Introduction. The ability to create patient-specific implants (PSI) at the point-of-care has become a desire for clinicians wanting to provide affordable and customized treatment. While some hospitals have already adopted extrusion-based 3D printing (fused filament fabrication; FFF) for creating non-implantable instruments, recent innovations have allowed for the printing of high-temperature implantable polymers including polyetheretherketone (PEEK). With interest in FFF PEEK implants growing, it is important to identify methods for printing favorable implant characteristics such as porosity for osseointegration. In this study, we assess the effect of porous geometry on the cell response and mechanical properties for FFF-printed porous PEEK. We also demonstrate the ability to design and print customized porous implants, specifically for a sheep tibial segmental defect model, based on CT images and using the geometry of triply periodic minimal surfaces (TPMS). Methods. Three porous constructs – a rectilinear pattern and gyroid/diamond TPMSs – were designed to mimic trabecular bone morphology and manufactured via PEEK FFF. TPMSs were designed by altering their respective equation approximations to achieve desired porous characteristics, and the meshes were solidified and shaped using a CAD workflow. Printed samples were mCT scanned to determine the resulting pore size and porosity, then seeded with pre-osteoblast cells for 7 and 14 days. Cell proliferation and alkaline phosphatase activity (ALP) were evaluated, and the samples were imaged via SEM. The structures were tested in compression, and stiffness and yield strength values were determined from resulting stress-strain plots. Roughness was determined using optical profilometry. Finally, our process of porous structure design/creation was modified to establish a proof-of-concept workflow for creating PSIs using geometry established from segmented sheep tibia CT images. Results. ALP activity measurements of the porous PEEK samples at 7 and 14 days were significantly greater than for solid controls (p < 0.001 for all three designs, 14 days). No difference between the porous geometries was found. SEM imaging revealed cells with flat, elongated morphology attached to the surface of the PEEK and into the pore openings, with filopodia and lamellipodia extensions apparent. mCT imaging showed average pore size to be 545 ± 43 µm (porosity 70%), 708 ± 64 µm (porosity 68%), and 596 ± 94 µm (porosity 69%) for the rectilinear, gyroid, and diamond structures, respectively. The average error between the theoretical and actual values was −16.3 µm (pore size) and −3.3 % (porosity). Compression testing revealed elastic moduli ranging from 210 to 268 MPa for the porous samples. Yield strengths were 6.6 ± 1.2 MPa for lattice, 14.8 ± 0.7 MPa for gyroid, and 17.1 ± 0.6 for diamond. Average roughness ranged from 0.8 to 3 µm. Finally, we demonstrated the ability to design and print a fully porous implant with the geometry of a sheep tibia segment. Assessments of implant geometrical accuracy and mechanical performance are ongoing. Discussion. We created porous PEEK with TPMS geometries via FFF and demonstrated a positive cellular response and mechanical characteristics similar to trabecular bone. Our work offers an innovative approach for advancing point-of-care 3D printing and PSI creation

Transforaminal lumbar interbody fusion (TLIF) using an implanted cage is the gold standard surgical treatment for disc diseases such as disc collapse and spinal cord compression, when more conservative medical therapy fails. Titanium (Ti) alloys are widely used implant materials due to their superior biocompatibility and corrosion resistance. A new Ti-6Al-4V TLIF cage concept featuring an I-beam cross-section was recently proposed, with the intent to allow bone graft to be introduced secondary to cage implantation. In designing this cage, we desire a clear pathway for bone graft to be injected into the implant, and perfused into the surrounding intervertebral space as much as possible. Therefore, we have employed shape optimization to maximize this pathway, subject to maintaining stresses below the thresholds for fatigue or yielding. The TLIF I-beam cage (Fig. 1(a)) with an irregular shape was parametrically designed considering a lumbar lordotic angle of 10°, and an insertion angle of 45° through the left or right Kambin's triangles with respect to the sagittal plane. The overall cage dimensions of 30 mm in length, 11 mm in width and 13 mm in height were chosen based on the dimensions of other commercially available cages. The lengths (la, lp) and widths (wa, wp) of the anterior and posterior beams determine the sizes of the cage's middle and posterior windows for bone graft injection and perfusion, so they were considered as the design variables for shape optimization. Five dynamic tests (extension/flexion bending, lateral bending, torsion, compression and shear compression, as shown in Fig. 2(b)) for assessing long term cage durability (10. 7. cycles), as described in ASTM F2077, were simulated in ANSYS 15.0. The multiaxial stress state in the cage was converted to an equivalent uniaxial stress state using the Manson-Mcknight approach, in order to test the cage based on uniaxial fatigue testing data of Ti-6Al-4V. A fatigue factor (K) and a critical stress (σcr) was introduced by slightly modifying Goodman's equation and von Mises yield criterion, such that a cage design within the safety design region on a Haigh diagram (Fig. 2) must satisfy K ≤ 1 and σcr ≤ SY = 875 MPa (Ti-6Al-4V yield strength) simultaneously. After shape optimization, a final design with la = 2.30 mm, lp = 4.33 mm, wa = 1.20 mm, wp = 2.50 mm, was converged upon, which maximized the sizes of the cage's windows, as well as satisfying the fatigue and yield strength requirements. In terms of the strength of the optimal cage design, the fatigue factor (K) under dynamic torsion approaches 1 and the critical stress (σcr) under dynamic lateral bending approaches the yield strength (SY = 875 MPa), indicating that these two loading scenarios are the most dangerous (Table 1). Future work should further validate whether or not the resulting cage design has reached the true global optimum in the feasible design space. Experimental validation of the candidate TLIF I-beam cage design will be a future focus. For any figures or tables, please contact authors directly (see Info & Metrics tab above).

