Posterior stabilized (PS) total knee arthroplasty (TKA), wherein mechanical engagement of the femoral cam and tibial post prevents abnormal anterior sliding of the knee, is a proven surgical technique. However, many patients complain about abnormal clicking sensation, and several reports of severe wear and catastrophic failure of the tibial post have been published. In addition to posterior cam-post engagement during flexion, anterior engagement with femoral intercondylar notch can also occur during extension. The goal of this study was to use dynamic simulations to explore sensitivity of tibial post loading to implant design and alignment, across different activities. LifeModeler KneeSIM software was used to calculate tibial post contact forces for four contemporary PS implants (Triathlon PS, Stryker; Journey BCS and Legion PS, Smith & Nephew; LPS Flex, Zimmer Biomet). An average model of the knee, including cartilage and soft tissue insertion locations, created from MRI data of 40 knees was used to mount and align the component. The Triathlon femoral component was mounted with posterior and distal condylar tangency at: a) both medial and lateral condylar cartilage (anatomic alignment), b) at the medial condylar cartilage and perpendicular to mechanical axis (mechanical alignment with medial tangency), and c) at lateral condylar cartilage and perpendicular to mechanical axis (mechanical alignment with lateral tangency). The influence of implant design was assessed via simulations for the other implant systems with the femoral components aligned perpendicular to mechanical axis with lateral tangency. Five different activities were simulated. The anterior contact force was significantly smaller than the posterior contact force, but it varied noticeably with tibial insert slope and implant design. For Triathlon PS, during most activities anatomic alignment of the femoral component resulted in greater anterior contact force compared to mechanical alignment, but absolute magnitude of forces remained small (<100N). Mechanical alignment with medial tangency resulted in greater posterior contact force for deep knee bend and greater anterior force for chair sit activity. For all implants, peak posterior contact forces were greater for activities with greater peak knee flexion. The magnitude of posterior contact forces for the various implants was comparable to other reports in literature. Overall activity type, implant design and slope had greater impact on post loading than alignment method. Tibial insert slope was shown to be important for anterior post loading, but not for posterior post loading. Anatomic alignment could increase post loading with contemporary TKA systems. In the case of the specific design for which effect of alignment was evaluated, the changes in force magnitude with alignment were modest (<200N). Nonetheless, results of this study highlight the importance of evaluating the effect of different alignment approaches on tibial post loading

Common post-operative problems in shoulder arthroplasty such as glenoid loosening and joint instability can be reduced by improvements in glenoid design shape, material choice and fixation method [1]. Innovation in shoulder replacement is usually carried out by introducing incremental changes to functioning implants [2], possibly overlooking other successful design combinations. We propose an automated framework for parametric analysis of implant design in order to efficiently assess different possible glenoid configurations. Parametric variations of reference geometries of a glenoid implant were automatically generated in SolidWorks. The different implants were aligned and implanted with repeatability using Rhino. The glenoid-bone models were meshed in Abaqus, and boundary conditions and loading applied via a custom-made Python script. Finally, another MATLAB script integrated and automated the different steps, extracted and analysed the results. This study compared the influence of reference shape (keel vs. 2-pegged) and material on the von Mises stresses and tensile and compressive strains of glenoid components with bearing surface thickness and fixation feature width of 3, 4, 5 or 6 mm. A total of 96 different glenoid geometries were implanted into a bone cube (E = 300 MPa, ν = 0.3). Fixed boundary conditions were applied at the distal surface of the cube and a contact force of 1000 N was distributed between the central nodes on the bearing surface. The implants were assigned UHMWPE (E = 1 GPa, ν = 0.46), Vitamin E PE (E = 800 MPa, ν = 0.46), CFR-PEEK (E = 18 GPa, ν = 0.41) or PCU (E = 2 GPa, ν = 0.38) material properties and the bone-implant surface was tied (Figure 1). The von Mises stresses, compressive and tensile strains for the different models were extracted. The influence of design parameters in the mechanical environment of the implant could be assessed. In this particular example, the 95. th. percentile values of the tensile and compressive strains induced by modifications in reference shape could be evaluated for all the different geometries simultaneously in form of radar plots. 2-pegged geometries (green) consistently produced lower tensile and compressive strains than the keeled (blue) configurations (Figure 2). Vitamin E PE and PCU glenoids also produced lower maximum von Mises stresses values than CFR-PEEK and UHMWPE designs (Figure 3). The developed method allows for simple, direct, rapid and repeatable comparison of different design features, material choices or fixation methods by analysing how they influence the mechanical environment of the bone surrounding the implant. Such tool can provide invaluable insight in implant design optimisation by screening through multiple potential design modifications at an early design evaluation stage and highlighting the best performing combinations. Future work will introduce physiological bone geometries and loading, a wider variety of reference geometries and fixation features, and look at bone/interface strength and osteointegration predictions

