The success of a cementless Total Hip Arthroplasty (THA) depends not only on initial micromotion, but also on long-term failure mechanisms, e.g., implant-bone interface stresses and stress shielding. Any preclinical investigation aimed at designing femoral implant needs to account for temporal evolution of interfacial condition, while dealing with these failure mechanisms. The goal of the present multi-criteria optimization study was to search for optimum implant geometry by implementing a novel machine learning framework comprised of a neural network (NN), genetic algorithm (GA) and finite element (FE) analysis. The optimum implant model was subsequently evaluated based on evolutionary interface conditions. The optimization scheme of our earlier study [1] has been used here with an additional inclusion of an NN to predict the initial fixation of an implant model. The entire CAD based parameterization technique for the implant was described previously [1]. Three objective functions, the first two based on proximal resorbed Bone Mass Fraction (BMF) [1] and implant-bone interface failure index [1], respectively, and the other based on initial micromotion, were formulated to model the multi-criteria optimization problem. The first two objective functions, e.g., objectives f1 and f2, were calculated from the FE analysis (Ansys), whereas the third objective (f3) involved an NN developed for the purpose of predicting the post-operative micromotion based on the stem design parameters. Bonded interfacial condition was used to account for the effects of stress shielding and interface stresses, whereas a set of contact models were used to develop the NN for faster prediction of post-operative micromotion. A multi-criteria GA was executed up to a desired number of generations for optimization (Fig. 1). The final trade-off model was further evaluated using a combined remodelling and bone ingrowth simulation based on an evolutionary interface condition [2], and subsequently compared with a generic TriLock implant. The non-dominated solutions obtained from the GA execution were interpolated to determine the 3D nature of the Pareto-optimal surface (Fig. 2). The effects of all failure mechanisms were found to be minimized in these optimized solutions (Fig. 2). However, the most compromised solution, i.e., the trade-off stem geometry (TSG), was chosen for further assessment based on evolutionary interfacial condition. The simulation-based combined remodelling and bone ingrowth study predicted a faster ingrowth for TSG as compared to the generic design. The surface area with post-operative (i.e., iteration 1) ingrowth was found to be ∼50% for the TSG, while that for the TriLock model was ∼38% (Fig. 3). However, both designs predicted similar long-term ingrowth (∼89% surface area). The long-term proximal bone resorption (upto lesser trochanter) was found to be ∼30% for the TSG, as compared to ∼37% for the TriLock model. The TSG was found to be bone-preserving with prominent frontal wedge and rectangular proximal section for better rotational stability; features present in some recent designs. The optimization scheme, therefore, appears to be a quick and robust preclinical assessment tool for cementless femoral implant design. To view tables/figures, please contact authors directly

Negative remodelling of the femoral cortex in the form of calcar resorption due to stress-shielding, and femoral cortical hypertrophy at the level of the tip of the implant due to distal load transfer, is frequenly noted following cemented total hip replacement, most commonly with composite beam implants, but also with polished double tapered components. The C-stem polished femoral component was designed with a third taper running from lateral to medial across and along the entire length of the implant, with the aim of achieving more proximal and therefore more natural loading of the femur. The implant is designed to subside within the femoral cement mantle utilising the cement property of creep, generating hoop stresses, which are transferred more proximally to the femoral bone, starting at the level of the medial calcar. The intention is to load the proximal femur minimising stress-shielding and calcar resorption, as well as reducing distal load transfer as signified by the lack of distal femoral cortical hypertrophy. We present the results of a consecutive series of 500 total hip replacements using C-stem femoral components, performed between March 2000 and December 2005 at a single institution. Data was collected prospectively and all patients remain under annual follow-up by a Specialist Arthroplasty Practitioner. The operations were performed using a standard surgical technique with third generation cementing using Palacos-R antibiotic loaded cement. 500 arthroplasties were performed on 455 patients with an average age at the time of surgery of 68.3 years (23-92). There were 282 (62%) female and 173 (38%) male patients with osteoarthritis being the predominant diagnosis. 77 patients have died (73 hips) and the average duration of follow-up for the entire series is 81 months (52-124). Only 2 femoral implants have been revised - one for deep sepsis and the other as part of a revision procedure for a loose acetabulum, although the femoral component itself was not loose. One implant is currently loose following a periprosthetic fracture treated by internal fixation, but none of the remaining implants demonstrates any progressive radiolucencies in any Gruen zones or any features suggestive of current or future loosening. Calcar rounding has been observed, but there have been no cases with obvious loss of calcar height and no cases of distal femoral cortical hypertrophy. The C-stem femoral component has therefore performed well in clinical practice and the objective of eradicating negative bone remodelling has been achieved. The study is ongoing

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. Negative remodelling of the femoral cortex in the form of calcar resorption due to stress shielding and cortical hypertrophy at the level of the tip of the implant, due to distal load transfer, is frequently noted following cemented total hip replacement, most commonly with composite beam implants, but also with polished double tapers. The C-stem polished femoral component was designed with a third taper running from lateral to medial across and along the entire length of the implant, with the aim of achieving more proximal and therefore more natural loading of the femur. The hoop stresses generated in the cement mantle are transferred to the proximal bone starting at the calcar, which should theoretically minimise stress-shielding and calcar resorption, as well as reducing distal load transfer, as signified by the development of distal femoral cortical hypertrophy. Materials/Methods. We present the results of a consecutive series of 500 total hip replacements performed between March 2000 and December 2005 at a single institution, using a standard surgical technique and third generation cementing with Palacos-R antibiotic loaded cement. Data was collected prospectively and the patients remain under annual follow-up. 500 arthroplasties were performed on 455 patients with an average age of 68.3 years (23–92). 77 patients have died (73 arthroplasties) and the average duration of follow-up for the entire series is 81 months (52–124). Results. Only 2 femoral implants have been revised - one for deep sepsis and the other as part of a revision procedure for a loose acetabulum, although the femoral component itself was not loose. One implant is currently loose following a periprosthetic fracture treated by internal fixation, but none of the other remaining implants demonstrates any progressive radiolucencies in any Gruen zones, or any features suggestive of current or future loosening. Rounding of the calcar has been observed, but there have been no cases with obvious loss of calcar height and no cases of distal femoral cortical hypertrophy. Conclusion. The C-stem femoral component has therefore performed well in clinical practice and the objective of eradicating negative bone remodelling has been achieved. The study is ongoing