Introduction. Dl-α-Tocopherol (VE)-blended non-crosslinked UHMWPE has been developed as a bearing surface material for knee prostheses due to the radical scavenging capabilities of vitamin E and has demonstrated a low wear rate in knee simulator testing [1,2]. In previous our study, VE-blended, crosslinked UHMWPE has demonstrated a low wear rate in hip simulator testing [3, 4]. As the radical scavenging capabilities also reduce the crosslinking degree of the material, multiple dose crosslinking has been investigated. However, these crosslinked UHMWPE materials may have different mechanical properties, as each crosslinking process, especially the annealing condition, is different. Additionally, there is little information about VE-blended, crosslinked UHMWPE with different annealing conditions. In this study, the effect of annealing temperature was investigated with regard to tensile strength, crosslink density, and crystallinity of VE blended, crosslinked UHMWPE. Method. VE blended samples were manufactured via direct compression molding following the blending of UHMWPE resin powder (GUR1050, Ticona Inc.) with VE (dl-α-tocopherol, Eisai Co. Ltd.) at 0.3wt%. The virgin samples were derived similarly, but without the addition of VE. Both materials underwent crosslinking by irradiation via a 10MeV electron beam at 300kGy and were then heat treated at several temperatures (25, 80, 110, 130 and 150 °C) for 24 hours. Gel content, which can be interpreted as cross-link density, was determined by measuring the weight of the samples before and after soaking in decahydronaphthalene at 150 °C for twelve days. Tensile tests were carried out following JIS K 7113, with the cross head speed set at 50 mm/min. Crystallinity was determined by using DSC and integrating over the enthalpy curve from 80 to 150 °C and normalizing with the enthalpy of melting for 100% crystalline polyethylene. Result. Fig. 1 shows the gel content of UHMWPE samples after crosslinking. Raising the annealing temperature caused an increase in the gel content regardless the VE content. Additionally, among samples with the same annealing temperature, VE samples had the lower gel content. Fig. 2 shows the yield strength of UHMWPE samples. Higher annealing temperature decreased the yield strength, and increased elongation. Fig. 3 shows the crystallinity of each UHMWPE sample. Higher annealing temperature decreased the crystallinity of UHMWPE. Discussion. In this study, the effect of annealing temperature on the mechanical properties of crosslinked UHMWPE was investigated. The results indicated that a greater volume of crystalline UHMWPE melted and reformed at the higher annealing temperatures. This was thought to occur due to the fact that UHMWPE consists of a range of different molecular weight chains, allowing for melting below 135°C. Therefore, the crystallinity and crosslink density changed for each annealing temperature. The annealing is a simple but effective method for designing the crystallinity and crosslinking of UHMWPE

Patellar fractures account for approximately 1% of all fractures. Open reduction and internal fixation is recommended to restore extensor continuity and articular congruity. However, complications such as nonunion and symptomatic hardware, still exist. Furthermore, there is a risk of re-fracturing of the healed bone during the removal of the implants. Magnesium (Mg), a biodegradable metal, has elastic moduli and compressive yield strength that are comparable to those of natural bone. Our previous study showed that released Mg ions enhanced fracture healing. However, Mg-based implants degrade rapidly after implantation and lead to insufficient mechanical strength to support the fracture. Microarc oxidation (MAO) is a metal surface coating that reduces corrosion. We hypothesized that Mg pins, with or without MAO, would enhance fracture healing radiologically, mechanically, and histologically, while MAO would decrease degradation of Mg pins. Patellar fracture was performed on forty-eight 18-week-old female New Zealand White rabbits according to established protocol. Briefly, the patella is osteotomized transversely and a tunnel (1.1mm) was drilled longitudinally through the two bone fragments. A pin (1 mm, stainless steel, Mg, or MAO-Mg) was inserted into the tunnel. The reduced construct was stabilized with a figure-of-eight band wire (⊘ 0.6 mm stainless steel wire). Cast immobilization was applied for 6 weeks. The rabbits were euthanized at week 8 and 12 post-operation. Microarchitecture and mechanical properties of the repaired patella were analyzed with microCT and tensile testing respectively. Histological sections of the repaired patella were stained. To evaluate the effect of the MAO treatment on degradation rate of Mg pin, the volume of the Mg pins in the patella was measured with microCT. At week 8, both Mg and Mg-MAO showed higher ratio of bone volume to tissue volume (BV/TV) than the control while there was no significant different between Mg and Mg-MAO. At week 12, Control, Mg, and Mg-MAO groups showed enlarged patella when compared to the normal patella. Tissue volume (TV) and bone volume (BV) of the patella in Mg and Mg-MAO were larger than those in the Control group. However, the Control had higher ratio of bone volume to tissue volume (BV/TV), TV density, and BV density than Mg and Mg-MAO. Tensile testing showed that the mechanical properties of the repaired patella (failure load, stiffness, ultimate strength, and energy-to-failure) of Mg and Mg-MAO were higher than that of the control at both week 8 and week 12. Histological analysis showed that there was significant new bone formation in the Mg and Mg-MAO group compared with the Control group at week 8 and 12. The degradation rate of the MAO-coated Mg pins was significantly slower than those without MAO at week 8 but no significant difference was detected at week 12. Mechanical, microarchitectural, and histological assessments showed that Mg pins, with or without MAO, enhanced fracture healing of the repaired patella compared to the Control. MAO treatment enhanced the corrosion resistance of the Mg pins at the early time point