Introduction:. Varus alignment of the knee is common in patients undergoing unicondylar knee replacement. To measure the geometry and morphology of these knees is to know whether a single unicondylar knee implant design is suitable for all patients, i.e. for patients with varus deformity and those without. The aim of this study was to identify any significant differences between normal and varus knees that may influence unicondylar implant design for the latter group. Methodology:. 56 patients (31 varus, 25 normal) were evaluated through CT imaging. Images were segmented to create 3D models and aligned to a tri-spherical plane (centres of spheres fitted to the femoral head and the medial and lateral flexion facets). 30 key co-ordinates were recorded per specimen to define the important axes, angles and shapes (e.g. spheres to define flexion and extension facet surfaces) that describe the femoral condylar geometry using in-house software. The points were then projected in sagittal, coronal and transverse planes. Standardised distance and angular measurements were then carried out between the points and the differences between the morphology of normal and varus knee summarised. For the varus knee group, trends were investigated that could be related to the magnitude of varus deformity. Results:. Several significant differences between normal and varus knees were found, but most of these were small differences unlikely to be clinically significant or have an influence on implant design. However, two strong trends were observed. Firstly, the version of the femoral neck was significantly less for patients with varus knees (mean difference 9°; p < 0.05). The second trend was a significant difference in the sagittal morphology of the medial condyle. The kink angle, the angle formed by the intersection of the circles fitted to the flexion and extension facet surfaces, and their centres (Figure 1) was either absent or small in normal knees (mean 1°). An absent kink angle occurs when the circle defining the flexion facet surface lies within or makes a tangent to the circle defining the extension facet. However, for varus knees, the mean kink angle was 9°, with positive correlation with the angle of varus deformity (Figure 2). Discussion:. Varus knees have a significantly larger kink angle than normal knees, influencing the relative positions of the flexion and extension facet spheres that define the medial condylar geometry, contributing to the commonly observed ‘flattening’ of the medial condyle in the sagittal plane. Varus knees are also associated with significantly less anteversion of the femoral neck. It has been shown that reduced femoral neck anteversion causes increased loading of the medial condyle [1], and our results support this finding. The data generated in this study will feed further biomechanical testing to investigate the influence of kink angle and femoral neck version on the kinematics and load distribution in the varus knee

