Primary stability of an anatomical cementless hip stem: a statistical analysis

The primary stability that the surgeon can achieve during surgery is a determinant of the clinical success of cementless implants. Thus, estimating what level of primary stability can be obtained with a new design is an important aspect of pre-clinical evaluation. The primary stability of a cementless hip stem is not only affected by the implant design, but also by other factors such as the mechanical quality of the host bone, the presence of gaps around the bone-implant interface, the body weight of the patient, and the size of the implant. Even the most extensive experimental study can only explore a small sub-set of all possible combinations found in vivo. To overcome this limitation, we propose a combination of experimental and numerical methods. The primary stability of a cementless anatomical stem is assessed in vitro. A finite element model is developed to accurately replicate the same experiment. The model is then parameterised over the various factors that affect the primary stability, and used in a Monte Carlo scheme to assess the primary stability over a simulated population. In this study, the method was used to investigate the mechanical stability of an anatomical cementless stem over more than 1000 simulated cases. Twenty cases were found macroscopically unstable, due to a combination of unfavourable conditions. The rest of the Monte Carlo sample showed on average a peak micromotion under stair climbing loading of 206 +/- 159 microm. The proposed method can be used to evaluate new designs in conditions more representative of the variability in clinical practice.     

Stair climbing is more critical than walking in pre-clinical assessment of primary stability in cementless THA in vitro

Pre-clinical testing of hip endoprostheses is a mandatory requirement before clinical release. Inadequate loading conditions may lead to lower elastic and plastic interface movements than those occurring post-operatively in vivo. This study investigated the influence of patient activity on the primary stability of cementless prostheses with a special emphasis on active simulation of muscle forces. A loading setup, based on validated musculo-skeletal analyses, was used to generate the hip contact force during walking and stair climbing by transmitting muscle forces through the femur. In addition, a loading configuration which only generated the hip contact force occurring during stair climbing at the prosthesis head was simulated. CLS prostheses were implanted in 18 composite femora and subjected to cyclical loading. The relative micro-movements at the bone-prosthesis interface were determined and appeared to be extremely sensitive to the specific patient activity. Compared to walking, stair climbing generated higher micro-movements, with pronounced axial and rotational components. Stair climbing with the femur loaded by the resultant hip contact force only exhibited a characteristic valgus tilt of the stem with significantly lower interface micro-movements than under active simulation of muscle forces. The analyses suggest that stair climbing induced the highest mechanical instability at the bone-prosthesis interface, a level which may compromise the necessary osseointegration process. Active simulation of muscle forces considerably affects the primary stability of cementless hip endoprostheses. Pre-clinical in vitro tests should therefore simulate stair climbing and include muscle activity in the assessment of initial implant stability, otherwise micro-movements may be underestimated and the primary stability overestimated.     

The influence of uncemented femoral stem length and design on its primary stability: a finite element analysis

One of the crucial factors for short- and long-term clinical success of total hip arthroplasty cementless implants is primary stability. Indeed, motion at the bone–implant interface above 40 μm leads to partial bone ingrowth, while motion exceeding 150 μm completely inhibits bone ingrowth. The aim of this study was to investigate the effect of two cementless femoral stem designs with different lengths on the primary stability. A finite element model of a composite Sawbones^® fourth generation, implanted with five lengths of the straight prosthesis design and four lengths of the curved prosthesis design, was loaded with hip joint and abductor forces representing two physiological activities: fast walking and stair climbing. We found that reducing the straight stem length from 146 to 54 mm increased the average micromotion from 17 to 52 μm during fast walking, while the peak value increased from 42 to 104 μm. With the curved stem, reducing length from 105 to 54 mm increased the average micromotion from 10 to 29 μm, while the peak value increased from 37 to 101 μm. Similar findings are obtained for stair climbing for both stems. Although the present study showed that femoral stem length as well as stem design directly influences its primary stability, for the two femoral stems tested, length could be reduced substantially without compromising the primary stability. With the aim of minimising surgical invasiveness, newer femoral stem design and currently well performing stems might be used with a reduced length without compromising primary stability and hence, long-term survivorship.     

