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.     

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.     

Finding and defining the ideal patellar resection plane in total knee arthroplasty

Asymmetric resection of the patella during total knee arthroplasty (TKA) correlates with anterior knee pain, bony impingement and patellar maltracking. Despite this, there is no consensus regarding the desired landmarks; the cut is often done freehand; and there has been no quantitative comparison of proposed resection planes. The objectives of this study were to: determine the intra- and inter-surgeon repeatability of two radiographic resection definitions (medial–divot, MD, and medial–lateral extents, MLE); calculate two additional definitions from the radiographic patellar circumferences (parallel to the anterior surface, ANT, and perpendicular to the anteroposterior tangent points, PERP); compare the clinical resection line to the previous four definitions before and after introducing the MD method clinically; and identify distinguishing features of patellae with better vs. worse resection angles. We hypothesized that the MD method would improve repeatability both radiographically and clinically, that the different radiographic definitions would produce comparable angles, and that we could identify distinguishing features. For the radiographic study, three surgeons drew lines on 40 preoperative X-rays plus 9 interspersed repetitions of 3 of these X-rays. For the clinical study, we compared the patellar resection angle for 20 patients immediately before and after implementing the new method. Given that the clinical goal is to have equal distances from the resection surface to the anterior surface, we compared all results to the ANT definition as the theoretically ideal definition. Confirming the first hypothesis, intra-surgeon repeatability (10 repetitions of 3 X-rays) and inter-surgeon repeatability (3 surgeons×40 X-rays) were both significantly better using the new MD method compared to the MLE method (p<0.001). Contrary to the second hypothesis, clinical use of the MD method did not improve resection symmetry. Contrary to the third hypothesis, the PERP definition was significantly different from the other three definitions. In agreement with the fourth hypothesis, female patellae and more deformed patella had significantly greater asymmetry (p<0.001). Given the inherent variability shown in drawing the ‘patellar horizon’, we encourage researchers to draw the line several times and average the results when comparing tilt or the resection angle to this horizon. Based on the distinguishing characteristics of asymmetrically resurfaced patellae in our series, we recommend that clinicians be particularly careful when resecting laterally deformed patellae and the patellae of female patients.     

A mathematical formula to calculate the theoretical range of motion for total hip replacement

The reduced range of motion (ROM) resulting from total hip replacement (THR) leads to frequent prosthetic impingement, which may restrict activities of daily living and cause subluxation and dislocation. Therefore, to know the ROM of THR is very important in clinical situations and in the design of prostheses. THR involves a pure ball and socket joint. We created a mathematical formula to calculate the theoretical ROM of THR limited by the prosthetic impingement. The ROM of THR is governed by the following five factors, (1) The prosthetic ROM (oscillation angle: obtained from company data), (2) cup abduction (3) cup anterior opening, (4) the angle of the femoral neck component from the horizontal plane, and (5) the femoral neck anteversion. The last 4 factors are able to be obtained from anterior-posterior, axial X-rays and CT of the patient's THR. The objective was to create mathematical formulas that could accurately and quickly calculate the ROM of THR. By entering the five values into a computer programmed with the formulas, one could obtain the ROM for the THR. This reveals the effect on ROM of the oscillation angle and the interaction of ROM with cup abduction, anterior opening and neck anteversion. Furthermore this readily would enable a clinical evaluation of the possibility of postoperative dislocation and help in postoperative rehabilitation. The calculated numerical values of ROM by these mathematical formulas were successfully compared with the ROMs obtained from 3-dimensional computer graphics (3D-CG).     