Iliopsoas tendonitis after total hip arthroplasty (THA) can be a considerable cause of pain and patient dissatisfaction. The optimal cup position to avoid iliopsoas tendonitis has not been clearly established. Implant designs have also been developed with an anterior recess to avoid iliopsoas impingement. The purpose of this cadaveric study was to determine the effect of cup position and implant design on iliopsoas impingement. Bilateral THA was performed on three fresh frozen cadavers using oversized (jumbo) offset head center revision acetabular cups with an anterior recess (60, 62 and 66 mm diameter) and tapered wedge primary stems through a posterior approach. A 2mm diameter flexible stainless steel cable was inserted into the psoas tendon sheath between the muscle and the surrounding membrane to identify the location of the psoas muscle radiographically. CT scans of each cadaver were imported in an imaging software. The acetabular shells, cables as well as pelvis were segmented to create separate solid models of each. The offset head center shell was virtually replaced with an equivalent diameter hemispherical shell by overlaying the outer shell surfaces of both designs and keeping the faces of shells parallel. The shortest distance between each shell and cable was measured. To determine the influence of cup inclination and anteversion on psoas impingement, we virtually varied the inclination (30°/40°/50°) and anteversion (10°/20°/30°) angles for both shell designs. The CT analysis revealed that the original orientation (inclination/anteversion) of the shells implanted in 3 cadavers were as follows: Left1: 44.7°/23.3°, Right1: 41.7°/33.8°, Left2: 40/17, Right2: 31.7/23.5, Left3: 33/2908, Right3: 46.7/6.3. For the offset center shells, the shell to cable distance in all the above cases were positive indicating that there was clearance between the shells and psoas. For the hemispherical shells, in 3 out of 6 cases, the distance was negative indicating impingement of psoas. With the virtual implantation of both shell designs at orientations 40°/10°, 40°/20°, 40°/30° we found that greater anteversion helped decrease psoas impingement in both shell designs. When we analyzed the influence of inclination angle on psoas impingement by comparing wire distances for three orientations (30°/20°, 40°/20°, 50°/20°), we found that the effect was less pronounced. Further analysis comparing the offset head center shell to the conventional hemispherical shell revealed that the offset design was favored (greater clearance between the shell and the wire) in 17 out of 18 cases when the effect of anteversion was considered and in 15 out of 18 cases when the effect of inclinations was considered. Our results indicate that psoas impingement is related to both cup position and implant geometry. For an oversized jumbo cup, psoas impingement is reduced by greater anteversion while cup inclination has little effect. An offset head center cup with an anterior recess was effective in reducing psoas impingement in comparison to a conventional hemispherical geometry. In conclusion, adequate anteversion is important to avoid psoas impingement with jumbo acetabular shells and an implant with an anterior recess may further mitigate the risk of psoas impingement

Introduction:. Patient specific instrumentation (PSI) generates customized guides from a magnetic resonance imaging based preoperative plan for use in total knee arthroplasty (TKA). PSI software must be able to accommodate differences in implant design. The purpose of the present study was to determine whether any differences in the accuracy of limb alignment, component alignment, component sizing, or bony resection could be identified in patients undergoing PSI TKA with identical PSI software and one of two different implant systems. Methods:. In this case-control study, two different implant systems from the same manufacturer were evaluated in 37 consecutive PSI TKA (Group 1) and 123 consecutive PSI TKA (Group 2) performed by a single surgeon. A third group (Group 3) consisted of 12 consecutive TKA performed with manual instrumentation and the same implant system as Group 1. Identical software was used to generate a preoperative plan from which planned limb alignment, component alignment, component sizes, and bony resection were determined. Intraoperatively, actual component sizes, bony resection, and recut frequency were determined. Long-standing and lateral radiographs were obtained preoperatively and 4-weeks postoperatively to evaluate limb and component alignment. Results:. Groups were similar with regard to age, gender, BMI, and preoperative alignment. No differences in the accuracy of limb alignment, component alignment, component sizing, or PSI-planned versus actual resection were found between Groups 1 and 2. The rate of recuts required was lower in Group 1 than Group 2 for the proximal tibia (3% vs. 35%; p < 0.05). No differences were found in limb alignment, component alignment, or bony resection between the Groups 1 and 3. Group 1 showed less variation than Group 3 in resection depth of the posterior femur (SD 1.4 mm vs. 2.1 mm) and proximal tibia (SD 1.5 mm vs. 2.3 mm). Discussion:. No discernible differences in the accuracy of limb alignment, component alignment, and component sizing were found between Groups 1 and 2. Group 1 required fewer recuts than Group 2 for the proximal tibia. There may be characteristics of implant design, e.g. the slope of the tibial plateau, that may influence the ability of PSI to accurately determine cut thickness. No differences in limb alignment, component alignment, or bony resection were identified between Groups 1 and 3. Group 1 showed less variability in resection depth than Group 3 in the posterior femur and proximal tibia. This study suggests that PSI can be equally accurate for different implant systems. For a given implant system, PSI shows less variation in resection depth when compared to manual instrumentation

