A direct comparison of patient and force-controlled simulator total knee replacement kinematics

The need to critically evaluate the efficacy of current total knee replacement (TKR) wear testing methodologies is great. Proposed international standards for TKR wear simulation have been drafted, yet their methods continue to be debated. The "gold standard" to which all TKR wear testing methodologies should be compared is measured in vivo TKR performance in patients. The current study compared patient TKR kinematics from fluoroscopic analysis and simulator TKR kinematics from force-controlled wear testing to quantify similarities in clinical ranges of motion and contact bearing kinematics and to evaluate the proposed ISO force-controlled wear testing methodology. The treadmill walking kinematics from eight well-functioning, 13 month average post-op patients were compared to the 2 million cycle interval walking cycle kinematics from a force-controlled (Instron/Stanmore Knee Joint Simulator, Instron, Canton, MA) knee simulator using identical implant designs (Natural Knee II, Standard Congruent, Zimmer, Warsaw, IN). The in vivo and simulator data showed good agreement in kinematic patterns and ranges of clinical motion. Tribologically the data sets showed similar contact pathway ranges of motion and wear travel distances per cycle. Surgical and simulator alignments of the implant systems were determined to be a contributing factor in observed kinematic differences. This study's statistical findings offer supporting evidence that the simulation of in vivo walking cycle wear kinematics can be accurately reproduced with a force controlled testing methodology.     

Design optimization of a total knee replacement for improved constraint and flexion kinematics

Total knee replacement (TKR) constraint and flexion range of motion can be limiting factors in terms of kinematics performance and cause for revision. These characteristics are closely related to the shape of the implant components. No previous studies have used a rigorous and systematic design optimization method to determine the optimal shape of TKR components. Previous studies have failed to define a quantifiable objective function for optimization, have not used any optimization algorithms, and have only considered a limited design space (4 or less design variables). This study addresses these limitations and determines the optimum shape of the femoral component and ultra high molecular weight polyethylene (UHMWPE) insert in terms of kinematics. The constraint characteristics with respect to those of the natural knee, the importance of the posterior cruciate ligament, and the flexion range of motion were all considered. The kinematics optimized design featured small femoral radii of curvature in the frontal and sagittal planes, but asymmetric with slightly larger radii of curvature for the lateral condyle. This condyle was also less conforming than the medial side. Compared to a commercially available TKR design, the kinematics performance (based on constraint and flexion range of motion) was improved by 81%, with constraint characteristics generally closer to those of the natural knee and a 12.6% increase in the flexion range of motion (up to 143°). The results yielded a new TKR design while demonstrating the feasibility of design optimization in TKR design.     

Comparison of long-term numerical and experimental total knee replacement wear during simulated gait loading

Pre-clinical experimental wear testing of total knee replacement (TKR) components is an invaluable tool for evaluating new implant designs and materials. However, wear testing can be a lengthy and expensive process, and hence parametric studies evaluating the effects of geometric, loading, or alignment perturbations may at times be cost-prohibitive. The objectives of this study were to develop an adaptive FE method capable of simulating wear of a polyethylene tibial insert and to compare predicted kinematics, weight loss due to wear, and wear depth contours to results from a force-controlled experimental knee simulator. Finite element-based computational wear predictions were performed to 5 million gait cycles using both force- and displacement-controlled inputs. The displacement-controlled inputs, by accurately matching the experimental tibiofemoral motion, provided an evaluation of the simple wear theory. The force-controlled inputs provided an evaluation of the overall numerical method by simultaneously predicting both kinematics and wear. Analysis of the predicted wear convergence behavior indicated that 10 iterations, each representing 500,000 gait cycles, were required to achieve numerical accuracy. Using a wear factor estimated from the literature, the predicted kinematics, polyethylene wear contours, and weight loss were in reasonable agreement with the experimental data, particularly for the stance phase of gait. Although further development of the simplified wear theory is important, the initial predictions are encouraging for future use in design phase implant evaluation. In contrast to the experimental testing which occurred over approximately 2 months, computational wear predictions required only 2h.     