Additive manufacturing (AM) techniques have gained attraction in orthopedic implant design with their ability to create unique shapes and structures. Depending on the application, there are different mechanical properties required. This study evaluated the mechanical properties of direct metal laser sintered (DMLS) Titanium alloy (Ti6Al4V) with and without hot isostatic pressure (HIP) treatment. Three dimensional computer modeling and the DMLS manufacturing assisted in building net or near-net samples for testing. The material testing consisted of uniaxial tension, Charpy impact, rotating beam fatigue (RBF), density, and hardness. Two sets of Ti6Al4V samples were created for testing using a DMLS process and stress relieved in a vacuum furnace prior to removal from the build platform. One set of samples were HIP treated. The two sets of samples were tested and the material properties of the non-HIP treated samples were compared to those with HIP treatment. Tension testing was conducted on fifteen (15) samples per treatment according to ASTM E8/E8M on as-built samples designed to a round specimen 3 per the standard. Fifteen (15) Charpy impact samples per treatment were built to near-net shapes. A low stress grind was performed on all surfaces and a notch was placed in the sample to comply with ASTM E23 and testing was performed in accordance with the standard. Fifteen (15) samples were built per treatment and machined for RBF per ISO 1143. RBF was performed on all samples at a frequency of 100 Hz with run out conditions of 10M cycles or failure. Density and hardness was measured on three (3) samples from each set using Archimedes' Principle and Rockwell hardness techniques respectively. The average (standard deviation) tensile strengths between the two groups were statistically different (p < 0.05). The non-HIP treated samples had an average ultimate strength of 956(10) MPa, yield strength of 896(13) MPa, and modulus of 118(2) GPa (Table 1). The HIP treated samples had an average ultimate strength of 909(4) MPa, yield strength of 832(9) MPa, and modulus of 112(3) GPa (Table 1). There was also statistical differences in the impact strength with the HIP treatment samples having a higher required force of 23.4(1.6) J compared to the non-HIP treated group of 19.8(1.8) J (Table 1). The fatigue strength of the samples HIP treated compared to the non-HIP treated group was 650 MPa and 396 MPa respectively (Table 1). This study shows that the HIP treatment of DMLS Ti6Al4V diminishes some mechanical strengths while greatly improving the fatigue life of the material. As we continue to evaluate these “new” materials for orthopedic devices, these mechanical and physical properties will help us understand the capabilities of this process and material

Introduction. Lipped liners have the potential to decrease the rate of revision for instability after total hip replacement since they increase the jumping distance in the direction of the lip. However, the elevated lip also may reduce the Range of Motion and may lead to early impingement of the femoral stem on the liner. It is unclear whether the use of a lipped liner has an impact on the level of lever-out moments or the contact stresses. Therefore, the aim of the current study was to calculate these values for lipped liners and compare these results to a conventional liner geometry. Materials and Methods. 3D Finite Element studies were conducted comparing a ceramic lipped liner prototype and a ceramic conventional liner both made from BIOLOX. ®. delta. The bearing diameter was 36 mm. To apply loading, a test taper made of titanium alloy was bonded to a femoral head, also made from BIOLOX. ®. delta. Titanium was modeled with a bilinear isotropic hardening law. For the bearing contact a coefficient of friction of both 0.09 or 0.3 was assumed to model a well and poorly lubricated system. Frictionless contact was modeled between taper and liner. Pre-load was varied between 500 N and 1500 N and applied along the taper axis. While keeping pre-load constant, lever-out force was applied perpendicular to the taper axis until subluxation occurred. Liners were fixed at the taper region. Lever-out moment, equivalent plastic strain and von Mises stress of the taper, bearing contact area and contact area between taper and liner was evaluated. Results. With increasing pre-load, larger lever-out moment, equivalent plastic strain, contact area between taper and liner and bearing contact area was found for both liner designs. However, von Mises stresses were nearly constant but slightly exceeded yield strength of titanium. For all evaluated parameters almost no differences were found between the liner designs. Lever-out moments were comparable for both designs ranging from 4.5–10.5 Nm for the lipped liner and 4.4–10.2 Nm for the conventional liner. The increase of the coefficient of friction strongly affected lever-out moments, equivalent plastic strain and contact area between taper and liner. The other parameters were not affected by varying the coefficient of friction. Discussion. This study did not find significant differences in the lever-out behavior of the lipped acetabular liner compared to the conventional liner design. The inner geometry of the lipped liner is comparable to the conventional liner inner geometry. Therefore, contact area showed no significant differences and contact mechanics are identical in the current setup leading to similar results of both liner designs. For both designs small plastic deformations in the contact point of the taper were found at the contact region between liner and taper. However, the investigated mechanical parameters did not differ between the two investigated liner types. For any figures or tables, please contact authors directly