Anterior positioning of a cephomedullary nail in the distal femur occurs in up to 88% of cases. This is considered to occur because of a mismatch between the radius of curvature of the femur and that of available implants. The hypothesis for this study was that the relative thicknesses of the cortices of the femur (referenced off the linea aspera) change with age and determine the final position of intramedullary implants.

This study used the data from CT scans undertaken as part of routine clinical practice in 919 patients with intact left femora (median age 66 years, 484 male and 435 female). The linea aspera and transverse intervals were plotted on a template femur between 25% – 60% femoral bone length (5% increments) and mapped automatically to all individual femora in the database with measurements taken in the plane of the linea aspera.

The linea aspera was found to be internally rotated as compared to the sagittal plane referenced off the posterior femoral condyles. An age related change in the posterior/anterior cortical thickness ratio was demonstrated. The >80 year old cohort shows a significantly disproportional posterior/anterior ratio increase of 70.0% from 25–50% bone length as compared to 48.1% for the <40 year old cohort (p<0.05).

This study has shown that assessment in the sagittal plane may be inaccurate because of rotational changes in the linea aspera. The centering influence of the corticies is lost with age with a relative thinning of the anterior cortex and thickening of the posterior cortex moving distally in the femur. This has a direct influence on the positioning of intramedullary implants explaining the preponderance of anterior malpositioning of intramedullary implants in the elderly.

Introduction. Conventional implant designs in total knee arthroplasty (TKA) are based on metal on UHMWPE bearing couples. Although this procedure is quite successful, early loosening is still a matter of concern. One of the causes for early failure is stress shielding, leading to loss of bone stock, periprosthetic bone fractures and eventually aseptic loosening of the component. The introduction of a polyetheretherketone (PEEK) on UHMWPE bearing couple could address this problem. With mechanical properties more similar to distal (cortical) bone it could allow stresses to be distributed more naturally in the distal femur. A potential adverse effect, however, is that the femoral component and the underlying cement mantle may be at risk of fracturing. Therefore, we analyzed the effect of a PEEK-Optima® femoral component on stress shielding and the integrity of the component and cement mantle, compared to a conventional Cobalt-Chromium (CoCr) alloy implant. Methods. We created a Finite Element (FE) model of a reconstructed knee in gait, based on the ISO-14243-1 standard. The model consisted of an existing cemented cruciate retaining TKA design implanted on a distal femur, and a tibial load applicator, which together with the bone cement layer and the tibial implant is referred to as the tibial construct. The knee flexion angle was controlled by the femoral construct, consisting of the femoral implant, the bone cement and the distal femur. The tibial construct was loaded with an axial force, anterior-posterior (AP) force and a rotational torque, representing the ground reaction force, soft tissue constraints and internal/external rotation of the tibia, respectively. The integrity of the femoral component and cement mantle were expressed as a percentage of their yield stress. Stress shielding in the periprosthetic femur was evaluated by the strain energy (density) in the bone and compared to a model replicating an intact knee joint. Results. Considering implant durability, the CoCr and PEEK-Optima® femoral components performed equally well, with peak stresses reaching only 12–18 percent of their respective yield stresses (Figure 1(A)). The bone cement experienced higher loads in the reconstruction with the PEEK-Optima® implant, but the principal stresses were within a safe range, with a maximum of 20 percent of the ultimate compressive load (Figure 1(B)). As anticipated, the more compliant polymer implant resulted in a strain energy magnitude and distribution similar to that of an intact knee (Figure 2,3), which could prevent the loss of bone stock on the longer term. Discussion. Our simulations indicate that the femoral implant and cement mantle are not at risk of failure during gait. Moreover, the hypothesis that stress shielding can be reduced by a polymer implant is corroborated by this model. ISO loads can be considered an underestimation and so we intend to expand the model with more comprehensive loading regimes, based on musculoskeletal simulations of gait as well as more arduous physical activities. We plan to include activities like squatting or stair ascending as they are likely to be more detrimental to the implant performance

