Introduction. Varus alignment in total knee replacement (TKR) results in a larger portion of the joint load carried by the medial compartment. [1]. Increased burden on the medial compartment could negatively impact the implant fixation, especially for cementless TKR that requires bone ingrowth. Our aim was to quantify the effect varus alignment on the bone-implant interaction of cementless tibial baseplates. To this end, we evaluated the bone-implant micromotion and the amount of bone at risk of failure. [2,3]. Methods. Finite element models (Fig.1) were developed from pre-operative CT scans of the tibiae of 11 female patients with osteoarthritis (age: 58–77 years). We sought to compare two loading conditions from Smith et al.;. [1]. these corresponded to a mechanically aligned knee and a knee with 4° of varus. Consequently, we virtually implanted each model with a two-peg cementless baseplate following two tibial alignment strategies: mechanical alignment (i.e., perpendicular to the tibial mechanical axis) and 2° tibial varus alignment (the femoral resection accounts for additional 2° varus). The baseplate was modeled as solid titanium (E=114.3 GPa; v=0.33). The pegs and a 1.2 mm layer on the bone-contact surface were modeled as 3D-printed porous titanium (E=1.1 GPa; v=0.3). Bone material properties were non-homogeneous, determined from the CT scans using relationships specific to the proximal tibia. [2,4]. The bone-implant interface was modelled as frictional with friction coefficients for solid and porous titanium of 0.6 and 1.1, respectively. The tibia was fixed 77 mm distal to the resection. For mechanical alignment, instrumented TKR loads previously measured in vivo. [5]. were applied to the top of the baseplate throughout level gait in 2% intervals (Fig.1a). For varus alignment, the varus/valgus moment was modified to match the ratio of medial-lateral force distribution from Smith et al. [1]. (Fig.1b). Results. For both alignments and all bones, the largest micromotion and amount of bone at risk of failure occurred during mid stance, at 16% of gait (Figs.2,3). Peak micromotion, located at the antero-lateral edge of the baseplate, was 153±32 µm and 273±48 µm for mechanical and varus alignment, respectively. The area of the baseplate with micromotion above 40 µm (the threshold for bone ingrowth. [3]. ) was 28±5% and 41±4% for mechanical and varus alignment, respectively. The amount of bone at risk of failure at the bone-implant interface was 0.5±0.3% and 0.8±0.3% for the mechanical and varus alignment, respectively. Discussion. The peak micromotion and the baseplate area with micromotion above 40 µm increased with varus alignment compared to mechanical alignment. Furthermore, the amount of bone at risk of failure, although small for both alignments, was greater for varus alignment. These results suggest that varus alignment, consisting of a combination of femoral and tibial alignment, may negatively impact bone ingrowth and increase the risk of bone failure for cementless tibial baseplates of this TKR design

INTRODUCTION. Loosening is a major cause for revision in uncemented hip prostheses due to insufficient primary stability. Primary stability after surgery is achieved through press-fit in an undersized cavity. Cavity preparation is performed either by extraction (removing bone) or compaction (crushing bone) broaching. Densification of trabecular bone has been shown to enhance primary stability in human femora; however, the effect of clinically used compaction and extraction broaches on human bone with varying bone mineral density (BMD) has not yet been quantified. The purpose of this study was to determine the influence of the broach design and BMD on the level of densification at the bone-cavity interface, stem seating, the bone-implant contact area and the press-fit achieved. METHODS. Paired human femora (m/f=11/12, age=60±18 y) were scanned with quantitative computed tomography (QCT, Philips Brilliance 16) before broaching, with the final broach, after its removal and after stem implantation. Compaction broaching (n=4) was compared in an in situ (cadaver) study against extraction broaching with blunt tooth types (n=3); in an ex situ (excised femora) study, compaction broaching was compared against extraction broaching with sharp tooth types (n=8 each). QCT data were resampled to voxel sizes of 1×1×1 mm (in situ) and 0.5×0.5×1 mm (ex situ). Mean trabecular BMD of the proximal femur was determined. The cavity volumes were segmented in the post-broach images (threshold: −250 mgHA/cm3, Avizo 9.2) and a volume of interest (VOI) of one-voxel thickness was added around the cavity to capture the interfacial bone. VOIs were transferred to the pre-broach image and bone densification was calculated within each VOI as the increase from pre- to post-broach image (MATLAB). Detailed surface data sets of broaches and stems were collected with a 3D laser-scanner (Creaform Handyscan 700) and aligned with the segmented components in the CT scans (Fig. 1). Stem seating was defined as the difference between the top edge of the stem coating and the final broach. Distance maps between the stem and cavity surface were generated to determine the bone-implant contact area and press-fit. All parameters were analysed between 5 mm distal to the coating and 1 cm distal to the lesser trochanter and analysed with related-samples Wilcoxon signed rank and Spearman's correlation tests (IBM SPSS Statistics 22). RESULTS. Trabecular BMD ranged from 81 to 221 mgHA/cm3. Densification was higher with compaction compared to sharp (p=0.034), but not blunt extraction broaching (p=1.000). Proximal bone-implant contact area, press-fit and stem seating did not differ between broaching methods. Bone-implant contact area and bone densification increased with trabecular BMD (rs=0.658, p=0.001 and rs=0.443, p=0.034), press-fit with stem seating (rs=0.746, p<0.001) and contact area with bone densification (rs=0.432, p=0.039). DISCUSSION. Sharp extraction broaching reduces densification at the bone-cavity interface, but does not affect the press-fit or contact area. Trabecular BMD was positively associated with contact area, and stem seating with press-fit. Future studies will aim to link these findings to primary stability and influence on periprosthetic fractures. For any figures or tables, please contact authors directly