Predicting the subject-specific primary stability of cementless implants during pre-operative planning: preliminary validation of subject-specific finite-element models

Pre-operative planning help the surgeon in taking the proper clinical decision. The ultimate goal of this work is to develop numerical models that allow the surgeon to estimate the primary stability during the pre-operative planning session. The present study was aimed to validate finite-element (FE) models accounting for patient and prosthetic size and position as planned by the surgeon. For this purpose, the FE model of a cadaveric femur was generated starting from the CT scan and the anatomical position of a cementless stem derived by a skilled surgeon using a pre-operative CT-based planning simulation software. In-vitro experimental measurements were used as benchmark problem to validate the bone-implant relative micromotions predicted by the patient-specific FE model. A maximum torque in internal rotation of 11.4 Nm was applied to the proximal part of the hip stem. The error on the maximum predicted micromotion was 12% of the peak micromotion measured experimentally. The average error over the entire range of applied torques was only 7% of peak measurement. Hence, the present study confirms that it is possible to accurately predict the level of primary stability achieved for cementless stems using numerical models that account for patient specificity and surgical variability.     

Virtual trial to evaluate the robustness of cementless femoral stems to patient and surgical variation

Primary stability is essential for the success of cementless femoral stems. In this study, patient specific finite element (FE) models were used to assess changes in primary stability due to variability in patient anatomy, bone properties and stem alignment for two commonly used cementless femoral stems, Corail® and Summit® (DePuy Synthes, Warsaw, USA). Computed-tomography images of the femur were obtained for 8 males and 8 females. An automated algorithm was used to determine the stem position and size which minimized the endo-cortical space, and then span the plausible surgical envelope of implant positions constrained by the endo-cortical boundary. A total of 1952 models were generated and ran, each with a unique alignment scenario. Peak hip contact and muscle forces for stair climbing were scaled to the donor’s body weight and applied to the model. The primary stability was assessed by comparing the implant micromotion and peri-prosthetic strains to thresholds (150 μm and 7000 µε, respectively) above which fibrous tissue differentiation and bone damage are expected to prevail. Despite the wide range of implant positions included, FE prediction were mostly below the thresholds (medians: Corail®: 20–74 µm and 1150–2884 µε, Summit®: 25–111 µm and 860–3010 µε), but sensitivity of micromotion and interfacial strains varied across femora, with the majority being sensitive (p < 0.0029) to average bone mineral density, cranio-caudal angle, post-implantation anteversion angle and lateral offset of the femur. The results confirm the relationship between implant position and primary stability was highly dependent on the patient and the stem design used.     

Efficient computational method for assessing the effects of implant positioning in cementless total hip replacements

The present work describes a statistical investigation into the effects of implant positioning on the initial stability of a cementless total hip replacement (THR). Mesh morphing was combined with design of computer experiments to automatically construct Finite Element (FE) meshes for a range of pre-defined femur-implant configurations and to predict implant micromotions under joint contact and muscle loading. Computed micromotions, in turn, are postprocessed using a Bayesian approach to: (a) compute the main effects of implant orientation angles, (b) predict the sensitivities of the considered implant performance metrics with respect to implant ante-retroversion, varus-valgus and antero-posterior orientation angles and (c) identify implant positions that maximise and minimise each metric. It is found that the percentage of implant area with micromotion greater than 50 μm, average and maximum micromotions are all more sensitive to antero-posterior orientation than ante-retroversion and varus-valgus orientation. Sensitivities, combined with the main effect results, suggest that bone is less likely to grow if the implant is increasingly moved from the neutral position towards the anterior part of the femur, where the highest micromotions occur. The computed implant best position leads to a percentage of implant area with micromotion greater than 50 μm of 1.14 when using this metric compared to 14.6 and 5.95 in the worst and neutrally positioned implant cases. In contrast, when the implant average/maximum micromotion is used to assess the THR performance, the implant best position corresponds to average/maximum micromotion of 9 μm/59 μm, compared to 20 μm/114 μm and 13 μm/71 μm in the worst and neutral positions, respectively. The proposed computational framework can be extended further to study the effects of uncertainty and variability in anatomy, bone mechanical properties, loading or bone-implant interface contact conditions.     