Introduction. Survival rates of recent total ankle replacement (TAR) designs are lower than those of other arthroplasty prostheses. Loosening is the primary indication for TAR revisions [NJR, 2014], leading to a complex arthrodesis often involving both the talocrural and subtalar joints. Loosening is often attributed to early implant micromotion, which impedes osseointegration at the bone-implant interface, thereby hampering fixation [Soballe, 1993]. Micromotion of TAR prostheses has been assessed to evaluate the stability of the bone-implant interface by means of biomechanical testing [McInnes et al., 2014]. The aim of this study was to utilise computational modelling to complement the existing data by providing a detailed model of micromotion at the bone-implant interface for a range of popular implant designs, and investigate the effects of implant misalignment during surgery. Methods. The geometry of the tibial and talar components of three TAR designs widely used in Europe (BOX®, Mobility® and SALTO®; NJR, 2014) was reverse-engineered, and models of the tibia and talus were generated from CT data. Virtual implantations were performed and verified by a surgeon specialised in ankle surgery. In addition to the aligned case, misalignment was simulated by positioning the talar components in 5° of dorsi- or plantar-flexion, and the tibial components in ± 5° and 10° varus/valgus and 5° and 10° dorsiflexion; tibial dorsiflexed misalignement was combined with 5° posterior gap to simulate this misalignment case. Finite element models were then developed to explore bone-implant micromotion and loads occurring in the bone in the implant vicinity. Results. Micromotion and bone loads peaked at the end of the stance phase for both the tibial and talar components. The aligned BOX and SALTO demonstrated lower tibial micromotion (with under 30% of bone-implant interface area subjected to micromotion larger than 100µm, as opposed to > 55% for Mobility; Figure 1). Talar micromotion was considerably lower for all designs, and no aligned talar component demonstrated micromotion larger than 100µm. The aligned SALTO showed the largest talar micromotion (Figure 2). Dorsiflexed implantation of all tibial components increased micromotion and bone strains compared to the reference case; interestingly, the SALTO tibial component, which demonstrated the lowest micromotion for the aligned case, also demonstrated the smallest changes in micromotion due to malpositioning (Figure 3). The posterior gap between the tibia and implant further increased bone strains. Dorsi- or plantar-flexed implantation of all talar components considerably increased micromotion and bone loads compared to the reference case (Figure 2), often resulting in micromotion exceeding 100µm. The SALTO talar component demonstrated the smallest changes in micromotion due to malpositioning. Discussion. The aligned Mobility had greater tibial micromotion than the SALTO and BOX, which agrees with higher revision rates reported in registry data (e.g. NZJR, 2014). The increased micromotion associated with dorsi- or plantar-flexion misalignment highlights the importance of aligning the implant correctly, and implies that SALTO can be more “forgiving” for malpositioning than the other TAR designs. Implant design and alignment are therefore important factors that affect the implant fixation and performance of the reconstructed ankle