Introduction. Fixation has been shown to be the primary indicator of an implant's long-term success. Failure to achieve attachment, especially in acetabular and TKR, has been attributed to a lack of initial stability and gaps between the implant and bone. Gaps greater than 150 microns allow fibrous tissue to form. Properly addressing implant design features can help avoid adverse outcomes. ASTM International Standards (F1854-09) do not assess the relationship between porosity of the coating and that of cancellous bone, which can lead to an absence of mechanical interlock. This study developed a virtual program that uses human cancellous bone to predict potential skeletal attachment for implants properly placed for TJR. The goal of the Virtual Paradigm was to assess initial contact surface area at the time of implantation. Methods. Seven human femurs and tibias were used. Bones from 11 males and 3 females were used, ages ranging from 40 to 61. Five porous coatings were assessed: Biofoam (Wright Medical), Fiber Mesh, CSTI, Tantalum (Zimmer), and P² (DJO Global). Specimen Processing. Each bone was resected 2 mm beyond the articulating surface into the cancellous host using surgical TKA instruments. The specimens and coatings were embedded in PMMA. For Part 1, the specimens and coatings were cut perpendicular to the neutral axis, displaying a surface view for scanning electron microscopy (SEM). For Part 2, the coatings were cross-sectioned for SEM, ground, and polished to optical finish. Imaging: Part 1. The bone and coating sections displaying the surface view were imaged using SEM under backscatter (BSE) at 22x. Three images were taken of each tibia section, resulting in 12 images. Three images were taken of each femur section, resulting in 9 images. Analysis: Part 1. Each bone image was overlaid onto each coating image. Using various computer programs (IQ Materials, Fastone Image Viewer, Corel Photopaint X3), available bone was normalized to 100% and bone-implant contact was marked red (Figure 1). Imaging: Part 2. The cross-sectioned coatings were imaged with SEM-BSE at 30x. For each implant, 3 images were taken and assembled together (Microsoft Research ICE). Analysis: Part 2. Using the programs, bone images were overlaid onto each coating to establish a 200-micron region of initial contact. The surface of the coating within this region was calculated to represent surface roughness (Figure 2). Results. Bone porosity ranged from 14.04%-23.04% in the femur and 11.85%-23.68% in the tibia. Percent contact between the implant and bone ranged from 3.28%-43.47% (Figure 1). Surface roughness ranged from 5.4–11.1 mm (Figure 2). Opening porosity of the coatings ranged from 52.54%-94.97% (Figure 3). Discussion. Long-term success of cementless TJR depends on mechanical stability and bone attachment. This virtual study addressed fixation and contact between coatings and cancellous bone, and it can be used to evaluate innovative materials intended for TJR. This program challenged the limits of ASTM Standards for screening coatings. The results of this study demonstrated that the Virtual Bone-Implant Surface Contact Paradigm could be used in the early phases of implant development and testing to assess clinical success

This study was performed to compare the mechanism of bone-implant integration and mechanical stability among three popularly used cementless implant surfaces. Plasma sprayed porous surface (TiPL), grit-blasted rough surface (TiGB), and hydroxyapatite coated implant surface (HA) were tested in a sheep model at 4 and 12 weeks. The integration patterns were investigated using histology, histomorphometry, and mechanical strength by push-out test. All three groups demonstrated early bone ongrowth on their surfaces, with much of the ongrowth resembling contact osteogenesis. TiPL group showed bone anchorage into porous coating with new bone ingrowth into the pores. HA group revealed small cracks at its coating at 12 weeks time point. Plasma sprayed porous surface also demonstrated its superior mechanical stability maybe reinforced by its bone anchorage, whearas, HA surface exhibited higher osteoconductivity with highest ongrowth rate

A durable biological fixation between implant and bone depends largely on the micro-motions [Pilliar et al., 1986]. Finite element analysis (FEA) is a numerical tool to calculate micro-motions during physiological loading. However, micromotions can be simulated and calculated in various ways. Generally, only a single peak force of an activity is applied, but it is also possible to apply discretized loads occurring during a continuous activity, offering the opportunity to analyze incremental micro-motions as well. Moreover, micro-motions are affected by the initial press-fit. We therefore aimed to evaluate the effect of different loading conditions and calculation methods on the micro-motions of an uncemented femoral knee component, while varying the interference-fit.

We created an FE model of a distal femur based on calibrated CT-scans. A Sigma® Cruciate-Retaining Porocoat® (DePuy Synthes, Leeds, UK) was placed following the surgical instructions. A range of interference-fits (0–100 µm) was applied, while other contact parameters were kept unchanged. Micro-motions were calculated by tracking the projection of implant nodes onto the bone surface. We defined three different micro-motions measures: micro-motions between consecutive increments of a full loading cycle (incremental), micro-motions for each increment relative to the initial position (reference), and the largest distance between projected displacements, occurring during a discretized full cycle (resulting) (Fig. 1A). Four consecutive cycles of normal gait and squat movements were applied, in different configurations. In the first configuration, incremental tibiofemoral and patellofemoral contact forces were applied, which were derived from Orthoload database using inverse dynamics [Fitzpatrick et al., 2012]. Secondly, we applied the same loads without the patellofemoral force, which is often used in experimental set-ups. Finally, only the peak tibiofemoral force was applied, as a single loading instance. We calculated the average of micro-motions of all nodes per increment to compare different calculation techniques. The percentage of area with resulting micro-motions less than 5 µm was also calculated.