Limited rotation of the mobile-bearing in a rotating platform total knee prosthesis

The hypothesis of this study was that the polyethylene bearing in a rotating platform total knee prosthesis shows axial rotation during a step-up motion, thereby facilitating the theoretical advantages of mobile-bearing knee prostheses. We examined 10 patients with rheumatoid arthritis who had a rotating platform total knee arthroplasty (NexGen LPS mobile, Zimmer Inc. Warsaw, USA). Fluoroscopic data was collected during a step-up motion six months postoperatively. A 3D-2D model fitting technique was used to reconstruct the in vivo 3D kinematics. The femoral component showed more axial rotation than the polyethylene mobile-bearing insert compared to the tibia during extension. In eight knees, the femoral component rotated internally with respect to the tibia during extension. In the other two knees the femoral component rotated externally with respect to the tibia. In all 10 patients, the femur showed more axial rotation than the mobile-bearing insert indicating the femoral component was sliding on the polyethylene of the rotating platform during the step-up motion. Possible explanations are a too limited conformity between femoral component and insert, the anterior located pivot location of the investigated rotating platform design, polyethylene on metal impingement and fibrous tissue formation between the mobile-bearing insert and the tibial plateau.     

Numerical analysis of the effects of material parameters on the lubrication mechanism for knee prosthesis

The tibial component of current knee prostheses made of ultra high molecular weight polyethylene (UHMWPE) has a high degree of wear that causes knee inflammation, prosthesis loosening and subsequent replacement in not more than 15 years. In order to know which UHMWPE material properties have more influence on wear, a steady state lubrication model with non-Newtonian synovial fluid has been studied through numerical solution. The results show that UHMWPE has a very high elastic modulus that makes difficult a well lubricated artificial joint and induces the formation of very thin lubricating films between the moving surfaces with the same magnitude of roughness components. This study shows that the use of deformable porous materials in the tibial component could cause the lubricating film thickness to be higher than the average roughness and the pressure levels to be lower than the one predicted for UHMWPE. These two facts imply friction and wear reduction.     

Meniscal wear at a three-component total ankle prosthesis by a knee joint simulator

Despite the fundamental value of wear simulation studies to assess wear resistance of total joint replacements, neither specialised simulators nor established external conditions are available for the human ankle joint. The aim of the present study was to verify the suitability of a knee wear simulator to assess wear rates in ankle prostheses, and to report preliminary this rate for a novel three-component total ankle replacement design. Four intact 'small' size specimens of the Box ankle were analysed in a four-station knee wear simulator. Special component-to-actuator holders were manufactured and starting spatial alignment of the three-components was sought. Consistent load and motion cycles representing conditions at the ankle joint replaced exactly with the prosthesis design under analysis were taken from a corresponding mechanical model of the stance phase of walking. The weight loss for the three specimens, after two million cycles, was 32.68, 14.78, and 62.28mg which correspond to a linear penetration of 0.018, 0.008, and 0.034mm per million-cycle, respectively for the specimens #1, #2, and #3. The knee wear simulator was able to reproduce load-motion patterns typical of a replaced ankle. Motion of the meniscal bearing in between the tibial and talar components was smooth, this component remaining in place and in complete congruence with the metal components throughout the test.     

Effect of conformity and contact stress on wear in fixed-bearing total knee prostheses

Ultra high molecular weight polyethylene (PE) remains the primary bearing surface of choice in total knee replacements (TKR). Wear is controlled by levels of cross-shear motion and contact stress. The aim of this study was to compare the wear of fixed-bearing total knee replacements with curved and flat inserts and to test the hypothesis that the flat inserts which give higher contact stresses and smaller contact areas would lead to lower levels of surface wear. A low-conforming, high contact stress knee with a low-medium level of cross shear resulted in significantly lower wear rates in comparison to a standard cruciate sacrificing fixed-bearing knee. The low wear solution found in the knee simulator was supported by fundamental studies of wear as a function of pressure and cross shear in the pin on plate system. Current designs of fixed-bearing knees do not offer this low wear solution due to their medium cross shear, moderate conformity and medium contact stress.     

Simulation of a knee joint replacement during a gait cycle using explicit finite element analysis.

