Introduction. Initial large-scale clinical studies of porous tantalum implants have been generally promising with well-fixed implants and few cases of loosening [1–3]. An initial retrieval study suggests increased bone ingrowth in a modular tibial tray design compared to the monoblock design [4]. Since micromotion at the bone-implant interface is known to influence bone ingrowth [5], the goal of this study was to determine the effect of implant design, bone quality and activity type on micromotion at the bone-implant interface, through FE modeling. Patients & Methods. Our case-specific FE model of bone was created from CT data (68 year-old female, right tibia, Fig-1). Isotropic properties of cortical and trabecular bone were derived from the calibrated CT data. Modular and monoblock porous tantalum tibial implants were virtually placed in the tibia following surgical guidelines. All models parts were 3D meshed with 4-noded tetrahedral elements (MSC.MARC-Mentat 2013, MSC Software Corporation, USA). Frictional contact was applied to the bone-tantalum interface (µ=0.88) and UHWMPE-Femoral condyle interface (µ=0.05) with all other interfaces bonded. Loading was applied to simulate walking, standing up and descending stairs. For each activity, a full load cycle [6] was applied to the femoral condyles in incremental steps. The direction and magnitude of micromotions were calculated by tracking the motions of nodes of the bone, projected onto the tibial tray. Micromotions were calculated parallel to the implant surface (shear), and perpendicularly (tensile). We report the maximum (resultant) micromotion that occurred during a cycle of each activity. The bone properties were varied to represent a range in BMD (−30%BMD, Norm, +30%BMD). We compared design type, bone quality and activity type considering micromotion below 40 µm to be favorable for bone ingrowth [5]. Results. The modular tibial tray showed lower shear micromotion than the monoblock design for shear micromotion (Fig-2). Tensile micromotion was similar between the two designs (Fig-2). Lower bone quality resulted in higher shear micromotion for the modular tibial tray design. The effect of lower bone quality on shear micromotion was less apparent for the monoblock tibial tray design. For both designs, change in the bone quality had minimal effect on the tensile micromotion. For both designs, standing up and descending stairs showed lower micromotion than walking for both the tensile and shear micromotion (Fig-3). The monoblock design showed higher micromotion for standing up and descending stairs compared to the modular design (Fig-3). Discussion. In our analysis, activity type had the highest effect on micromotion. Additionally, the modular design showed lower shear micromotion than the monoblock. Although the designs were similar for the the modular and monoblock implants, the difference in micromotion, representing the initial stability of the implant, may partially explain why retrieved modular porous tantalum tibial trays had higher bone ingrowth than the monoblock design

Introduction. The goal of tibial tray placement in total knee arthroplasty (TKA) is to maximize tibial surface coverage while maintaining proper rotation. Maximizing tibial surface coverage without component overhang reduces the risk of tibial subsidence. Proper tibial rotation avoids excess risk of patellar maltracking, knee instability, inappropriate tibial loading, and ligament imbalance. Different tibial tray designs offer varying potential in optimizing the relationship between tibial surface coverage and rotation. Patient specific instrumentation (PSI) generates customized guides from an MRI- or CT-based preoperative plan for use in TKA. The purpose of the present study was to utilize MRI information, obtained as part of the PSI planning process, to determine, for anatomic, symmetric, and asymmetric tibial tray designs, (1) which tibial tray design achieves maximum coverage, (2) the impact of maximizing coverage on rotation, and (3) the impact of establishing neutral rotation on coverage. Methods. In this prospective comparative study, MR images for 100 consecutive patients were uploaded into Materialise™ PSI software that was used to evaluate characteristics of tibial component placement. Tibial component rotation and surface coverage was analyzed using the preoperative planning software. Anatomic (Persona™), symmetric (NexGen™), and asymmetric (Natural-Knee II™) designs from a single manufacturer (Zimmer™) were evaluated to assess the relationship of tibial coverage and tibial rotation. Tibial surface coverage, defined as the proportion of tibial surface area covered by a given implant, was measured using Adobe Photoshop™ software (Figure 1). Rotation was calculated with respect to the tibial AP axis, which was defined as the line connecting the medial third of the tibial tuberosity and the PCL insertion. Results. When tibial surface coverage was maximized, the anatomic tray compared to the symmetric/asymmetric trays showed significantly higher surface coverage (82.1% vs 80.4/80.1%; p<0.01), significantly less deviation from the AP axis (0.3° vs 3.0/2.4°; p<0.01), and a significantly higher proportion of cases within 5° of the AP axis (97% vs 73/77%). When constraining rotation to the AP axis, the anatomic tray showed significantly higher surface coverage compared to the symmetric/asymmetric trays (80.8% vs 76.3/75.8%; p<0.01). No significant differences were found between symmetric and asymmetric trays. Discussion. We found that the anatomic tibial tray resulted in significantly higher tibial coverage with significantly less deviation from the AP axis compared to the symmetric and asymmetric trays. When rotation was constrained to the AP axis, the anatomic tray resulted in significantly higher tibial coverage than the symmetric and asymmetric trays. Tibial rotation is recognized as an important factor in the success of a total knee replacement. Maximizing coverage with the least compromise in rotation is the goal for tibial tray design. In this study, the anatomic tibia seemed to optimize the relationship between tibial surface coverage and rotation. This study additionally illustrates the way by which advanced preoperative planning tools (ie. MRI/computer reconstructions) allow us to obtain valuable information with regard to implant design