The percentage of surface area was increased non-linearly when the interference fit changed from 0 to 100 µm particularly for squat movement. Tracking nodes over multiple cycles showed implant migration with interference-fits lower than 30µm (Fig. 1A). Loading configurations without the patellofemoral force, and with only the peak tibiofemoral force slightly overestimated and underestimated the resulting micro-motions of squat movement, respectively; although, the effect was less obvious for the gait simulation when no patella force was applied. Both incremental and reference micro-motions underestimated the resulting micro-motions (Fig. 1B). Interestingly, the reference micro-motions followed the pattern of the tibiofemoral contact force (Fig. 1B).

The calculation technique has a substantial effect on the micro-motions, which means there is a room for interpretation of micro-motions analyses. This furthermore stresses the importance of validation of the predicted micro-motions against experimental set-ups. In addition, the minor effect of loading configurations indicates that a simplified loading condition using only the peak tibiofemoral force is suitable for experimental studies. From a clinical perspective, the migration pattern of femoral components implanted with a low interference fit stresses the role of an adequate surgical technique, to obtain a good initial stability.

Recently, the osteoregenerative properties of allograft have been enhanced by addition of autogenous skeletal stem cells to treat orthopaedic conditions characterised by lost bone stock. There are multiple disadvantages to allograft, and trabecular tantalum represents a potential alternative. This metal is widely used, although in applications where there is poor initial stability, or when it is used in conjunction with bone grafting, loading may need to be limited until sound integration has occurred. Strategies to speed up implant incorporation to surrounding bone are therefore required. This may improve patient outcomes, extending the clinical applications of tantalum as a substitute for allograft.

Patients receiving reverse total shoulder arthroplasty (RTSA) often have osseous erosions because of glenohumeral arthritis, leading to increased surgical complexity. Glenoid implant fixation is a primary predictor of the success of RTSA and affects micromotion at the bone-implant interface. Augmented implants which incorporate specific geometry to address superior erosion are currently available, but the clinical outcomes of these implants are still considered short-term. The objective of this study was to investigate micromotion at the glenoid-baseplate interface for a standard, 3 mm and 6 mm lateralized baseplates, half-wedge, and full-wedge baseplates. It was hypothesized that the mechanism of load distribution from the baseplate to the glenoid will differ between implants, and these varying mechanisms will affect overall baseplate micromotion. Clinical CT scans of seven shoulders (mean age 69 years, 10°-19° glenoid inclinations) that were classified as having E2-type glenoid erosions were used to generate 3D scapula models using MIMICS image processing software (Materialise, Belgium) with a 0.75 mm mesh size. Each scapula was then repeatedly virtually reconstructed with the five implant types (standard,3mm,6mm lateralized, and half/full wedge; Fig.1) positioned in neutral version and inclination with full backside contact. The reconstructed scapulae were then imported into ABAQUS (SIMULIA, U.S.) finite element software and loads were applied simulating 15°,30°,45°,60°,75°, and 90° of abduction based on published instrumented in-vivo implant data. The micromotion normal and tangential to the bone surface, and effective load transfer area were recorded for each implant and abduction angle. A repeated measures ANOVA was used to perform statistical analysis. Maximum normal micromotion was found to be significantly less when using the standard baseplate (5±4 μm), as opposed to the full-wedge (16±7 μm, p=0.004), 3 mm lateralized (10±6 μm, p=0.017), and 6 mm lateralized (16±8 μm, p=0.007) baseplates (Fig.2). The half-wedge baseplate (11±7 μm) also produced significantly less micromotion than the full-wedge (p=0.003), and the 3 mm lateralized produced less micromotion than the full wedge (p=0.026) and 6 mm lateralized (p=0.003). Similarly, maximum tangential micromotion was found to be significantly less when using the standard baseplate (7±4 μm), as opposed to the half-wedge (12±5 μm, p=0.014), 3 mm lateralized (10±5 μm, p=0.003), and 6 mm lateralized (13±6 μm, p=0.003) baseplates (Fig.2). The full wedge (11±3 μm), half-wedge, and 3 mm lateralized baseplate also produced significantly less micromotion than the 6 mm lateralized (p=0.027, p=012, p=0.02, respectively). Both normal and tangential micromotion were highest at the 30° and 45° abduction angles (Fig.2). The effective load transfer area (ELTA) was lowest for the full wedge, followed by the half wedge, 6mm, 3mm, and standard baseplates (Fig.3) and increased with abduction angle. Glenoid baseplates with reduced lateralization and flat backside geometries resulted in the best outcomes with regards to normal and tangential micromotion. However, these types of implants are not always feasible due to the required amount of bone removal, and medialization of the bone-implant interface. Future work should study the acceptable levels of bone removal for patients with E-type glenoid erosion and the corresponding best implant selections for such cases. For any figures or tables, please contact the authors directly

