Directly molding IB, MG and AGC UHMWPE tibial inserts has provided excellent clinical performance. This performance may be related to the oxidation resistance and higher fracture toughness provided by the direct molding process. Directly molded UHMWPE components have been reported not to oxidize after either nine years post irradiation aging on the shelf or after 11 years of implantation. Retrievals show that molded IB inserts to have lower oxidation, better polyethylene quality and less surface damage than machined IB II inserts. However, the IB, MG and AGC products were directly molded from 1900 UHMWPE resin which is no longer available. The question remains if directly molding resins other than 1900 in a contemporary modular design will provide the same benefits. We report here on the first knee simulation wear of a contemporary total knee system comprised of a directly molded 1020 esin tibial insert. This result will be compared to the knee simulation result of an IBII machined from 4150 extruded ro 4 Optetrak tibial inserts made by directly molding 1020 resin were tested on a 4 station Instron/Stanmore simulator at 1.4 Hz with a 2279 N maximum load and right knee kinematics. The lubricant was bovine calf serum with EDTA and sodium azide. Axial loads were applied from 0 to 40& #778; flexion and internal/external rotation was −3/+6 degrees. Location, type and area of surface damage, were evaluated every 1 million cycles (Mc). The wear rate of the directly molded inserts was 6X less than reported for machined IB II inserts (2 vs 12 mg/million cycles respectively). There were no signs of delamination or pitting with either design. The more conforming Optetrak provided 52% reduction in wear area over the IB II (21 vs 32 % respectively). This demonstrates that resins other than 1900 may be directly molded in a contemporary and provide the same historical advantages

Aims. Patient dissatisfaction is not uncommon following primary total knee arthroplasty. One proposed method to alleviate this is by improving knee kinematics. Therefore, we aimed to answer the following research question: are there significant differences in knee kinematics based on the design of the tibial insert (cruciate-retaining (CR), ultra-congruent (UC), or medial congruent (MC))?. Methods. Overall, 15 cadaveric knee joints were examined with a CR implant with three different tibial inserts (CR, UC, and MC) using an established knee joint simulator. The effects on coronal alignment, medial and lateral femoral roll back, femorotibial rotation, bony rotations (femur, tibia, and patella), and patellofemoral length ratios were determined. Results. No statistically significant differences were found regarding coronal alignment (p = 0.087 to p = 0.832). The medial congruent insert demonstrated restricted femoral roll back (mean medial 37.57 mm; lateral 36.34 mm), while the CR insert demonstrated the greatest roll back (medial 42.21 mm; lateral 37.88 mm; p < 0.001, respectively). Femorotibial rotation was greatest with the CR insert with 2.45° (SD 4.75°), then the UC insert with 1.31° (SD 4.15°; p < 0.001), and lowest with the medial congruent insert with 0.8° (SD 4.24°; p < 0.001). The most pronounced patella shift, but lowest patellar rotation, was noted with the CR insert. Conclusion. The MC insert demonstrated the highest level of constraint of these inserts. Femoral roll back, femorotibial rotation, and single bony rotations were lowest with the MC insert. The patella showed less shifting with the MC insert, but there was significantly increased rotation. While the medial congruent insert was found to have highest constraint, it remains uncertain if this implant recreates native knee kinematics or if this will result in improved patient satisfaction. Cite this article: Bone Jt Open 2024;5(7):592–600

INTRODUCTION. Postoperative functional limitations after Total Knee Arthroplasty (TKA) are caused, in part, by a mismatch between a patient's natural anatomy and conventional “off-the-shelf” implants. To address this, we propose a new concept combining off-the-shelf femur and tibia implants with custom polyethylene tibial inserts designed to account for a patient's unique anatomy. Our goal in this study was to use knee specific computational modeling to determine the neutral path of motion and laxity of an intact knee under axial compression and shear forces through full flexion and compare intact motion against the same knee implanted with a conventional off-the-shelf vs. a custom tibial insert. METHODS. 3D models of a healthy knee joint were acquired from an open development repository funded by the National Institute of Biomedical Imagining and Bioengineering (Harris et al., 2016). The knee model was virtually implanted with conventional (off-the-shelf) posterior cruciate retaining (CR) components including the femoral component, tibial tray, and a conventional insert. A custom CR tibial insert was designed taking into account native articular geometry and compatibility with placement of the off-the-shelf femoral/tibial tray. Bone, cartilage and implant models were imported into ANSYS Workbench. Ligaments were calibrated using data from in-vitro experimental tests (Harris et al., 2016). The following load conditions were applied to the femur: 20 N axial compression (neutral path), 20 N axial compression with 80 N anterior shear force, and 20 N axial compression with 80 N posterior shear force. Simultaneously for each loading condition, the knee was flexed from 0 – 120 degrees. A circular axis system was used to describe the motion of the femur relative to the tibia. RESULTS. For the intact case, neutral path was characterized by greater posterior femoral displacement on the lateral side than on the medial side, especially in early flexion. Neutral path of the custom insert was closer to intact condition than the conventional insert. Overall AP laxity was similar between intact and implanted models except at 30 degrees where increased laxity occurred posteriorly for the implanted models, likely due to resection of the anterior cruciate ligament (ACL) as part of the TKA procedure. For intact and implanted models, AP laxity significantly decreased at the higher flexion angles. DISCUSSION. Our findings indicate that motion with a custom tibial insert was closer to intact than the conventional design. Nonetheless, custom articular surface alone may not fully reproduce intact motion due to limitations such as resection of the ACL, and such custom inserts may benefit from guiding features such as a cam, post, or retention of the native ACL to more closely reproduce normal knee function. We did not simulate specific activities of daily living. Increasing the magnitudes of compression and shear forces would not change the neutral path of motion, although, a reduction in laxity would be expected