Introduction. Backside wear of polyethylene (PE) inlays in fixed-bearing total knee replacement (TKR) generates high number of wear debris, but is poorly studied in modern plants with improved locking mechanisms. Aim of study. Retrieval analysis of PE inlays from contemporary fixed bearing TKRs - to evaluate the relationship between backside wear and liner locking mechanism and material type and roughness of the tibial tray. Methods. MATERIAL. We included five types of implants, revised after min. 12 months (14–71): three models with a peripheral locking rim and two models with a dove-tail locking mechanism. Altogether this study included 15 inlays were removed from TKRs with CoCr alloy tray with a roughened surface and a peripheral locking lip liner (Stryker Triathlon, Ra 5,61 µm), 9 from CoCr trays with peripheral locking lip and untreated surface (Aesculap Search, Ra 0,81 µm), 13 from Ti alloy trays with peripheral locking lip and untreated surface (DePuy PFC Sigma 0,61 µm), 11 from Ti alloy trays with untreated surface and dovetail locking mechanism (Zimmer NexGen, 0,34 µm), and 9 from iplants with a Ti alloy tibial tray with mirror polished surface and dovetail locking mechanism (Smitn&Nephew Genesis II, 0,11 µm). METHODS. Wear of bearing surface and back side of retrieved inlays was examined in 10 sectors under a light microscope. Seven modes of wear were analysed and quantified according to the Hood scale: surface deformation, pitting, embedded third bodies, pitting, scratching, burnishing (polishing), abrasion and delamination. Damage of inlays caused by backside wear was also evaluated using scanning electron microscopy (SEM). Roughness of tibial tray was evaluated using a contact profilometer. Results. We found no differences between wear scores on the articulating surface in all group, they did not correlate with backside wear scores in all groups as well. Compared to all other groups, backside wear scores were significantly higher in implants with untreated Ti alloy tibial tray (P<0,001 Wilcoxon test). Lowest wear rates were found in implants from both Ti and CoCr alloys and peripheral locking rim. Interestingly there was no difference between wear of implants with polished and untreated surface (Fig. 1). SEM analysis demonstrated different wear modes in implants with dovetail mechanism and peripheral rim. The first group demonstrated signs of gross rotational instability, with severe abrasion with an arch-shaped pattern and delaminated PE (Fig 2). In one design we observed severe extrusion of PE into screw holes of the tibial tray. Inlays from trays with peripheral rim presented two types of wear: flattening of machining marks or protrusion of the material caused by the rough surface (Fig 3). Conclusions. This study demonstrates that backside wear is still a problem in modern TKR. Our findings suggest that it is predominantly affected by type of locking mechanism (with peripheral rim performing better), to a lesser extent by surface roughness of the tibial component, while material type does not seem to play an important role. This study was funded by a grant from the National Science Centre nr 2012/05/D/NZ5/01840. To view tables/figures, please contact authors directly

Introduction. Post-operative clinical outcomes of TKA are dependent on a multitude of surgical and patient-specific factors. Malrotation of the femoral and/or tibial component is associated with pain, accelerated wear of the tibial insert, joint instability, and unfavorable patellar tracking and dislocation. Using the transepicondylar axis to guide implantation of the femoral component is considered to be an accurate anatomical reference and is widely used. However, no gold standard currently exists with respect to ensuring optimal rotation of the tibial tray. Literature has suggested that implantation methods, which reference the tibial tubercle, reduce positioning outliers with more consistency than other anatomical landmarks. Therefore, the purpose of this evaluation is to use data collected from intraoperative sensors to assess the true rotational accuracy of using the mid-medial third of the tibial tubercle in 98 TKAs. Methods. The data for this evaluation was retrieved from 98 consecutive patients who underwent primary TKA from the same highly experienced surgeon. Femoral component rotation was verified in every case via the use of the Whiteside line, referencing the transepicondylar axis, and confirming appropriate patellar tracking. Tibial tray rotation was initially established by location of the mid-medial third of the tibial tubercle. Rotational adjustments of the tibial tray were evaluated in real-time, as the surgeon corrected any tibiofemoral incongruency and tray malpositioning. The initial and final angles of tibial tray rotation were captured with intraoperative video feed, and recorded. A z-test of differences between pre- and post-rotational correction was performed to assess the statistical significance of malrotation present in this cohort. Results. All patients in this study received a primary TKA, using the mid-medial third of the tibial tubercle to dictate tibial tray rotation. After the sensor-equipped tibial insert was implanted, it was shown that 63.1% of patients exhibited unfavorable rotation. Of those patients, 70% were shown to have internal rotation; 30% were shown to have external rotation. The average malrotation of the tibial tray deviated from a neutral position by 6.3° ± 4.3°, ranging from 0.5° to 19.2°. The z-test of differences yielded a p-value <0.0001, indicating that the proportion of malrotation was statistically significant. The 95% confidence interval of this cohort was calculated to be between 44.8% and 71.8% of malrotation. Discussion. Malrotation in TKA isassociated with poor clinical outcomes. While no gold standard anatomic landmark currently exists for positioning the tibial tray, the mid-medial third of the tibial tubercle is widely used as a reference. However, the data from this evaluation demonstrates that, not only is this landmark insufficient for establishing optimal rotation (p < 0.0001), but that it had guided the surgeon to an average of 6.3° outside of the optimized implant congruency zone. The large confidence interval indicates that the rotational alignment of the tibial tray—based on the location of the mid-medial third of the tibial tubercle—is not only inaccurate, but also highly variable. Based on this intraoperative sensor data, we suggest that care should be taken when utilizing the tibial tubercle as the sole rotational landmark for the tibial tray

