaction forces before amputation and following osseointegration. We also conducted pullout postmortem tests on the implanted pylons. One pig received in dorsum the modified SBIPs with and without silver coating. RESULTS:Six cats from the SBIP groups had implant for 70 days. One cat developed infection and did not receive prosthesis. Five cats had pylon for 148 to 183 days, showed substantial loading of the prosthesis during locomotion (40.4% below presurgery control), and demonstrated deep ingrowth of skin and bone tissue into SBIP (over 60%). Seven of eight cats from the SBIP-PNI group demonstrated poor pylon integration without clinical signs of infection. One cat had prosthesis for 824 days (27 months). The use of the bidirectionally controlled prosthesis by this animal during level walking demonstrated increased vertical loading to nearly normal values, although the propulsion force was significantly reduced. From the study on pigs, it was found that symmetry in loading between the intact and prosthetic limbs during locomotion was 80 ± 5.5%. Skin-implant interface was infection-free, but developed a stoma, probably because of the high mobility of the skin and soft tissues in the pig's thigh. Dorsal implantation resulted in the infection-free deep ingrowth of skin into the SBIP implants. CONCLUSIONS:Cats with SBIP (n = 5) and SBIP-PNI (n = 1) pylons developed a sound interface with the residuum skin and bone and demonstrated substantial loading of prosthetic limb during locomotion. One animal with SBIP developed infection and seven cats with SBIP-PNI demonstrated poor bone integration without signs of infection. Future studies of the SBIP-PNI should focus on reliability of integration with the residuum. Ongoing study with pigs requires decreasing the extra mobility of skin and soft tissues until the skin seal is developed within the SBIP implant.

ABSTRACT Introduction This case series study laid out principles for characterization of loading profile applied on osseointegrated implant by transtibial bone-anchored prostheses fitted with various feet while presenting benchmark loading data. Materials and Methods Three individuals walked and ascended and descended stairs and ramps with instrumented prostheses fitted with a load cell as well as usual and anthropomorphic feet successively. The characterization of the loading profile involved the comparison of 100 variables including spatiotemporal characteristics, loading boundaries, local extremum, and impulse. Results The absolute maximum load extracted from 319 gait cycles (GCs) with both prostheses across all activities was 48 %BW, 17 %BW, and 112 %BW for the forces as well as 2 %BWm, 13 %BWm, and 1 %BWm for the moments on and around the anteroposterior, mediolateral, and long axes of the implant, respectively. Discussion New evidence presented here indicated that a specific and comprehensive loading characterization capable of differentiating transtibial bone-anchored prostheses was achievable when relying on triaxial direct measurements, recording a range of daily activities in addition to walking, and considering at least nine loading extremum. Conclusions Prosthetic care providers could use this characterization for evidence-based fitting of components to the growing population of individuals with transtibial amputation fitted with osseointegrated implants worldwide.

The data in this paper are related to the research article entitled "Loading applied on osseointegrated implant by transtibial bone-anchored prostheses during daily activities: Preliminary characterization of prosthetic feet" (Frossard et al., 2019: Accepted). This article contains the individual and grouped loading characteristics applied on transtibial osseointegrated implant generated while walking with bone-anchored prostheses including prosthetic feet with different index of anthropomorphicity. Inter-participant variability was presented for (A) the spatio-temporal characteristics, (B) the loading boundaries and (C) the loading local extremum during walking, ascending and descending ramp and stairs. These initial inter-participant variability benchmark datasets are critical to improve the efficacy and safety of prosthetic components for transtibial prostheses as well as the design of future automated algorithms and clinical trials. Online repository contains the files: https://doi.org/10.17632/vhc6sf7ngy.1.

The data in this paper are related to the research article entitled "Automated characterization of anthropomorphicity of prosthetic feet fitted to bone-anchored transtibial prosthesis" (Frossard et al., 2019: DOI: 10.1109/TBME.2019.2904713). This article contains the individual angles of dorsiflexion and bending moments generated while walking with transtibial bone-anchored prostheses including prosthetic feet with different index of anthropomorphicity. Inter-participant variability were presented for the (A) position of the load cell measuring directly to the bending moments, (B) patterns of angles of dorsiflexion and bending moment as well as moment-angle curves and (C) variations of magnitude of angles of dorsiflexion as well as the raw and bodyweight-normalized bending moments between toe contact and heel off. These initial inter-participant variability benchmark datasets are critical to design future automated algorithms and clinical trials. Online repository contains the files: https://eprints.qut.edu.au/127745/1/127745.pdf.

Ankle stiffness of a prosthetic foot is conventionally represented by a curve showing the progression of angle of dorsiflexion in relation to the bending moment at the ankle joint over the flat foot phase of a gait cycle. Typical moment-angle curve of prosthetic feet have either a convex or concave shape associated with or without anthropomorphic ankle joint design, respectively. Some prosthetic ankle generating concave moment-angle curve seen in anatomical ankle decreased noticeably pressure in the socket compared to prosthetic feet generating convex moment-angle curve. However, it is unclear how anthropomorphicity of prosthetic feet fitted to transtibial bone-anchored prostheses (BAP) affect osseointegrated fixation. The purpose of this presentation will be to suggest a way to report anthropomorphicity of prosthetic feet fitted to BAP that could be subsequently used to assess effects of anthropomorphicity and the developments of osseointegration.

Objective: This study describes differentiating prosthetic feet designs fitted to bone-anchored transtibial prostheses based on an automated characterization of ankle stiffness profile relying on direct loading measurements. The objectives were, first, to present a process characterizing stiffness using innovative macro, meso, and micro analyses, second, to present stiffness profiles for feet with and without anthropomorphic designs, where anthropomorphicity is defined as a similarity of the moment-angle dependency in prosthetic and in the anatomical ankle, and third, to determine the sensitivity of characterization. Methods: Three participants walked consecutively, with two instrumented bone-anchored prostheses, including their own prosthetic feet and free-flow foot, meeting the anthropomorphicity criterion by design. Angle of dorsiflexion was extracted from video footage. Bending moment was recorded usingmulti-axis transducer attached to osseointe-grated fixation. The automated characterization of stiffness involved a 12-step process relying on data-based criterion. Results: The meso analyses confirmed bilinear behavior of moment-angle curves with Index of Anthropomorphicity of -2.966 +/- 2.369 Nm/Deg and 2.681 +/- 1.089 Nm/Deg indicating a convex and concave shape of usual and free-flow feet without and with anthropomorphic designs, respectively. Conclusions: The proposed straightforward meso analysis of the stiffness was capable to report clinical meaningful differences sensitive to feet's anthropomorphicity. Results confirmed the benefits for clinicians to rely on direct loading measurement providing individualized complementary insight into impact of components. Significance: This work could assist the development of standards and guidelines for the manufacturing and safe fitting of components to a growing population requiring transtibial prostheses with socket or direct skeletal attachment worldwide.