Detection of Total Hip Replacement Loosening Based on Structure-Borne Sound: Influence of the Position of the Sensor on the Hip Stem.

Accurate detection of implant loosening is crucial for early intervention in total hip replacements, but current imaging methods lack sensitivity and specificity. Vibration methods, already successful in dentistry, represent a promising approach. In order to detect loosening of the total hip replacement, excitation and measurement should be performed intracorporeally to minimize the influence of soft tissue on damping of the signals. However, only implants with a single sensor intracorporeally integrated into the implant for detecting vibrations have been presented in the literature. Considering different mode shapes, the sensor's position on the implant is assumed to influence the signals. In the work at hand, the influence of the position of the sensor on the recording of the vibrations on the implant was investigated. For this purpose, a simplified test setup was created with a titanium rod implanted in a cylinder of artificial cancellous bone. Mechanical stimulation via an exciter attached to the rod was recorded by three accelerometers at varying positions along the titanium rod. Three states of peri-implant loosening within the bone stock were simulated by extracting the bone material around the titanium rod, and different markers were analyzed to distinguish between these states of loosening. In addition, a modal analysis was performed using the finite element method to analyze the mode shapes. Distinct differences in the signals recorded by the acceleration sensors within defects highlight the influence of sensor position on mode detection and natural frequencies. Thus, using multiple sensors could be advantageous in accurately detecting all modes and determining the implant loosening state more precisely.

The Morphology of the Femur Influences the Fracture Risk during Stumbling and Falls on the Hip-A Computational Biomechanical Study.

Proximal femur fracture risk depends on subject-specific factors such as bone mineral density and morphological parameters. Here, we aim to analyze the dependency of the femoral strength on sixteen morphological parameters. Therefore, finite-element analyses of 20 human femurs during stumbling and lateral falls on the hip were conducted. Pearson correlation coefficients were calculated and morphological parameters with significant correlations were examined in principal component analysis and linear regression analysis. The dependency of the fracture strength on morphological parameters was more pronounced during lateral falls on the hip compared to stumbling. Significant correlations were observed between the neck shaft angle (r = -0.474), neck diameter (r = 0.507), the true distance between the femoral head center and femoral shaft axis (r = 0.459), and its projected distance on the frontal plane (r = 0.511), greater trochanter height (r = 0.497), and distance between the femoral head center and a plane parallel to the frontal plane containing the projection of the femoral head center to the femoral neck axis (r = 0.669). Principal component analysis was strongly weighted by parameters defining the lever arm during a lateral fall as well as the loaded cross-section in the femoral neck.

[Numerical simulation in musculoskeletal biomechanics : Application perspectives and possibilities]. / Numerische Simulation in der muskuloskelettalen Biomechanik : Anwendungsperspektiven und Möglichkeiten.

BACKGROUND: Computational research methods, such as finite element analysis (FEA) and musculoskeletal multi-body simulation (MBS), are important in musculoskeletal biomechanics because they enable a better understanding of the mechanics of the musculoskeletal system, as well as the development and evaluation of orthopaedic implants. These methods are used to analyze clinically relevant issues in various anatomical regions, such as the hip, knee, shoulder joints and spine. Preoperative simulation can improve surgical planning in orthopaedics and predict individual results. EXAMPLES FROM PRACTICE: In this article, the methods of FE analysis and MBS are explained using two practical examples, and the activities of the "Numerical Simulation" cluster of the "Musculoskeletal Biomechanics Research Network (MSB-NET)" are presented in more detail. An outlook classifies numerical simulation in the age of artificial intelligence and draws attention to the relevance of simulation in the (re)approval of implants.

A new approach to identify wear regions on bearing surfaces of retrieved endoprostheses.