Introduction. Malpositioning of the tibial component is a common error in TKR. In theory, placement of the tibial tray could be improved by optimization of its design to more closely match anatomic features of the proximal tibia with the motion axis of the knee joint. However, the inherent variability of tibial anatomy and the size increments required for a non-custom implant system may lead to minimal benefit, despite the increased cost and size of inventory. This study was undertaken to test the hypotheses: . 1. That correct placement of the tibial component is influenced by the design of the implant. 2. The operative experience of the surgeon influences the likelihood of correct placement of contemporary designs of tibial trays. Materials and Methods. CAD models were generated of all sizes of 7 widely used designs of tibial trays, including symmetric (4) and asymmetric (3) designs. Solid models of 10 tibias were selected from a large anatomic collection and verified to ensure that they encompassed the anatomic range of shapes and sizes of Caucasian tibias. Each computer model was resected perpendicular to the canal axis with a posterior slope of 5 degrees at a depth of 5 mm distal to the medial plateau. Fifteen joint surgeons and fourteen experienced trainees individually determined the ideal size and placement of each tray on each resected tibia, corresponding to a total of 2030 implantations. For each implantation we calculated: (i) the rotational alignment of the tray; (ii) its coverage of the resected bony surface, and (iii) the extent of any overhang of the tray beyond the cortical boundary. Differences in the parameters defining the implantations of the surgeons and trainees were evaluated statistically. Results. On average, the tibial tray was placed in 5.5 ± 3.1° of external rotation. The overall incidence of internal rotation was only 4.8%: 10.5% of trainee cases vs. 0.7% of surgeon cases (p < 0.0001). The incidence of internal rotation varied significantly with implant design, ranging from 1.7% to 6.2%. Bony coverage averaged 76.0 ± 4.5%, and was less than 70% in 8.6% of cases. Tibial coverage also varied significantly between designs (73.2 ± 4.3% to 79.2 ± 3.8%; p < .0001). Clinically significant cortical overhang (>1 mm), primarily in the posterior-lateral region, was present in 12.1% of cases, and varied by design, as expressed by the area of the tray overhanging the cortical boundary (min: 2.3 ± 6.7 mm. 2. ; max: 4.7 ± 7.9 mm. 2. ; p < .0001). The surgeons and the trainees also differed in terms of the incidence of sub-optimal tibial coverage (10.0% vs. 14.4%, p < 0.001), and cortical overhang (7.4% vs. 9.7%, p < 0.001). Discussion. 1. Malrotation, bony coverage and cortical overhang are all strongly influenced by the design of the tibial tray selected and the experience of the surgeon. 2. Compared to trainees, experienced surgeons tend to position tibial trays in more external rotation, and with less concern for reduced bony coverage and cortical overhang than trainees. 3. This study supports the hypothesis that improvements in the outcome and reliability of TKR may be achieved through attention to implant design

Introduction. Many prosthetic design changes have been introduced in attempt to improve outcomes following TKA; however there is no consensus as to whether these changes confer benefits to patients. This study aimed to assess whether patients treated with a modern implant design had an enhanced patient outcome compared to a traditional model in a double blind randomised controlled trial. Methods. 212 consecutive patients were prospectively randomised to receive either a modern (Triathlon) or a traditional (Kinemax) TKA (both Stryker Orthopaedics). 6 surgeons at a single unit performed all procedures in a standardised manner. A single researcher, blinded to implant allocation, performed all assessments. Patients were assessed pre-operatively, and at 6, 26, 52 weeks post-surgery with the Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, goniometry, timed functional assessment, lower limb power (Leg Extensor Power Rig) and pain numerical rating scales (NRS). Change in scores and between group differences were assessed with Two-Way Repeated Measures ANOVAs. Results. Both groups benefited from TKA demonstrating significant improvement in all parameters (p = < 0.001 in all cases). Significant interaction of the implant was observed in 1 year change score of OKS (F = 4.28, p = 0.04), knee flexion (F = 8.42, p = 0.004), lower limb power output (F = 11.33, p = 0.001) and maximal pain report (F = 7.44, p = 0.001), the modern implant superior in each case. Larger change scores were observed in WOMAC and timed functional assessments, but were not statistically significant. Conclusions. In a large prospective double blind randomised controlled trial, patients receiving a modern implant design demonstrated a significantly enhanced patient outcome in terms of knee range of motion, lower limb power output, reduced maximal pain report, and a clinically meaningful reduction in the OKS compared to a traditional design