Introduction. A tibial insert with choices in size, thickness, and posterior slope is proposed to improve ligament balancing in total knee arthroplasty. However, increasing posterior slope, or the angle between the distal and proximal insert surfaces, will redistribute ultra-high molecular weight polyethylene (UHMWPE) thickness in the sagittal plane, potentially affecting wear. This study used in-vitro testing to compare wear for a standard cruciate-retaining tibial insert (STD) and a corresponding 6° sloped insert (SLP), both manufactured from direct-compression molded (DCM) UHMWPE. Our hypothesis was slope variation would have no significant effect on wear. Methods. Two of each insert (STD and SLP) were tested on an Instron-Stanmore knee simulator with a force-control regime. The gait cycle and other settings followed ISO 14243-1 and -2, except for reference positions. The STD insert was tilted 6° more than the SLP insert to level the articular surfaces. Wear was gravimetrically measured at intervals according to strict protocol. Results. No statistical difference (p=0.36) in wear rates was found for the STD (9.5 ±1.8 mg/Mc)) and SLP (11.4 ±0.5 mg/Mc) inserts. Discussion. The overall wear rate measured was higher than previously published rates for implants similar to the STD inserts. This may result from increased shear loads due to the shift in reference position and 6° slope. This is the first time the effect of tibial insert slope on wear has been evaluated in-vitro. For inserts made from DCM UHMWPE with a slope limited to 6°, this test suggests altering tibial insert slope has an insignificant effect on wear

A tibial insert with choices in posterior slope, size, and thickness is proposed to improve ligament balancing in total knee arthroplasty. However, increasing slope, or the angle between the distal and proximal insert surfaces, will redistribute ultra-high molecular weight poly-ethylene (UHMWPE) thickness in the sagittal plane, potentially affecting wear. This study used in-vitro testing to compare UHMWPE wear for a standard cruciate-retaining (CR) tibial insert (STD) and a corresponding 6° sloped insert (SLP). Our hypothe sis was that slope variation would have little effect on wear. Two of each style inserts were tested on an Instron-Stanmore knee simulator with a force-control regime. The gait cycle and other settings followed ISO 14243-1 & 2, except for the reference position, which was posteriorly shifted 6 mm to simulate the worst-case scenario. The STD insert was tilted 6° more than the SLP to level the articular surfaces. Wear was gravimetrically measured at intervals according to strict protocol. No statistical difference (p=0.36) was found between wear for the STD (9.5 ±1.8 mg/Mc) and SLP (11.4 ±0.5 mg/Mc) inserts. The overall wear rate measured was higher than previously published rates using implants similar to the STD inserts. This may relate to the shift in the reference position and the 6° slope, leading to increased shear loads. This is the first time the effect of tibial insert slope on wear has been evaluated in-vitro. When limited to 6°, wear testing suggests that al tering the tibial insert slope will have a minor effect on UHMWPE wear

Aims. Mobile-bearing unicompartmental knee arthroplasty (UKA) with a flat tibial plateau has not performed well in the lateral compartment, leading to a high rate of dislocation. For this reason, the Domed Lateral UKA with a biconcave bearing was developed. However, medial and lateral tibial plateaus have asymmetric anatomical geometries, with a slightly dished medial and a convex lateral plateau. Therefore, the aim of this study was to evaluate the extent at which the normal knee kinematics were restored with different tibial insert designs using computational simulation. Methods. We developed three different tibial inserts having flat, conforming, and anatomy-mimetic superior surfaces, whereas the inferior surface in all was designed to be concave to prevent dislocation. Kinematics from four male subjects and one female subject were compared under deep knee bend activity. Results. The conforming design showed significantly different kinematics in femoral rollback and internal rotation compared to that of the intact knee. The flat design showed significantly different kinematics in femoral rotation during high flexion. The anatomy-mimetic design preserved normal knee kinematics in femoral rollback and internal rotation. Conclusion. The anatomy-mimetic design in lateral mobile UKA demonstrated restoration of normal knee kinematics. Such design may allow achievement of the long sought normal knee characteristics post-lateral mobile UKA. However, further in vivo and clinical studies are required to determine whether this design can truly achieve a more normal feeling of the knee and improved patient satisfaction. Cite this article: Bone Joint Res 2020;9(7):421–428