Although total hip replacements (THR) can be considered one of the most successful implantable medical devices in history, wear remains the ultimate challenge in order to further increase clinical success. Wear assessment on retrieved implants is the most reliable way to perform research into failure mechanisms. Therefor the bearing surface of the explant is measured geometrically by coordinate measuring machine (CMM). Wear determination in geometrical data is carried out in 3 steps: (1) identifying the worn area, (2) reconstructing the pre-wear geometry and (3) quantify wear as the difference between worn area and pre-wear geometry. In previous studies, assumptions to pre-wear geometry had been made for wear determination (step 2) and the worn area was identified by deviations between measured data and assumed form. Thus, the original form of the retrieved endoprostheses, including form deviations due to the manufacturing process and implantation, was not considered which leads to uncertainties in the wear computed. This work introduces a method which allows to identify the wear area without making assumptions to the original form. Instead, the curvature of the bearing surface obtained by simple computations on the measurement data is analysed and the edge of the wear region is recognized by its deviation in curvature. The method is applied to a retrieved Metal-on-Metal prosthetic head and the results are compared to those of the well-known method introduced by Jaeger et al., in 2013. With the new approach the wear region is identified more accurately.

The influence of surgical technique guidance and surgeon's experience on the femoral head assembly in total hip arthroplasty.

INTRODUCTION: The importance of the assembly procedure on the taper connection strength is evident. However, existent surgical technique guides frequently lack comprehensive and precise instructions in this regard. The aim of our experimental study was to evaluate the influence of the surgical technique guide on the femoral head assembly procedure in surgeons with differing levels of experience in total hip arthroplasty. MATERIALS AND METHODS: Twenty-eight participants, divided into four groups based on their lifetime experience in total hip arthroplasty, conducted a femoral head assembly procedure in a simulated intraoperative environment before and after reviewing the surgical technique guide. Demographic information and the number of hammer blows were documented. Hammer velocity and impaction angle were recorded using an optical motion capturing system, while the impaction force was measured using a dynamic force sensor within the impactor. RESULTS: We observed a high variation in the number of hammer blows, maximum force, and impaction angle. Overall, the number of hammer blows decreased significantly from 3 to 2.2 after reviewing the surgical technique guide. The only significant intragroup difference in the number of hammer blows was observed in the group with no prior experience in total hip arthroplasty. No correlation was found between individual factors (age, weight, height) or experience and the measured parameters (velocity, maximum force and angle). CONCLUSIONS: The present study demonstrated a high variation in the parameters of the femoral head assembly procedure. Consideration of the surgical technique guide was found to be a limited factor among participants with varying levels of experience in total hip arthroplasty. These findings underline the importance of sufficient preoperative training, to standardize the assembly procedure, including impaction force, angle, and use of instruments.

Multifunctional Hybrid Material for Endoprosthetic Implants Based on Alumina-Toughened Zirconia Ceramics and Additively Manufactured TiNbTa Alloys.

Aseptic implant loosening after a total joint replacement is partially influenced by material-specific factors when cobalt-chromium alloys are used, including osteolysis induced by wear and corrosion products and stress shielding. Here, we aim to characterize a hybrid material consisting of alumina-toughened zirconia (ATZ) ceramics and additively manufactured Ti-35Nb-6Ta (TiNbTa) alloys, which are joined by a glass solder. The structure of the joint, the static and fatigue shear strength, the influence of accelerated aging, and the cytotoxicity with human osteoblasts are characterized. Furthermore, the biomechanical properties of the functional demonstrators of a femoral component for total knee replacements are evaluated. The TiNbTa-ATZ specimens showed a homogenous joint with statistically distributed micro-pores and a slight accumulation of Al-rich compounds at the glass solder-TiNbTa interface. Shear strengths of 26.4 ± 4.2 MPa and 38.2 ± 14.4 MPa were achieved for the TiNbTa-ATZ and Ti-ATZ specimens, respectively, and they were not significantly affected by the titanium material used, nor by accelerated aging (p = 0.07). All of the specimens survived 107 cycles of shear loading to 10 MPa. Furthermore, the TiNbTa-ATZ did not impair the proliferation and metabolic activity of the human osteoblasts. Functional demonstrators made of TiNbTa-ATZ provided a maximum bearable extension-flexion moment of 40.7 ± 2.2 Nm. The biomechanical and biological properties of TiNbTa-ATZ demonstrate potential applications for endoprosthetic implants.

Testing Mechanical Properties of Silicone Gel-Filled Breast Implants and Their Degradation.