Surgical failure, mainly caused by loosening implants, causes great mental and physical trauma to patients. Improving the physicochemical properties of implants to achieve favourable osseointegration will continue to be the focus of future research. Strontium (Sr), a trace element, is often incorporated into hydroxyapatite (HA) to improve its osteogenic activity. Our previous studies have shown that miR-21 can promote the osteogenic differentiation of mesenchymal stem cells by the PI3K/β-catenin pathway. The aim of this study is to fabricate a SrHA and miR-21 composite coating and it is expected to have a favorable bone healing capability. Ti discs (20 mm diameter and one mm thickness for the in vitro section) and rods (four mm diameter and seven mm length for the in vivo section) were prepared by machining pure Ti. The Ti cylinders were placed in a Teflon-lined stainless-steel autoclave for treating at 150°C for 24 h to form SrHA layer. The miR-21 was encapsulated in nanocapsules. The miR-21 nanocapsules were mixed with CMCS powder to form a gel-like sample and uniformly coated on the SrHA modifed Ti. Osteoblast-like MG63 cells were cultured on SrHA and miR-21 modified Ti, Cell proliferation activity and osteogenesis-related gene expression were evaluated. A bone defect model was established with mature New Zealand to evaluate the osseointegration. Cylindrical holes (four mm in diameter) were created at the distal femur and tibial plateau. Each rabbit was implanted with four of the aforementioned rods (distal femur and tibial plateau of the hind legs). After implantation for one, two and three months, the rabbits were observed by X-ray and scanned using u-CT. Histological and Immunohistochemical analysis were performed to examine the osteogenic markers. A biomechanical push-in test was used to assess the bone-implant bonding strength. Both SrHA nanoparticles with good superhydrophilicity and miR-21 nanocapsules with uniform sizes were distributed evenly on the surface of the Ti. In vitro experiments revealed that the composite coating was beneficial to osteoblast proliferation, differentiation and mineralization. In vivo evaluations demonstrated that this coating could not only promote the expression of angiogenic factor CD31 but also enhance the expression of osteoblastic genes to facilitate angio-osteogenesis. In addition, the composite coating also showed a decreased RANKL expression compared with the miR-21 coating. As a result, the SrHA/miR-21 composite coating promoted new bone formation and mineralization and thus enhanced osseointegration and bone-implant bonding strength. A homogeneous SrHA and miR-21 composite coating was fabricated by generating pure Ti through a hydrothermal process, followed by adhering miR-21 nanocapsules. This coating combined the favorable physicochemical properties of SrHA and miR-21 that synergistically promoted angiogenesis, osteogenesis, osseointegration, bone mineralization and thus bone-implant bonding strength. This study provided a new strategy for surface modification of biomedical implants

Introduction: The mechanobiology and response of bone formation to strain under physiological loading is well established, however investigation into exceedingly soft scaffolds relative to cancellous bone is limited. In this study we designed and 3D printed mechanically-optimised low-stiffness implants, targeting specific strain ranges inducing bone formation and assessed their biological performance in a pre-clinical in vivo load-bearing tibial tuberosity advancement (TTA) model. The TTA model provides an attractive pre-clinical framework to investigate implant osseointegration within an uneven loading environment due to the dominating patellar tendon force. A knee finite element model from ovine CT data was developed to determine physiological target strains from simulated TTA surgery. We 3D printed low-stiffness Ti wedge osteotomy implants with homogeneous stiffness of 0.8 GPa (Ti1), 0.6 GPa (Ti2) and a locally-optimised design with a 0.3 GPa cortex and soft 0.1 GPa core (Ti3), for implantation in a 12-week ovine tibial advancement osteotomy (9mm). We quantitatively assessed bone fusion, bone area, mineral apposition rate and bone formation rate. Optimised Ti3 implants exhibited evenly high strains throughout, despite uneven wedge osteotomy loading. We demonstrated that higher strains above 3.75%, led to greater bone formation. Histomorphometry showed uniform bone ingrowthin optimised Ti3 compared to homogeneous designs (Ti1 and Ti2), and greater bone-implant contact. The greatest bone formation scores were seen in Ti3, followed by Ti2 and Ti1. Results from our study indicate lower stiffness and higher strain ranges than normally achieved in Ti scaffolds stimulate early bone formation. By accounting for loading environments through rational design, implants can be optimised to improve uniform osseointegration. Design and 3D printing of exceedingly soft titanium orthopaedic implants enhance strain induced bone formation and have significant importance in future implant design for knee, hip arthroplasty and treatment of large load-bearing bone defects