The effects of metal ion release and wear particle debris in metal-on-metal articulation warrants an investigation of alternative material, like ceramics, as a low-wear bearing couple [1]. Short-stem resurfacing femoral implant, with a stem-tip located at the centre of the femoral head, appears to provide a better physiological load transfer within the femoral head and therefore seems to be a promising alternative to the long-stem design [2]. The objective of this study was to investigate the effect of evolutionary bone adaptation on load transfer and interfacial failure in cemented metallic and ceramic resurfacing implant. Bone geometry and material properties of 3D finite element (FE) models (intact, short-stem metallic and ceramic resurfaced femurs of 44 mm head diameter) were derived from the CT scan data. The FE models consisted of 170352 quadratic tetrahedral elements and 238111 nodes with frictional contact at the implant-cement (μ = 0.3) and stem-bone interfaces (μ = 0.4) and fully bonded cement-bone interface. Normal walking and stair climbing were considered as two different loading conditions. A time-dependant “site specific” bone remodelling simulation was based on the strain energy density and internal free surface area of bone [3]. The variable time-step was determined after each remodelling iteration. The Hoffman failure criterion was used to assess cement-bone interfacial failure. Predicted change in bone density due to bone remodelling was very much similar in both the metallic and ceramic resurfaced femurs (Fig. 1). Both the metallic and ceramic implant resulted in strain reduction in the proximal regions (Region of interest, ROI 2 and 4) and subsequent bone resorption, average bone density reduction by 72% (Fig. 1). Higher strains were generated in ROI 5 and 7, which caused bone apposition, an average increase in bone density of 145% (Fig. 1). The tensile stresses in the resurfacing implants increased with change in bone density; a maximum stress of 83 MPa and 63 MPa were observed in the ceramic and the metallic implants, respectively. The tensile stress in the cement mantle also increased with bone remodelling. Although the cement-bone interface was secure against interface debonding in the post-operative situation, calculations of Hoffman number indicated that risk of cement-bone interfacial failure was increased with peri-prosthetic bone adaptation. During the remodelling simulation, maximum tensile stress in the implant and the cement was far below its strength. However, with bone adaptation greater volume of cement mantle was exposed to higher stresses which, in-turn, resulted in greater risk of interfacial failure around the periphery of the cement mantle. Both the short-stem ceramic and metallic resurfacing component, under debonded stem-bone interface, resulted in more physiological stress distribution across the femoral head. Based on these results, short-stem ceramic resurfacing component appears to be a viable alternative to the metallic design

The Accolade®TMZF is a taper-wedge cementless metaphyseal coated femoral stem widely utilized from 2002-2012. In recent years, there have been reports of early catastrophic failure of this implant. Establishing a deeper understanding of the rate and causes of revision in patients who developed aseptic failure in stems with documented concerns about high failure rates is critical. Understanding any potential patient or implant factors which are risk factors for failure is important to inform both clinicians and patients. We propose a study to establish the long-term survival of this stem and analyze patients who underwent aseptic revision to understand the causes and risk factors for failure. A retrospective review was undertaken of all patients who received a primary total hip arthroplasty with an Accolade® TMZF stem at a high-volume arthroplasty center. The causes and timing of revision surgery were documented and cross referenced with the Canadian Institute of Health Information Discharge Abstract Database to minimize loss to follow-up. Survivorship analysis was performed with use of the Kaplan-Meier curves to determine the overall and aseptic survival rates at final follow-up. Patient and implant factors commonly associated with aseptic failure were extracted and Cox proportional hazards model was used. A consecutive series of 2609 unilateral primary THA patients implanted with an Accolade®TMZF femoral hip stem were included. Mean time from primary surgery was 12.4 years (range 22 days to 19.5 years). Cumulative survival was 96.1% ± 0.2 at final follow-up. One hundred and seven patients underwent revision surgery with aseptic loosening of the femoral component was the most common cause of aseptic failure in this cohort (33/2609, 1.3%). Younger age and larger femoral head offset were independent risk factors for aseptic failure. To our knowledge, this is the largest series representing the longest follow-up of this taper-wedge cementless femoral implant. Despite early concerns, the Accolade® TMZF stem has excellent survivorship in this cohort. Trunnionosis as a recognized cause for revision surgery was rare. Younger age and larger femoral head offset were independent risk factors for aseptic failure

Introduction. Patellofemoral joint is an important aspect of the tri-compartmental knee joint complex. Total knee arthroplasty (TKA) replaces the articulating surfaces of distal femur and proximal tibia, and often times the patella as well. Understanding the size relationship between the femur and patella bones can provide valuable information for new prosthesis design and biomechanical analysis. However, taking anthropometric measurements on a large population of patients or even cadaveric specimens could be a challenge. As a result, there are currently little quantitative data existing in the literature regarding the size relationship between TKA patient's femur and patella. This study attempted to attack this question using a novel statistical approach and a large TKA patient database. Methods. A multi-site clinical database operated by Exactech was used in this study. The database contains patient information of Optetrak TKA implant recipients from over 30 physicians in US, UK, and Colombia since 1995. Nine femoral implant sizes (0, 1, 2, 2.5, 3, 3.5, 4, 5 and 6) and six patellar implant sizes (26, 29, 32, 35, 38, 41 mm) were seen in these patients. Due to the low usage, femoral sizes 0 and 6 were excluded from this analysis. Taking primary TKA only, a total of 2,698 cases were included in this study. The size relationship between femoral implant and patellar implant was analyzed in this patient population. Gender effect was also examined. Results. The usage histograms showed that the most frequently used femoral implant in the database was size 3, and the most frequently used patellar implant sizes were 32 and 35 mm. In general, patients who received a larger femoral implant also received a larger patellar implant. There was a strong correlation between the anterior/posterior (AP) dimension of the femoral implant and the diameter of the spherical patellar implant, with a linear regression showing R2 > 0.9. On average, for 1 mm increase of the femoral AP dimension, the patellar implant increased by 0.36 mm in diameter. The strong correlation between the femoral and patellar dimensions exists for both male and female populations (R2 > 0.9 in both genders). The slope of the regression line was slightly greater for the males than for the females (0.38 vs. 0.33). Discussion. By using a novel statistical approach, this study was able to provide a quantitative assessment of the size relationship between femoral and patellar implants of TKA patients. There was a strong correlation between the femoral implant's AP dimension and the patellar implant's diameter. The increase ratio of the two dimensions was about 1:0.36. There was a minor difference between genders in terms of the increase ratio, but the overall trends were similar. Statistically we can assume that the femoral implant resembled the AP dimension of the distal femur, and the patellar implant diameter resembled the short axis of the patellar oval. Thus, the results in this study also provided a meaningful anthropometric measurement of the native femur and the patella bones