Material and surface factors influencing backside fretting wear in total knee replacement tibial components

Retrieval studies have shown that the interface between the ultra-high molecular weight polyethylene insert and metal tibial tray of fixed-bearing total knee replacement components can be a source of substantial amounts of wear debris due to fretting micromotion. We assessed fretting wear of polyethylene against metal as a function of metal surface finish, alloy, and micromotion amplitude, using a three-station pin-on-disc fretting wear simulator. Overall, the greatest reduction in polyethylene wear was achieved by highly polishing the metal surface. For example, highly polished titanium alloy surfaces produced nearly 20 times less polyethylene wear compared with blasted titanium alloy, whereas, decreasing the micromotion amplitude from 200 to 50 μm produced approximately four times less polyethylene wear for the same blasted titanium alloy surface. Although the effect of the metal alloy was much smaller than the effect of metal surface roughness or the micromotion amplitude, CoCr discs produced slightly greater polyethylene fretting wear than titanium alloy discs under each condition. The results are essential in design and manufacturing decisions related to fixed-bearing total knee replacements.     

Biofeedback as a means to alter electromyographic activity in a total knee replacement patient

This paper presents a single case controlled study of a 75-year-old male having bilateral total knee replacement. Baseline EMG recordings demonstrated differential levels of vastus medialis and vastus lateralis muscle activity in both knees during exercise, with increased vastus lateralis activity compared to vastus medialis activity. The purpose of the study was to use electromyographic (EMG) biofeedback training to train the patient to equalize vastus medialis and vastus lateralis EMG activity during exercise. After 11 and 13 training sessions for the left and right knees, respectively, differences between vastus medialis and vastus lateralis activity had markedly decreased. Following the termination of biofeedback training, EMG activity during exercise showed a return toward baseline levels. Several concomitant changes in psychological and physical function were noted. These results suggested that EMG biofeedback can be used to train vastus medialis and vastus lateralis activity in total knee replacement patients, and that biofeedback training may produce positive benefits in other functional areas.The authors wish to express thanks to Dr. Karen Gil for her helpful comments on a draft of this article, and Christianne Herman and Allison Roodman for their help in data collection and entry.     

Biofeedback as a means to alter electromyographic activity in a total knee replacement patient

This paper presents a single case controlled study of a 75-year-old male having bilateral total knee replacement. Baseline EMG recordings demonstrated differential levels of vastus medialis and vastus lateralis muscle activity in both knees during exercise, with increased vastus lateralis activity compared to vastus medialis activity. The purpose of the study was to use electromyographic (EMG) biofeedback training to train the patient to equalize vastus medialis and vastus lateralis EMG activity during exercise. After 11 and 13 training sessions for the left and right knees, respectively, differences between vastus medialis and vastus lateralis activity had markedly decreased. Following the termination of biofeedback training, EMG activity during exercise showed a return toward baseline levels. Several concomitant changes in psychological and physical function were noted. These results suggested that EMG biofeedback can be used to train vastus medialis and vastus lateralis activity in total knee replacement patients, and that biofeedback training may produce positive benefits in other functional areas.     

Computational assessment of constraint in total knee replacement

Anterior-posterior (AP) and internal-external (IE) rotational constraint of total knee replacement (TKR) components is frequently assessed experimentally in a multi-axis loading machine. This constraint is of clinical interest because it represents the contribution of the implants to passive joint constraint following surgery. A standard has been published to establish a uniform protocol of constraint testing (American Society of Testing and Materials (ASTM) International, 2005; Designation: F 1223-05. Standard Test Method for Determination of Total Knee Replacement). In the present study a dynamic computer simulation of a posterior-substituting TKR design undergoing an AP and IE range of constraint test was developed and tested. Implant surfaces in the simulation were specified based on the manufacturer's CAD representations, and contact between implants was computed using a rigid-body-spring-model formulation. Predictions of constraint force compared favorably to experimental values when the compliance of the testing frame was modeled. The simulated constraint test was then used to evaluate the selective locking of secondary degrees of freedom (motions other than AP displacement and IE rotation) during constraint testing. The published ASTM standard does not clearly define either the design of the testing machine to accommodate secondary motions or which coupled motions should be allowed. Predicted component constraint for a posterior cruciate-retaining TKR design was sensitive to both varus-valgus joint location and the combinations of allowed secondary motions. Computational prediction of implant constraint can expedite the design cycle and allow an objective comparison between TKR components tested in different locations.     