Breast augmentation procedures using silicone implants have become increasingly popular over the past six decades. This article addresses the concerns of patients regarding implant strength by providing clinicians with valuable information in addition to video and pictorial evidence to share, fostering reassurance. The article focuses on the structural integrity and stability of breast implants, which play a critical role in their long-term performance and patient satisfaction. Specifically, it examines the industry standards outlined by the International Organization for Standardization (ISO), with a particular emphasis on ISO14607-2018, which encompasses a range of mechanical and physio-mechanical tests, including the assessment of silicone gel-fill firmness, evaluation of shell integrity, and examination of the impact of environmental conditions on implant performance. Breast implants are not static devices and are subject to aging and fatigue-based degradation. This emphasizes the need for ongoing monitoring and evaluation to ensure the long-term safety and satisfaction of patients. By providing a comprehensive examination of breast implant structure and industry standards, this article equips clinicians with the necessary knowledge to address patient concerns and foster confidence in the safety and longevity of breast augmentation procedures using silicone implants.Level of Evidence III This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Stability of ceramic coatings on retrieved knee prostheses.

BACKGROUND: In total knee arthroplasty, femoral components with coated or oxidized surfaces are commonly used as alternative to CoCrMo in metal sensitive patients. Data on the in vivo behaviour of different coating types is, however, rare. Aim of the study was the investigation of coating stability with respect to implant and patient specific parameters. METHODS: Coating thickness and coating thickness reduction, respectively, was measured at 37 retrieved femoral components with TiNbN, TiN, ZrN or oxidized zirconium (OxZr) surface by the crater grinding method. The results were correlated to surface type, manufacturer, time in vivo of the implant, patient body weight and patient activity. RESULTS: Mean coating thickness reduction in the overall retrieval collection was 0.6 µm ± 0.8 µm. There was no correlation between coating thickness reduction and coating type, time in vivo, patient body weight, and patient activity. If grouped according to manufacturers, implants of one manufacturer showed an increased coating thickness reduction. 10 of 37 retrievals exhibited coating abrasion with exposure of the underlying alloy. TiNbN coatings showed the highest incidence (9/17) of coating abrasion. No coating breakthrough was observed in the ZrN or OxZr surfaces. CONCLUSION: Our results indicate that TiNbN coatings should be optimized to improve their wear resistance in the long-term.

Do hip resurfacing and short hip stem arthroplasties differ from conventional hip stem replacement regarding impingement-free range of motion?

Total hip joint replacement (THR) is clinically well-established. In this context, the resulting range of motion (ROM) is crucial for patient satisfaction when performing joint movements. However, the ROM for THR with different bone preserving strategies (short hip stem and hip resurfacing) raises the question of whether the ROM is comparable with conventional hip stems. Therefore, this computer-based study aimed to investigate the ROM and type of impingement for different implant systems. An established framework with computer-aided design 3D models based on magnetic resonance imaging data of 19 patients with hip osteoarthritis was used to analyse the ROM for three different implant systems (conventional hip stem vs. short hip stem vs. hip resurfacing) during typical joint movements. Our results revealed that all three designs led to mean maximum flexion higher than 110°. However, hip resurfacing showed less ROM (-5% against conventional and -6% against short hip stem). No significant differences were observed between the conventional and short hip stem during maximum flexion and internal rotation. Contrarily, a significant difference was detected between the conventional hip stem and hip resurfacing during internal rotation (p = 0.003). The ROM of the hip resurfacing was lower than the conventional and short hip stem during all three movements. Furthermore, hip resurfacing shifted the impingement type to implant-to-bone impingement compared with the other implant designs. The calculated ROMs of the implant systems achieved physiological levels during maximum flexion and internal rotation. However, bone impingement was more likely during internal rotation with increasing bone preservation. Despite the larger head diameter of hip resurfacing, the ROM examined was substantially lower than that of conventional and short hip stem.

Experimental analysis of early periprosthetic femoral fractures with uncemented straight hip stems.