AM Open Cell porous Ti Structures were investigated for compressive strength, morphology (i.e. pore size, struts size and porosity), and wear resistance with the aim to improve design capability at support of implant manufacturing. Specimens were manufactured in Ti6Al4V using a SLM machine. Struts sizes had nominal diameters of 200µm or 100µm, pores had nominal diameters of 700µm, 1000µm or 1500µm. These dimensions were applied to three different open-cell geometrical configurations: one with unit-cells based on a regular cubic arrangement (Regular), one with a deformed cubic arrangement (Irregular), and one based on a fully random arrangement (Fully Random). Morphological analysis was performed by image analysis applied onto optical and SEM acquired pictures. The analyses estimated the maximum and minimum Feret pores diameter, and the latter was used as one of the key parameters to describe the interconnected network of pores intended for bone colonization. Outcome revealed the systematic oversizing of the actual struts diameter Vs designed diameter; by opposite min. Feret diameters of the pores resulted significantly smaller than nominal pore diameters, thus better fitting within the range of pores dimension acknowledged to favor the osseointegration. Consequently, the actual total porosity is also reduced. Many technologic factors are responsible for the morphologic differences design vs actual, among these the influence of melting pool dimension, the struts orientation during building and the layer thickness have a significant impact. Mechanical compression was performed on porous cylinder samples. Test revealed the Yield Strength and Stiffness are highly sensitive to the actual porosity. Deformation behavior follows densification phenomenon at lower porosity, whereas at higher porosity the Gibson-Ashby model fits for most of the structure tested. The relationship among load direction, struts alignment and the collapse behavior of the unit cell geometries are discussed. Stiffness of the porous structure is evaluated in both quasistatic and cyclic compression. Wear was investigated according to Taber test method. The abrasion resistance is measured by scratching a ceramic wheel against the different AM porous structures along a circular path. Metal debris eventually loss were quantified by gravimetric analysis at different number of cycles. Correlation among AM porous structure geometry, porosity and wear loss is discussed. All the tested structures showed a debris loss within the limit suggested by FDA for the porous coating in contact with the bone tissue. The actual AM porous Titanium unit cell geometry and features are a key design input. In combination with all the other design factors of a device they may result helpful in address the stress shielding and prevent metal debris release issues. The study underlines the importance of the research activity in AM to support Design for Additive Manufacturing (DFAM) capability. For any figures or tables, please contact authors directly