Accuracy of intramedullary alignment in total knee replacement

The accuracy of a system of intramedullary alignment using 6 mm rods was assessed in 100 patients undergoing total knee replacements. Post-operative, full length weight-bearing X-rays were used; the mechanical axis from head was used as the reference axis. The method of calculating the errors produced by flexion and rotation of the limb in relation to the X-ray beam is described, the mean deviation from the mechanical axis in 100 cases being 0.67° valgus with a standard deviation of 2.47°. The maximum error was 6.68° valgus and 4.62° varus. The purpose of this study is twofold, first to assess the accuracy of this system of intramedullary alignment and, second, to develop a method of correcting for apparent radiological misalignment using standard radiographic equipment.     

The development,calibration and validation of a numerical total knee replacement kinematics simulator considering laxity and unconstrained flexion motions

Kinematics testing is essential during the development of total knee replacement (TKR) designs. Although computational analysis cannot replace physical testing, it offers repeatability and consistency at a much lower cost and shorter time, making it an excellent complement to experiments. Previous numerical models have been limited by several factors: the validity of the models is usually only considered for a single TKR design, friction models are typically overly simplified and the determination of simulation parameters is often inadequate, or tedious and expensive. The objective of this study is to develop, calibrate and validate a TKR kinematics simulation considering multiple TKR geometries, an accurate friction model and simulation parameters determined using a systematic optimisation method. The calibrated model was able to predict TKR kinematics for different TKR geometries, and is ideal for screening new implant designs, reducing the number of experiments required at the design stage.     

The development, calibration and validation of a numerical total knee replacement kinematics simulator considering laxity and unconstrained flexion motions

Kinematics testing is essential during the development of total knee replacement (TKR) designs. Although computational analysis cannot replace physical testing, it offers repeatability and consistency at a much lower cost and shorter time, making it an excellent complement to experiments. Previous numerical models have been limited by several factors: the validity of the models is usually only considered for a single TKR design, friction models are typically overly simplified and the determination of simulation parameters is often inadequate, or tedious and expensive. The objective of this study is to develop, calibrate and validate a TKR kinematics simulation considering multiple TKR geometries, an accurate friction model and simulation parameters determined using a systematic optimisation method. The calibrated model was able to predict TKR kinematics for different TKR geometries, and is ideal for screening new implant designs, reducing the number of experiments required at the design stage.     

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.     

A subject-specific finite element musculoskeletal framework for mechanics analysis of a total knee replacement

Concurrent use of finite element (FE) and musculoskeletal (MS) modeling techniques is capable of considering the interactions between prosthetic mechanics and subject dynamics after a total knee replacement (TKR) surgery is performed. However, it still has not been performed in terms of favorable prediction accuracy and systematic experimental validation. In this study, we presented a methodology to develop a subject-specific FE-MS model of a human right lower extremity including the interactions among the subject-specific MS model, the knee joint model with ligament bundles, and the deformable FE prosthesis model. In order to evaluate its accuracy, the FE-MS model was compared with a traditional hinge-constraint MS model and experimentally verified over a gait cycle. Both models achieved good temporal agreement between the predicted muscle force and the electromyography results, though the magnitude on models is different. A higher predicted accuracy, quantified by the root-mean-square error (RMSE) and the squared Pearson correlation coefficient (r²), was found in the FE-MS model (RMSE = 177.2 N, r² = 0.90) when compared with the MS model (RMSE = 224.1 N, r² = 0.81) on the total tibiofemoral contact force. The contact mechanics, including the contact area, pressure, and stress were synchronously simulated, and the maximum contact pressure, 22.06 MPa, occurred on the medial side of the tibial insert without exceeding the yield strength of the ultra-high-molecular-weight polyethylene, 24.79 MPa. The approach outlines an accurate knee joint biomechanics analysis and provides an effective method of applying individualized prosthesis design and verification in TKR.     