Gram-negative prosthetic joint infections (GN-PJI) present unique challenges in management due to their distinct pathogenesis of biofilm formation on implant surfaces. To date, there are no animal models that can fully recapitulate how a biofilm is challenged in vivo in the setting of GN-PJI. The purpose of this study is to establish a clinically representative GN-PJI in vivo model that can reliably depict biofilm formation on titanium implant surface. We hypothesized that the biofilm formation on the implant surface would affect the ability of the implant to be osseointegrated. The model was developed using a 3D-printed, medical-grade titanium (Ti-6Al-4V), monoblock, cementless hemiarthroplasty hip implant. This implant was used to replace the femoral head of a Sprague-Dawley rat using a posterior surgical approach. To induce PJI, two bioluminescent Pseudomonas aeruginosa (PA) strains were utilized: a reference strain (PA14-lux) and a mutant strain that is defective in biofilm formation (DflgK-lux). PJI development and biofilm formation was quantitatively assessed in vivo using the in vivo imaging system (IVIS), and in vitro using the viable colony count of the bacterial load on implant surface. Magnetic Resonance Imaging (MRI) was acquired to assess the involvement of periprosthetic tissue in vivo, and the field emission scanning electron microscopy (FE-SEM) of the explanted implants was used to visualize the biofilm formation at the bone-implant interface. The implant stability, as an outcome, was directly assessed by quantifying the osseointegration using microCT scans of the extracted femurs with retained implants in vitro, and indirectly assessed by identifying the gait pattern changes using DigiGaitTM system in vivo. A localized prosthetic infection was reliably established within the hip joint and was followed by IVIS in real-time. There was a quantitative and qualitative difference in the bacterial load and biofilm formation between PA14 and DflgK. This difference in the ability to persist in the model between the two strains was reflected on the gait pattern and implant osseointegration. We developed a novel uncemented hip hemiarthroplasty GN-PJI rat model. This model is clinically representative since animals can bear weight on the implant. PJI was detected by various modalities. In addition, biofilm formation correlated with implant function and stability. In conclusion, the proposed in vivo GN-PJI model will allow for more reliable testing of novel biofilm-targeting therapetics

INTRODUCTION. Reaming of the acetabular cavity prior to cementless cup implantation aims to create a defined press-fit between implant and bone. The goal is to achieve full implant seating with the desired press-fit to reduce the risk of early cup loosening and the risk of excessive cup deformation. Current research concentrated on the spherical deviations of the reamed cavity compared to the reamer size, but the direct relationship between nominal press-fit, reamer geometry, cavity shape and bone-implant contact has not yet been investigated. The aim of this study was to determine the influence of the reaming process, the surface coating, and the implantation force on the achieved press-fit situation. METHODS. Fresh-frozen porcine acetabulae (n = 20) were prepared and embedded. Hemispherical reamers were used and the last reaming step was performed using a vertical drilling machine to ensure a proper alignment of the cavity axis. A hand-guided 3D laser scanner was used (HandySCAN 700, Creaform) to determine the reamer geometry and the cavity shape. Press-fit cups with two different surface coatings (Ø44 mm, Porocoat/Gription, DePuy Synthes) were implanted using a drop tower. The Porocoat cup was implanted with impacts from lower drop heights (low implantation force) and press-fits of 1 mm and 2 mm. The Gription cup, exhibiting a rougher surface, was implanted with low and high implantation forces and a press-fit of 1 mm. Bone-implant contact was analysed by the registration of the cup and cavity surface models, scanned prior to implantation, to the scan of the implanted cup. The cup surface was divided in areas with and without contact to the surrounding cavity. Overhang indicates that there was no adjacent cavity surface surrounding the implanted cup. The transition between contact and a gap at the cup dome was defined as contact depth and used as indicator for the cup seating. RESULTS. The peripheral cavity diameter was on average 0.94 ± 0.29 mm smaller than the reamer diameter due to the sub-hemispherical distribution of the cutting blades. This led to an increased effective press-fit in the peripheral area of the cavity. The contact area between cup and bone increased with the implantation force (p = 0.008) and ranged from 13.1 % to 27.8 %. The contact depth was larger for the smoother Porocoat coating (p = 0.008), a press-fit of 2 mm (p = 0.008) and a higher implantation force (p = 0.008). DISCUSSION. This study shows that, assuming similar implantation forces, an increased surface roughness of the cup coating increases the risk of an insufficient cup seating. For a given press-fit, higher implantation forces would be necessary to fully seat the cup in order to enhance the bone-implant contact. Implantation of a cup without a defined nominal press-fit could increase the contact area; however a high reaming accuracy and an increased friction coefficient of the cup coating are required to compensate for a reduction in initial fixation strength caused by reduced radial compressive forces. For any figures or tables, please contact authors directly