Introduction. Cementless total knee arthroplasty (TKA) has several advantages compared to the cemented approach, including elimination of bone cement, a quicker and easier surgical technique, and potentially a stronger long-term fixation. However, to ensure the successful long-term biological fixation between the porous implant and the bone, initial press-fit stability is of great importance. Undesired motion at the bone-implant interface may inhibit osseointegration and cause failure of biological fixation. Initial stability of a cementless femoral implant is affected by implant geometry, bone press-fit dimension, and characteristics of the porous coating. The purpose of this study was to compare the initial fixation stability of two types of porous femoral implants by quantifying the pull-out force using a paired cadaveric study design. Methods. The two types of cementless TKA femoral implants evaluated in this study had identical implant geometry but different porous coatings (Figure 1). The first type had a conventional spherical-bead coating (Type A), while the second type had an innovative irregularly-shaped-powder coating (Type B). The porous coating thickness was equivalent for both types of implants, thus the dimensional press-fit with bone was also equivalent. Three pairs of cadaveric femurs were prepared using standard TKA surgical technique, with each pair of the femurs receiving one of each porous implant type. An Instron 3366 load frame (Norwood, MA, USA) was used to pull the femoral implant out from the distal femur bone (Figure 2). The testing fixture was designed to allow free rotation between the implant and the actuator. The pullout was performed under a displacement control scheme (5 mm/min). Peak pull-out force was recorded and compared between the two implant groups. Results. Mean pull-out force for the Type B porous femoral implants (512 ± 246 N) was greater than that of the Type A porous femoral implants (310 ± 185 N), although the difference was not statistically significant (p>0.05) (Figure 3). Discussion. This paired cadaveric study showed that the innovative Type B porous coating provides equivalent and potentially greater pull-out force than the conventional Type A porous coating. Lack of statistical significance could be attributed to the limited sample size. Although pull-out testing is not a physiological loading scenario for TKA implant, it provides a relevant assessment of the implant-bone press-fit stability. With all other factors the same, the greater pull-out force observed in the Type B implants is likely related to the higher roughness and friction of the new porous coating. Previous experiments have shown that the Type B porous coating has significantly greater friction against Sawbones surface (coefficient of friction 0.89) compared to Type A porous coating (coefficient of friction 0.50), which was consistent with the findings in this study. Greater initial fixation stability is more favorable in cementless TKA as it reduces the risk of interface motion and better facilitates long-term biological fixation

Introduction. Recent advances in 3D printing enable the use of custom patient-specific instruments to place drill guides and cutting slots for knee replacement surgery. However, such techniques limit the ability to intra-operatively adjust an implant plan based on soft-tissue tension and/or joint pathology observed in the operating room, e.g. cruciate ligament integrity. It is hypothesized that given the opportunity, a skilled surgeon will make intra-operative adjustments based on intra-operative information not captured by the hard tissue anatomy reconstructed from a pre-operative CT scan or standing x-ray. For example, tibiofemoral implant gaps measured intra-operatively are an indication of soft-tissue tension in the patient's knee, and may influence a surgeon to adjust implant position, orientation or size. This study investigates the frequency and magnitude of intra-operative adjustments from a single orthopedic surgeon during 38 unicondylar knee arthroplasty (UKA) cases. Methods. For each patient, a pre-operative plan was created based on the bony anatomy reconstructed from the pre-operative CT. This plan is analogous to a plan created with patient-specific cutting blocks or customized implants. With robotic technology that utilizes pre-operative imaging, intra-operative navigation and robotic execution, this “anatomic” plan can be fine-tuned and adjusted based on the soft tissue envelop measured intra-operatively. The relative positions of the femur and the tibia are measured intra-operatively under a valgus load (for medial UKA, varus load for lateral UKA) for each patient from extension to deep knee flexion and used to compute the predicted space between the implants (gaps) throughout flexion. The planned position, orientation and size of the components can then be adjusted to achieve an optimal dynamic ligament balance prior to any bony cuts. This is the plan that is then executed under robotic guidance. Intra-operative adjustments are defined as any size, position or orientation changes occurring intra-operatively to the pre-operative anatomic plan. Results. The surgeon adjusted the pre-operative implant plan in 86.8% of cases, leading to combined RMS changes of 2.0 mm and 2.1 degrees to the femoral implant, and 0.9 mm and 1.4 degrees to the tibial implant. The RMS femoral implant translations and rotations were 1.0, 1.5, 0.9 mm and 1.0, 1.0, 1.7 degrees in the medial, anterior, and superior directions, respectively. The RMS tibial implant translations and rotations were 0.2, 0.4, 0.8 mm and 1.3, 0.4, 0.6 degrees in the medial, anterior, and superior directions, respectively. Implant sizes were adjusted in 36.8% of cases, with all changes occuring to the femoral implant, and 13 out of those 14 cases showing a reduction in the femoral implant size. Conclusions. These data support the hypothesis that surgical planning of UKA components based on accurate 3D dimensional reconstructions of anatomy alone is not adequate to create optimal implant gap spacing throughout flexion. Measurement and knowledge of the patient's soft tissue envelope allows for signficiant changes to the implant plan prior to any bony cuts