Computational wear prediction of a total knee replacement from in vivo kinematics

Wear of ultra-high molecular weight polyethylene bearings in total knee replacements remains a major limitation to the longevity of these clinically successful devices. Few design tools are currently available to predict mild wear in implants based on varying kinematics, loads, and material properties. This paper reports the implementation of a computer modeling approach that uses fluoroscopically measured motions as inputs and predicts patient-specific implant damage using computationally efficient dynamic contact and tribological analyses. Multibody dynamic simulations of two activities (gait and stair) with two loading conditions (70-30 and 50-50 medial-lateral load splits) were generated from fluoroscopic data to predict contact pressure and slip velocity time histories for individual elements on the tibial insert surface. These time histories were used in a computational wear analysis to predict the depth of damage due to wear and creep experienced by each element. Predicted damage areas, volumes, and maximum depths were evaluated against a tibial insert retrieved from the same patient who provided the in vivo motions. Overall, the predicted damage was in close agreement with damage observed on the retrieval. The gait and stair simulations separately predicted the correct location of maximum damage on the lateral side, whereas a combination of gait and stair was required to predict the correct location on the medial side. Predicted maximum damage depths were consistent with the retrieval as well. Total computation time for each damage prediction was less than 30 min. Continuing refinement of this approach will provide a robust tool for accurately predicting clinically relevant wear in total knee replacements.     

Measuring the sensitivity of total knee replacement kinematics and laxity to soft tissue imbalances

Ligament balancing during total knee replacement (TKR) is receiving increased attention due to its influence on resulting joint kinematics and laxity. We employed a novel in vitro technique to measure the kinematics and laxity of TKR implants during gait, and measured how these characteristics are influenced by implant shape and soft tissue balancing, simulated using virtual ligaments. Compared with virtual ligaments that were equally balanced in flexion and extension, the largest changes in stance-phase tibiofemoral AP and IE kinematics occurred when the virtual ligaments were simulated to be tighter in extension (tibia offset 1.0 ± 0.1 mm posterior and 3.6 ± 0.1° externally rotated). Virtual ligaments which were tight in flexion caused the largest swing-phase changes in AP kinematics (tibia offset 2.3 ± 0.2 mm), whereas ligaments which were tight in extension caused the largest swing-phase changes in IE kinematics (4.2 ± 0.1° externally rotated). When AP and IE loads were superimposed upon normal gait loads, incremental changes in AP and IE kinematics occurred (similar to laxity testing); and these incremental changes were smallest for joints with virtual ligaments that were tight in extension (in both the stance and swing phases). Two different implant designs (symmetric versus medially congruent) exhibited different kinematics and sensitivities to superimposed loads, but demonstrated similar responses to changes in ligament balancing. Our results demonstrate the potential for pre-clinical testing of implants using joint motion simulators with virtual soft tissues to better understand how ligament balancing affects implant motion.     

A theoretical approach to zonation in a bioartificial liver

Bioartificial livers have yet to gain clinical acceptance. In a previous study, a theoretical model was utilized to create operating region charts that graphically illustrated viable bioartificial liver configurations. On this basis a rationale for the choice of operating and design parameters for the device was created. The concept is extended here to include aspects of liver zonation for further design optimization. In vivo, liver cells display heterogeneity with respect to metabolic activity according to their position in the liver lobule. It is thought that oxygen tension is a primary modulator of this heterogeneity and on this assumption a theoretical model to describe the metabolic zonation within an in vitro bioartificial liver device has been adopted. The distribution of the metabolic zones under varying design and operating parameters is examined. In addition, plasma flow rates are calculated that give rise to an equal distribution of the metabolic zones. The results show that when a clinically relevant number of cells are contained in the BAL (10 billion), it is possible to constrain each of the three metabolic zones to approximately one-third of the cell volume. This is the case for a number of different bioreactor designs. These considerations allow bioartificial liver design to be optimized.     