Artificial knee joints are continuously loaded by higher contact stress than artificial hip joints due to a less conformity and much smaller contact area between the femoral and tibial surfaces. The higher contact stress causes severe surface damage such as pitting or delamination of polyethylene (PE) tibial inserts. To decrease the risks of these surface damages, the oxidation degradation of cross-linked polyethylene (PE) induced by residual free radicals resulting from gamma-ray irradiation for cross-linking or sterilization should be prevented. Vitamin E (VE), as an antioxidant, blended PE (PE(VE)) has been used to solve the problems. In addition, osteolysis induced by PE wear particles, bone cement and metallic debris is recognized as one of the important problems for total knee arthroplasty (TKA). To decrease the generation of PE wear particles, we have developed the bearing surface mimicking the articular cartilage; grafting a biocompatible polymer, poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC), onto the PE surface having high wear resistance. In this study, we have evaluated the surface, mechanical under severe oxidative condition, and wear properties of PMPC-grafted cross-linked PE(VE) (PMPC-CLPE(VE)) material for artificial knee joints. Untreated and PMPC-grafted 0.1 mass% VE-blended PE (GUR1020E resin) with a gamma-ray irradiation of 100 kGy for cross-linking and 25 kGy for sterilization were prepared (CLPE(VE) and PMPC-CLPE(VE), respectively). Surface properties were evaluated by Fourier-transform infrared (FT-IR) spectroscopy and transmission electron microscope (TEM) observations. Surface wettability and frictional property were measured by static water contact angle measurement and ball-on-plate friction test. To evaluate the oxidation degradation resistance, mechanical and physical properties such tensile test, izod impact test, small punch test and cross-link density measurement before and after accelerated aging were measured. Wear properties of the tibial inserts were examined by using knee simulator in the combination of Co-Cr-Mo femoral components according to ISO14243-3. Gravimetric wear, volumetric penetration and the number of generated wear particles were measured. By the FT-IR measurements and TEM observation, P–O peaks attributed to MPC unit and uniform PMPC layer with 100–200 nm thick was observed only on PMPC-CLPE(VE) surface. Static water contact angle of CLPE(VE) was almost 100 degree, while that of PMPC-CLPE(VE) decreased significantly to almost 35 degree. There was no significant difference in the mechanical and physical properties between CLPE(VE) and PMPC-CLPE(VE). Moreover, both the CLPE(VE) and PMPC-CLPE(VE) maintained these properties even after the accelerated aging of 12 weeks [Fig. 1]. Blended VE in CLPE would act as radical scavengers to prevent oxidation degradation. In the knee simulator wear test, the PMPC-CLPE(VE) tibial inserts showed about a half gravimetric wear compared to the CLPE(VE) tibial inserts [Fig. 2]. This would be due to the significant differences observed in wettability of the surface. Water thin film formed on the hydrated PMPC graft layer, would act as significantly efficient lubricant. From these results, the PMPC-CLPE(VE) is expected to be one of the great bearing materials not only preventing surface damages due to higher contact stress and oxidation degradation but also improving wear resistance, and to provide much more lifelong artificial knee joints. For any figures or tables, please contact authors directly (see Info & Metrics tab above).