The goal of tibial tray placement in total knee arthroplasty (TKA) is to maximise tibial surface coverage while maintaining proper rotation. Maximising tibial surface coverage without component overhang reduces the risk of tibial subsidence. Proper tibial rotation avoids excess risk of patellar maltracking, knee instability, inappropriate tibial loading, and ligament imbalance. Different tibial tray designs offer varying potential in optimising the relationship between tibial surface coverage and rotation. Patient specific instrumentation (PSI) generates customised guides from an MRI- or CT-based preoperative plan for use in TKA. The purpose of the present study was to utilise MRI information, obtained as part of the PSI planning process, to determine, for anatomic, symmetric, and asymmetric tibial tray designs, (1) which tibial tray design achieves maximum coverage, (2) the impact of maximising coverage on rotation, and (3) the impact of establishing neutral rotation on coverage. MR images for 100 consecutive patients were uploaded into Materialise™ PSI software that was used to evaluate characteristics of tibial component placement. Tibial component rotation and surface coverage was analysed using the preoperative planning software. Anatomic (Persona™), symmetric (NexGen™), and asymmetric (Natural-Knee II™) designs from a single manufacturer (Zimmer™) were evaluated to assess the relationship of tibial coverage and tibial rotation. Tibial surface coverage, defined as the proportion of tibial surface area covered by a given implant, was measured using Adobe Photoshop™ software. Rotation was calculated with respect to the tibial AP axis, which was defined as the line connecting the medial third of the tibial tuberosity and the PCL insertion. When tibial surface coverage was maximised, the anatomic tray compared to the symmetric/asymmetric trays showed significantly higher surface coverage (82.1% vs 80.4/80.1%; p<0.01), significantly less deviation from the AP axis (0.3° vs 3.0/2.4°; p<0.01), and a significantly higher proportion of cases within 5° of the AP axis (97% vs 73/77%). When constraining rotation to the AP axis, the anatomic tray showed significantly higher surface coverage compared to the symmetric/asymmetric trays (80.8% vs 76.3/75.8%; p<0.01). No significant differences were found between symmetric and asymmetric trays. We found that the anatomic tibial tray resulted in significantly higher tibial coverage with significantly less deviation from the AP axis compared to the symmetric and asymmetric trays. When rotation was constrained to the AP axis, the anatomic tray resulted in significantly higher tibial coverage than the symmetric and asymmetric trays. Tibial rotation is recognised as an important factor in the success of a total knee replacement. Maximising coverage with the least compromise in rotation is the goal for tibial tray design. In this study, the anatomic tibia seemed to optimise the relationship between tibial surface coverage and rotation. This study additionally illustrates the way by which advanced preoperative planning tools (ie. MRI/computer reconstructions) allow us to obtain valuable information with regard to implant design

Introduction:. Appropriate transverse rotation of the tibial component is critical to achieving a balance of tibial coverage and proper tibio-femoral kinematics in total knee replacement (TKR), yet no consensus exists on the best anatomic references to determine rotation. Historically, surgeons have aligned the tibial component to the medial third of the tibial tubercle. 1. , but recent literature suggests this may externally rotate the tibial component relative to the femoral epicondylar axis (ECA) and that the medial border of the tubercle is more reliable. 2. Meanwhile, some TKR components are designed with asymmetry of the tibial tray assuming that maximizing component coverage of the resected tibia will result in proper alignment. The purpose of this study was to determine how different rotational landmarks and natural variation in osteoarthritic patient anatomy may affect asymmetry of the resected tibial plateau. Methods:. Pre-operative computed-tomography scans were collected from 14,791 TKR patients. The tibia and femur were segmented and anatomic landmarks identified: tibial mechanical axis, medial third and medial border of the tibial tubercle, PCL attachment site, and the surgical ECA of the femur. Virtual surgery was performed with an 8-mm resection (referencing the high side) made perpendicular to the tibial mechanical axis in the frontal plane, with 3° posterior slope, and transversely aligned with three different landmarks: the ECA, the medial border, and medial third of the tubercle. In each of these rotational alignments, the relative asymmetry of the medial and lateral plateaus was calculated (Medial AP/Lateral AP) (Fig. 1). Results:. Rotational alignment of the tibial component to the ECA, medial border, and medial third of the tubercle resulted in progressive external rotation of the tibial tray on the bone. Alignment to the medial border and medial third of the tubercle resulted in average 0.9° ± 5.7° and 7.8° ± 5.3° external rotations of the tray relative to the ECA, respectively (Fig. 2). Greater external rotation of the tibial implant relative to the bone increased the appearance of tibial asymmetry (Fig. 3). Referencing the medial border and medial third of the tubercle resulted in apparent tibial bone asymmetry of 1.10 ± 0.10 and 1.12 ± 0.10, respectively. Discussion:. Assuming the ECA is the appropriate rotational reference to re-establish appropriate kinematics. 2. , alignment to the medial border of the tubercle resulted in the most favorable tray alignment. However, there was a great deal of variation between the relative position of the ECA and the tubercle across the patient population. Rotational alignment to either the medial border or medial third of the tubercle resulted in external tray alignment relative to the ECA of greater than 3 degrees for 36% and 84% of patients, respectively. In addition, increased tray asymmetry (broader medial plateau) necessitates relative external rotation of the tray on the bone reducing the flexibility of intra-operative rotational adjustment. Tray asymmetry greater than 1.10 (the asymmetry of the resected tibia when aligned to the ECA) may result in external mal-rotation for a significant portion of the patient population