The stress distribution within the polyethylene insert of a total knee joint replacement is dependent on the kinematics, which in turn are dependent on the design of the articulating surfaces, the relative position of the components and the tension of the surrounding soft tissues. Implicit finite element analysis techniques have been used previously to examine the polyethylene stresses. However, these have essentially been static analyses and hence ignored the influence of the kinematics. The aim of this work was to use an explicit finite element approach to simulate both the kinematics and the internal stresses within a single analysis. A simulation of a total knee joint replacement subjected to a single gait cycle within a knee wear simulator was performed and the results were compared with experimental data.The predicted kinematics were in close agreement with the experimental data. Various solution-dependent parameters were found to have little influence on the predicted kinematics. The predicted stresses were found to be dependent on the mesh density. This study has shown that an explicit finite element approach is capable of predicting the kinematics and the stresses within a single analysis at relatively low computational cost.     

A novel low wearing differential hardness, ceramic-on-metal hip joint prosthesis

Osteolysis and loosening of artificial joints caused by polyethylene wear debris has prompted renewed interest in alternative bearing materials for hip prosthesis designs. Lower wearing metal-on-metal (MOM) and ceramic-on-ceramic prostheses are being used more extensively, and there is considerable interest in further improving on their performance. This study investigated the wear properties and debris morphology of a novel differential hardness ceramic-on-metal (COM) prosthesis, in comparison with MOM articulations in a physiological anatomical hip joint simulator.The COM pairings were found to have wear rates approximately 100-fold lower than the MOM pairings. The MOM pairings showed a higher "bedding in" wear rate (3.09+/-0.46mm(3)/10(6) cycles) in the first million cycles, which then reduced to a steady state wear rate of 1.23+/-0.5mm(3)/10(6) cycles. The wear rate of the COM pairings over the duration of the test was approximately 0.01mm(3)/10(6) cycles with very little wear detected on the surface of the prosthesis components.The wear particles from both articulations were oval to round in shape and in the nanometer size range. After one million cycles the mean maximum diameter of the MOM and COM wear particles were 30+/-2.25 and 17.57+/-1.37nm, respectively. After five million cycles the wear particles were statistically significantly smaller than at one million cycles, 13.9+/-0.72nm for the MOM pairings and 6.11+/-0.40nm for the COM pairings.The wear rates of the MOM prostheses were representative of clinical values. The use of differential hardness COM pairings dramatically reduced the wear rate compared to MOM hip prostheses. The wear particles from the MOM articulation were similar to particles found in retrieved tissues from around MOM prostheses. The extremely low wearing differential hardness COM bearings presented in this study produced far smaller volumetric particle loads compared to MOM prostheses currently used clinically.     

A holistic numerical model to predict strain hardening and damage of UHMWPE under multiple total knee replacement kinematics and experimental validation

Experimental wear testing is an essential step in the evaluation of total knee replacement (TKR) design. Unfortunately, experiments can be prohibitively expensive and time consuming, which has made computational wear simulation a more desirable alternative for screening designs. While previous attempts have demonstrated positive results, few models have fully incorporated the affect of strain hardening (or cross shear), or tested the model under more than one loading condition. The objective of this study was to develop and evaluate the performance of a new holistic TKR damage model, capable of predicting damage caused by wear, including the effects of strain hardening and creep. For the first time, a frictional work-based damage model was compared against multiple sets of experimental TKR wear testing data using different input kinematics. The wear model was tuned using experimental measurements and was then able to accurately predict the volumetric polyethylene wear volume during experiments with different kinematic inputs. The size and shape of the damage patch on the surface of the polyethylene inserts were also accurately predicted under multiple input kinematics. The ability of this model to predict implant damage under multiple loading profiles by accounting for strain hardening makes it ideal for screening new implant designs, since implant kinematics are largely a function of the shape of the components.     

Effect of joint laxity on polyethylene wear in total knee replacement

Experimental simulator studies are frequently performed to evaluate wear behavior in total knee replacement. It is vital that the simulation conditions match the physiological situation as closely as possible. To date, few experimental wear studies have examined the effects of joint laxity on wear and joint kinematics and the absence of the anterior cruciate ligament has not been sufficiently taken into account in simulator wear studies.The aim of this study was to investigate different ligament and soft tissue models with respect to wear and kinematics.A virtual soft tissue control system was used to simulate different motion restraints in a force-controlled knee wear simulator.The application of more realistic and sophisticated ligament models that considered the absence of anterior cruciate ligament lead to a significant increase in polyethylene wear (p=0.02) and joint kinematics (p<0.01). We recommend the use of more complex ligament models to appropriately simulate the function of the human knee joint and to evaluate the wear behavior of total knee replacements. A feasible simulation model is presented.     