BACKGROUND: The periprosthetic femoral fracture is one of the most severe complications after total hip arthroplasty and is associated with an increased mortality. The underlying causes and the patient- and implant-specific risk factors of periprosthetic femoral fractures remain insufficiently understood. The aim of this study was to gain a more profound understanding of the underlying fracture mechanisms and to provide experimental datasets for validation of computational models. METHODS: Six cadaveric femurs were implanted with straight hip stems (Zweymueller design) and loaded until fracture reproducing the clinically relevant load cases stumbling and sideways fall. Displacements and the strain distribution on the surface of the femurs and implants, as well as the fracture load and implant subsidence were measured. FINDINGS: For the load case stumbling the mean fracture load was 6743 N and two different mechanisms leading to fracture could be identified: high subsidence with low femoral bending and small subsidence with high femoral bending. For the load case sideways fall the mean fracture load was 1757 N and both tested femurs fractured due to a rotation of the hip stem around its own axis. The detailed datasets provided by this study can be used in future computational models. INTERPRETATION: We demonstrated that the underlying fracture mechanisms of periprosthetic femoral fractures can be fundamentally different in the load case stumbling. The seating and exact position of the hip stem in the femur may correlate with implant subsidence and therefore lead to different types of fracture mechanisms resulting in different patient-specific fracture risks.

Correction: Lange et al. Performance of a Piezoelectric Energy Harvesting System for an Energy-Autonomous Instrumented Total Hip Replacement: Experimental and Numerical Evaluation. Materials 2021, 14, 5151.

The authors wish to make the following corrections to their paper [...].

Performance of a Piezoelectric Energy Harvesting System for an Energy-Autonomous Instrumented Total Hip Replacement: Experimental and Numerical Evaluation.

Instrumented implants can improve the clinical outcome of total hip replacements (THRs). To overcome the drawbacks of external energy supply and batteries, energy harvesting is a promising approach to power energy-autonomous implants. Therefore, we recently presented a new piezoelectric-based energy harvesting concept for THRs. In this study, the performance of the proposed energy harvesting system was numerically and experimentally investigated. First, we numerically reproduced our previous results for the physiologically based loading situation in a simplified setup. Thereafter, this configuration was experimentally realised by the implantation of a functional model of the energy harvesting concept into an artificial bone segment. Additionally, the piezoelectric element alone was investigated to analyse the predictive power of the numerical model. We measured the generated voltage for a load profile for walking and calculated the power output. The maximum power for the directly loaded piezoelectric element and the functional model were 28.6 and 10.2 µW, respectively. Numerically, 72.7 µW was calculated. The curve progressions were qualitatively in good accordance with the numerical data. The deviations were explained by sensitivity analysis and model simplifications, e.g., material data or lower acting force levels by malalignment and differences between virtual and experimental implantation. The findings verify the feasibility of the proposed energy harvesting concept and form the basis for design optimisations with increased power output.

Computational Analysis of Bone Remodeling in the Proximal Tibia Under Electrical Stimulation Considering the Piezoelectric Properties.

The piezoelectricity of bone is known to play a crucial role in bone adaptation and remodeling. The application of an external stimulus such as mechanical strain or electric field has the potential to enhance bone formation and implant osseointegration. Therefore, in the present study, the objective is to investigate bone remodeling under electromechanical stimulation as a step towards establishing therapeutic strategies. For the first time, piezoelectric bone remodeling in the human proximal tibia under electro-mechanical loads was analyzed using the finite element method in an open-source framework. The predicted bone density distributions were qualitatively and quantitatively assessed by comparing with the computed tomography (CT) scan and the bone mineral density (BMD) calculated from the CT, respectively. The effect of model parameters such as uniform initial bone density and reference stimulus on the final density distribution was investigated. Results of the parametric study showed that for different values of initial bone density the model predicted similar but not identical final density distribution. It was also shown that higher reference stimulus value yielded lower average bone density at the final time. The present study demonstrates an increase in bone density as a result of electrical stimulation. Thus, to minimize bone loss, for example, due to physical impairment or osteoporosis, mechanical loads during daily physical activities could be partially replaced by therapeutic electrical stimulation.

Reporting checklist for verification and validation of finite element analysis in orthopedic and trauma biomechanics.

