Abstract: As is widely recognized, advancements in new design and rapid prototyping techniques such as CAD modeling and 3D printing are pioneering individualized medicine, facilitating the implementation of new methodologies for creating customized orthoses. The aim of this paper is to develop a new automatic technique for producing personalized orthoses in a straightforward manner, eliminating the necessity for doctors to collaborate directly with technicians. A novel design method for creating customized wrist orthoses has been implemented, notably featuring a generative algorithm for the parametric modeling of the orthosis. To assess the efficacy of the developed algorithm, a case study was conducted involving the design and rapid prototyping of a wrist orthosis using Fused Deposition Modeling (FDM) technology. Subsequently, the developed algorithm was tested by clinicians and patients. The results obtained indicate that the implemented algorithm is user-friendly and could potentially enable non-expert users to design customized orthoses. These results introduce innovative elements of originality within the CAD modeling, offering promising solutions to the challenges associated with the design and production of customized orthoses. Future developments could consist of a better investigation regarding the parameters that influence the accuracy of the scanning and of the printing processes.

Keywords: additive manufacturing | CAD | generative design | reverse engineering | wrist orthosis

Abstract: Osseointegrated implant is a promising solution for limb amputations, but its widespread use is limited by risks such as bone resorption, infections, and strict patient requirements. Typically, the bone and prosthesis are coupled using a press-fit condition, providing short-term stability, or primary stability (PS), which leads to bone in-growth and long-term stability, or secondary stability (SS). However, the greater stiffness of the implant compared to the bone is a concern for SS. Currently, osseointegrated implants are commercially available only in fixed configurations, with a limited use of customization. This study aims to compare the contact effectiveness of three press-fitted intramedullary stems for femoral amputations, developed using three designs (straight, standard curvature, and patient-specific curvature). Moreover, a novel implant design methodology is reported, such is an easy way to develop a patient-specific design. The von Mises stress distribution at the bone-implant interface was analyzed. The study uses CAD models of a femur acquired through CT scans. A FEA was conducted to evaluate the elastic behavior of the bone when the implant is press-fitted with an interference of 0.1 mm. The outcomes show how the patient-specific implant result in a more physiological distribution of the load in the bone. This study could be used as a starting point for further studies on primary and secondary stabilities.

Keywords: 3D Modelling | Finite Element Model | Osseointegration | Patient-Specific Design | Transfemoral Implant

Abstract: Background: Osteoporosis can reduce bone quality and increase the risk of fractures. In addition to pharmacological approaches, physical activity, and implanted devices, external devices can also be detected in the literature as a technique to strengthen bones. This type of intervention arises to be particularly promising because it minimizes the invasiveness of therapy. Methods: A systematic review of the technologies involved in such devices was carried out to identify the most fruitful ones in improving bone quality. This review, according to the PRISMA Statement, focuses on studies involving animals, and excludes pharmaceutical approaches. Findings: The animal models and devices used, their settings, interventions, outcomes measured, and consequent effect on bone quality are reported for each detected technology. Ultrasound and laser arose to be the most studied technologies in the literature, even if they have yet to be proved to have a significant effect on bone quality. Interpretation: External devices for bone quality improvement offer a non-invasive approach that causes minimum discomfort to the patient. This review aimed to detect which technologies reported in the literature significantly affect bone quality. The results showed that several technologies are currently used to improve bone quality. However, each study measures different outcomes and uses different measurement methods, device settings, and interventions. This lack of standardization and the reduced number of articles found do not allow for proper quantitative comparisons.

Keywords: Bone quality | External devices | Non-invasive approach | Osteoporosis

Abstract: In orthopedic medical devices, differences in elasto-plastic behavior between bone and metallic materials could lead to mechanical issues at the bone-implant interface, such as stress shielding, bone fracture or implant failure. To reduce mismatching-related adverse events between bone and prosthetic mechanical properties, an in-body geometry optimization could be the right approach to reduce prosthetic stiffness. Therefore, this study aims to assess the elastic behavior of four different in-body gap prismatic geometries (quadratic, hexagonal, octagonal, and circular) and how much they reduce bulk stiffness. Uniaxial compression tests were performed on five cubes with a 20 mm thickness, each containing a different set of internal prismatic gaps. For each design, the elastic response was calculated and compared with a full-volume cube, used as control. All cubes showed a stiffness reduction compared to the control, greater in cubes with quadratic (21%), octagonal (18%), and circular (17%) transversal sections, compared to the hexagonal one (6%). Moreover, finite element models were implemented and tested, showing coherent values obtained through the experimental tests. In addition, a bi-material approach was studied in silico and the results suggested that variable elastic behavior could be obtained by using composite material, providing lower mechanical properties than commonly used commercial prosthetic materials.