Primary stability of cementless stem in THA improved with reduced interfacial gaps

Large interfacial gaps between the stem and the bone in cementless total hip arthroplasty may prevent successful bone ingrowth at the sites, and can also be a passage for wear particles. Furthermore, interfacial gaps between the stem and the bone are believed to compromise the primary stability of the implant. Thus, a broaching method that serves to reduce gaps is expected to give clinically preferable results. A modified broach system with a canal guide is introduced to enhance the accuracy of femoral canal shaping in comparison with the conventional broach system for a Versys fibermetal taper stem. The primary stability of the hip systems and the ratios of the stem surface in contact with the femur were measured in a composite femur model. With the conventional method, an average of 67% of the stem surface was shown to be in contact with the bone, and an average stem micromotion/migration of 35 microm 290 microm was observed under 1000 cycles of stair climbing loads. With the modified method, the stem-bone contact ratio significantly increased to 82% (p<0.05), and the average micromotion/migration reduced to 29 microm 49 microm, respectively (p<0.05 for migration). Our finite element models of the hip systems supported that the difference in micromotion could be attributed to the difference in interfacial contact. Interfacial gaps occurring with the conventional broach system were effectively reduced by the proposed method, resulting in improved primary stability.     

Analysis of bone–prosthesis interface micromotion for cementless tibial prosthesis fixation and the influence of loading conditions

A lack of initial stability of the fixation is associated with aseptic loosening of the tibial components of cementless knee prostheses. With sufficient stability after surgery, minimal relative motion between the prosthesis and bone interfaces allows osseointegation to occur thereby providing a strong prosthesis-to-bone biological attachment. Finite element modelling was used to investigate the bone–prosthesis interface micromotion and the relative risk of aseptic loosening. It was anticipated that by prescribing different joint loads representing gait and other activities, and the consideration of varying tibial–femoral contact points during knee flexion, it would influence the computational prediction of the interface micromotion. In this study, three-dimensional finite element models were set up with applied loads representing walking and stair climbing, and the relative micromotions were predicted. These results were correlated to in-vitro measurements and to the results of prior retrieval studies. Two load conditions, (i) a generic vertical joint load of 3×body weight with 70%/30% M/L load share and antero-posterior/medial-lateral shear forces, acted at the centres of the medial and lateral compartments of the tibial tray, and (ii) a peak vertical joint load at 25% of the stair climbing cycle with corresponding antero-posterior shear force applied at the tibial–femoral contact points of the specific knee flexion angle, were found to generate interface micromotion responses which corresponded to in-vivo observations. The study also found that different loads altered the interface micromotion predicted, so caution is needed when comparing the fixation performance of various reported cementless tibial prosthetic designs if each design was evaluated with a different loading condition.     

Finite element modelling of primary hip stem stability: the effect of interference fit

The most commonly reported complications related to cementless hip stems are loosening and thigh pain; both of these have been attributed to high levels of relative micromotion at the bone-implant interface due to insufficient primary fixation. Primary fixation is believed by many to rely on achieving a sufficient interference fit between the implant and the bone. However, attempting to achieve a high interference fit not infrequently leads to femoral canal fracture either intra-operatively or soon after. The appropriate range of diametrical interference fit that ensures primary stability without risking femoral fracture is not well understood. In this study, a finite element model was constructed to predict micromotion and, therefore, instability of femoral stems. The model was correlated with an in vitro micromotion experiment carried out on four cadaver femurs. It was confirmed that interference fit has a very significant effect on micromotion and ignoring this parameter in an analysis of primary stability is likely to underestimate the stability of the stem. Furthermore, it was predicted that the optimal level of interference fit is around 50 microm as this is sufficient to achieve good primary fixation while having a safety factor of 2 against femoral canal fracture. This result is of clinical relevance as it indicates a recommendation for the surgeon to err on the side of a low interference fit rather than risking femoral fracture.     