A computational model for the prediction of total knee replacement kinematics in the sagittal plane

A computational model has been developed using a current generation computer-aided engineering (CAE) package to predict total knee replacement (TKR) kinematic in the sagittal plane. The model includes friction and soft tissue restraint varying according to the flexion angle. The model was validated by comparing the outcomes of anterior-posterior (A-P) laxity tests of two contemporary knee replacements against data obtained from a knee simulating machine. It was also validated against predictions from a computer model reported in the literature. Results show good agreement in terms of A-P displacements. Further tests were performed to determined the influence of the soft tissue restraints varying with flexion angle. This work represents the first attempt to use a sophisticated commercial CAE package to predict TKR motions and the advantages of the modelling procedure chosen are discussed.     

A randomized controlled trial comparing patellar retention versus patellar resurfacing in primary total knee arthroplasty: 5-10 year follow-up

ABSTRACT: BACKGROUND: The primary purpose of this randomized controlled trial (RCT) was to compare knee-specific outcomes (stiffness, pain, function) between patellar retention and resurfacing up to 10 years after primary total knee arthroplasty (TKA). Secondarily, we compared re-operation rates. METHODS: 38 subjects with non-inflammatory arthritis were randomized at primary TKA surgery to receive patellar resurfacing (n = 21; Resurfaced group) or to retain their native patella (n = 17; Non-resurfaced group). Evaluations were performed preoperatively, one, five and 10 years postoperatively by an evaluator who was blinded to group allocation. Self-reported kneespecific stiffness, pain and function, the primary outcomes, were measured by the Western Ontario McMaster Osteoarthritis Index (WOMAC). Revision rate was determined at each evaluation and through hospital record review. RESULTS: 30 (88%) and 23 (72%) of available subjects completed the five and 10-year review respectively. Knee-specific scores continued to improve for both groups over the 10-years, despite diminishing overall health with no significant group differences seen. All revisions occurred within five years of surgery (three Non-resurfaced subjects; one Resurfaced subject) (p = 0.31). Two revisions in the Non-resurfaced group were due to persistent anterior knee pain. CONCLUSIONS: We found no differences in knee-specific results between groups at 5-10 years postoperatively. The Non-resurfaced group had two revisions due to anterior knee pain similar to rates reported in other studies. Knee-specific results provide useful postoperative information and should be used in future studies comparing patellar management strategies. ClinicalTrials.gov identifier NCT01500252.     

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.     

The conflicting requirements of laxity and conformity in total knee replacement

Bearing surfaces of total condylar knees which are designed with a high degree of conformity to produce low stresses in the polyethylene tibial insert may be overconstrained. This study determines femoral and tibial bearing surface geometries which will induce the least destructive fatigue mechanisms in the polyethylene whilst conserving the laxity of the natural knee. Sixteen knee designs were generated by varying four parameters systematically to cover the range of contemporary knee designs. The parameters were the femoral frontal radius (30 or 70 mm), the difference between the femoral and tibial frontal radii (2 or 10 mm), the tibial sagittal radius (56 or 80 mm) and the posterior-distal transition angle (-8 or -20 degrees), which is the angle at which the small posterior arc of the sagittal profile transfers to the larger distal arc. Rigid body analyses determined the anterior-posterior and rotational motions as well as the contact points during the stance phase of gait for the different designs. In addition, a damage function which accumulated the fluctuating maximum shear stresses was used to predict the susceptibility to delamination wear of the polyethylene (damage score). This study predicted that of the 16 designs, the knee with a frontal radius of 70 mm, a difference in femoral and tibial frontal radii of 2 mm, a tibial sagittal radius of 80 mm and a posterior distal transition angle of -20 degrees would satisfy the conflicting needs of both resistance to delamination wear and natural kinematics.