Introduction. Computed tomography (CT) can be utilized to design patient specific instruments (PSI) for total knee arthroplasty (TKA). The PSI preoperative plans predict bone resection, anterior-posterior implant position, implant rotation and implant size. The purpose of this study was to compare preoperatively predicted implant sizes (tibia and femur) to the actual implanted sizes. Data were compiled from two surgeons, one in the United Kingdom (Surgeon 1, cruciate retaining) and one in the United States (Surgeon 2, posterior stabilizing). Both used the same primary TKA implant systems (Sigma® and Attune®; DePuySynthes®, Warsaw, Indiana). This is the largest comparison of CT-based PSI size accuracy between two implant systems. Methods. An international cohort of 396 CT-based PSI-TKA preoperative plans (TruMatch®)were compared to postoperative implant records. Data were retrospectively analyzed for Sigma®(n=351) and Attune® (n=45), both as separate cohorts and as a combined cohort (Sigma® + Attune®). Three analyses were performed: Tibia and femur plan accuracy, major size changes (femoral size change or tibial size change resulting in a femoral size change) and minor size changes (tibial size change not impacting femoral size). Inter-rater reliability analyses using ICC (intra-class correlation) and the Kappa statistic were performed to determine reliability and agreement among the groups. Combined TKA implant data (Sigma® + Attune®) for surgeons 1 and 2 were compared for accuracy between users utilizing different implant designs, cruciate retaining (CR) versus posterior stabilized (PS). Results. In the combined system analysis (Sigma® + Attune®) femoral implant prediction was 97.0% accurate and combined tibial implant size accuracy was 79.5%. There were no significant differences between the systems for tibial or femoral accuracy. See Table 1. There were 12 major size changes, 11 downsized femoral implants and 1 upsized femoral implant (all femoral changes were with Sigma® system). There were 81 minor size changes. Per Kappa, the plans were in excellent agreement with the femoral implant size and had substantial agreement with tibial implant size (p<.01). See Table 2. Comparing size accuracy between Surgeon 1 and Surgeon 2, Surgeon 1 had significantly greater tibial accuracy (p<.01), while femoral accuracy showed no significant difference (p=0.49). See Table 3. Discussion. In this combined data set of two surgeons, we report high implant sizing accuracy overall. This accuracy was noted across implant systems (Sigma® and Attune®) and across surgeons (1 and 2) utilizing different implant designs (CR vs. PS) using TruMatch® PSI. In all cohorts, the femur was more accurately predicted than the tibia. Accurate size reconstitution and reconstruction of the femur is critical for maintenance of posterior condylar offset, avoidance of anterior compartment overstuffing and avoidance of anterior femoral cortical notching. This study demonstrates the reproducibility of CT-based PSI TKA across different implant systems (Sigma® and Attune®), implant designs (CR and PS) and different surgeons. The ability to accurately predict implant size can also contribute system efficiencies: improved implant inventory management, development of size-focused instrumentation sets and potentially reduced workload for sterile processing departments

Background. Despite the success of total hip arthroplasty (THA), there are still challenges including restoration of leg length, offset, and femoral version. The Tsolution One combines preoperative planning with an active robotic system to assist in femoral canal preparation during a THA. Purpose of Study. To demonstrate the use of an active robotic system in femoral implant placement and determine the accuracy of femoral implant position. This was evaluated in a cadaveric study. Study Design and Methods. Four THA's were performed in fresh frozen cadaveric hips with assistance of the TSolution One System for preparation of the femoral canal. CT scans of the hip were used as input for TPLAN preoperative planning software to position the implants in three-dimensions (3D). The intraoperative process includes exposure of the joint using a posterolateral approach, fixation of the femur relative to the TCAT system, and registration of the femur. TCAT then actively milled the femoral canal in each of the cases after which Depuy Trilock implants were inserted by the surgeon. Only the femoral stem implants were considered in this study. Postoperative CT was used to compare actual implant position with preoperatively planned implant position in 3D. The translations between the centroids of the implant positions were compared. Findings of Study. All femoral stems were successfully implanted with no complications. Implant position very closely matched the preoperative plan. Compared to the preoperative plan, the mean (± SD) positions of the centroid of the implant were off by 0.6 (±0.6) mm in the medial-lateral direction, 0.8 (±0.3) mm in the anterior-posterior direction, and 2.0 (±1.3) mm in the superior-inferior direction. No intraoperative fractures occurred. A sample of the preoperative planned position (left) and actual postoperative position (right) as seen on TPLAN can be seen in Figure 1. An example of the final 3D implant position in blue as compared to the preoperative implant position in red can be seen in Figure 2. Conclusions. Overall, the post-operative stems positions were superior compared to the preoperative plan and it is believed that this is likely a result of not impacting the stems enough during the procedure. The medial-lateral and anterior-posterior stem positions were within 1 mm of what was planned. Active robotics can successfully be used to improve accuracy, precision, and reproducibility when considering final implant position in THA. These improvements can reduce unwanted human error and reduce complications. Further in vivo study is planned to demonstrate the clinical benefits of such improved precision