Keywords: compression tests | experimental tests | finite element analysis | in-body gaps | Material stiffness | validation

Abstract: The aim of the present case report was to provide a longitudinal functional assessment of a patient with transfemoral amputation from the preoperative status with socket-type prosthesis to one year after the osseointegration surgery. A 44 years-old male patient was scheduled for osseointegration surgery 17 years after transfemoral amputation. Gait analysis was performed through 15 wearable inertial sensors (MTw Awinda, Xsens) before surgery (patient wearing his standard socket-type prosthesis) and at 3-, 6-, and 12-month follow-ups after osseointegration. ANOVA in Statistical Parametric Mapping was used to assess the changes in amputee and sound limb hip and pelvis kinematics. The gait symmetry index progressively improved from the pre-op with socket-type (1.14) to the last follow-up (1.04). Step width after osseointegration surgery was half of the pre-op. Hip flexion-extension range significantly improved at follow-ups while frontal and transverse plane rotations decreased (p < 0.001). Pelvis anteversion, obliquity, and rotation also decreased over time (p < 0.001). Spatiotemporal and gait kinematics improved after osseointegration surgery. One year after surgery, symmetry indices were close to non-pathological gait and gait compensation was sensibly decreased. From a functional point of view, osseointegration surgery could be a valid solution in patients with transfemoral amputation facing issues with traditional socket-type prosthesis.

Keywords: biomechanics | case report | gait analysis | gait symmetry | osseointegration | socket-type | transfemoral amputation | wearable sensors

Abstract: Background and objective: In orthopedic medical devices, elasto-plastic behavior differences between bone and metallic materials could lead to mechanical issues at the bone-implant interface, as stress shielding. Those issue are mainly related to knee and hip arthroplasty, and they could be responsible for implant failure. To reduce mismatching-related adverse events between bone and prosthesis mechanical properties, modifying the implant's internal geometry varying the bulk stiffness and density could be the right approach. Therefore, this feasibility study aims to assess which in-body gap geometry improves, by reducing, the bulk stiffness. Methods: Using five finite element models, a uniaxial compression test in five cubes with a 20 mm thickness was simulated and analyzed. The displacements, strain and Young Modulus were calculated in four cubes, each containing internal prismatic gaps with different transversal sections (squared, hexagonal, octagonal, and circular). Those were compared with a fifth full-volume cube used as control. Results: The most significant difference have been achieved in displacement values, in cubes containing internal gaps with hexagonal and circular transversal sections (82 µm and 82.5 µm, respectively), when compared to the full-volume cube (69.3 µm). Conclusions: This study suggests that hexagonal and circular shape of the gaps allows obtaining the lower rigidity in a size range of 4 mm, offering a starting approach to achieve a “close-to-bone” material, with a potential use in prosthetic devices with limited thickness.

Keywords: Finite element analysis | In-body gaps | Material stiffness

Abstract: Purpose: The study aims were to assess the kinematic data, Internal-External (IE) rotation, and Antero-Posterior (AP) translation of the contact points between the femoral condyles and polyethylene insert and to develop a combined dynamic RSA-FE (Radiostereometric – Finite Element) model that gives results congruent with the literature. Methods: A cohort of 15 patients who underwent cemented cruciate-retaining highly congruent mobile-bearing total knee arthroplasty were analyzed during a sit-to-stand motor task. The kinematical data from Dynamic RSA were used as input for a patient-specific FE model to calculate condylar contact points between the femoral component and polyethylene insert. Results: The femoral component showed an overall range about 4 mm of AP translation during the whole motor task, and the majority of the movement was after 40° of flexion. Concerning the IE rotation, the femoral component started from an externally rotate position (− 6.7 ± 10°) at 80° of flexion and performed an internal rotation during the entire motor task. The overall range of the IE rotation was 8.2°. Conclusions: During the sit to stand, a slight anterior translation from 40° to 0° of flexion of the femoral component with respect to polyethylene insert, which could represent a paradoxical anterior translation. Despite a paradoxical anterior femoral translation was detected, the implants were found to be stable. Dynamic RSA and FE combined technique could provide information about prosthetic component’s stress and strain distribution and the influence of the different designs during the movement.