INTRODUCTION. Wear induced osteolysis, material property degradation and oxidation remain a concern in cobalt chrome on polyethylene THR. ECIMA is a cold-irradiated, mechanically annealed, vitamin E blended HXLPE developed to maintain mechanical properties, minimise wear and improve long-term oxidation resistance. This study aimed to compare the in-vitro wear rate and mechanical properties of three different acetabular liners; UHMWPE, HXLPE and ECIMA. METHODS. Twelve liners (Corin, UK) underwent a 3 million cycle (mc) hip simulation. Three UHMWPE (GUR1050, Ø32 mm, γ sterilised), three HXLPE (GUR1020, Ø40 mm, 75 kGy γ, EtO sterilised) and six ECIMA (0.1 wt% vitamin E GUR1020, Ø40 mm, 120 kGy γ, mechanically annealed, EtO sterilised) liners articulated against CoCrMo femoral heads (Corin, UK). Wear testing was performed in accordance with ISO 14242 parts 1 and 2, in calf serum, with a maximum force of 3.0 kN and at a frequency of 1 Hz. Volumetric wear rate was determined gravimetrically. ASTM D638 type V specimens were machined from ECIMA material for uniaxial tension testing. Ultimate tensile strength (UTS), yield strength and elongation values were measured. These values were compared to mechanical data available for the other material types. Following completion of the ECIMA wear testing, three of the tested liners were cut in half. One half of each was subject to accelerated ageing in accordance with ASTM F2003-02, while the other half was tested as received. Each liner half was cross-sectioned and a microtome was used to section 200μm thick slices from each cross-section. Oxidation analysis was performed using a Fourier Transform Infra-red technique in accordance with ASTM F2102-01 throughout the thickness of each liner half. Average oxidation indices for each sample were determined. RESULTS. The reduction in wear rate for the ECIMA liners compared to the UHMWPE and HXLPE liners was 95 % and a 83 % respectively. There was an increase in UTS, yield strength and percent elongation of 45%, 16% and 32% respectively, for unaged ECIMA compared to HXLPE. Following ageing of the ECIMA samples, there was minimal change in all three mechanical properties. Importantly, the mechanical properties were not substantially degraded and were more comparable to conventional UHMWPE than HXLPE. Further to this, following an aggressive ageing protocol, the ECIMA material maintains the mechanical properties of the unaged condition. All of the oxidation values for the wear tested ECIMA liners, before and after ageing, and the aged, untested ECIMA samples were negative, which shows oxidation levels below the level of detection throughout the thickness of the samples. This indicates a high level of through-thickness oxidation resistance for the ECIMA specimens even after being subject to an aggressive ageing protocol and cyclic loading. DISCUSSION. These in-vitro wear results indicate that ECIMA is a very low wearing material with the potential to reduce wear related osteolysis in-vivo. Importantly, the mechanical properties were generally maintained unlike the degradation found in many modified polyethylene materials and were more comparable to UHMWPE than HXLPE. These properties make ECIMA a promising next generation bearing material

Introduction. The ability to manufacture implants at the point-of-care has become a desire for clinicians wanting to provide efficient patient-specific treatment. While some hospitals have adopted extrusion-based 3D printing (fused filament fabrication; FFF) for creating non-implantable instruments with low-temperature plastics, recent innovations have allowed for the printing of high-temperature polymers such as polyetheretherketone (PEEK). Due to its low modulus of elasticity, high yield strength, and radiolucency, PEEK is an attractive biomaterial for implantable devices. Though concerns exist regarding PEEK for orthopaedic implants due to its bioinertness, the creation of porous networks has shown promising results for bone ingrowth. In this study, we endeavor to manufacture porous PEEK constructs via clinically-used FFF. We assess the effect of porous geometry on cell response and hypothesize that porous PEEK will exhibit greater preosteoblast viability and activity compared to solid PEEK. The work represents an innovative approach to advancing point-of-care 3D printing, cementless fixation for total joint arthroplasty, and additional applications typically reserved for porous metal. Methods. Three porous constructs – a rectilinear pattern and two triply period minimal surface (TPMSs) - were designed to mimic the morphology of trabecular bone. The structures, along with solid PEEK samples for use as a control, were manufactured via FFF using PEEK. The samples were mCT scanned to determine the resulting pore size and porosity. The PEEK constructs were then seeded with pre-osteoblast cells for 7 and 14 days. Cell proliferation and alkaline phosphatase activity (ALP) were evaluated at each time point, and the samples were imaged via SEM. Results. mCT imaging showed the pores in the PEEK constructs to be open and interconnected. The average pore size was 535 ± 92 µm for the rectilinear, 484 ± 237 µm for the diamond, and 669 ± 216 µm for the gyroid. Porosity was 71% for the rectilinear, 76% for the diamond, and 68% for the gyroid. The average error between the theoretical and actual values was −37.3 µm for pore size and −2.3 % for porosity. Normalized ALP activity of the three porous PEEK samples at 7 days were found to be significantly greater than the solid sample (p < 0.05 rectilinear, p < 0.005 gyroid, p < 0.001 diamond). At 14 days, the same relationships were observed (p < 0.001 for all three designs). No difference between the three geometries was found. SEM imaging revealed cells with flat, elongated morphology attached to the surface of the PEEK. The 14-day samples appeared to have proliferated well and spread along the PEEK pores. Extensions of filopodia and lamellipodia were observed along with large blankets of cells covering the PEEK surface. Discussion. We demonstrated the ability of FFF printed porous PEEK surfaces to promote cellular processes necessary for bone-implant fixation. While all porous structures showed promising results, more investigation into their material characteristics and osteogenic potential are necessary to determine which geometry may be suitable for orthopaedic use. Our work offers an innovative approach to advancing point-of-care 3D printing, cementless implant fixation, and additional applications typically reserved for porous metal