Shoulder arthroplasty is effective at restoring function and relieving pain in patients suffering from glenohumeral arthritis; however, cortex thinning has been significantly associated with larger press-fit stems (fill ratio = 0.57 vs 0.48; P = 0.013)1. Additionally, excessively stiff implant-bone constructs are considered undesirable, as high initial stiffness of rigid fracture fixation implants has been related to premature loosening and an ultimate failure of the implant-bone interface2. Consequently, one objective which has driven the evolution of humeral stem design has been the reduction of stress-shielding induced bone resorption; this in-part has led to the introduction of short stems, which rely on metaphyseal fixation. However, the selection of short stem diametral (i.e., thickness) sizing remains subjective, and its impact on the resulting stem-bone construct stiffness has yet to be quantified. Eight paired cadaveric humeri (age = 75±15 years) were reconstructed with surgeon selected ‘standard’ sized and 2mm ‘oversized’ short-stemmed implants. Standard stem sizing was based on a haptic assessment of stem and broach stability per typical surgical practice. Anteroposterior radiographs were taken, and the metaphyseal and diaphyseal fill ratios were quantified. Each humerus was then potted in polymethyl methacrylate bone cement and subjected to 2000 cycles of compressive loading representing 90º forward flexion to simulate postoperative seating. Following this, a custom 3D printed metal implant adapter was affixed to the stem, which allowed for compressive loading in-line with the stem axis (Fig.1). Each stem was then forced to subside by 5mm at a rate of 1mm/min, from which the compressive stiffness of the stem-bone construct was assessed. The bone-implant construct stiffness was quantified as the slope of the linear portion of the resulting force-displacement curves. The metaphyseal and diaphyseal fill ratios were 0.50±0.10 and 0.45±0.07 for the standard sized stems and 0.50±0.06 and 0.52±0.06 for the oversized stems, respectively. Neither was found to correlate significantly with the stem-bone construct stiffness measure (metaphysis: P = 0.259, diaphysis: P = 0.529); however, the diaphyseal fill ratio was significantly different between standard and oversized stems (P < 0.001, Power = 1.0). Increasing the stem size by 2mm had a significant impact on the stiffness of the stem-bone construct (P = 0.003, Power = 0.971; Fig.2). Stem oversizing yielded a construct stiffness of −741±243N/mm; more than double that of the standard stems, which was −334±120N/mm. The fill ratios reported in the present investigation match well with those of a finite element assessment of oversizing short humeral stems3. This work complements that investigation's conclusion, that small reductions in diaphyseal fill ratio may reduce the likelihood of stress shielding, by also demonstrating that oversizing stems by 2mm dramatically increases the stiffness of the resulting implant-bone construct, as stiffer implants have been associated with decreased bone stimulus4 and premature loosening2. The present findings suggest that even a small, 2mm, variation in the thickness of short stem humeral components can have a marked influence on the resulting stiffness of the implant-bone construct. This highlights the need for more objective intraoperative methods for selecting stem size to provide guidelines for appropriate diametral sizing. For any figures or tables, please contact the authors directly

Patients undergoing revision surgery of a primary total hip arthroplasty often exhibit bone loss and poor bone quality, which make achieving stable fixation and osseointegration challenging. Implant components coated in porous metals are used clinically to improve mechanical stability and encourage bone in-growth. We compared ultra-porous titanium coatings, known commercially as Gription and Porocoat, in an intra-articular model by press-fitting coated cylindrical implants into ovine femoral condyles and evaluating bone in-growth and fixation strength 4, 8 and 16 weeks post-operatively. Bilateral surgery using a mini-arthrotomy approach was performed on twenty-four Dorset-Rideau Arcott rams (3.4 ± 0.8 years old, 84.8 ± 9.3 kg) with Institutional Animal Care Committee approval in accordance with the Canadian Council on Animal Care. Cylindrical implants, 6.2 mm in diameter by 10 mm in length with surface radius of curvature of 35 mm, were composed of a titanium substrate coated in either Porocoat or Gription and press-fit into 6 mm diameter recipient holes in the weight-bearing regions of the medial (MFC) and lateral (LFC) femoral condyles. Each sheep received 4 implants; two Gription in one stifle (knee) and two Porocoat in the contralateral joint. Biomechanical push-out tests (Instron ElectroPuls E10000) were performed on LFCs, where implants were pushed out relative to the condyle at a rate of 2 mm/min. Force and displacement data were used to calculate force and displacement at failure, stiffness, energy, stress, strain, elastic modulus, and toughness. MFCs were fixed in 70% ethanol, processed undecalcified, and polished sections, approximately 70 µm thick (Exakt Micro Grinding system) were carbon-coated. Backscattered electron images were collected on a scanning electron microscope (Hitachi SU3500) at 5 kV and working distance of 5 mm. Bone in-growth within the porous coating was quantified using software (ImageJ). Statistical comparisons were made using a two-way ANOVA and Fisher's LSD post-hoc test (Statistica v.8). Biomechanical evaluation of the bone-implant interface revealed that by 16 weeks, Gription-coated implants exhibited higher force (2455±1362 N vs. 1002±1466 N, p=0.046) and stress (12.60±6.99 MPa vs. 5.14±7.53 MPa, p=0.046) at failure, and trended towards higher stiffness (11510±7645 N/mm vs. 5010±8374 N/mm, p=.061) and modulus of elasticity (591±392 MPa vs. 256±431 MPa, p=0.61). Similarly, by 16 weeks, bone in-growth in Gription-coated implants was approximately double that measured in Porocoat (6.73±3.86 % vs. 3.22±1.52 %, p=0.045). No statistically significant differences were detected at either 4 nor 8 weeks, however, qualitative observations of the exposed bone-implant interface, made following push-out testing, showed more bony material consistently adhered to Gription compared to Porocoat at all three time points. High variability is attributed to implant placement, resulting from the small visual window afforded during surgery, unique curvatures of the condyles, and presence of the extensor digitorum longus tendon which limited access to the LFC. Ultra-porous titanium coatings, know commercially as Gription and Porocoat, were compared for the first time in a challenging intra-articular ovine model. Gription provided superior fixation strength and bone in-growth, suggesting it may be beneficial in hip replacement surgeries where bone stock quality and quantity may be compromised