Introduction. The design and manufacture of patient specific implants at Hospital for Special Surgery (HSS) was started in the fall of 1976. The first implant designed and manufactured was an extra large total knee. This effort expanded to include all arthroplasty devices including hips, knees, shoulders and elbows along with fracture fixation devices. In the 1980s, the hospital was designing and manufacturing over 100 custom implants per year. This reduced significantly in the 1990s due to the introduction of modular total knee replacements. In 1996, HSS ceased manufacture due to rising costs and a greater regulatory burden. However, implants are still designed at HSS with manufacturing outsourced to commercial companies. Since 1976, the hospital has designed over 2500 implants. Patient Population. Currently, we design implants for ∼30 cases per year, hips, knees, and upper extremity devices (mainly elbow). We've seen an increase in acetabular revision cases over the last few years and now design about 10 revision acetabular components each year. Regulatory Challenges. Patient specific implants can be provided under a variety of regulatory pathways. Some have received 510(k) clearance as the manufacturer has provided a matrix of sizes; if the device fits within the matrix, the device can be supplied commercially. For devices that fall outside of the 510(k) pathway, the process is more complex. The 2012 FDA Safety and Innovation Act attempts to clarify the ambiguous nature of the prior statute in which the number of custom implants allowed of a specific type was unclear, setting the limit to 5 units per year of a particular device type. However, such a low number has led to rationing by the device manufacturers and even cessation of manufacturing of custom implants by one of the major companies. Another option available for obtaining patient specific implants is the Compassionate Use process. This process has been used, for example, when a patient needs a replacement of a part for a device that is not approved for use in the United States. The surgeon can request an exemption from FDA to use the part. To obtain this exemption, the surgeon must provide to FDA a justification letter explaining why using this device is in the best interests of the patient, a letter from a second surgeon who agrees with this conclusion, a letter from the implant company agreeing to manufacture the device, IRB approval from the institution where the device will be implanted, and consent from the patient. Though gathering this information can be time consuming, once the application is submitted, FDA has rapidly responded in providing exemptions (in less than two weeks). Conclusion. Even with the increase in modular components and the variety of devices in the commercial market, the need still exists for patient specific implants at HSS. The regulatory environment creates additional challenges to obtaining these devices. In spite of these challenges, we are able to provide the devices required for our patients

Introduction. Many uncemented femoral implant designs have had successful outcomes in total hip arthroplasty (THA). Different uncemented stem designs achieve initial and long term stability through shape, size, coating and fit. There is increasing emphasis on bone preservation, particularly in younger and more active patients. The desire to optimize load transfer has led to the development of short stems that seek to achieve fixation in the proximal femur. Short stems designed to achieve stability by engaging the metaphysis or the proximal femoral necks are currently in clinical use. The purpose of this study was to examine the extent to which five stems designed to achieve proximal fixation contact the bone in the proximal femur. Using three-dimensional CT models of 30 femurs, we assessed the fit, fill and contact of each of the five different implants. Methods. Using three-dimensional computerized templating software designed to navigate robotic surgery, pre-operative CT scans of 30 patients were analyzed. Each of five femoral implant designs (TRILOCK, ARC, ABGII, CITATION, ACCOLADE) was then optimized for size and fit based on manufacturer technique guide and design rationale. The proximal femoral metaphysis was divided into four zones in the axial plane. Five contact points were determined on the frontal plane using anatomical landmarks. Each zone was assessed for cortical contact and fill of the bone-implant interface. We graded contact from 1 to 5, with 5 being 100% contact. Results. In the 150 different templates analyzed significant variability existed in contact areas of the proximal femur depending on implant design and femoral morphology. High femoral neck resection design (ARC) had the greatest contact area in the most proximal zones (Figure 1). The ABG II and Trilock stems had comparable contact in the antero-medial zones, while the ABG II had greater fill in the sagittal plane (Figures 2 & 3). The Trilock was the only stem that consistently achieved lateral cortical contact at the distal landmarks. All stems showed a pattern of mostly posteromedial contact proximally and mostly anteromedial distally. Discussion. To our knowledge, this is the first study to examine the contact points of metaphyseal engaging stems in the proximal femur. By directly comparing implant contact points in the same femur we found significant variability in the extent of fit, fill and contact of the metaphysis. These differences in proximal femoral contact are like to have implications for fixation in bone of varying quality and for long term proximal bone remodeling

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

Background

Multiple retrospective studies have compared UC with traditional bearings and shown comparable results and outcomes when looking at clinical and radiologic variables, complications rates, and implant survivorship; however, debate still exists regarding the optimum bearing surface. The present study seeks to determine whether there are any preoperative patient demographic or medical factors or anatomic variables including femoral condylar offset and tibial slope that may predict use of a UC bearing when compared to a standard CR group.