INTRODUCTION. Avascular necrosis (AVN) of the femoral head (FH) initiates from biological disruptions in the bone and may progress to mechanical failure of the hip. Mechanical and structural properties of AVN bone have not been widely reported, however such understanding is important when designing therapies for AVN. Brown et al.[1] assessed mechanical properties of different regions of AVN FH bone and reported 52% reduction in yield strength and 72% reduction in elastic modulus of necrotic regions when compared to non-necrotic bone. This study aimed to characterise structural and mechanical properties of FH bone with AVN and understand the relationship between lesion volume and associated mechanical properties. METHODS. Twenty FH specimens from patients undergoing hip arthroplasty for AVN and six non-pathological cadaveric FH controls were collected. Samples were computed tomography scanned and images analysed for percentage lesion volume with respect to FH volume. Samples were further divided for structural and mechanical testing. The mechanical property group were further processed to remove 9mm cylindrical bone plugs from the load bearing and non-load-bearing regions of the FHs. FH and bone plug samples were tested in compression (1mm/min); elastic modulus and yield stress were calculated. RESULTS. Imaging. Individual lesion size within AVN FHs varied: multiple small lesions or small numbers of large lesions were present in all FHs. Mean lesion volume percentage for AVN FHs was significantly greater than control FHs (p30% total FH volume. Structural Properties: The mean elastic modulus for AVN FHs was 15% lower than that of control FHs and mean yield stress was 4% lower than that of control FHs, however this difference was not significant. Mechanical Properties. The mean elastic modulus and yield stress of bone plugs from the load-bearing regions of AVN FHs were significantly lower than those of control samples (79% and 77% respectively; p<0.05, Kruskal-Wallis), however, for non-load-bearing samples, mean elastic modulus and yield stress of AVN FHs were significantly higher than control samples (by 153% and 123% respectively; p<0.05, Kruskal-Wallis). DISCUSSION. Although mechanical properties of bone in load-bearing regions of AVN FHs were significantly less than those of control FHs, replicating previous findings by Brown et al. (1981, CORR. 156, 240-7), mechanical properties in the non-load bearing regions were increased. This may be due to adaptation of the non-load bearing region to support loads following AVN in normally load bearing regions, or due to the presence of denser sclerotic tissue. In this study, necrotic bone samples demonstrated smaller changes in mechanical properties in the load-bearing region with respect to those regions in the control samples than previously reported by Brown et al.. This may be due to differences in experimental methods (e.g. patient demographics, quality of control bone samples, loading rate, and location of samples) or due to the disease stage of the AVN FHs from which tissues were taken. In addition, this study has demonstrated that necrotic lesions are not consistent in quantity, size and location

Purpose. The purpose of this study is to analyse regional differences in the microstructural and mechanical properties of the distal femur depending on osteoarthritic changes using micro-images based on finite element analysis. Materials and Methods. Distal femur specimens were obtained from ten donors composed of 10 women with OA (mean age of 65 years, ranging from 53 to 79). As controls, the normal distal femur was sampled from age and gender matched donors consisting of 10 women(mean age of 67 years, ranging from 58 to 81). The areas of interest were six regions of the condyles of the femur(Lateral-Anterior, Middle, Posterior; Medial=Anterior, Middle, Posterior). A total of 20 specimens were scanned using the micro-CT system. Micro-CT images were converted to micro-finite element model using the mesh technique, and micro-finite element analysis was then performed for assessment of the mechanical properties. Results. Trabecular bones from the distal femur in control and OA groups exhibited different microstructural and mechanical properties in the same region. BV/TV, Tb.N, Tb.S and Yield strength were different between LA and MMsignificantly (p=0.005). In control group, the lateral anterior region of the distal femur reflected subchondral trabecular remodeling, while in advanced OA group, the medial middle region showed prominent changes in the microstructural and mechanical properties. Conclusion. The authors concluded that with aging and the progress of primary OA, changes of patello-femoral reaction force induced subchondral trabecular changes of the anterolateral region initially, and then progressed to the medial middle and posterior region in advanced OA

Introduction. Originally, the vertical expandable titanium rib (VEPTR™) was developed to treat children with Thoracic insufficiency syndrome secondary to fused ribs and congenital scoliosis. Over the years its usage has widen and is currently being used to treat all etiology of early onset scoliosis (EOS). A major draw back remains the size of the titanium VEPTR™ implant. In keeping with the new trend of chrome-cobalt alloy (CoCr). spinal implants, we set out to explore if redesigning the VEPTR™ was mechanically sound. The aim of this study was twofold. Firstly, we investigate the mechanical properties of a VEPTR™ made with CoCr alloy compared to that of titanium alloy. Secondly we investigated how much we could down size the VEPTR™. Materials & Methods. Finite element analyses were performed on 3 different VEPTR™ designs (rod diameter of 6mm, 5mm and 4mm) subjected to a compressive load of 500N (equivalent to a 50Kg child). For each configuration, two materials, titanium alloy and chrome-cobalt alloy, were used. Maximum Von Mises stress distribution (VMSD), plastic strain (PS) and total displacement (TD) of the VEPTR™ were measured as indicators of mechanical properties of the implant. Results. Results for the maximum Von Mises stress distribution (VMSD), plastic strain and total displacement (TD) can be seen on the table 1. Discussion. Results confirm that yield strength of titanium material is greater than that of Co-Cr, while Plastic strain (PS) is greater for a CoCr VEPTR™ than for titanium VEPTR™. As expected a 6 mm CoCr VEPTR resist displacement almost twice as a 6 mm titanium VEPTR. Little difference is noted in plastic strain and VonMises stress at 6mm. Down sizing the implant to 5 mm in titanium or CoCr may runs the risk of implant failure as both exceeds their failure point and they both deform 0.29% and 6.6% respectively, placing the 5mm CoCr at higher risk of failure. Our results suggest that the VEPTR™ design could be reduced to 5mm however requires a new design to minimize the risk of failure. 4mm rods will not withstand a 50kg load