Introduction:. Adequate coverage of the resected tibial plateau with the tibial tray is necessary to reduce the theoretical risk of tibial subsidence after primary total knee arthroplasty (TKA). Maximizing tibial coverage is balanced against avoiding excessive overhang of the tray causing soft tissue irritation, and establishing proper tray alignment improving implant longevity and patella function. 1. Implant design factors, including the number of tray sizes, tray shape, and tray asymmetry influence the ability to cover the tibial plateau. 2. Furthermore, rotating platform (RP) tray designs decouple restoring proper tibial rotation from maximizing tibial coverage, which may enhance the ability to maximize coverage. The purpose of the current study was to assess the ability of five modern tray designs (Fig. 1), including symmetric, asymmetric, fixed-bearing, and RP designs, to maximize coverage of the tibial plateau across a large patient population. Methods:. Lower limb computed-tomography scans were collected from 14,791 TKA patients and the tibia was segmented. Virtual surgery was performed with an 8-mm tibial resection (referencing the high side) made perpendicular to the tibial mechanical axis in the frontal plane, with 3° posterior slope, and aligned transversely to the medial third of the tibial tubercle. An automated algorithm placed the largest possible tray on the plateau, optimizing the ML and AP placement (and I-E rotation for the RP tray), to minimize overhang. The largest sized tray that fit the plateau with less than 2-mm of tray overhang was identified for each of the five implant systems. The surface area of the tibial tray was divided by the area of the resected plateau and the percentage of patients with greater than 85% plateau coverage was calculated. Results:. The percentage of patients with greater than 85% plateau coverage across the tray designs ranged from 17.0% to 61.4% (Fig. 1). The tray with the greatest number of size options (Tray 4, 10 sizes) had the best coverage among the fixed-bearing trays. The RP variant of the same tray had the best overall coverage. Tibial asymmetry did not significantly improve the overall tibial coverage across the patient distribution for both asymmetric designs. Incorporating a broader medial condyle improved fit along the posterior medial corner for Tray 2, but increased the average under-hang along the posterior lateral plateau offsetting any improvement in total coverage. Discussion:. This analysis represents the most comprehensive assessment of tray coverage to date across a large TKA-patient population. Large variations exist in the size and shape of the proximal tibia among TKA patients. 3. Developing a tray design which provides robust coverage despite this variation remains challenging. This analysis suggests that tibial asymmetry may not robustly improve coverage. Conversely, incorporating an increased number of tray sizes and utilizing an RP implant to decouple coverage from alignment may provide the most reliable solution for maximizing coverage across the patient population

Introduction. Cementless total knee arthroplasty (TKA) designs are clinically successful and allow for long term biological fixation. Utilizing morselized bone to promote biological fixation is a strategy in cementless implantation. However, it is unknown how bone debris influences the initial placement of the tray. Recent findings show that unseated tibia trays without good contact with the tibial resection experience increased motion. This current study focuses on the effect of technique and instrument design on the initial implantation of a cementless porous tibia. Specifically, can technique or instrument design influence generation of bone debris, and thereby change the forces required to fully seat a cementless tray with pegs?. Methods. This bench top test measured the force-displacement curve during controlled insertion of a modern cementless tibia plate with two fixation pegs. A total of nine pairs of stripped human cadaver tibias were prepared according to the surgical technique. However, the holes for the fixation pegs were drilled intentionally shallow to isolate changes in insertion force due to the hole preparation. A first generation instrument set (Instrument 1.0) and new instrument set design (Instrument 2.0), including a new drill bit designed to remove debris from the peg hole, were used. The tibias prepared with Instrument 1.0 were either cleaned to remove bone debris from the holes or not cleaned. The tibias prepared with the Instrument 2.0 instruments were not cleaned, resulting in three groups: Instrument 1.0 (n=7), Instrument 1.0 Cleaned (n=5), and Instrument 2.0 (n=6). Following tibia resection and preparation of holes for the fixation pegs, the tibias were cut and potted in bone cement ensuring the osteotomy was horizontal. The tibial tray was mounted in a load frame (Enduratec) and the trays were inserted at a constant rate (0.169mm/sec) while recording the force. The test was concluded when the pegs were clearly past the bottom of the intentionally shallow holes. Results. The force-displacement curves from this method were dependent on the instrument used and cleaning of the holes. Instrument 2.0 specimens were inserted about 2 mm past the maximum peg depth before experiencing a significant increased resistance. The Instrument 1.0 Cleaned holes saw an increase in force slightly past the maximum peg depth, while the Instrument 1.0 group saw increase in force around 1 mm before reaching the maximum peg depth. The average insertion force required to reach maximum peg depth was significantly higher (p<0.05) for the Instrument 1.0 group (790.7 N, sd=185.9) than both the Instrument 1.0 Cleaned (429.7 N, sd=116.8) and the Instrument 2.0 group (580.4 N, sd=89.3). The insertion forces at a ‘mid-tunnel’ location, before the increase in resistance, were not affected by drill design as the drill diameters were the same, resulting in the same press fit. Conclusions. Bone debris in fixation feature holes increases the force to fully seat a cementless tibia plate. This suggests there is a cost to leaving morselized bone in place. Removing bone debris through instrument design or surgical technique can ensure that a tibial plate is fully seated at time of implantation, maximizing initial fixation

Recent clinical data suggest improvement in the fixation of tibia trays for total knee arthroplasty when the trays are additive manufactured with highly porous bone ingrowth structures. Currently, press-fit TKA is less common than press-fit THA. This is partly because the loads on the relatively flat, porous, bony apposition area of a tibial tray are more demanding than those same porous materials surrounding a hip stem. Even the most advanced additive manufactured (AM) highly porous structures have bone ingrowth limitations clinically as aseptic loosening still remains more common in press-fit TKA vs. THA implants. Osseointegration and antibacterial properties have been shown in vitro and in vivo to improve when implants have modified surfaces that have biomimetic nanostructures designed to mimic and interact with biological structures on the nano-scale. Pre-clinical evaluations show that TiO. 2. nanotubes (TNT), produced by anodization, on Ti6Al4V surfaces positively enhance the rate at which osseointegration occurs and TNT nano-texturization enhances the antibacterial properties of the implant surface. 2. In this in vivo sheep study, identical Direct Metal laser Sintered (DMLS) highly porous Ti6Al4V specimens with and without TNT surface treatment are compared to sintered bead specimens with plasma sprayed hydroxyapatite-coated surface treatment. Identical DMLS specimens made from CoCrMo were also implanted in sheep tibia bi-cortically (3 per tibia) and in the cancellous bone of the distal femur and proximal tibia (1 per site). Animals were injected with fluorochrome labels at weeks 1, 2 and 3 after surgery to assess the rate of bone integration. The cortical specimens were mechanically tested and processed for PMMA histology and histomorphometry after 4 or 12 weeks. The cancellous samples were also processed for PMMA histology and histomorphometry. The three types of bone labels were visualized under UV light to examine the rate of new bony integration. At 4 weeks, a 42% increase in average pull-out shear strength between nanotube treated specimens and non-nanotube treated specimens was shown. A 21% increase in average pull-out shear strength between nanotube treated specimens and hydroxyapatite-coated specimens was shown. At 12 weeks, all specimens had statistically similar pull-out values. Bone labels demonstrated new bone formation into the porous domains on the materials as early as 2 weeks. A separate in vivo study on 8 rabbits infected with methicillin-resistant Staphylococcus aureus showed bacterial colonization reduction on the surface of the implants treated with TNT. In vitro and in vivo evidence suggests that nanoscale surfaces have an antibacterial effect due to surface energy changes that reduce the ability of bacteria to adhere. These in vivo studies show that TNT on highly porous AM specimens made from Ti6Al4V enhances new bone integration and also reduce microbial attachment