During revision total knee arthroplasty (rTKA), proximal tibial bone loss is frequently encountered and can result in a less-stable bone-implant fixation. A 3D printed titanium alloy (Ti6Al4V) revision augment that conforms to the irregular shape of the proximal tibia was recently developed. The purpose of this study was to evaluate the fixation stability of rTKA with this augment in comparison to conventional cemented rTKA. Eleven pairs of thawed fresh-frozen cadaveric tibias (22 tibias) were potted in custom fixtures. Primary total knee arthroplasty (pTKA) surgery was performed on all tibias. Fixation stability testing was conducted using a three-stage eccentric loading protocol. Static eccentric (70% medial/ 30% lateral) loading of 2100 N was applied to the implants before and after subjecting them to 5×103 loading cycles of 700 N at 2 Hz using a joint motion simulator. Bone-implant micromotion was measured using a high-resolution optical system. The pTKA were removed. The proximal tibial bone defect was measured. One tibia from each pair was randomly allocated to the experimental group, and rTKA was performed with a titanium augment printed using selective laser melting. The contralateral side was assigned to the control group (revision with fully cemented stems). The three-stage eccentric loading protocol was used to test the revision TKAs. Independent t-tests were used to compare the micromotion between the two groups. After revision TKA, the mean micromotion was 23.1μm ± 26.2μm in the control group and 12.9μm ± 22.2μm in the experimental group. There was significantly less micromotion in the experimental group (p= 0.04). Prior to revision surgery, the control and experimental group had no significant difference in primary TKA micromotion (p= 0.19) and tibial bone loss (p= 0.37). This study suggests that early fixation stability of revision TKA with the novel 3D printed titanium augment is significantly better then the conventional fully cemented rTKA. The early press-fit fixation of the augment is likely sufficient for promoting bony ingrowth of the augment in vivo. Further studies are needed to investigate the long-term in-vivo fixation of the novel 3D printed augment

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. Implant stability immediately after implantation is vital for long term success and improvement in patient outcomes for total hip arthroplasty (THA). Of the many factors that influence stability and resistance to migration for press-fit metaphaseal-fixed stems, this work attempted to evaluate the effect of distal stem taper angle on initial stem axial stability. Two THA stem designs having a distal taper angle of 3.5° and 5° were evaluated with cadaveric specimens with a simulated walking gait while stem motion was measured with respect to the periprosthetic bone. Methods. Specimen Preparation. Three fresh-frozen matched pairs with no sign of orthopedic deformities were procured and evenly distributed between the two stem implant groups. The stems were manufactured without a neck region to eliminate ancillary bone-implant contact from confounding the interactions between taper angle and implant motion and migration. A board-certified orthopedic surgeon prepared each specimen and implanted the stems before each specimen was rigidly constrained within a custom test fixture. The test fixture oriented each femur vertically (±1°). Simulated Gait & Motion Measurement. The simulated gait loading and motion measurements were performed separately, with bone-implant relative motion measured immediately after the loading challenge had been completed. Loading was applied in three stages of incremental load increase of 1000 cycles. The magnitudes included 0.5× body weight (BW), 1×BW, and 2.5xBW with the final magnitude corresponding to loads measured in vivo with an instrumented femoral stem during a normal walking gait. Force was applied sinusoidally at 2Hz with a minimum force of 100N consistent between all loading magnitudes. Values for BW were taken from the specimen data sheets provided for each matched pair. Stem motion was measured at the apex and trough of the loading waveform for the last 10 cycles of the last loading magnitude with a high resolution (±0.001mm) digital displacement indicator (Fowler High Precision; Newton, MA). Measurements were made with the displacement indicator superiorly fixed to the femur in order to limit bone flexion from influencing the results. The trough measurements were subtracted from the apex to calculate axial displacement of the stem (see Figure 1) with respect to the superior periprosthetic bone. Results. The ten sets of measurements recorded for each specimen were averaged and plotted for Figure 2. Bone-implant motion ranged from 9 – 29µm, with an overall measurement uncertainty of 1.9µm. The magnitude of displacement was found to be independent of BW (Pearson correlation = 0.027), and the difference between stem designs was not found to be statistically significant (p≤0.803). Conclusion. The paired cadaveric study demonstrated that both the 3.5° and 5° THA stem taper angles had high initial stability, with bone-implant motion less than 30µm during a simulated gait. The difference between stem designs was not found to be statistically significant, and future work aims to determine spatial differences in bone-implant contact, and possible influence on the susceptibility for periprosthetic fracture

Titanium knee, shoulder and hip implants are typically grit-blasted, thermal plasma spray coated, or sintered to provide ingrowth surface features having texture with pore sizes on the order of hundreds of micrometers. This provides macro and micro-mechanical locking upon bone remodeling. However, at the nanoscale and cellular level, these surfaces appear smooth. In vitro and in vivo research shows surfaces with nanoscale features result in enhanced osseointegration, greater bone-implant contact area and pullout force, and the potential to be bactericidal via a simple hybrid anodization surface modification process. Prior processes for creating nanotube nano-textured surfaces via electrochemical anodization relied on hydrofluoric acid electrolyte and platinum cathodes. This novel process uses ammonium fluoride electrolytes and graphite cathodes which are more cost effective and easier to handle during processing. Hybrid electrolytes with differing concentrations of ethylene glycol, water, and ammonium fluoride provide a variety of nanotube morphologies and sizes. Nano-tubular surfaces on knee tibial and femoral implants, hip stems and acetabular cups, bone screws and other 3D printed parts have been enhanced by this method of nano-texturing in as little as 30 minutes. In vivo work in a Sprague Dawley rat model showed bone-implant contact area up to 2.9-times greater, and uniaxial pullout forces up to 6.9-times greater, than implanted smooth titanium controls at 4 and 12-week time points. In these tests, 1.25mm Kirschner wires were implanted in the rat femora to simulate an intramedullary nail. Histomorphometry in the mid-shaft and distal regions showed greater trabecular thickness and bone tissue mineral density than controls. Axial pullout tests often resulted in bone failure before the bone-implant interface. In vitro evidence suggests that nanoscale surfaces may have an antibacterial effect due to surface energy changes that reduce the ability of bacteria to adhere. However, it is recognized that silver is highly antibacterial in appropriate concentrations. It is also recognized that nanosilver, approximately 10–20nm, is especially effective. Ammonium fluoride anodization is modified using a hybrid electrolyte that includes silver fluoride. By substituting some of the ammonium fluoride with silver fluoride, to maintain a constant total fluorine mass, nanosilver is integrated within and among the nanotubes in the same single process that forms the nanotubes. This hybrid process in nano-texturing titanium implants can be integrated into current manufacturing production at low cost