Analysis of wear asymmetry in a series of 94 retrieved polyethylene tibial bearings

Knee joint kinematics is the focus of a significant amount of experimental study for the purpose of knee prosthesis design and for testing the wear of current and prospective bearing materials. This study reports the wear assessment of a series of 94 explanted tibial bearings of various designs and manufacturers and focuses on the extent to which clinical wear is symmetric in the medial-lateral aspect, or is indicative of a systematic asymmetry that would be informative to the design and testing of knee prostheses or surgical practice. Wear assessment of the series of retrievals indicates that, statistically, there was more clinical wear on the medial side. Patterns of wear varied greatly among individual knees; a majority showed very similar extents of wear on the medial and lateral sides, however there were cases with significantly more wear on one condylar articulation than the other. Evidence of edge loading, whereby the femoral component articulates at the margin of the tibial bearing, was common. It was seen most frequently in the central zone of the medial condylar area, and, like the overall wear, edge loading was significantly more frequent on the medial side of bearings. Total bearing wear was seen to generally increase with time over the 208 months of in vivo duration covered by the retrievals in the study. The medial-lateral asymmetry of the wear does not appear to be significantly dependent on duration, however.     

Predicting knee replacement damage in a simulator machine using a computational model with a consistent wear factor

Wear of ultrahigh molecular weight polyethylene remains a primary factor limiting the longevity of total knee replacements (TKRs). However, wear testing on a simulator machine is time consuming and expensive, making it impractical for iterative design purposes. The objectives of this paper were first, to evaluate whether a computational model using a wear factor consistent with the TKR material pair can predict accurate TKR damage measured in a simulator machine, and second, to investigate how choice of surface evolution method (fixed or variable step) and material model (linear or nonlinear) affect the prediction. An iterative computational damage model was constructed for a commercial knee implant in an AMTI simulator machine. The damage model combined a dynamic contact model with a surface evolution model to predict how wear plus creep progressively alter tibial insert geometry over multiple simulations. The computational framework was validated by predicting wear in a cylinder-on-plate system for which an analytical solution was derived. The implant damage model was evaluated for 5 million cycles of simulated gait using damage measurements made on the same implant in an AMTI machine. Using a pin-on-plate wear factor for the same material pair as the implant, the model predicted tibial insert wear volume to within 2% error and damage depths and areas to within 18% and 10% error, respectively. Choice of material model had little influence, while inclusion of surface evolution affected damage depth and area but not wear volume predictions. Surface evolution method was important only during the initial cycles, where variable step was needed to capture rapid geometry changes due to the creep. Overall, our results indicate that accurate TKR damage predictions can be made with a computational model using a constant wear factor obtained from pin-on-plate tests for the same material pair, and furthermore, that surface evolution method matters only during the initial "break in" period of the simulation.     

Oxidation in ultrahigh molecular weight polyethylene and cross-linked polyethylene acetabular cups tested against roughened femoral heads in a hip joint simulator

This study was aimed at comparing the oxidative degradation of commercial acetabular cups made of cross-linked polyethylene (XLPE) and conventional ultrahigh molecular weight polyethylene (UHMWPE). After testing against deliberately scratched CoCrMo femoral heads in a hip joint simulator, the cups, microtomed parallel to the articulating surface, were analyzed by IR spectroscopy. Due to the potential for artifacts caused by absorbed contaminants, the IR spectra were compared only after hexane extraction; actually, XLPE was found to absorb more serum than UHMWPE. The two sets of unworn acetabular cups showed different oxidation patterns with consequently different distributions of carbonyl species; unworn XLPE was characterized by lower contents of carbonyl species and hydrogen-bonded alcohols and higher contents of trans-vinylene species than unworn UHMWPE. Upon simulator testing, UHMWPE showed more significant changes in oxidation indexes and distribution of carbonyl compounds than XLPE, confirming a better wear behavior for XLPE under the adopted testing conditions.     