Introduction:. Primary stability is crucial for long-term fixation of cementless tibial trays. Micromotion less than 50 μm is associated with stable bone ingrowth and greater than 150 μm causes the formation of fibrous tissue around the implant [1, 2]. Finite element (FE) analysis of complete activities of daily living (ADL's) have been used to assess primary stability, but these are computationally expensive. There is an increasing need to account for both patient and surgical variability when assessing the performance of total joint replacement. As a consequence, an implant should be evaluated over a spectrum of load cases. An alternative approach to running multiple FE models, is to perform a series of analyses and train a surrogate model which can then be used to predict micromotion in a fraction of the time. Surrogate models have been used to predict single metrics, such as peak micromotion. The aim of this work is to train a surrogate model capable of predicting micromotion over the entire bone-implant interface. Methods:. A FE model of an implanted proximal tibia was analysed [3] (Fig. 1). A statistical model of knee kinetics, incorporating subject-specific variability in all 6-DOF joint loads [4], was used to randomly generate loading profiles for 50 gait cycles. A Latin Hypercube (LH) sampling method was applied to sample 6-DOF loads of the new population throughout the gait cycle. Kinetic data was sampled at 10, 50 and 100 instances and FE predictions of micromotion were calculated and used to train a surrogate model capable of describing micromotion over the entire bone-implant interface. The surrogate model was tested for an unseen gait cycle and the resulting micromotions were compared with FE predictions. Results and discussion:. Accuracy of the surrogate model increased with increasing sample size in the training set; with a LH sample of 10, 50 and 100 trials, the surrogate model predicted micromotion at the bone-implant interface during gait with RMS accuracy of 61, 44 and 33 μm, respectively (Fig. 2). Similar range in micromotion was measured in FE and surrogate models; although the surrogate model tended to over-predict micromotion early in the gait cycle (Fig. 2). There was good agreement in location and magnitude of micromotion at the interface surface through out the gait cycle (Fig. 3). Although encouraging, further work is required to optimize the number and distribution of the training samples to minimize the error in the surrogate model. Analysis time for the FE model was 15 hours, compared to 30 seconds for the surrogate model. The results suggest that surrogate models have significant potential to rapidly predict micromotion over the entire bone-implant interface, allowing for a greater range in loading conditions to be explored than would be possible through conventional methods

Introduction. Current pre-clinical testing is performed using knee wear simulators with standardized walking profiles. Differences in generated damage patterns to those observed on retrieved liners have been explained with the absence of activities other than walking, less severe loading conditions, and a discrepancy in the simulator's tibiofemoral contact mechanics and in vivo knee excursion. While it has been recognized that rotational alignment of the knee may also drive the location and shape of wear scars, to the best of our knowledge this parameter has not been investigated in knee simulator studies. Methods. Here, we use patient specific gait as input to the simulation to approximate the patient specific contact mechanics. Kinematic and kinetic input data was obtained from gait analysis of a patient with a MGII (Zimmer Inc.) prosthesis at 11 years post-op using the point cluster technique for tibiofemoral kinematics, and a mathematical model for internal force calculations. Using the identical type of prosthesis on the simulator, wear tests were conducted in displacement mode on a closed-loop controlled station. Because x-rays of the patient suggested an internal rotation of the tibial tray, it was varied form 0–10° and the effect on location and wear scar dimension was assessed. Results were compared with the retrieved liner (obtained after 13 years in vivo). Results. The simulator inputs generated from the gait data were compared with ISO 14243–3 (Figure 1). The first contact force peak of the patient was significantly lower, while second contact force peak similar to ISO. There were minimal differences in the flexion/extension profiles. For stance phase, the anterior/posterior translation and internal/external rotation kinematics did not show similar patterns, but they did fall within similar ranges from zero. There was little similarity for the swing phase. The total wear scar area of the retrieval was measured to be 919.8 mm. 2. The average total wear scar of the tested components was 853.0 ± 59.8 mm. 2. (p= 26.28%) The outcome values of the tested components compared to the retrieval are shown in Figure 2. All offsets produced a smaller wear scar than the retrieval, but the 7° offset produced the closest area which was within 1 mm. 2. of the retrieval. The 7° offset also had the closed centroid offset angle, which was within 0.2° of the retrieval (Figure 3). On the retrieval, a small wear scar was observed on the anterior- medial aspect of the intracondylar eminence (not shown). Among the tested components, the 7° and 10° offsets recreated damage at this location. Discussion. Rotational alignment affected the wear scar size by as much as 15% in this study. Only, the 7° offset produced outcome values very similar to the retrieval, highlighting the importance of rotational mismatch for wear. It should be noted that ± 10° of rotational mismatch is clinically well tolerated [5] and therefore may occur frequently. All tested components had smaller wear scar areas than the retrieved liner. This suggests that other activities other than walking may have contributed to wear in vivo