Introduction. Ability to accommodate increased range of motion is a design objective of many modern TKA prostheses. One challenge that any “high-flex friendly” prosthesis has to overcome is to manage the femorotibial contact stress at higher flexion angle, especially in the polyethylene tibial insert. When knee flexion angle increases, the femorotibial contact area tends to decrease thus the contact stress increases. For a high-flex design, considerations should be taken to control the contact stress to reduce the risk of early damage or failure on the tibial insert. This study evaluated the effect of femoral implant design on high flexion contact stress. Two prostheses from a same TKA family were compared – one as a conventional design and the other as a high-flex design. Methods. Two cruciate retaining (CR) prostheses from a same TKA product family were included in this study. The first is a conventional design for up to 125° of flexion (Optetrak CR, Exactech, USA). The second is a high-flex design for up to 145° of flexion (Logic CR, Exactech, USA). The high-flex design has a femoral component which has modified posterior condyle geometry (Figure 1), with the intent to increase femorotibial contact area and decrease contact stress at high flexion. Three sizes (sizes 1, 3, and 5) from each prosthesis line were included to represent the commonly used size spectrum. Contact stress was evaluated at 135° of flexion using finite element analysis (FEA). The CAD models were simplified and finite element models were created assuming all materials as linear elastic (Figure 2). For comparison purpose, a compressive force of 20% body weight was applied to the femoral component. The average body masses of sizes 1, 3 and 5 patients are 69.6 kg, 89.9 kg, and 106.3 kg based on the manufacture's clinical database. A nonlinear FEA solver was used to solve the simulation. Von Mises stress in the tibial insert was examined and compared between the two prostheses. Results. The high-flex design demonstrated lower tibial insert stresses compared to the conventional design, and the stress reduction is consistent across different sizes (Figure 3). The peak von Mises stress of the high-flex design was 8.6 MPa, 10.8 MPa, and 11.9 MPa for sizes 1, 3 and 5, representing a 40% to 60% decrease compared to those of the conventional design (14.3 MPa, 26.5 MPa, and 25.6 MPa respectively). Discussion/Conclusion. One limitation of the study was that no material nonlinearity was considered in the FEA, thus stress values above the yield strength of polyethylene could be over-estimated. However, as a qualitative comparison, the analysis demonstrated the effectiveness of the high-flex design on reducing tibial insert contact stress. Although the actual flexion angle of a CR TKA patient is not fully defined by the prosthesis and largely affected by the patient's anatomy and pre-operative range of motion, a lower contact stress at high flexion indicates a more forgiving mechanical structure and less risk for polyethylene damage when the patient is able to perform high flexion activities

Introduction. Total knee arthroplasty (TKA) prostheses are semi-constrained artificial joints. Femorotibial constraint is a key property of a TKA prosthesis and should be designed to match the device's intended function. Cruciate Retaining (CR) prostheses are usually used for patients with a functioning posterior cruciate ligament (PCL). For patients without a fully functioning PCL, CR-Constrained (CRC) prostheses may be used. A CRC tibial insert usually has a more conforming sagittal profile especially in the anterior aspect to provide increased constraint to prevent paradoxical femoral translation during knee flexion. A quantitative understanding of the constraint behavior of a prosthesis design is critical to ensure its functional outcome. Using a validated computer simulation, this study evaluated the anterior-posterior (AP) constraint of two types of tibial inserts (CR and CRC) from a same TKA product family. Methods. Both the CR and CRC prostheses are from the same TKA product family (Optetrak Logic, Exactech, USA). Three sizes (sizes 1, 3, and 5) from each product line were included in this study. Computer simulations using finite element analysis (FEA) were performed at 0° flexion per ASTM F1223 standard [1] (Figure 1). The simulation has been validated with physical testing (more details submitted in a separate abstract to ISTA 2013). Briefly, FEA models were created with all materials considered linear elastic. The tibial baseplate was distally fixed and a constant compressive force (710 N) was applied to the femoral component. Nonlinear Surface-Surface-Contact was established at the articulating surfaces. A coefficient of friction of 0.1 was assumed for all articulations [2]. The femoral component was driven under a displacement-controlled scheme to slide along AP direction on the tibial insert. Constraint force occurring at the articulation was derived from the reaction force at the distal fixation. A nonlinear FEA solver was used to solve the simulations. Results. The force-displacement curves predicted by the simulation exhibited the hysteresis loop appearance for both CR and CRC inserts (Figure 2). The anterior aspect of the CRC curves showed a steeper raise than the CR curves, and the trend was consistent across sizes. Taking the slope from 0 to 5 mm range, the anterior constraint of the CRC insert was significantly greater than the CR insert, while the posterior constraint of the CRC insert was also slightly greater (Figure 3). Discussion/Conclusion. The increased AP constraint of the CRC insert revealed in the study is consistent with the design geometry and functional intent of the device. With a much increased anterior lip, the CRC insert is expected to provide substantially greater anterior constraint than the CR insert to prevent paradoxical femoral translation for patients without a fully functioning PCL. The CRC insert is also expected to provide slightly increased posterior constraint due to its gently elevated posterior lip. This study quantitatively demonstrated the effect of design geometry on the outcome constraint function of different TKA prostheses