The use of a force-controlled dynamic knee simulator to quantify the mechanical performance of total knee replacement designs during functional activity

The experimental evaluation of any total knee replacement (TKR) design should include the pre-implantation quantification of its mechanical performance during tests that simulate the common activities of daily living. To date, few dynamic TKR simulation studies have been conducted before implantation. Once in vivo, the accurate and reproducible assessment of TKR design mechanics is exceedingly difficult, with the secondary variables of the patient and the surgical technique hindering research. The current study utilizes a 6-degree-of-freedom force-controlled knee simulator to quantify the effect of TKR design alone on TKR mechanics during a simulated walking cycle. Results show that all eight TKR designs tested elicited statistically different measures of tibial/femoral kinematics, simulated soft tissue loading, and implant geometric restraint loading during an identical simulated gait cycle, and that these differences were a direct result of TKR design alone. Maximum ranges of tibial kinematics over the eight designs tested were from 0.8mm anterior to 6.4mm posterior tibial displacement, and 14.1 degrees internal to 6.0 degrees external tibial rotation during the walking cycle. Soft tissue and implant reaction forces ranged from 106 and 222N anteriorly to 19 and 127N posteriorly, and from 1.6 and 1.8Nm internally to 3.5 and 5.9Nm externally, respectively. These measures provide valuable experimental insight into the effect of TKR design alone on simulated in vivo TKR kinematics, bone interface loading and soft tissue loading. Future studies utilizing this methodology should investigate the effect of experimentally controlled variations in surgical and patient factors on TKR performance during simulated dynamic activity.     

Tibio-femoral kinematics in different total knee arthroplasty designs during a loaded squat: A numerical sensitivity study

Total Knee Arthroplasty (TKA) is a very successful surgical procedure but clinical outcomes were reported to be affected by implant design, ligament balancing, alignment or patient-related anatomical factors. It was recently demonstrated that malpositioning of the TKA components and patient related anatomical factors can considerably alter tibio-femoral (TF) and patellofemoral maximum contact forces. However, up to now, how a component malpositioning and different soft-tissue anatomy changes TF knee kinematics was not yet fully investigated. The goal of this study was to evaluate how sensitive TF kinematics are to these factors during a simulated loaded squat for different TKA designs. Four TKA types (a fixed bearing, posterior stabilized prosthesis; a high flexion fixed bearing guided motion prosthesis; a mobile bearing prosthesis and a hinge prosthesis) were virtually implanted on the same virtual cadaver leg model which underwent a loaded squat between 0° and 120°. The reference models were then modified to simulate either component malpositioning in several directions or changes in ligaments geometry by change in the collateral ligament insertions. The results showed that, for all implant designs, TF kinematics were affected by changes in implant positioning and anatomical factors. While the ranges of motion predicted for all tested configurations were generally similar to the reference configuration for each type of TKA, the modifications resulted in shifts in the maximum and minimum values for the TF rotations and translations.     

Kinematic evaluation of cruciate-retaining total knee replacement patients during level walking: A comparison with the displacement-controlled ISO standard

Differences between wear-scar features of simulator-tested and retrieved tibial total knee replacement (TKR) liners have been reported. This disagreement may result from differences between in vivo kinematic profiles and those defined by the International Organization for Standardization (ISO). The purpose of this study was to determine the knee kinematics of a TKR subject group during level walking and compare them with the motion profiles defined by the ISO standard for a displacement-controlled knee wear testing simulator. Twenty-nine patients with a posterior cruciate ligament-retaining TKR design were gait tested using the point cluster technique to obtain flexion–extension (FE) rotation, anterior–posterior (AP) translation and internal–external (IE) rotation knee motions during a complete cycle of level walking. Relative ranges of motion and timing of key points within the in vivo motion data were compared against the same ranges and same key points from the input profiles of the displacement-controlled wear testing standard ISO14243-3. The subjects exhibited a FE pattern similar to ISO, with an insignificant difference in range of FE rotation from midstance to terminal stance. However, the subjects had a significantly higher range of knee flexion from terminal stance into swing. The subjects also exhibited a phase delay for the entire gait cycle. For AP translation, the standard profile had statistically significant lower magnitudes than seen in vivo. Opposite pattern of AP motion was also apparent from midstance and swing. Similarly, ISO specified a smaller IE total range of rotation with a motion pattern in complete opposition to that seen in vivo. In conclusion, significant differences were found in both the magnitudes and pattern of in vivo motion compared with ISO.     