Introduction. Cementless tibial fixation has been used for over 30 years. There are several potential advantages including preservation of bone stock and ease of revision. More importantly, for young active patients there is the potential for increased longevity of fixation. However, the clinical results have been variable, with reports of extensive radiolucent lines, rapid early migration and aseptic loosening. Problems appear to stem from a failure to become sufficiently osseointegrated, which in turn suggests a lack of primary stability. In order to achieve boney ingrowth, interface micromotions should be less than 50 microns, whereas fibrous tissue formation is known to occur if micrmotions are in excess of 150 microns. The degree of micromotion at the bone-implant interface are dependent on the kinematics and kinetics of the replaced joint. Finite element analyses has been used to assess primary stability, however, it is becoming increasing difficult to differentiate performance. The aim of this study was too examine the micromotion for a variety of different activities for three commercially available tibial tray designs. Methods. A finite element model of the implanted proximal tibia was generated form CT scans of a 72 year old male and material properties were assigned based on the Hounsfield units. Three tray designs were evaluated: LCS, Duofix and Sigma (DePuy Inc, Warsaw USA). The implants were assumed to be debonded, with a coefficient of friction of 0.4 applied to the bone-implant interface except for the porous coated region of the Duofix design, which was assumed to be 0.6. The distal portion the tibia was rigidly constrained. Five activities were simulated based on data from Orthoload.com (patient K1L) including walking, stair ascent, stair descent, sitting down and a deep knee bend. The three force and three moment time histories were discritised to give between 44 and 48 individual load steps. Custom written scripts were used to generate composite peak micromotion plots, which report the peak micromotion that occurs at each point of the contact surface during the gait cycle. The primary stability was then assessed by reporting the maximum micromotion, the average peak micromotion and the percentage of the contact area experiencing micromoitons less than 50 microns. Results and discussion. Similar trends were observed for all three designs across the range of activities. Stair ascent and descent generated the highest micromotions, closely followed by level gait. Across these three activities the mean peak (maximum) micromotions ranged from 64-78 (186-239) microns for PFC Sigma, 61-72 (199-251) microns for Duofix and 92-106 (229-264) microns for LCS. The peak micromotions did not necessarily occur at the peak loads. For instance, for level walking the peak micromotions occurred when there were low axial forces, but moderate varus-valgus moments. This highlights the need to examine the whole gait cycle in order to properly determine the initial stability tibiae tray designs. By exploring a range of activities and interrogating the entire contact surface, it is easier to differentiate between the relative performance of different implant designs

Objectives

We identified an unusual pattern of backside deformation on polyethylene (PE) inserts of contemporary total knee replacements (TKRs). The PE backside's margins were inferiorly deformed in TKRs with NexGen central-locking trays. This backside deformation was significantly associated with tray debonding. Furthermore, recent studies have shown high rate of tray debonding in PS NexGen TKRs. Subsequently, a field safety notice was issued regarding the performance of this particular device combination and the Option tray has been withdrawn from use. Therefore, we hypothesised that the backside deformation of PS inserts may be greater than that of CR inserts.

INTRODUCTION

Many studies have looked at the effect of titanium versus cobalt chrome baseplates on backside wear. However, the surface finish of the materials is usually different [1,2]. There may also be subtle locking mechanism design changes [2]. The purpose of this study was to evaluate the wear performance of polyethylene inserts when mated with titanium baseplates to cobalt chrome baseplates, where both have non-polished topside surfaces and an identical locking mechanism.

Introduction

The number of total knee joint replacements has increased dramatically, from 28,000 in 2004 to over 73,000 in 2008 in the UK. This increase in procedures means that there is a need to assess the performance of an implant design in the general population. For younger, more active patients, cementless tibial fixation is an attractive alternative means of fixation and has been used for over 30 years. However, the clinical results with cementless fixation have been variable, with reports of extensive radiolucent lines, rapid early migration and aseptic loosening [1]. This study investigates the inter-patient variability of bone strain at the implant-bone interface of 130 implanted tibias over a full gait cycle.

Introduction. Realistic in-vivo loads on knee implants from telemetric analyses were recently published. Impacting an implant, especially a ceramic one, will produce high peak stresses within the component. Data for loads occurring during implantation of a knee implant are scarce. To ensure a safe impaction of ceramic tibial trays the stresses caused by it need to be known. Materials and Methods. Impaction testing including force measurements (using Kistler piezo load cell 9351B) was performed on a ceramic tibial tray. The same test was simulated by computational analysis using FEM (Finite-Element-Method). Because the forces measured and those calculated by FEM were significantly different, an in vitro impaction study was performed to obtain realistic loads for a ceramic tibial tray. A surgeon was asked to perform heavy hammer blows which may occur during implantation. Using a high speed camera (phantom V7.2) the velocity of the hammer at the time of impaction was determined. Using this parameter instrumented ceramic tibial trays (BPK-S Knee, P. Brehm) were implanted into a biomechanical Sawbones® model. Linear strain gauges were attached to the four fins of the tibial tray as these are the regions of highest stresses. Simulating the surgeon's highest impacts measurements were conducted at a frequency of 1 MHz. The identical hammer was used in this in vitro study and the velocity of the hammer was measured by using the same high speed camera. To investigate the damping effect of bone cement Palacos®R bone cement was used. Only worst-case impacts within the range achieved by the surgeon were applied to evaluate the stress distribution within the ceramic tibial tray. Results. Impaction forces determined from the FEM were significantly higher compared to the force measurements. Therefore the verification by the measured impaction forces failed. Simulating worst-case impacts which may occur during implantation of a tibial tray resulted in hammer velocities within a range of 4.7 m/s to 6.7 m/s. Applying these impacts to instrumented tibial trays high peak stresses similar to those determined by the FEM were observed within the implant. Using bone cement as a realistic approach and damping material stresses decreased significantly but still remained at a high level. Discussion. For extremely high dynamic loads such as the impaction of implants verification of FEM with physical force measurements may not be possible. To achieve reliable values of the stress state within the implant strain gauge measurements are the most appropriate way to evaluate the stress distribution. Although the viscosity of the cement reduces the stress values significantly, the stresses still remained at a considerably high level. Data from more surgeons is needed to improve the quality of the loading estimation (range of hammer velocity) and thus to improve the reliability of the stress evaluation