Purpose: This study develops and validates a technique to quantify polyethylene wear in tibial inserts using micro-computed tomography (micro-CT), a nondestructive high resolution imaging technique that provides detailed images of surface geometry in addition to volumetric measurements. Method: Six unworn and six wear-simulated Anatomic Modular Knee (DePuy Inc, Warsaw, IN) tibial inserts were evaluated. Each insert was scanned three times using micro-CT at a resolution of 50 μm. The insert surface was reconstructed for each scan through automatic segmentation and the insert volume was calculated. Gravimetric analysis was also performed for all inserts, and the micro-CT and gravimetric volumes were compared to determine accuracy. The utility of surface deviation maps derived from micro-CT was demonstrated by co-registering a worn and unworn insert. 3D deviations were measured continuously across the entire insert surface, including the articular and backside surfaces. Results: The mean percent volume difference between the micro-CT and gravimetric techniques was 0.04% for the unworn inserts and 0.03% for the worn inserts. No significant difference was found between the micro-CT and gravimetric volumes for the unworn or worn inserts (P = 0.237 and P = 0.135, respectively). The mean coefficient of variation for volume between scans was 0.07% for both unworn and worn inserts. The map of surface deviations between the worn and unworn insert revealed focal deviations exceeding 750 μm due to wear. Conclusion: Micro-CT provides precise and accurate volumetric measurements of polyethylene tibial inserts. Quantifiable 3D articular and backside surface deviation maps can be created from the detailed geometry provided by the technique. Compared to coordinate mapping, micro-CT provides 10 times greater surface sampling resolution (50 μm vs 500 μm) across the entire insert surface. Micro-CT is a useful analysis tool for wear simulator and retrieval studies of the polyethylene components used in total knee replacement

To reveal if patient reported knee-related pain, function, quality of life, general health and satisfaction at one year after primary total knee arthroplasty (TKA) is different between patients not being subject to revision surgery and those having had early treatment with open debridement and exchange of the tibial insert for postoperative PJI. The Swedish Knee Arthroplasty Register was used to identify 50 patients in the region of Skane that had a primary TKA during the years 2008 – 2012 and within 6 months were revised with open debridement and exchange of the tibial insert due to suspected or verified PJI. Only patients without further revisions were included. Patient reported outcome measurements (PROM) were obtained preoperatively and 1 year postoperatively and included knee related pain, function, quality of life using the Knee injury and Osteoarthritis Outcome Score (KOOS), general health using the EQ-VAS as well as satisfaction with the surgery. The scores were compared to those reported by 3,913 patients having a TKA during the same time but not revised during the first year. Welch's t-test and the Chi2-test were used in statistical analysis. Compared to the controls the infected patients were older (mean age 72 vs 69 years, p = 0.04) and were more morbid (ASA 3; 14/50 patients vs 14%, p = 0.02). The preoperative PROM data were similar. Complete 1 year PROM data was available for 31 of the patients. Those patients reported somewhat worse outcome one year postoperatively than the controls with statistically and clinically significant differences in general health (mean 61 vs 76, p=0.002), KOOS ADL (mean 65 vs 76, p=0.03) and knee related quality of life (mean 51 vs 63, p=0.02) with large variations on individual level. Just over half of the patients (17/29) treated for PJI were very satisfied or satisfied with the surgery compared to 79% of the controls. Patients treated with open debridement and exchange of the tibial insert due to early PJI after primary TKA reported less beneficial postoperative outcome than those without revision surgery during the first postoperative year but with large individual variations

One third of the world population have a life style to sit sedentary on a floor. Thus far the patients who had undergone TKA surgery loose deep flexion of the knee and various designs of artificial knee joint capable of deep knee flexion have been proposed. Among them, Bi-surface knee prosthesis (Kyocera Inc., Japan) is of special interest because of its unique design with a ball-and-socket joint. Although some patients attained a sedentary sitting with this prosthesis, the X-ray studies revealed that the femoral condyles and tibial insert tended to separate at about 150° of knee flexion, indicating a risk of subluxation when standing up. Thus we have developed CFK (Complete Flexion Knee, Japan Medical Material Co., Japan) by further improving Bi-surface knee to enable the patient to make knee flexion as much as 180°. Our CFK has a ball-and-socket joint and whose socket part is jutted to form a tibial post. Since the ball and the cam become into a single sphere and the ball-socket and post-cam joints form a spherical bearing, CFK can provide high stability and mobility at the same time. Besides its kinematic performance, CFK has to be assessed with its strength and durability. Since the durability of an artificial knee joint is attributed to wear of the polyethylene insert, it is essential to focus on determining the stress on it. Although the FEM analyses have been most extensive for stress analysis, whose results greatly depend upon the way how to create the meshes. The stress values introduced from the FEM are the Von Misses stresses; while wear is mainly attributed to the shear stresses. For these reasons, we employed a photoelasticity for determining the magnitude and distributions of stresses on the insert. The models of Bi-surface, CFK and a conventional posterior stabilizer knee, Scorpio NRG (Stryker Co., USA) were used for the experiments. Epoxy resins (Araldite AER 250, 2400, Ciba Geigy Co., Japan) were selected to fabricate the tibial insert models. Special equipment was used to apply 2 kg force on the model by setting knee flexion angle at 0°, 30°, 60°, 90° and 120° respectively. After that the stressed model was sliced along the anterio-posterior direction and photoelastic fringes in each slice were observed. The results demonstrated that while knee angle was smaller than 90°, shear stress on the lateral slice became higher in the order, NRG, CFK, and Bi-surface, indicating NRG has high conformity in the condylar surface. After knee angle bacame larger than 90°, shear stress on the mid-posterior slice became higher in the order, CFK, Bi-surface and NRG. We may conclude that CFK has optimal configuration at deep knee flexion not only for kinematic but also for load bearing viewpoints