The primary stability of an uncemented femoral total knee replacement component is provided by press-fit forces at the bone-implant interface. This press-fit is achieved by resecting the bone slightly larger than the inner dimensions of the implant, resulting in a so-called interference fit. Previous animal studies have shown that an adequate primary stability is required to minimize micromotions at the bone-implant interface to achieve bone-ingrowth, which provides the secondary (long-term) fixation. It is assumed that during implantation a combination of elastic and plastic deformation and abrasion of the bone will occur, but little is known about what happens at the bone-implant interface and how much interference fit eventually is achieved. Purpose of this study was therefore to assess the actual and effective interference fit and the amount of bone damage during implantation of an uncemented femoral knee component. In this study, five cadaveric distal femora were prepared and femoral knee components were implanted by an experienced surgeon. Micro-CT scans and conventional CT-scans were obtained pre- and post-implantation for geometrical measurements and to measure bone mineral density. In addition, the position of the implant with respect to the bone was determined by optical scanning of the reconstructions (Figure.1). By measuring the differences in surface geometry, assessments were made of the cutting error, the actual interference fit, the amount of bone damage, and the effective interference fit. Our analysis showed an average cutting error of 0.67± 0.17 mm, which pointed mostly towards bone under-resections. We found an average actual AP interference fit of 1.48± 0.27 mm, which was close to the nominal value of 1.5 mm. We observed combinations of bone damage and elastic deformation in all bone specimens (Figure. 2), which showed a trend to be related with bone density. Higher bone density tended to lead to lower bone damage and higher elastic deformation (Figure. 3). The results of the current study indicate different factors that interact while implanting an uncemented femoral knee component. This knowledge can be used to fine-tune design criteria of femoral components and obtain adequate primary stability for all patients in a more predictable way

Aim. Cementless prosthesis is one of the major bone-implant interface fixation methods in total joint replacement. Grit blasted surface, hydroxyapatite coated surface and plasma sprayed metallic porous coating have been popularly used. The latter has demonstrated higher bone implant mechanical stability in previous laboratory study in early and middle stages. However, question remains what the mechanism is to make it performing better and how to improve them further. This study is designed to examine the mode of failure in bone-implant interface in a sheep model. Method. Plasma sprayed porous coated (TiPL); hydroxyapatite (HA) coated and and grit blasted (TiGB) titanium implants were examined in the study. Each type has 36 specimens. Implants were inserted into cortical bones in a press-fit fashion in a total of 22 sheep bilateral hind limbs. Specimens were retrieved at 4 weeks and 12 weeks. Push- out testing was performed to just reach ultimate failure. Failed bone-implant interface were investigated by histology and BSEM. The percentage of failure at bone-coating interface, bone itself fracture, coating itself failure, and coating-substrate dissociation were measured by BSEM. Results. In TiPL group, failure occurred mainly at new bone itself on ingrowing new bone and adjacent bone, with 74% at 4 weeks, and 82% at 12 weeks. The percentages were significantly higher than that of the failure at bone-porous coating dissociation. Furthermore, the percentage of failure occurred at bone was also higher in TiPS group than in the other groups at both time points. In HA group, the main proportion of failure, 69%, occurred at bone-HA dissociation at 4 weeks, higher than the 25% at bone itself fracture. 57% of failure occurred at HA-substrate dissociation at 12 weeks, which was followed by HA coating itself breakage (Figure 1). Bone itself fracture has the lowest proportion of only 4% breakage at 12 weeks. HA coating revealed micro cracks at some area although not all of them were failed. In TiGB group, failure mainly occurred at bone-implant surface dissociation at both time points. Conclusion. The failure mode at the HA and TiGB groups demonstrate that new bone was less likely to break, or stronger, than bone-implant surface interface at early stage, and new bone at middle stage was stronger than the other interfaces. The bone ingrowth to metallic porous coating results in that major proportion failure has to occur at bone anchorage, either at the entry level or at adjacent bone. The anchorage is the reason why TiPS has higher mechanical shear strength in previous study. Improving bone itself remodelling or maturing process may increase the porous coated implant in vivo mechanical strength; improving HA quality and HA-substrate adhesion may enhance HA coated implant performance; and improving bone implant surface bonding may strengthen grit blasted implant mechanical stability

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