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. There is considerable interest in the orthopaedic community in understanding the multifactorial process of taper fretting corrosion in total hip arthroplasty (THA). Previous studies have identified some patient and device factors associated with taper damage, including length of implantation, stem flexural rigidity, and head offset. Due to the complexity of this phenomenon, we approached the topic by developing a series of matched cohort studies, each attempting to isolate a single implant design variable, while controlling for confounding factors to the extent possible. We also developed a validated method for measuring material loss in retrieved orthopaedic tapers, which contributed to the creation of a new international standard (ASTM F3129-16). Methods. Based on our implant retrieval collection of over 3,000 THAs, we developed independent matched cohort studies to examine (1) the effect of femoral head material (metal vs. ceramic, n=50 per cohort) and (2) stem taper surface finish (smooth vs. microgrooved, n=60 per cohort). Within each individual study, we adjusted for confounding factors by balancing implantation time, stem taper flexural rigidity, offset, and, when possible, head size. We evaluated fretting and corrosion using a four-point semiquantitative score. We also used an out-of-roundness machine (Talyrond 585) to quantify the material loss from the tapers. This method was validated in a series of experiments of controlled material removal on never-implanted components. Results. In the first study, the ceramic cohort exhibited a 92% reduction in cumulative volumetric loss from both the head and neck taper surfaces compared to the CoCr cohort (p < 0.001). In the CoCr cohort, there was greater material loss from femoral head tapers as compared with stem tapers (p < 0.0001). There was also a correlation between visual scoring and volumetric material loss (ρ = 0.67, p < 0.01). In the second study, taper damage was not different between the smooth and microgrooved taper cohorts when evaluated at the head bore (p=0.14) or the stem tapers (p=0.35). There was also no difference in material loss between the most damaged CoCr heads in the two cohorts (p>0.05). Conclusions. Our findings suggest that fretting and corrosion damage and material loss from the stem taper are mitigated, and on the head taper, eliminated with the use of a ceramic vs. metal femoral head. We also found that fretting and corrosion damage was insensitive to differences in stem taper surface finish and the presence of microgrooves. Although visual scoring was effective for preliminary screening to separate tapers with no or mild damage from tapers with moderate to severe damage, it was not capable of discriminating within the large range of material loss observed at the taper surfaces with high fretting-corrosion scores. Thus, for moderate to severely damaged conical tapers, direct measurement is necessary. A drawback of a matched cohort approach is that a large retrieval collection is necessary to effectively match an investigational group of implants with an appropriate control cohort. Notwithstanding this limitation, the matched cohort approach has been an effective approach to study the complex multifactorial problem of taper fretting and corrosion

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

There is great interest to provide repeatable and durable treatments for arthritis localized to one or two compartments in the cruciate-ligament intact knee. We report a series of efforts to develop and characterize an implant system for partial knee resurfacing. We studied distal femoral morphology and found that the sagittal-plane relationships between the condylar and trochlear surfaces are highly variable (Figs 1 and 2). In response, we report the design of a multi-compartmental system of implants intended to anatomically resurface any combination of compartments (Fig 3). Finally, we report the results of a pilot fluoroscopic study of the in vivo knee kinematics in patients who received medial, medial plus patellofemoral and bi-condylar knee arthroplasty. The kinematic results suggest these treatments provide a stable knee with intact cruciate ligament function. This work shows various partial knee resurfacing treatments have the potential to provide excellent knee mechanics and clinical outcomes.