Knee prostheses have widely been used for severely damaged knee with osteoarthritis or articular rheumatism. PS type knee prosthesis is one of typical artificial knee joint systems and characterized by possessing the post-cam structure to stabilize the motion of the knee at large flexion angles. Post is a projection placed on the surface of UHMWPE tibial insert, and severe fracture and wear of the post are sometimes reported. It is therefore very important to understand the stress state of the post under real flexion motions in order to prevent such damages. It is also well known that the contact and bearing surfaces of a human knee is subjected to very high force especially during deep knee flexional motion such as squatting, and it is naturally expected that the tibial insert of a knee prosthesis deforms plastically under such high force condition. In this study, three dimensional dynamic finite element analysis of two types of PS knee prosthesis clinically used worldwide, Stryker’s Scorpio Superflex and NRG, are performed to characterize the plastic deformation behavior due to stress concentration generated in their tibial inserts under deep knee flexion motions. The new system NRG is recognized as a modified version of Superflex. Especially, the shape of the post is tried to be improved in order to reduce stress concentration and mobility. Continuous repeated flexional motion such as flexion-extension-flexion motion is considered in the analysis. Internal rotation of the tibial component and insert with flexional motion is also considered. It is found that severe stress concentration is generated in the post for both models and also in the condylar surfaces, and the stress concentration in Superflex is much higher and wider in NRG. Plastic deformation is therefore observed at these stress concentration points. The relationship between residual stress and plastic deformation in the tibial inserts is then discussed based on the analytical results

The goal of total knee arthroplasty (TKA) is to relieve pain and restore the function of the knee joint. Recently the number of TKA cases in Korea has increased considerably with increase in elderly population and change in life style. Accordingly, demand for TKA design that is capable of better accommodating anatomical dimensions and life styles of Koreans is also on the rise. During the prototype design process for the Korean-TKA, different stem and keel designs of the tibial base plate have been attempted to improve fixation and longevity of the implant. In this study, we conducted a biomechanical analysis of the tibial base plate using finite element analysis (FEA). Specifically, biomechanical effects of insert positioning in the tibia were assessed to investigate the likelihood of tibial fracture and implant loosening due to mal-positioning of the implant. A 3-D finite element(FE) models of the left femur, patella, and tibia were developed from computed tomography (CT) scan data (a normal Korean male, 27 years of age, 70 kg). 2-D truss elements were chosen to represent ligamentous structures such as lateral & medial collateral ligament, posterior cruciate ligament, patella tendon and patella ligament. Nonlinear elastic materal properties for the soft-tissue structures were also adopted from literatures. The surgical model was then constructed after inserting Korean-TKA prototype in the intact model. Here, the implant was the posterior cruciate ligament retaining type (CR) with the fixed bearing system. To simulate loading on the knee joint in heel strike and toe off positions, 15° and 45° flexions of the femur orientation were simulated under the compressive load of 3.8 and 5.7 times of body weight (BW= 700N), respectively, in a uniform pressure at the horizontal section of the femur. The tibia was assumed to be completely constrained. The surgical position of the tibial insert was varied from the center either to the medial or to the lateral direction by 3-mm. The peak von mises stresses (PVMS) at the stem and the keel regions of the tibial insert were assessed. With respect to the central positioning the lateral shift of the tibial plate resulted in higher PVMS than the medial. Particularly, increases of 24.5 %, 29.8%, and 28.4% were observed at the stem, the lateral keel, and the medial keel, respectively, due to lateral mal-positioning of the implant. With the medial shift, on the other hand, PVMS increase remained at around 6% level at the stem and the lateral keel. A decrease of 4.5 % was noted at the medial keel region. In this study, a computational approach was used to evaluate biomechanical effect of tibial plate positioning on the stress distribution within the implant. The lateral mal-positioning showed more stress concentration than the medial. This may be due to the fact that body weight is transmitted more to the lateral portion of the tibia (5.5:4.5) that is smaller and thinner than its counterpart. These results suggest that the lateral deviation of the implant can be more likely cause TKR loosening and tibial fracture