Introduction. Achieving proper ligament tension in knee flexion within cruciate retaining (CR) total knee arthroplasty (TKA) has long been associated with clinical success. The distal femoral joint line (DFJL) is routinely used as a variable to assist in achieving proper flexion-extension gap balancing. No prior study has observed the possible effects of properly restoring the DFJL may have on ligament tension in flexion. The purpose of this computational analysis was to determine what effect the DFJL may have on ligament strains and tibiofemoral kinematics of CR knee designs in flexion. Methods. A computational analysis was performed utilizing a musculoskeletal modeling system with ligaments modeled as non-linear elastic. Tibiofemoral kinematics, contact points estimated from the femoral condyle low points, and ligament strain, change in length relative to the unloaded length, were measured at 90° knee flexion during a deep knee bend activity. Two different knee implants, a High Flexion CR (HFCR) and a Guided Motion CR (GMCR) design were used. Simulations were completed for changes in superior-inferior (SI) positioning of the femoral implant relative to the femur bone, in 2mm increments to simulate over and under resection of the DFJL. Results. The medial condyle of the femoral implant was 0.67mm and 0.47mm more posterior relative to the tibia per 1mm elevation of the DFJL for the HFCR and GMCR designs respectively. The lateral condyle was 0.80mm and 1.06mm more posterior relative to the tibia per 1mm elevation of the DFJL for the HFCR and GMCR designs, respectively. The strain in the LCL and MCL changed less than 0.0005mm/mm per 1mm change in DFJL indicating that those structures were not affected. The PCL bundles and the ITB were affected by changes in DFJL with strain increasing 0.005 and 0.004mm/mm in the AL PCL bundle respectively for HFCR and GMCR, strain increasing 0.006mm/mm in the PM PCL for both HFCR and GMCR, and ITB strain decreasing 0.006 and 0.004mm/mm respectively for the HFCR and GMCR per 1mm elevation of the DFJL. Discussion. Our findings suggest that DFJL affects ligament tension at 90° knee flexion and therefore flexion balance for cruciate retaining implants. The effect on ligament tension results from changes in the position of the femur bone and its ligament attachments with respect to the tibia, which is dependent on the implant geometry. DFJL places greater strain on the PCL because the conformity of the medial condyle prevents the femoral implant from sitting more posterior by the full amount of the DFJL elevation, which would be necessary to maintain the same AP position of the of the femur bone relative to the tibia and avoid increasing PCL strain. These results indicate that elevating the DFJL to address a tight extension space in a CR knee while the flexion space is well balanced could result in increased flexion tension especially when the flexion-extension mismatch is large, so to achieve balanced flexion and extension the amount of DFJL elevation may need to be reduced and the tibial resection may also need to be increased

Introduction. Persistent anterior knee pain, subluxation or dislocation of the patella as well as early aseptic loosening and increased polyethylene wear of the patella implant are common clinical problems after total knee arthroplasty (TKA) which are associated with the patellofemoral joint. In addition to patellar resurfacing, the design of the patellofemoral joint surfaces is attributed a large influence. While for patients without patella resurfacing, the native patella is sliding on the standardized femoral component and therefore the possibility of a reduced surface matching is high, patella resurfacing has been shown to decrease the joint contact area and yield to increased patellofemoral pressure. With regard to a further design optimization, the current study examined patellar biomechanics after TKA without and with resurfacing, comparing 5 differently designed patellofemoral joint surfaces of the femoral implant. Methods. The femoral implant of the Genesis II prosthesis (Smith & Nephew) was scanned and an adaptable CAD-model was built using CATIA. Five different designs of the patellofemoral groove were created:. original. completely flat. laterally elevated (+2mm lateral, −1mm medial). medially elevated (+2mm medial, −1mm lateral). laterally & medially elevated (+3mm lateral+medial). The tibiofemoral joint as well as patellofemoral groove path and radius remained unchanged. Rapid Prototyping was used to produce prototypes made of polyamide. A dynamic muscle loaded knee squat was simulated on 10 fresh frozen knee specimens with an upright knee simulator. The patellofemoral pressure distribution was measured using a flexible, resistive force sensor (TEKSCAN) while tibiofemoral and patellofemoral kinematics were recorded with an ultrasonic motion tracking system (ZEBRIS). In addition, patellar stability was measured in different flexion angles on another 10 specimens using a robot (KUKA). Measurements were taken on the native knee as well as after TKA and after additional patellar resurfacing with alternating femoral implant. Results. Considering patellofemoral kinematics, the largest influence was found for the flat design where increased lateral tilt (up to 6°) and medial shift (up to 5mm) were measured after TKA compared to the native knee. Similar results were achieved for patellar stability, where increased lateral displacement (up to +6mm) was measured for the flat design. The other designs only had a small effect on patellar kinematics and patellar lateral stability. Regarding maximal peak pressure, on average, only a small influence of the designs was found. However, for the individual knee specimens, the pressure distribution and peak pressures varied clearly among the different designs. After additional patellar resurfacing, patellofemoral peak pressures significantly increased (almost doubled), but for the different designs, similar results as before were achieved regarding patellar kinematics, stability and pressures. Conclusions. Increased mediolateral motion was found for the flat design compared to the others and the native knee concluding that a moderate groove is necessary but also sufficient to guarantee stable motion. Especially for maximal patellofemoral peak pressures, large individual differences between the designs were measured while the average influence was small. Therefore, an individual choice between some standard implants might be an interesting option, if appropriate criteria can be found

The infected TKA is one of the most challenging complications of knee surgery, but spacers can make them easier to treat. An articulating spacer allows weight bearing and range of motion of the knee during rehabilitation. This spacer is made using antibiotic-impregnated bone cement applied to the tibial and femoral implants. For our purpose, 4.8g powdered tobramycin is mixed with 2gm vancomycin and one batch of antibiotic. Cement is applied early to the components, but applied late to the femur, tibia, and patella to allow molding to the defects and bone without solid adherence to bone. Patients have tailored intravenous antibiotic therapy for 6 weeks for treatment of various gram-positive and gram-negative organisms. At 10–12 weeks patients are revised to a cemented revision total knee arthroplasty using standard cementing techniques. From our experience, range of motion before reimplantation was 5 – 90 degrees. Follow-up averaged 73 months for fifty patients with 90% good to excellent results; 10% had a recurrence of infections. Use of an articulating spacer achieves soft tissue compliance, allows for ease of re-operation, reduced postoperative pain, improved function, and eradicates infection equal to standards reported in the literature