Effectiveness and long term stability of hip resurfacing and total hip arthroplasty for osteoarthritis patients are still debated nowadays. Several clinical and biomechanical issues have to be considered, including pain relief, return to function, femoral neck fractures, impingement and prosthesis loosening. Normally, patients with hip arthroplasties are facing gait adaptation and at risk of fall. Sudden impact loading and twisting during sideway falls may lead to femoral fractures and joint failures. The purposes of this study are (i) to investigate the stress behavior of hip resurfacing and total hip arthroplasty, and (ii) to predict pattern of femoral fractures during sideway falls and twisting configurations. Computed tomography (CT) based images of a 54-year old male were used in developing a 3D femoral model. The femur model was designed to be inhomogeneous material as defined by Hounsfield Unit of the CT images. CAD data of hip arthroplasties were imported and aligned to represent RHA and THA femur modelas shown in Fig.1. Prosthesis stem is modeled as Ti-6Al-4V material while femoral ball as Alumina properties. Meanwhile, RHA implant is assigned as Co-Cr-Mo material. Four types of loading and boundary conditions were assigned to demonstrate different falling (FC) and twisting (TC) configurations (see Fig.2). Finite element analysis combined with a damage mechanics model was then performed to predict bone fractures in both arthroplasty models. Different loading magnitudes up to 4BW were applied to extrapolate the fracture patterns. Prediction of femoral fracture for RHA and THA femurs are discussed in corresponding to maximum principal stress and damage formation criterion. The load bearing strain was set to 3000micron, the physiological bone loading that leads to bone formation. The test strength was wet to 80% of the yield strength determined from the CT images. Different locations of fracture are predicted in each configuration due to different loading direction and boundary conditions as shown in Fig.3. For falling configurations, fractures were projected at trochanteric region for intact and RHA femur, while THA femurs experience fracture at inner proximal region of bone. Differs to twisting configurations, both arthroplasties were predicted to fracture at the distal end of femurs

Orthopaedic reconstruction procedures to combat osteoarthritis, inflammatory arthritis, metabolic bone disease and other musculoskeletal disorders have increased dramatically, resulting in high demand on the advancement of bone implant technology. In the past, joint replacement operations were commonly performed primarily on elderly patients, in view of the prosthesis survivorship. With the advances in surgical techniques and prosthesis technology, younger patients are undergoing surgeries for both local tissue defects and joint replacements. This patient group is now more active and functionally more demanding after surgery. Today, implanted prostheses need to be more durable (load-bearing), they need to better match the patient's original biomechanics and be able to survive longer. Additive manufacturing (AM) provides new possibilities to further combat the problem of stress-shielding and promote better bone remodelling/ingrowth and thus long term fixation. This can be accomplished by matching the varying strain response (stiffness) of trabecular or subchondral bone locally at joints. The purpose of this research is therefore to determine whether a porous structure can be produced that can match the required behaviour and properties of trabecular bone regardless of skeletal location and can it be incorporated into a long-term implant. A stochastic structure visually similar to trabecular bone was designed and optimised for AM (Figure 1) and produced over a range of porosities in multiple materials, Stainless Steel 316, Titanium (Grade 23 – Ti6Al4V ELI) and Commercially Pure Titanium (Grade 2) using a Renishaw AM250 metal additive manufacturing system. Over 150 cylindrical specimens were produced per material and subjected to a compression test to determine the specimens' Elastic Modulus (Stiffness) and Compressive Yield Strength. Micro-CT scans and gravimetric analysis were also performed to determine and validate the specimens' porosity. Results were then graphed on a Strength vs. Stiffness Ashby plot (Figure 2) comparing the values to those of trabecular bone in the tibia and femur. It was found that AM can produce porous structures with an elastic modulus as low as 100 MPa up to 2.7 GPa (the highest stiffness investigated in this study). Titanium structures with a stiffness <500MPa had compressive strengths towards the bottom range of similar stiffness trabecular bone. Between 500 MPa − 1 GPa Titanium AM porous structures match the compressive strength of equivalent stiffness trabecular bone and from 1 GPa − 2 GPa the Ti structures exceed the strength of equivalent stiffness trabecular bone up to ∼2.5 times and consequently increase by a power law. These results show that AM can produce structures with similar stiffness to trabecular bone over a range of skeletal locations whilst matching or exceeding the compressive strength of bone. The results have not yet taken into account fatigue life with the fatigue life of these types of structures tending to be between 0.1 – 0.4 of their compressive strength. This means that a titanium porous structure would need to be 2.5 – 10 times stiffer or stronger than the portion of trabecular bone it is replacing. This data is highly encouraging for AM manufactured, bone stiffness matched implant technology