Probabilistic finite element prediction of knee wear simulator mechanics

Computational models have recently been developed to replicate experimental conditions present in the Stanmore knee wear simulator. These finite element (FE) models, which provide a virtual platform to evaluate total knee replacement (TKR) mechanics, were validated through comparisons with experimental data for a specific implant. As with any experiment, a small amount of variability is inherently present in component alignment, loading, and environmental conditions, but this variability has not been previously incorporated in the computational models. The objectives of the current research were to assess the impact of experimental variability on predicted TKR mechanics by determining the potential envelope of joint kinematics and contact mechanics present during wear simulator loading, and to evaluate the sensitivity of the joint mechanics to the experimental parameters. In this study, 8 component alignment and 4 experimental parameters were represented as distributions and used with probabilistic methods to assess the response of the system, including interaction effects. The probabilistic FE model evaluated two levels of parameter variability (with standard deviations of component alignment parameters up to 0.5mm and 1 degrees ) and predicted a variability of up to 226% (3.44mm) in resulting anterior-posterior (AP) translation, up to 169% (4.30 degrees ) in internal-external (IE) rotation, but less than 10% (1.66MPa) in peak contact pressure. The critical alignment parameters were the tilt of the tibial insert and the IE rotational alignment of the femoral component. The observed variability in kinematics and, to a lesser extent, contact pressure, has the potential to impact wear observed experimentally.     

Dynamic finite element knee simulation for evaluation of knee replacement mechanics

In vitro pre-clinical testing of total knee replacement (TKR) devices is a necessary step in the evaluation of new implant designs. Whole joint knee simulators, like the Kansas knee simulator (KKS), provide a controlled and repeatable loading environment for comparative evaluation of component designs or surgical alignment under dynamic conditions. Experimental testing, however, is time and cost prohibitive for design-phase evaluation of tens or hundreds of design variations. Experimentally-verified computational models provide an efficient platform for analysis of multiple components, sizes, and alignment conditions. The purpose of the current study was to develop and verify a computational model of a dynamic, whole joint knee simulator. Experimental internal-external and valgus-varus laxity tests, followed by dynamic deep knee bend and gait simulations in the KKS were performed on three cadaveric specimens. Specimen-specific finite element (FE) models of posterior-stabilized TKR were created from magnetic resonance images and CAD geometry. The laxity data was used to optimize mechanical properties of tibiofemoral soft-tissue structures on a specimen-specific basis. Each specimen was subsequently analyzed in a computational model of the experimental KKS, simulating both dynamic activities. The computational model represented all joints and actuators in the experimental setup, including a proportional-integral-derivative (PID) controller to drive quadriceps actuation. The computational model was verified against six degree-of-freedom patellofemoral (PF) and tibiofemoral (TF) kinematics and actuator loading during both deep knee bend and gait activities, with good agreement in trends and magnitudes between model predictions and experimental kinematics; differences were less than 1.8 mm and 2.2° for PF and TF translations and rotations. The whole joint FE simulator described in this study can be applied to investigate a wide range of clinical and research questions.     

RandomPOD--a new method and device for advanced wear simulation of orthopaedic biomaterials

A 16-station wear simulator of the pin-on-disc type, called RandomPOD, was designed, built, and validated. The primary area of application of the RandomPOD is wear studies of orthopaedic biomaterials. The type of relative motion between the bearing surfaces, generally illustrated as shapes of slide tracks, has been found to have a strong effect on the type and amount of wear produced. The computer-controlled RandomPOD can be programmed to produce virtually any slide track shape and load profile. In the present study, the focus is on the biomechanically realistic random variation in the track shape and load. In the reference test, the established combination of circular translation and static load was used. In addition, the combinations of random motion/static load, and circular translation/random load were included. The pins were conventional ultra-high molecular weight polyethylene (UHMWPE), the discs were polished CoCr, and the lubricant was diluted calf serum. The UHMWPE wear factor resulting from random motion was significantly higher than that resulting from circular translation. This was probably caused by the fact that in the random motion the direction of sliding changed more than in circular translation with the same sliding distance. The type of load, random vs. static, was unimportant with respect to the wear factor produced. The principal advantage of using the present random track is that possible unrealistic wear phenomena related to the use of fixed track shapes can be avoided.