Summary. The mathematical model has proven to be highly accurate in measuring leg length before and after surgery to determine how leg length effects hip joint mechanics. Introduction. Leg length discrepancy (LLD) has been proven to be one of the most concerning problems associated with total hip arthroplasty (THA). Long-term follow-up studies have documented the presence of LLD having direct correlation with patient dissatisfaction, dislocation, back pain, and early complications. Several researchers sought to minimize limb length discrepancy based on pre-operative radiological templating or intra-operative measurements. While often being a common occurrence in clinical practice to compensate for LLD intra-operatively, the center of rotation of the hip joint has often changes unintentionally due to excessive reaming. Therefore, the clinical importance of LLD is still difficult to solve and remains a concern for clinicians. Objective. The objective of this study is two-fold: (1) use a validated forward-solution hip model to theoretically analyze the effects of LLD, gaining better understanding of mechanisms leading to early complication of THA and poor patient satisfaction and (2) to investigate the effect of the altered center of rotation of the hip joint regardless LLD compensation. Methods. The theoretical mathematical model used in this study has been previously validated using fluoroscopic results from existing implant designs and telemetric devices. The model can be used to theoretically investigate various surgical alignments, approaches, and procedures. In this study, we analyzed LLD and the effects of the altered center of rotation regardless of LLD compensation surgeons made. The simulations were conducted in both swing and stance phase of gait. Results. During swing phase, leg shortening lead to loosening of the hip capsular ligaments and subsequently, variable kinematic patterns. The momentum of the lower leg increased to levels where the ligaments could not properly constrain the hip leading to the femoral head sliding from within the acetabular cup (Figure 1). This piston motion led to decreased contact area and increased contact stress within the cup. Leg lengthening did not yield femoral head sliding but increased joint tension and contact stress. A tight hip may be an influential factor leading to back pain and poor patient satisfaction. During stance phase, leg shortening caused femoral head sliding leading to decreased contact area and an increase in contact stress. Leg lengthening caused an increase in capsular ligaments tension leading to higher stress in the hip joint (Figure 2). Interestingly, when the acetabular cup was superiorized and the surgeon compensated for LLD, thus matching the pre-operative leg length by increasing the neck length of the femoral implant, the contact forces and stresses were marginally increased at heel strike (Figure 3). Conclusion and Discussion. Altering the leg length during surgery can lead to higher contact forces and contact stresses due to tightening the hip joint or increasing likelihood of hip joint separation. Leg shortening often lead to higher stress within the joint. Further assessment must be conducted to develop tools that surgeons can use to ensure post-operative leg length is similar to the pre-operative condition. For any figures or tables, please contact authors directly

Introduction. The success of cementless total hip arthroplasty (THA), primary as well as for revision, largely depends on the initial stability of the femoral implant. In this respect, several studies have estimated that the micromotion at the bone-implant interface should not exceed 150µm (Jasty 1997, Viceconti 2000) in order to ensure optimal bonding between bone and implant. Therefore, evaluating the initial stability through micromotion measurements serves as a valid method towards reviewing implant design and its potential for uncemented THAs. In general, the methods used to measure the micromotion assume that the implant behaves as a rigid body. While this could be valid for some primary stems (Østbyhaug 2010), studies that support the same assumption related to revision implants were not found. The aim of this study is to assess the initial stability of a femoral revision stem, taking into account possible non-rigid behaviour of the implant. A new in vitro measuring method to determine the micromotion of femoral revision implants is presented. Both implant and bone induced displacements under cyclic load are measured locally. Methods. A Profemur R modular revision stem (MicroPort Orthopedics Inc. Arlington, TN, United States of America) and artificial femora (composite bone 4th generation #3403, Sawbones Europe AB, Malmö, Sweden) prepared by a surgeon were used. The micromotions were measured in proximal-distal, medial-lateral or anterior-posterior directions at four locations situated in two transverse planes, using pin and bushing combinations. At each measuring location an Ø8mm bushing was attached to the bone, and a concentric Ø3mm pin was attached to the implant [Fig.1 and 2]. A supporting structure used to hold either guiding bushings or linear variable displacement transducers (LVDT) is attached to the proximal part of the implant. The whole system was installed on a hydraulic force bench (PC160N, Schenck GmbH, Darmstadt, Germany) and 250 physiological loading cycles were applied [Fig.3]. Results. By combining the local bone and implant displacements, the relative average micromotion appeared to be less than 25µm in the proximal region and less than 50µm in the distal region. These data correspond to a regular implant-bone fit. Also the micromotion is on average larger in the medial-lateral plane than in the posterior-anterior plane. If the implant deformations were not taken into account then the average values for micromotion were overestimated up to 20µm at proximal levels, and up to 140µm at distal levels. Conclusion. Good initial stability is achieved in each case, suggesting a successful long-term outcome. These findings are consistent with a success rate of 96% reported for the used implant over an average of 10 years (Köster 2008). To adequately evaluate the initial stability of femoral implants, the non-rigid behaviour cannot be ignored. Acknowledgments. This research is supported by BVOT (Belgian Association for Orthopaedics and Traumatology) and Impulse Fund KU Leuven