Probabilistic finite element analysis of the uncemented hip replacement—effect of femur characteristics and implant design geometry

In the present study, a probabilistic finite element tool was assessed using an uncemented total hip replacement model. Fully bonded and frictional interfaces were investigated for combinations of three proximal femurs and two implant designs, the Proxima short stem and the IPS hip stem prostheses. The Monte Carlo method was used with two performance indicators: the percentage of bone volume that exceeded specified strain limits and the maximum nodal micromotion. The six degrees of freedom of bone-implant relative position, magnitude of the hip contact force (L), and spatial direction of L were the random variables. The distal portion of the proximal femurs was completely constrained and some of the main muscle forces acting in the hip were applied. The coefficients of the linear approximation between the random variables and the output were used as the sensitivity values. In all cases, bone-implant position related parameters were the most sensitive parameters. The results varied depending on the femur, the implant design and the interface conditions. Values of maximum nodal micromotion agreed with results from previous studies, confirming the robustness of the implemented computational tool. It was demonstrated that results from a single model study should not be generalised to the entire population of femurs and that bone variability is an important factor that should be investigated in such analyses.     

Validation of model-predicted tibial tray-synthetic bone relative motion in cementless total knee replacement during activities of daily living

As fixation of cementless total knee replacement components during the first 4–6 weeks after surgery is crucial to establish bony ingrowth into the porous surface, several studies have quantified implant-bone micromotion. Relative motion between the tray and bone can be measured in vitro, but the full micromotion contour map cannot typically be accessed experimentally. Finite element models have been employed to estimate the full micromotion map, but have not been directly validated over a range of loading conditions. The goal of this study was to develop and validate computational models for the prediction of tray-bone micromotion under simulated activities of daily living. Gait, stair descent and deep knee bend were experimentally evaluated on four samples of a cementless tibial tray implanted into proximal tibial Sawbones™ constructs. Measurements of the relative motion between the tray and the anterior cortical shell were collected with digital image correlation and used to validate a finite element model that replicated the experiment. Additionally, a probabilistic analysis was performed to account for experimental uncertainty and determine model sensitivity to alignment and frictional parameters. The finite element models were able to distinguish between activities and capture the experimental trends. Best-matching simulations from the probabilistic analysis matched measured displacement with an average root mean square (RMS) difference of 14.3 µm and Pearson-product correlation of 0.93, while the mean model presented an average RMS difference of 27.1 µm and a correlation of 0.8. Maximum deviations from average experimental measurements were 40.5 and 87.1 µm for the best-matching and average simulations, respectively. The computational pipeline developed in this study can facilitate and enhance pre-clinical assessment of novel implant components.     

Simultaneous and multisite measure of micromotion, subsidence and gap to evaluate femoral stem stability

The initial stability of cementless femoral components is crucial for the long-term success of total hip arthroplasty. This has been reported in animal and clinical studies. Until now, the stability was evaluated by the measurement of relative micromotion on a few simultaneous locations around the stem in cadaveric experiments. This paper presents an extended experimental setup to measure simultaneously local micromotion, subsidence and gap on hundreds of points at the bone-stem interface. This technique we applied to anatomical and straight stems in three pairs of cadaveric femurs. Measurements were in agreement with typically reported values. Conversely to other methods, which measure micromotion between implant and bone anchoring points of the measuring device, our method provides local micromotion between stem surface and adjacent bone surface. The observed variation of micromotion at the peri-implant surface confirms the importance of this simultaneous measure on a lot of points around the implant.     

Robust design for acetabular cup stability accounting for patient and surgical variability

The stability of cementless acetabular cups depends on a close fit between the components and reamed acetabular cavities to promote bone ingrowth. Cup performance and stability are affected by both design and environmental (patient-dependent and surgical) factors. This study used a statistically based metamodel to determine the relative influences of design and environmental factors on acetabular cup stability by incorporating a comprehensive set of patient-dependent and surgical variables. Cup designs with 2 mm or 3 mm intended equatorial bone-implant interferences appeared to perform the best, improving implant stability with smaller mean and variability in cup relative motions and greater mean and smaller variability in ingrowth areas. Cup eccentricity was found to have no effect on implant performance. Design variables did not contribute as much to the variation in performance measures compared to the environmental variables, except for potential ingrowth areas.     