Introduction. Kinematics post-TKA are complex; component alignment, component geometry and the patient specific musculoskeletal environment contribute towards the kinematic and kinetic outcomes of TKA. Tibial rotation in particular is largely uncontrolled during TKA and affects both tibiofemoral and patellofemoral kinematics. Given the complex nature of post- TKA kinematics, this study sought to characterize the contribution of tibial tray rotation to kinematic outcome variability across three separate knee geometries in a simulated framework. Method. Five 50. th. percentile knees were selected from a database of planned TKAs produced as part of a pre-operative dynamic planning system. Virtual surgery was performed using Stryker (Kalamazoo, MI) Triathlon CR and PS and MatOrtho (Leatherhead, UK) SAIPH knee medially stabilised (MS) components. All components were initially planned in mechanical alignment, with the femoral component neutral to the surgical TEA. Each knee was simulated through a deep knee bend, and the kinematics extracted. The tibial tray rotational alignment was then rotated internally and externally by 5° & 10°. The computational model simulates a patient specific deep knee bend and has been validated against a cadaveric Oxford Knee Rig. Preoperative CT imaging was obtained, landmarking to identify all patient specific axes and ligament attachment sites was performed by pairs of trained biomedical engineers. Ethics for this study is covered by Bellberry Human Research Ethics Committee application number 2012-03-710. Results and Discussion. From the 360 Knee Systems database, 1847 knees were analysed, giving an average coronal alignment of 4.25°±5.66° varus. Five knees were selected with alignments between 4.1° and 4.3° varus. Kinematic outcomes were averaged over the 5 knees. The component geometries resulted in characteristically distinct kinematics, in which femoral rollback was most constrained by the PS components, whereas tibiofemoral axial rotation was most constrained in MS components. Patella lateral shift was comparable amongst all components in extension, medialising in flexion. Patella shift remained more lateral in MS components compared to PS and CR. Average patella lateral shift, medial and lateral facet rollback separated by tibial tray rotation are shown for all component systems in Figure 1. Medial and lateral facet rollback in the PS and CR components are symmetrical and opposite, indicating that with tibial tray rotation, the tibiofemoral articulation point balances between component rotation and neutral alignment, reflecting the restoring force exerted by the simulated collateral ligaments. As such, with higher internal tibial rotation and subsequent lateralisation of the tubercle, patella lateral shift increases. MS medial and lateral facet rollback however are not symmetrical nor opposite, reflecting the chirality of the tibiofemoral articulation. With internal tibial tray rotation, relatively high lateral facet rollback is observed, lateralising the femoral component centre, giving the patella component a relatively more medial position. Conclusions. Component geometry was found here to produce characteristically distinct tibiofemoral and patellofemoral kinematics. Medial stabilised components reported asymmetric kinematic changes, compared to either CR or PS components, in which a higher rate of change was observed for internal tray rotation, indicating that neutral or external rotation of medial stabilised components will result in more predictable kinematic outcomes

INTRODUCTION. Cementless tibial trays commonly fail through failure of fixation due to excessive interface motion. However, the specific combination of axial and shear forces precipitating implant failure is unknown. This has led to generic loading profiles approximating walking to perform pre-clinical assessment of new designs, even though telemetric data demonstrates that much larger forces and moments are generated during other functional activities. This study was undertaken to test the hypotheses: (i) interface motion of cementless tibial trays varies as a function of specific activities, and (ii) the response of the cementless tibial interface to walking loading is not representative of other functional activities. MATERIALS and METHODS. Six fresh-frozen cadaveric tibias were tested using a custom designed functional activity simulator after implantation of a posterior stabilized total knee replacement (NexGen LPS, Zimmer, Warsaw IN). Activity scenarios were selected using force (Fx, Fy, Fz) and moment (Mx, My, Mz) data from patients with instrumented tibial trays (E-tibia) published by Bergmann et al. A pattern of black and white spray paint was applied to the surface of the specimen including the tibial tray and bone. Each specimen was preconditioned through application of a vertical load of 1050N for 500 cycles of flexion-extension from 5–100°. Following preconditioning, each tibia was loaded using e-tibia values of forces and moments for walking, stair-descent, and sit-to-stand activities. The differential motion of the tibial tray and the adjacent bony surface was monitored using digital image correlation (DIC) (resolution: 1–2 microns in plane; 3–4 microns out-of-plane). Four pairs of stereo-images of the tray and tibial bone were prepared at sites around the circumference of the construct in both the loaded and unloaded conditions: (i) before and after pre-conditioning and (ii) before and after the 6 functional loading profiles. The images were processed to provide circumferential measurements of interface motion during loading. Differences in micromotion and migration were evaluated statistically using step-wise multivariate regression. RESULTS. The average 3D motion of the tibial tray varied extensively with the loading conditions corresponding to the different activities (Figs 1,2). The largest 3D motion was seen during the first peak of stair descent (86.6±8.0µm) and the first peak of walking (83.1±10.2µm; p=0.5516), both of which were characterized by large adduction moments (18.5 and 19.1Nm respectively). The differences between 3D micromotion of all other pairs of activities were statistically significant (p<0.0001 to p=0.0127). Each of the 6 loading scenarios simulated elicited a different combination of components of implant displacement at the cementless interface. The largest differences in interface motion were observed between the first peak of walking and all of the other loading modes with reversal of the direction of the SI (p=0.3828), AP (p<0.0001) and ML (p<0.0001) components of tray displacement (Figs. 2,3). CONCLUSIONS. 1. Magnitude and direction of interface motion between the tibia and a cementless tibial tray vary with specific loading patterns. 2. Interface motion observed during loading conditions representative of walking are not indicative of the stability of cementless implant fixation when exposed to loading conditions generated by other activities. For figures/tables, please contact authors directly.