Finite element analysis (FEA) has become a fundamental tool for biomechanical investigations in the last decades. Despite several existing initiatives and guidelines for reporting on research methods and results, there are still numerous issues that arise when using computational models in biomechanical investigations. According to our knowledge, these problems and controversies lie mainly in the verification and validation (V&V) process as well as in the set-up and evaluation of FEA. This work aims to introduce a checklist including a report form defining recommendations for FEA in the field of Orthopedic and Trauma (O&T) biomechanics. Therefore, a checklist was elaborated which summarizes and explains the crucial methodologies for the V&V process. In addition, a report form has been developed which contains the most important steps for reporting future FEA. An example of the report form is shown, and a template is provided, which can be used as a uniform basis for future documentation. The future application of the presented report form will show whether serious errors in biomechanical investigations using FEA can be minimized by this checklist. Finally, the credibility of the FEA in the clinical area and the scientific exchange in the community regarding reproducibility and exchangeability can be improved.

Endurance testing and finite element simulation of a modified hip stem for integration of an energy harvesting system.

Instrumented implants are a promising approach to further improve the clinical outcome of total hip arthroplasties. For the integrated sensors or active functions, an electrical power supply is required. Energy harvesting concepts can provide autonomous power with unlimited lifetime and are independent from external equipment. However, those systems occupy space within the mechanically loaded total hip replacement and can decrease the life span due to fatigue failure in the altered implant. We previously presented a piezoelectric energy harvesting system for an energy-autonomous instrumented total hip stem that notably changes the original implant geometry. The aim of this study was to investigate the remaining structural fatigue failure strength of the metallic femoral implant component in a worst-case scenario. Therefore, the modified hip stem was tested under load conditions based on ISO 7206-4:2010. The required five million cycles were completed twice by all samples (n = 3). Additionally applied cycles with incrementally increased load levels up to 4.7 kN did not induce implant failure. In total, 18 million cycles were endured, outperforming the requirements of the ISO standard. Supplementary finite element analysis was conducted to determine stress distribution within the implant. A high stress concentration was found in the region of modification. The stress level showed an increase compared to the previously evaluated physiological loading situation and was close to the fatigue data from the literature. The stress concentration factor compared to the original geometry amounted to 2.56. The assessed stress level in accordance with the experimental fatigue testing can serve as a maximum reference value for further implant design modifications and optimisations.

Finite element analysis of bone remodelling with piezoelectric effects using an open-source framework.

Bone tissue exhibits piezoelectric properties and thus is capable of transforming mechanical stress into electrical potential. Piezoelectricity has been shown to play a vital role in bone adaptation and remodelling processes. Therefore, to better understand the interplay between mechanical and electrical stimulation during these processes, strain-adaptive bone remodelling models without and with considering the piezoelectric effect were simulated using the Python-based open-source software framework. To discretise numerical attributes, the finite element method (FEM) was used for the spatial variables and an explicit Euler scheme for the temporal derivatives. The predicted bone apparent density distributions were qualitatively and quantitatively evaluated against the radiographic scan of a human proximal femur and the bone apparent density calculated using a bone mineral density (BMD) calibration phantom, respectively. Additionally, the effect of the initial bone density on the resulting predicted density distribution was investigated globally and locally. The simulation results showed that the electrically stimulated bone surface enhanced bone deposition and these are in good agreement with previous findings from the literature. Moreover, mechanical stimuli due to daily physical activities could be supported by therapeutic electrical stimulation to reduce bone loss in case of physical impairment or osteoporosis. The bone remodelling algorithm implemented using an open-source software framework facilitates easy accessibility and reproducibility of finite element analysis made.

[Is the unlimited use of surgical instruments safe? : Discussion using the example of endoprosthetics]. / Ist der unbegrenzte Gebrauch von chirurgischen Instrumenten unbedenklich? : Diskussion am Beispiel der Endoprothetik.

As medical devices surgical instruments are important components when performing surgery. They can significantly influence the course and outcome of the surgery. Instruments are mechanically stressed in daily use and resterilized multiple times. The majority of manufacturer documentation for endoprostheses lacks specific information regarding tolerable instrument wear and the maximum number of applications for surgical instruments. So far, there are no mandatory algorithms for the necessity of checking and replacing surgical instruments. The risk of mechanical failure, surface damage and ultimately incidents is illustrated using endoprosthesis instruments as examples.

Primary stability of a cementless modular revision hip stem in relation with the femoral defect size: A biomechanical study.