Introduction. In total knee arthroplasty (TKA), tibial insert thickness is determined intraoperatively by applying forces that generate varus-valgus moments at the knee and estimating the resulting gaps. However, how the magnitude of applied moments and the surgeon's perception of gaps affect the thickness selection is unclear. We determined this relationship using an in vitro human cadaveric model. Methods. Six pelvis-to-toe specimens (72±6 years old, four females) were implanted by an expert surgeon with a PS TKA using measured resection. Pliable sensors were wrapped around medial and lateral aspects of the foot and ankle to measure the applied forces. The forces were scaled by limb length to obtain the moments generated at the knee. Six surgeons with different experience levels independently assessed balance by applying moments in extension and 90° of flexion and choosing the insert they believed fit each knee. Peak moments and the accompanying extension and flexion gap openings as perceived by surgeons were recorded. The two measures were then related to insert choice using a generalized estimating equation. Results. The peak applied moments varied among surgeons (mean of 14±2.5 Nm in extension and 10±3 Nm in flexion). In extension, surgeons perceived a medial gap of 1.3±0.8 mm and a lateral gap of 0.9±0.7 mm. In flexion, surgeons perceived a medial gap of 1.1±0.9 mm and a lateral gap of 1.7±1.6 mm. Despite these differences, surgeons' choices of insert thickness varied by at most 1 mm, with no association found between the selected thickness and either peak moments or surgeons' gap perception (p>0.05). Conclusions. In a controlled setting, surgeons of varying experience levels showed remarkable convergence in insert thickness selection. This notable consistency was unrelated to either the applied moments or their estimation of extension and flexion gaps, indicating that other factors may be driving this decision

Postoperative functional outcomes and patients’ satisfaction after total knee arthroplasty are associated with postoperative range of motion. Severe deformities require surgical correction such as soft tissue release and appropriate bone resection. The goal of surgery is to correct the contracture and bring the knee to good range of motion. Using gap-balancing technique is one of the major techniques to obtain good range of motion. Although the gaps are well balanced, the thickness of tibial insert would affect the range of motion. In this study, we analyzed the difference between intraoperative extension joint gap and the thickness of implanted insert (DJI). The objective of this study was to investigate whether DJI affected the postoperative extension of the knee. A total of 155 knees were analyzed retrospectively. Subject included 27 males and 128 females with an average of 72.7 ± 7.0 years. The mean preoperative knee flexion angle was 136.1 ± 20.0°and the mean preoperative knee extension deficit was 4.0 ± 6.1°. All the patients had a diagnosis of varus-type osteoarthritis, identical prostheses (Stryker NRG posterior-stabilized type) implanted with a modified gap-balancing technique and no postoperative complications which may have affected the range of motion. Range of motion was measured using a goniometer before surgery and 12 months after surgery. Joint gap between femoral component and proximal tibia in full extension was measured by a tensor/ balancer device which added joint gap an expansion force by 30 inch pounds intra-operatively. Although we empirically regarded the appropriate DJI was 5 mm for this prosthesis, we determined the thickness of the tibial inserts considering preoperative range of motion. Thinner inserts compared with the joint gap was implanted for knees with flexion contracture and thicker inserts was implanted for knees with hyperextension. In this study, to determine the relationship of DJI and flexion contracture, the correlation coefficient between DJI and extension deficit was calculated. The diagram of DJI and postoperative extension angle is shown in Figure 1. The correlation coefficient between DJI and postoperative extension deficit was 0.24, which showed that DJI slightly affected the postoperative extension of the knee. Flexion contracture cannot be corrected by simply adjusting DJI

Numerous studies have reported on the effects of modular insert design on stress at the tibial/femoral articular surface. However, while the insert / tibial component surface (“backside”) wear and motion have been investigated, backside stress is not well delineated. Because stress may be related to observed backside damage, this study addressed the backside stress response to insert thickness, material, and articular geometry. Twelve Natural Knee II tibial inserts (Sulzer Orthopedics Inc.) with three thicknesses (6, 12.5, and 18.5 mm), two materials (Durasul and 4150 UHMWPE), and two types of condylar geometry (congruent and ultra-congruent) were tested. Fuji film was placed between the baseplate and insert. A femoral component was loaded onto the insert in axial compression at four times Body Weight. The film was scanned into Adobe Photoshop to measure mean and peak luminosity, which was converted into stress. Analysis of Variance was performed with main effects and all two-way interactions to determine significance. The mean stress ranged from 0.61 to 3.92 MPa and the peak stress ranged from 2.17 to 10.4 MPa. Insert thickness significantly influenced both mean (p=0.001) and peak (p=0.001) backside stress. Stress for the 6 mm inserts (7.17 MPa mean, 9.91 MPa peak) were approximately 2.1 times the 12.5 mm inserts (3.47 MPa mean, 4.66 MPa peak), and were approximately 2.6 times the 18.5 mm inserts (2.74 MPa mean, 3.71 MPa peak). There was not a significant effect on mean or peak stress from material or condylar geometry. None of the interactions were significant. This study provides two important contributions. First, it establishes the backside stress magnitude during simple loading. Second, the relationship between backside stress and the insert thickness is experimentally quantified. Understanding this stress magnitude and response may be important to controlling observed in-vivo backside damage