Note - A full paper was submitted for consideration of the Hap Paul Award. The figure legends and numbers in the attached figures correspond to those in the full paper.

With the increasing use of 3D medical imaging, it is possible to analyze 3D patient anatomy to extract features, trends and population specific shape information. This is applied to the development of ‘standard implants’ targeted to specific population groups.

Background:

The number of young patients undergoing total knee arthroplasty is rapidly increasing. Long-term follow-up of modern type implants is needed to provide a benchmark of implant longevity for these patients.

Introduction

In DDH cases often have high anteversion. They also often have high hip center. THA for those cases sometimes requires subtrochanteric derotational/shortening osteotomy. To achieve good results of the surgery, accurate preoperative planning based on biomechanics of the high anteversion cases, method for accurate application of the plan, and stable fixation are very important. At ISTA 2008, we have reported that the location of the anteversion exist several centimeters below the lesser trochanter. Independently from the extent of anteversion, femoral head, grater trochanter, and lesser trochanter are aligned in the same proportion. We have also reported in 2007, in improper high anteversion cases, many cases grow osteophytes posterior side of femoral head to reduce it functionally. In 2014, we reported about development of the stem for subtrochanteric osteotomy. (ModulusR)[Fig.1] In the present study, we established systematic planning way for estimate proper derotation and shortening and apply it for the surgery.

Femoral knee implants have promising outcomes, although some high-flex designs have shown rather high loosening rates (Han et al., 2007). In uncemented implants, it is vital to limit micromotions at the implant-bone interface, to facilitate secondary fixation through bone ingrowth (kienapfel et al., 1999). Hence, it is essential to investigate how micromotions of different uncemented implants are affected by various loading conditions when a range of bone qualities as a patient-related factor is applied.

Using finite element (FE) analysis, we simulated implant-bone interface micromotions during four consecutive cycles of normal gait and squat movements. An FE model of a distal femur was generated based on calibrated CT-scans, after which Sigma® and LCS® Cruciate-Retaining Porocoat® components (DePuy Synthes, Leeds, UK) were implanted. Using a frictional contact algorithm (µ=0.95), an initial press-fit fixation was simulated, which was previously validated against experimental data. The micromotions were calculated by tracking the projection of implant nodes on the bone surface excluding overhang area. The applied loading patterns were based on discretized simulations, providing incremental loads for each activity based on implant-specific kinematics, which was derived from Orthoload database using inverse dynamics (Fitzpatrick et al., 2012). This provided the opportunity to calculate incremental micromotions, but also the resulting micromotions for each single cycle, for both activities. In addition, the percentage of implant surface area with resulting micromotions less than a defined threshold was calculated.

Regardless of the type of loading, in all simulations, the predicted micromotions were highest in the first cycle, suggesting settling of the implant during initial cycle. The Sigma®implant displayed a 30% larger area with micromotions below the threshold of 5 microns, for both loading conditions (Fig. 1A). The highest micromotions occurred at the anterior flange, regardless of type of activity or design. Squatting had a more detrimental effect on the primary stability, with smaller areas of low micromotions as compared to the gait load (Fig. 1B). Bone stiffness had a minor effect, which was more apparent for squatting (Fig. 1B).

We found acceptable low ranges of micromotions in both implant designs, although demanding activities such as squatting generated higher motions. In addition, LCS® experienced higher micromotions, probably caused by the smaller contact area at bone-implant interface compared with Sigma®. Nevertheless, the predicted micromotions were all below the clinically relevant threshold for bone ingrowth (<40 microns) (kienapfel et al., 1999). Furthermore, our simulated settling behavior stresses the necessity for simulating multiple loading cycles, rather than just a single cycle. The effect of bone stiffness was evident, but only to a limited extent. The main current limitation of our study is the utilization of an elastic material model for the bone which is probably the reason to predict a low range of micromotions. We are planning to make the material model more realistic, by including plasticity and viscoelastic bone behavior.