PURPOSE: Cementless modular fluted hip stems are commonly used in revision arthroplasty. Nevertheless, there is a wide spectrum of recommendations concerning the minimum bone stock required to enable osseous ingrowth and implant-bone micromotions <100 µm. This experimental study investigated the primary stability of a tapered cementless fluted revision stem depending on different types of bone defects. METHODS: Implant-bone interface movements with a bimodular stem were examined under cyclic axial and torsional loading using composite femora. In four degrees of freedom, the implant subsidence and micromotions were captured with linear variable differential transformers for the intact femora and seven different defects ranging from Paprosky type I to type IIIB. RESULTS: With a 7-cm length of intact diaphysis proximal to the isthmus (Paprosky IIIA), mean implant-bone micromotions of 66 µm occurred. An implant-bone contact zone of only 5 cm (Paprosky IIIA) resulted in micromotions notably over 100 µm and significantly increased subsidence (p < 0.05). With a Paprosky IIIB defect (3 cm of intact diaphysis) rotational instability occurred in all specimens. CONCLUSIONS: Aside from critically increased interfacial micromotions (>100 µm), rotational instability emerged as a mechanism of fixation failure when the implant-bone contact zone was only 5 cm or less. Hence, future studies investigating the implant fixation in the case of femoral bone defects should consider both axial and torsional loading. With regard to the clinical application, our data suggest maintaining 7 cm of diaphyseal implant-bone contact for a safe anchorage of cementless fluted hip revision stems.

Fixation Stability of Uncemented Acetabular Cups With Respect to Different Bone Defect Sizes.

BACKGROUND: In total hip arthroplasty, acetabular press-fit cups require a proper bone stock for sufficient primary implant fixation. The presence of acetabular bone defects compromises the primary fixation stability of acetabular press-fit cups. The aim of the present study is to determine the fixation stability of a cementless acetabular cup regarding standardized bone defects in an experimental setup. METHODS: An acetabular defect model was developed and transferred to a biomechanical cup-block model. The lack of superior cup coverage was divided into 4 stages of superior rim loss (33%, 50%, 67%, and 83%) in the anterior-posterior direction and into 4 stages of mediolateral wall absence (11%, 22%, 33%, and 50%). This resulted in 11 different defect cavities, which were compared to the intact cavity in push-in and lever-out tests of one press-fit cup design (56 mm outer diameter). Thereby, push-in force, lever-out moment, lever-out angle, and interface stiffness were determined. RESULTS: The determined lever-out moments range from 15.53 ± 1.38 Nm (intact cavity) to 1.37 ± 0.54 Nm (83%/50% defect). Smaller defects (33%/11%, 33%/22%, and 50%/11%) reduce the lever-out moments by an average of 33.9% ± 2.8%. CONCLUSION: The lack of mediolateral acetabular coverage of 50% was assessed as critical for cementless cup fixation, whereby the contact zone between implant and bone in the defect is lost. A lack of 20% to 30% mediolateral coverage appears to be acceptable for press-fit cup fixation in the presence of primary stability. A defect of 50%/50% was identified as the threshold for using additional fixation methods.

A round-robin finite element analysis of human femur mechanics between seven participating laboratories with experimental validation.

Finite element analysis is a common tool that has been used for the past few decades to predict the mechanical behavior of bone. However, to our knowledge, there are no round-robin finite element analyses of long human bones with more than two participating biomechanics laboratories published yet, where the results of the experimental tests were not known in advance. We prepared a fresh-frozen human femur for a compression test in a universal testing machine measuring the strains at 10 bone locations as well as the deformation of the bone in terms of the displacement of the loading point at a load of 2 kN. The computed tomography data of the bone with a calibration phantom as well as the orientation of the bone in the testing machine with the according boundary conditions were delivered to seven participating laboratories. These were asked to perform a finite element analysis simulating the experimental setup and deliver their results to the coordinator without knowing the experimental results. Resultantly, four laboratories had deviations from the experimentally measured strains of less than 40%, and three laboratories had deviations of their numerically determined values compared to the experimental data of more than 120%. These deviations are thought to be based on different material laws and material data, as well as different material mapping methods. Investigations will be conducted to clarify and assess the reasons for the large deviations in the numerical data. It was shown that the precision of finite element models of the human femur is not yet as developed as desired by the biomechanics community.