Optimal soft tissue tension maximises function after total knee arthroplasty (TKA). Excessive tension may lead to stiffness and or pain, while inadequate tension can lead to instability. Composite component thickness is a prime determinant of this soft tissue tension. The thickness provided by polyethylene inserts currently allows for a 2–3 mm incremental change. This study analyses the effect of incremental change in polyethyl-ene thickness on soft tissue tension. Computer assisted (Stryker Knee Nav) TKA was performed on 8 cadaveric knee specimens (4 pairs). Kinematic data was collected through the navigation software. The soft tissue tension was analysed by measuring compartmental loads. A validated load cell instrumented tibial insert was used to measure medial and lateral compartmental loads independently. The effect of 1mm increments in polyethylene thickness on compartmental loads was evaluated. We measured an increase in compartmental loads with increasing insert thickness. The peak loads in each compartment showed different behaviour reflecting varying tension in the medial and lateral sides. The peak loads generated showed a reduction after reaching a maximal level with further increase in insert thickness. With a one mm increase in insert thickness, 75 % of specimens showed greater than 200 % increase in the peak loads in the lateral compartment. Similarly the medial loads showed a greater than 100% increase. Individual specimens showed a high variability in loading patterns. Our study highlights high variation of knee loads present between subjects. The compartmental loads vary as a function of insert thickness. The high sensitivity of compartmental loads with a 1mm increment is significant and has not been previously appreciated, especially intraoperatively. The currently available TKA inserts with 2–3 mm increments may make obtaining optimal soft tissue tension difficult. In addition to the current focus of obtaining accurate leg alignment, further computer aided techniques are required to address soft tissue tension

Introduction: Optimal soft tissue tension maximises function after total knee arthroplasty (TKA). Excessive tension may lead to stiffness and or pain, while inadequate tension can lead to instability. Composite component thickness is a prime determinant of this soft tissue tension. The variable component thickness provided by polyethylene inserts generally allows for 2-3 mm incremental change. This study analyses the effect of incremental change in polyethylene thickness on soft tissue tension. Methodology: Computer assisted (Stryker Knee Nav) TKA was performed on 8 cadaveric knee specimens (4 pairs). Kinematic data was collected through the navigation software. The soft tissue tension was analysed by measuring compartmental loads. A validated load cell instrumented tibial insert was used to measure medial and lateral compartmental loads independently. The effect of 1mm increments in polyethylene thickness on compartmental loads was evaluated. Results: We measured an increase in compartmental loads with increasing insert thickness. However the peak loads in each compartment showed different behaviour reflecting varying tension in the medial and lateral sides. The peak loads generated also showed a reduction after reaching a maximal level with further increase in insert thickness. With a 1 mm increase in insert thickness, 50 % of specimens showed greater than 200 % increase in the peak loads in the lateral compartment. Conclusions: The compartmental loads vary as a function of insert thickness. The high sensitivity of compartmental loads with a 1mm increment is significant and has not been previously appreciated, especially intraoperatively. The currently available TKA inserts with 2-3 mm increments may make obtaining optimal soft tissue tension difficult. In addition to the current focus of obtaining accurate leg alignment, further computer aided techniques are required to address soft tissue tension

Aims: To determine the in vivo movements between the polyethylene and the metal tibial tray in modular fixed bearing TKA. Methods: 16 patients (median age 72) operated with the NexGen TKA were studied. The metal tray of the tibial component was equipped with 5 tantalum markers, and the polyethylene insert with 6 markers. Radiostereometric (RSA) investigation was performed within one week postop., and at 12 months. Change in position of the poly insert in relation to the metal tray between the postop and the 12 months investigation was analyzed. Insert motion index (IMI) = √AP² +ML2 was also calculated where AP is the largest AP-translation and ML the largest ML-translation. Results: The polyethylene component rotated a median 0.55° (0.09° to 1.21°) in relation to the metal tray in the horizontal plane, mostly externally, corresponding to a median IMI of 415 μm (19 to 920 μm). Movements of the polyethylene out of the plane of the tibial tray were very small and generally below the precision of the RSA method. Conclusions: This study shows for the first time that movements do occur in vivo between the polyethylene insert and the metal tray in modular fixed bearing TKA. Almost all movements occur in the horizontal plane of the metal tray and very little movements are detected in directions out of this plane. The magnitudes of IMI found in vivo study are equivalent to those found in vitro in studies of explanted components.