Micromotion-induced peri-prosthetic fluid flow around a cementless femoral stem

Micromotion-induced interstitial fluid flow at the bone-implant interface has been proposed to play an important role in aseptic loosening of cementless implants. High fluid velocities are thought to promote aseptic loosening through activation of osteoclasts, shear stress induced control of mesenchymal stem cells differentiation, or transport of molecules. In this study, our objectives were to characterize and quantify micromotion-induced fluid flow around a cementless femoral stem using finite element modeling. With a 2D model of the bone-implant interface and full-factorial design, we first evaluated the relative influence of material properties, and bone-implant micromotion and gap on fluid velocity. Transverse sections around a femoral stem were built from computed tomography images, while boundary conditions were obtained from experimental measurements on the same femur. In a second step, a 3D model was built from the same data-set to estimate the shear stress experienced by cells hosted in the peri-implant tissues. The full-factorial design analysis showed that local micromotion had the most influence on peak fluid velocity at the interface. Remarkable variations in fluid velocity were observed in the macrostructures at the surface of the implant in the 2D transverse sections of the stem. The 3D model predicted peak fluid velocities extending up to 2.2 mm/s in the granulation tissue and to 3.9 mm/s in the trabecular bone. Peak shear stresses on the cells hosted in these tissues ranged from 0.1 to 12.5 Pa. These results offer insight into mechanical stimuli encountered at the bone-implant interface.     

Hip contact forces and gait patterns from routine activities.

In vivo loads acting at the hip joint have so far only been measured in few patients and without detailed documentation of gait data. Such information is required to test and improve wear, strength and fixation stability of hip implants. Measurements of hip contact forces with instrumented implants and synchronous analyses of gait patterns and ground reaction forces were performed in four patients during the most frequent activities of daily living. From the individual data sets an average was calculated. The paper focuses on the loading of the femoral implant component but complete data are additionally stored on an associated compact disc. It contains complete gait and hip contact force data as well as calculated muscle activities during walking and stair climbing and the frequencies of daily activities observed in hip patients. The mechanical loading and function of the hip joint and proximal femur is thereby completely documented. The average patient loaded his hip joint with 238% BW (percent of body weight) when walking at about 4 km/h and with slightly less when standing on one leg. This is below the levels previously reported for two other patients (Bergmann et al., Clinical Biomechanics 26 (1993) 969-990). When climbing upstairs the joint contact force is 251% BW which is less than 260% BW when going downstairs. Inwards torsion of the implant is probably critical for the stem fixation. On average it is 23% larger when going upstairs than during normal level walking. The inter- and intra-individual variations during stair climbing are large and the highest torque values are 83% larger than during normal walking. Because the hip joint loading during all other common activities of most hip patients are comparably small (except during stumbling), implants should mainly be tested with loading conditions that mimic walking and stair climbing.     

Primary stability of uncemented femoral resurfacing implants for varying interface parameters and material formulations during walking and stair climbing

Primary stability of uncemented resurfacing prosthesis is provided by an interference fit between the undersized implant and the reamed bone. Dependent on the magnitude of interference, the implantation process causes high shear forces and large strains which can exceed the elastic limit of cancellous bone. Plastification of the bone causes reduced stiffness and could lead to bone damage and implant loosening. The purpose in this study was to determine press-fit conditions which allow implantation without excessive plastic bone deformation and sufficient primary stability to achieve bone ingrowth. In particular, the influence of interference, bone quality and friction on the micromotion during walking and stair-climbing was investigated. Therefore elastic and plastic finite element (FE) models of the proximal femur were developed. Implantation was realized by displacing the prosthesis onto the femur while monitoring the contact pressure, plastic bone deformation as well as implantation forces. Subsequently a physiologic gait and stair-climbing cycle was simulated calculating the micromotion at the bone-implant interface. Results indicate that plastic deformation starts at an interference of 30 μm and the amount of plastified bone at the interface increases up to 90% at 150 μm interference. This effect did not reduce the contact pressure if interference was below 80 μm. The micromotion during walking was similar for the elastic and plastic FE models. A stable situation allowing bony ingrowth was achieved for both constitutive laws (elastic, plastic) for walking and stair climbing with at least 60 μm press-fit, which is feasible with clinically used implantation forces of 4 kN.     

Experimental method for the in vitro testing of the initial stability of cementless hip prostheses

Micromotions at the interface between bone and prosthesis are believed to induce bone resorption and ultimately lead to loosening of the implant. Thus the initial stability achieved by a hip prosthesis is an important factor for the long-term function of the implant. Knowing the biological consequences of the mechanical conditions, it appears to be mandatory to measure the extent of these three-dimensional movements. An in vitro dynamic method for measurement of the micromotion of the femoral component of hip prostheses has been developed. Tests in cemented prostheses have confirmed that the use of cement reduces sinkage and rotation manyfold and have yielded reference values for stability. Comparison with two types of cementless prostheses has shown that certain cementless implants may achieve stability comparable to cemented ones in some load directions.     