Introduction. Proper alignment (tibial alignment, femoral alignment, and overall anatomic alignment) of the prosthesis during total knee replacement is critical in maximizing implant survival[7] and to reduce polyethylene wear[1]. Poor overall anatomic alignment of a total knee replacement was associated with a 6.9 times greater risk of failure due to tibial collapse, that varus tibial alignment is associated with a 3.2 times greater risk[2] and valgus femoral alignment is associated with a 5.1 times greater risk of failure[7]. To reduce this variability intramedullary (IM) instruments have been widely used, with increased risk of the fat emboli rate to the lungs and brain during TKA[6] and possible increase of blood loss[4, 5]. Or, alternatively, navigation has been used to achieve proper alignment and to reduce morbidity[3]. Recently, for distal femoral resection, inertial sensors have been coupled to extramedullary (EM) instruments to improve TKA surgery in terms of femoral implant alignment, with respect to femoral mechanical axis, and reduced morbidity by avoidance of IM canal violation. The purpose if this study is to compare blood loss and alignment of distal femoral cut in three cohorts of patients: 1 Operated with inertial based cutting guide; 2 Operated with navigation instruments; 3 operated with conventional IM instruments. Material and methods. From September to November 2014 30 consecutive patients, eligible for TKA, were randomly divided into three cohorts with 10 patients each:x 1 “EM Perseus”, patient operated with EM inertial based instruments (Perseus, Orthokey Italia srl, Florence, Italy); 2 “EM Nav”, operated with standard navigated technique, where bone resections were planned and verified by mean of navigation system (BLUIGS, Orthokey Italia srl, Florence, Italy); 3 “IM Conv”, operated with standard IM instrumentation. All patients were operated by the same surgical technique, implanted TKA were mobile bearing PS models, Gemini (Waldemar Link, Hamburg, Germany) and Attune (Depuy, Warsaw, Indiana). Anteroposterior, lateral, and full-limb weightbearing views preoperatively and postoperatively at discharge were obtained, taking care of neutral limb rotational positioning in all patients enrolled in the study. Angles between femoral mechanical axis and implant orientation on frontal and lateral planes were measured with a CAD software (Rhinoceros 3, McNeel Europe, Rome, Italy) by two independent persons, average value was used for statistical analysis. Haemoglobin values were recorded at three time intervals: the day before surgery, at 24h follow-up and at patients discharge. Statistical analysis. Kruskal-Wallis test was used to compare differences between the three cohorts in blood loss and femoral implant alignment. Results. All the three cohorts were comparable in terms of age, sex, preoperative limb alignment and preoperative haemoglobin values (Tab. 1). Haemoglobin ad discharge was reduced for all three cohorts (Tab. 2), no significant differences was found even if IM Conv group showed higher loss compared to EM Perseus and EM Nav groups. Femoral implant alignment deviation, considering perpendicularity with femoral mechanical axis as goal, was comparable in frontal and lateral plane for all three cohorts (Tab. 2). Discussion. The aim of the study was to compare the accuracy in femoral component positioning, on the coronal and sagittal plane obtained with a new inertial based EM instrument, with a standard IM distal femoral cutting jig and with navigation. We confirm our hypothesis that the use of inertial based EM instruments to perform the distal femoral bone cut in TKA is reliable and at least as accurate as the standard IM technique and navigation. Our study did not show a statistical decrease in blood loss when the femoral canal was not reamed (in inertial based EM, and navigated groups), even if patient operated with IM instruments had sensibly higher blood loss compared to the other two groups. This study was not exactly powered for that purpose, a study with a larger cohort and strict patient selection criteria would be required. This study demonstrates that inertial based EM instruments is accurate for femoral component alignment in TKA and compares favorably to navigation systems and standard IM techniques. Other indications for the use of inertial based EM instruments include all major femoral extraarticular deformities, the presence of ipsilateral long-stemmed hip arthroplasty, and the presence of hardware such as distal femoral plates and screws or IM nails

BACKGROUND. Trochlear geometry of modern femoral implants is designed for the mechanical alignment (MA) technique for Total Knee Arthroplasty (TKA). The biomechanical goal is to create a proximalised and more valgus trochlea to better capture the patella and optimize tracking. In contrast, Kinematic alignment (KA) technique for TKA respects the integrity of the soft tissue envelope and therefore aims to restore native articular surfaces, either femoro-tibial or femoro-patellar. Consequently, it is possible that current implant designs are not suitable for restoring patient specific trochlea anatomy when they are implanted using the kinematic technique. This could cause patellar complications, either anterior knee pain, instability or accelerated wear or loosening. The aim of our study is therefore to explore the extent to which native trochlear geometry is restored when the Persona. ®. implant (Zimmer, Warsaw, USA) is kinematically aligned. METHODS. A retrospective study of a cohort of 15 patients with KA-TKA was performed with the Persona. ®. prosthesis (Zimmer, Warsaw, USA). Preoperative knee MRIs and postoperative knee CTs were segmented to create 3D femoral models. MRI and CT segmentation used Materialise Mimics® and Acrobot Modeller® software, respectively. Persona. ®. implants were laser-scanned to generate 3D implant models. Those implant models have been overlaid on the 3D femoral implant model (generated via segmentation of postoperative CTs) to replicate, in silico, the alignment of the implant on the post-operative bone and to reproduce in the computer models the features of the implant lost due to CT metal artefacts. 3D models generated from post-operative CT and pre-operative MRI were registered to the same coordinate geometry. A custom written planner was used to align the implant, as located on the CT, onto the pre-operative MRI based model (figure 1). In house software enabled a comparison of trochlea parameters between the native trochlea and the performed prosthetic trochlea (figure 2). Parameters assessed included 3D trochlear axis and anteroposterior offset from medial facet, central groove, and lateral facet. Sulcus angle at 30% and 40% flexion was also measured. Inter and intra observer measurement variabilities have been assessed. RESULTS. Varus-valgus rotation between the native and prosthetic trochleae was significantly different (p<0.001), with the prosthetic trochlear groove being on average 7.9 degrees more valgus. Medial and lateral facets and trochlear groove were significantly understuffed (3 to 6mm) postoperatively in the proximal two thirds of the trochlear, with greatest understuffing for the lateral facet (p<0.05). The mean medio-lateral translation and internal-external rotation of the groove and the sulcus angle showed no statistical differences, pre and postoperatively (figure 3). CONCLUSION. Kinematic alignment of Persona. ®. implants poorly restores native trochlear geometry. The clinical impact of this finding remains to be defined. For figures/tables, please contact authors directly.