Introduction. Porous scaffolds for bone ingrowth have numerous applications, including correcting deformities in the foot and ankle. Various materials and shapes may be selected for bridging an osteotomy in a corrective procedure. This research explores the performance of commercially pure Titanium (CPTi) and Tantalum (Ta) porous scaffold materials for use in foot and ankle applications under simplified compression loading. Methods. Finite element analysis was performed to evaluate von Mises stress in 3 porous implant designs: 1) a CPTi foot and ankle implant (Fig 1) 2) a similar Ta implant (wedge angle = 5°) and 3) a similar Ta implant with an increased wedge angle of 20°. Properties were assigned per reported material and density specifications. Clinically relevant axial compressive load of 2.5X BW (2154 N) was applied through fixtures which conform to ASTM F2077–11. Compressive yield and fatigue strength was evaluated per ASTM F2077–11 to compare CPTi performance in design 1 to the Ta performance of design 3. Results. FEA results indicate peak stresses at fixture contact locations. Similar designs (CPTi design 1 and Ta design 2) resulted in similar von Mises stresses (Fig 1). Increasing the wedge angle (Ta design 3) increased stress by 15%. The static compressive yield strength of CPTi design 1 (20,560 N) was similar to the Ta design 3 (20,902 N), with yield manifesting as barreling and crushing of the components (Fig 2a). However, the fatigue strength of CPTi (6,000 N) was 40% lower than the Ta design 3 (9,500 N) (Fig 3). In both cases fracture initiated from regions of highest stress predicted in FEA. Fracture progression was not instantaneous and was characterized by an accumulation of damage (Fig 2b–c) leading to gross component fracture and loss of implant integrity. Discussion. FEA is a useful tool to determine stress variations and can be used to identify worst case within a material: in this case, a larger implant wedge angle leads to higher stresses. Additionally, FEA accurately predicted fracture initiation location. However, material selection plays a large role in porous implant performance: although FEA predicted higher stresses in a Ta component with a greater wedge angle than a similar sized CPTi component, static compressive strengths were nearly identical, and the Ta component had 58% higher fatigue strength. When selecting a material or geometry for an implant application, both FEA and static testing allow for rapid evaluation of designs. However, caution should be used in interpreting the results: the ultimate performance of an implant in-vivo will depend on its ability to maintain integrity over a long period of time, and should be characterized by dynamic testing

Background. Calcium phosphate cement (CPC) is a promising biomaterial which can be used in numerous medical procedures for bone tissue repairing because of its excellent osteoconductivity. An injectable preparation and relatively short consolidation time are particularly useful characteristics of CPC. However, the low strength of CPC and its brittleness restrict its use. One method for toughening brittle CPC is to incorporate fibrous materials into its matrix to create a composite structure. Fibers are widely used to reinforce matrix materials in a variety of areas. Objective. We hypothesized that there must be an optimal fiber length and structure which can balance these conflicting aspects of fiber reinforcement. The purpose of this study is to prove our conjectures that adding a small amount of short fibers significantly improves the hardness and the toughness of CPC while maintaining its injectability with a syringe and that fiber morphologies that have crimps and surface roughness are favorable for reinforcing. Material and Methods. We used 3 types of short fibers of approximately 20–50 micrometer in diameter and 2 mm in length in this study: crimpy wool, crimpy polyethylene and straight polyethylene fibers. All of the materials were prepared by mixing a solvent with CPC powder with or without fiber. We grouped as follow, the control group, the wool group, the crimpy polyethylene group, the straight polyethylene group. After soaking in 37 degrees Celsius Simulated Body Fluid∗∗∗∗∗ for 1, 3, or 7 days, they were tested for each period. Impact strength test by the falling weight and compression test were performed. Result. In the impact strength test, after soaking for 1 day, impact resistance in the wool group was approximately 180 times greater than in the control group. When soaking for 3 days or more, impact resistance of wool group improve better than control group. The impact resistance of the wool group was the greatest among the four groups in soaking for 3 days. In the compression test, the yield strength and ultimate strength of the wool group were significantly higher than ultimate strength of the control group. The wool group has stress–strain curves that are typical of those of ductile materials, whereas the stress–strain curves of the control group resemble those of brittle materials. This indicates that fiber reinforcement drastically alters the physical properties of CPC converting it from brittle to ductile. Conclusion. In the present study, we sought to develop a method for producing injectable fiber-reinforced CPC. We focused on morphology and surface roughness of fiber in the reinforcement of CPC. This study clearly showed that CPC was substantially strengthened and toughened by crimpy short fiber reinforcement. CPC reinforced with short fibers which have morphology similar to wool should be a promising tool for orthopedic surgeons

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