Probabilistic analysis of the influence of the bonding degree of the stem-cement interface in the performance of cemented hip prostheses

The long-term behavior of the stem-cement interface is one of the most frequent topics of discussion in the design of cemented total hip replacements, especially with regards to the process of damage accumulation in the cement layer. This effect is analyzed here comparing two different situations of the interface: completely bonded and debonded with friction. This comparative analysis is performed using a probabilistic computational approach that considers the variability and uncertainty of determinant factors that directly compromise the damage accumulation in the cement mantle. This stochastic technique is based on the combination of probabilistic finite elements (PFEM) and a cumulative damage approach known as B-model. Three random variables were considered: muscle and joint contact forces at the hip (both for walking and stair climbing), cement damage and fatigue properties of the cement. The results predicted that the regions with higher failure probability in the bulk cement are completely different depending on the stem-cement interface characteristics. In a bonded interface, critical sites appeared at the distal and medial parts of the cement, while for debonded interfaces, the critical regions were found distally and proximally. In bonded interfaces, the failure probability was higher than in debonded ones. The same conclusion may be established for stair climbing in comparison with walking activity.     

Comparative in vitro study on the long term performance of cemented hip stems: validation of a protocol to discriminate between "good" and "bad" designs

The long-term clinical success of cemented hip stems is influenced both by the implant design, and by the surgical procedure. A methodology is proposed for discriminating between implant designs with different clinical outcomes. The protocol was designed with industrial pre-clinical validation in mind.Two cemented stem types were tested, one (Lubinus SPII) having good and the other (Müller Curved) having poor clinical outcomes. Three implants for each type were subjected to a mechanical in vitro test of one million loading cycles. Each cycle reproduced the load components of stair climbing. Interface shear micromotion was measured during the test in the direction of rotation and along the stem axis. The stem roughness before and after the test was compared. After the test, the cement mantles were retrieved and inspected through dye penetrants to detect evidences of micro-damage. For each specimen, the events of the loosening process were examined, based on the in vitro data available, so as to analyze the whole failure mechanism.The protocol developed was sensitive to the implant design, with significantly different results being found for the two stem types, both in terms of stem-cement micromotions, surface roughness alteration, and cement mantle damage. The information yielded by the three different investigation techniques was consistent for each of the two groups of specimens tested, allowing a better understanding of the failure process. In vitro inducible micromotion and permanent migration measurements, together with cement-stem interface fretting damage and cement fatigue damage, can help predicting the clinical performance of cemented stems.     

Musculo-skeletal loading conditions at the hip during walking and stair climbing.

Musculo-skeletal loading plays an important role in the primary stability of joint replacements and in the biological processes involved in fracture healing. However, current knowledge of musculo-skeletal loading is still limited. In the past, a number of musculo-skeletal models have been developed to estimate loading conditions at the hip. So far, a cycle-to-cycle validation of predicted musculo-skeletal loading by in vivo measurements has not been possible. The aim of this study was to determine the musculo-skeletal loading conditions during walking and climbing stairs for a number of patients and compare these findings to in vivo data.Following total hip arthroplasty, four patients underwent gait analysis during walking and stair climbing. An instrumented femoral prosthesis enabled simultaneous measurement of in vivo hip contact forces. On the basis of CT and X-ray data, individual musculo-skeletal models of the lower extremity were developed for each patient. Muscle and joint contact forces were calculated using an optimization algorithm. The calculated peak hip contact forces both over- and under-estimated the measured forces. They differed by a mean of 12% during walking and 14% during stair climbing.For the first time, a cycle-to-cycle validation of predicted musculo-skeletal loading was possible for walking and climbing stairs in several patients. In all cases, the comparison of in vivo measured and calculated hip contact forces showed good agreement.Thus, the authors consider the presented approach as a useful means to determine valid conditions for the analysis of prosthesis loading, bone modeling or remodeling processes around implants and fracture stability following internal fixation.