Introduction. Long term data on the survivorship of cemented total knee arthroplasty (TKA) has demonstrated excellent outcomes; however, with younger, more active patients, surgeons have a renewed interest in improved biologic fixation obtained from highly porous, cementless implants. Early designs of cementless total knees systems were fraught with high rates of failure for aseptic loosening, particularly on the tibial component. Prior studies have assessed the bone ingrowth extent for tibial tray designs reporting near 30% extent of bone ingrowth . (1,2). While these analyses were performed on implants that demonstrated unacceptably high rates of clinical failure, a paucity of data exists on the extent on bone ingrowth in contemporary implant designs with newer methods for manufacturing the porous surfaces. We sought to evaluate the extent of attached bone on retrieved cementless tibial trays to determine if patient demographics, device factors, or radiographic results correlate to the extent of bone ingrowth in these contemporary designs. Methods. Using our IRB approved retrieval database, 17 porous tibial trays were identified and separated into groups based on manufacturer: Zimmer Natural Knee (1), Zimmer NexGen (10), Stryker Triathlon (4) and Biomet Vanguard Regenerex (2). Differences in manufacturing methods for porous material designs were recorded. Patient demographics and reason for revision are described in Table 1. Radiographs were used to measure tibiofemoral alignment and the tibial mechanical axis alignment. Components were assessed using visual light microscopy and Photoshop to map bone ingrowth extent across the porous surface. ImageJ was used to threshold and calculate values for bone, scratched metal, and available surface for bone ingrowth (Fig. 1). Percent extent was determined as the bone ingrowth compared to the surface area excluding any scratched regions from explantation. Statistics were performed among tray designs as well as between the lateral and medial pegs, if designs had pegs available for bony ingrowth. Results. Mean bone ingrowth extent was 51.4% for the tibial tray for the entire cohort. Bone ingrowth extent was statistically greater in the Zimmer NexGen design (63.8%; p=.027) compared to the other three designs (Table 2). Four sets of pegs were excluded from analysis due to lack of porous coatings or pegs having been removed at revision surgery. Across all designs, the medial peg had 45.2% ingrowth and the lateral peg had 66.1% ingrowth. The medial peg for the NexGen design had significantly less bone ingrowth compared to the lateral peg (58.7% vs. 75.4%; p=0.044). No significant differences were found in tibiofemoral alignment or tibial mechanical axis alignment between the implant groups. No significant differences were found among implants revised for aseptic loosening versus any other reason for revision (54% vs 30%; p=.18). Discussion. Our results demonstrate high rates of bone ingrowth extent in contemporary designs, further supporting porous design rationales and a role for additive manufacturing to form enhanced porosity. We plan on exploring staining techniques to confirm our visual inspection. Contemporary designs have shown successful rates for improved longevity for cementless total knee systems. For any figures or tables, please contact the authors directly

Introduction. For nearly 58% of total knee arthroplasty (TKA) revisions, the reason for revision is exacerbated by component malalignment. Proper TKA component alignment is critical to functional outcomes/device longevity. Several methods exist for orthopedic surgeons to validate their cuts, however, each has its limitations. This study developed/validated an accurate, low-cost, easy to implement first-principles method for calculating 2D (sagittal/frontal plane) tibial tray orientation using a triaxial gyroscope rigidly affixed to the tibial plateau of a simulated leg jig and validated 2D tibial tray orientation in a human cadaveric model. Methods. An initial simulation assessed error in the sagittal/frontal planes associated with all geometric assumptions over a range of positions (±10°, ±10°, and −3°/0°/+3° in the sagittal, frontal, and transverse planes, respectively). Benchtop experiments (total positions - TP, clinically relevant repeated measures - RM, novice user - NU) were completed using a triaxial gyroscope rigidly affixed to and aligned with the tibial tray of the fully adjustable leg-simulation jig. Finally, two human cadaveric experiments were completed. A similar triaxial gyroscope was mounted to the tibial tray of a fresh frozen human cadaver to validate sagittal and frontal plane tibial tray orientation. In cadaveric experiment one, three unique frontal plane shims were utilized to measure changes in frontal plane angle. In cadaveric experiment two, measurements using the proprosed gyroscopic method were compared with computer navigation at a series of positions. For all experiments, one rotation of the leg was completed and gyroscopic data was processed through a custom analysis algorithm. Results. Mathematical simulations showed that over the range of tested orientations, error from our geometric assumptions would be less than 1° and 0.2° in the sagittal and frontal planes, respectively. Results of all bench-top experiments are shown in Figure 1. The average angular error during the TP experiment (black bars) was 1.09°±0.80° and 0.60°±0.46° in the sagittal/frontal planes. The average angular error during the RM experiment (white bars) in the sagittal/frontal planes was 0.27°±0.25° and 0.30°±0.23°. The average angular error from the NU experiment (grey bars) in the sagittal/frontal planes was 1.50°±1.57° and 0.82°±0.77°. During cadaveric experiment one (Figure 2), computed frontal plane angles were 2.83°±0.98°, −1.67°±1.99°, and −4.33°±0.53° after placing distinct 2° lateral, 2° medial, and 4° medial shims. Finally, the average angular error from cadaveric experiment two (Figure 3) over all positions was 1.73°±1.12° and 1.56°±1.45° in the sagittal and frontal planes, respectively. Discussion. Despite the high frequency of TKA procedures, a significant number fail and need to be revised for improper component alignment. This study showed through a first-principles approach that surgeons can assess 2D orientation of the tibial component intraoperatively with 1° of accuracy with a single triaxial gyroscope rigidly affixed to the tibial plateau. Moreover, this study showed through the use of a cadaveric model that surgeons could assess 2D alignment of the tibial component with a gyroscope rigidly affixed to the tibial plateau. To our knowledge, this is first method to offer true 2D tibial tray orientation assessment using only a single triaxial gyroscope