Keywords: Dynamic RSA | FE analysis | Kinematics | Mobile bearing | TKA

Abstract: Background and objective: The aim of the present study was to review the literature concerning the analysis of periprosthetic bone remodeling through finite element (FE) simulation. Methods: A systematic review was conducted on 9 databases, taking into account a ten-year time period (from 2009 until 2020). The inclusion criteria were: articles published in English, publication date after 2009, full text articles, articles containing the keywords both in the abstract and in the title. The articles were classified through the following parameters: dimensionality of the simulation, modelling of the bone-prosthesis interface, output parameters, type of simulated prosthesis, bone remodeling algorithm. Results: Sixty-seven articles were included in the study. Femur and tooth were the most evaluated bone segment (respectively 41.8% and 29.9%). The 55.2% of the evaluated articles used a bonded bone-prosthesis interface, 73% used 3D simulations, 67.2% of the articles (45 articles) evaluate the bone remodeling by the bone density variation. At last, 59.7% of the articles employed algorithms based on a specific remodeling function. Conclusions: Increasing interest in the bone remodeling FE analysis in different bone segments emerged from the review, and heterogeneous solutions were adopted. An optimal balance between computational cost and accuracy is needed to accurately simulate the bone remodeling phenomenon in the post-operative period.

Keywords: Biological processes | Bone remodeling | Computational analysis | FE simulations | Prosthesis | Systematic review

Abstract: In the last two decades, osseointegrated prostheses have been shown to be a good alternative for lower limb amputees experiencing complications in using a traditional socket-type prosthesis; however, restraining biomechanical issues, such as peri-prosthetic bone fractures or loosening, are present. To better understand and overcome these limiting issues, and thus reduce the number of implant failures, many studies have investigated the stress distribution on bone and implant during normal daily activities. The aim of this study was a biomechanical analysis of two different osseointegrated implants, a screw-type (OPRA) and a press fit system (OPL, Osseointegrated Prosthetic Limb), to evaluate the stresses generated in bone and prosthesis during a fall. In particular, four scenarios have been experimentally reproduced to determine the loads on the limb during different kinds of fall. For this purpose, a motion capture system and a force plate have been used. Numerical FEM (Finite Element Method) simulations have been performed to compare the behaviour of the OPRA and OPL systems in different fall scenarios. The obtained results showed that a fall backwards due to balance loss is the most stressful scenario among the ones analysed. As regards the comparison between OPRA and OPL devices, it emerged they have similar behaviours in terms of peak values of the stress, but the OPL implant generates larger high-stress areas in the distal femur as compared with the OPRA system. © 2020 by the authors.

Keywords: CAD | Finite element analysis | OPL osseointegrated prosthesis | OPRA | Transfemoral amputee

Abstract: Introduction: Traditional prosthetic solutions expose the amputee to numerous problems that limit his ability to safely perform the normal activities of daily life. In order to eliminate the problems related to the use of the traditional prosthesis with socket, a new technique was developed for fixing the prosthesis to the amputees based on the principle of osseointegration. The aim of this paper is to study and analyze the stress distribution on the interface between a trans-humeral osseointegrated prosthetic implant and the residual bone, identifying the most stressed areas and thus foreseeing possible failure phenomena of the entire prosthetic system and, after, to compare the stress distribution on three different prosthetic designs that differ from each other for some geometric characteristics. Materials and methods: A healthy individual mimics two fall scenarios of which the trans-humeral amputees can most likely be victims: Static fall and Dynamic fall. A force platform (P-6000, BTS Bioengineering) is required for load data acquisition. The CAD model of the trans-humeral osseointegrated implant was created following the guidelines of the OPRA implant. The bone model was created starting from the CAT scan of a left humerus. The FEM simulation was conducted throught a linear analysis. Results: Both during static fall and dynamic fall, similar trends have been observed for the reaction force Fz, the torque moment Tz, the bending moments Mx and My. From the analysis of the von Mises stress distribution it was found that the stress distribution is more homogeneous in the case where the thread of the fixture is made by a triangular profile with height of the thread equal to 0.5 mm. However, it can be seen that, when passing from a thread with height of 0.5 mm to a 1 mm, there is a slight decrease in the stress on the whole contact zone between the fixture and the humerus. The same improvement can also be seen in the case of trapezoidal threading. Conclusion: By modifying the height and/or by varying the thread profile, are obtained slightly better results with respect to the case with a 0.5 mm height triangular thread.

Keywords: Amputees | Finite element method | Osseointegration | Prosthesis | Upper limb