Revision surgeries for orthopaedic infections are done in two stages – one surgery to implant an antibiotic spacer to clear the infection and another to install a permanent implant. A permanent porous implant, that can be loaded with antibiotics and allow for single-stage revision surgery, will benefit patients and save healthcare resources. Gyroid structures can be constructed with high porosity, without stress concentrations that can develop in other period porous structures [1] [2]. The purpose of this research is to compare the resulting bone and prosthesis stress distributions when porous versus solid stems are implanted into three proximal humeri with varying bone densities, using finite element models (FEM). Porous humeral stems were constructed in a gyroid structure at porosities of 60%, 70%, and 80% using computer-aided design (CAD) software. These CAD models were analyzed using FEM (Abaqus) to look at the stress distributions within the proximal humerus and the stem components with loads and boundary conditions representing the arm actively maintained at 120˚ of flexion. The stem was assumed to be made of titanium (Ti6Al4V). Three different bone densities were investigated, representing a healthy, an osteopenic, and an osteoporotic humerus, with an average bone shape created using a statistical shape and density model (SSDM) based on 75 cadaveric shoulders (57 males and 18 females, 73 12 years) [3]. The Young's moduli (E) of the cortical and trabecular bones were defined on an element-by-element basis, with a minimum allowable E of 15 MPa. The Von Mises stress distributions in the bone and the stems were compared between different stem scenarios for each bone density model. A preliminary analysis shows an increase in stress values at the proximal-lateral region of the humerus when using the porous stems compared to the solid stem, which becomes more prominent as bone density decreases. With the exception of a few mesh dependent singularities, all three porous stems show stress distributions below the fatigue strength of Ti-6Al-4V (410 MPa) for this loading scenario when employed in the osteopenic and osteoporotic humeri [4]. The 80% porosity stem had a single strut exceeding the fatigue strength when employed in the healthy bone. The results of this study indicate that the more compliant nature of the porous stem geometries may allow for better load transmission through the proximal humeral bone, better matching the stress distributions of the intact bone and possibly mitigating stress-shielding effects. Importantly, this study also indicates that these porous stems have adequate strength for long-term use, as none were predicted to have catastrophic failure under the physiologically-relevant loads. Although these results are limited to a single boney geometry, it is based on the average shape of 75 shoulders and different bone densities are considered. Future work could leverage the shape model for probabilistic models that could explore the effect of stem porosity across a broader population. The development of these models are instrumental in determining if these structures are a viable solution to combatting orthopaedic implant infections

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

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

Surface coatings have been introduced to total joint orthopaedics over the past decades to enhance osseointegration between metal implants and bone. However, complications such as aseptic loosening and infection persist. Inadequate osseointegration remains a complication associated with implants that rely on osseointegration for proper function. This is particularly challenging with implants having relatively flat and small surface areas that have high shear loading, such as noncemented uni and total condylar knee tibial trays. Faster osseointegration can enhance recovery as a result of improved load distribution and a more stable bone-implant interface. Traditionally noncemented porous bone ingrowth coatings on knee, hip and shoulder implants are typically texturised by thermal plasma spray coating, sintered metal bead coatings, or 3-D additive manufactured structures that provide porous surface features having the rough texture with pore sizes on the order of 150 to 300 micrometers. These surfaces are often further chemically enhanced with hydroxyapatite (HA) deposition. This provides macro-mechanical (millimeter scale) and micro-mechanical (micrometer scale) bone remodeling into the implant surface. However, at the nanoscale and cellular level, these surfaces appear relatively smooth. More recent studies are showing the importance of controlling the macro, micro, and the nano (nanometer scale) surface topographies to enhance cell interaction. In vitro and in vivo research shows surfaces with nanoscale features in the metal substrate result in enhanced osseointegration, greater bone-implant contact area and pullout force, and potentially bactericidal. One surface modification treatment technique of particular promise is nano-texturing via electrochemical anodization to bio-mimicking TiO2 nanotube arrays that are superimposed onto existing porous surface microstructures to further enhance the already known bone ingrowth properties of these porous structures by superimposing onto the existing microstructure arrays of nanotubes approximately 100 nanometers in outside diameter and 300–500 nanometers in height. In an ovine model, 3-D printed Direct Metal Laser Deposition (DMLS) additive manufactured porous Ti-6Al-4V implant with and without TiO2 nanotube array nano-texturing were compared to similar sized implants with commercially available sintered beads with HA coating and additive manufactured cobalt chrome implants. The average bond strength was significantly higher (42%) when the implants were nano-texturised and similarly stronger (53%) compared to HA coated sintered bead implants. Histology confirms over 420% more direct bonded growth of new bone from 0.5mm to 1.0mm deep into the porosity on the implants when the same implants are nano-texturised. Nano-texturing also changes the surface of the implant to repel methicillin-resistant staphylococcus aureus (MRSA) in an in vivo rabbit model limiting biofilm formation on the porous surface compared with non-treated porous surfaces. Since nano-texturizing only modifies the nano-morphology of the surface and does not add antibiotics or other materials to the implant, these animal studies shows great promise that nano-texturizing the TiO2 coating may not only enhance osseointegration, but also repels bacteria from porous implant surfaces. As such, we believe nano-texturing of porous implants will be the next advancement in surface coating technology

OSSTEC is a pre-spin-out venture at Imperial College London seeking industry feedback on our orthopaedic implants which maintain bone quality in the long term. Existing orthopaedic implants provide successful treatment for knee osteoarthritis, however, they cause loss of bone quality over time, leading to more dangerous and expensive revision surgeries and high implant failure rates in young patients. OSSTEC tibial implants stimulate healthy bone growth allowing simple primary revision surgery which will provide value for all stakeholders. This could allow existing orthopaedics manufacturers to capture high growth in existing and emerging markets while offering hospitals and surgeons a safer revision treatment for patients and a 35% annual saving on lifetime costs. For patients, our implant technology could mean additional years of quality life by revising patients to a primary TKA before full revision surgery. Our implants use patent-filed additive manufacturing technology to restore a healthy mechanical environment in the proximal tibia; stimulating long term bone growth. Proven benefits of this technology include increased bone formation and osseointegration, shown in an animal model, and restoration of native load transfer, shown in a human cadaveric model. This technology could help capture the large annual growth (24%) currently seen in the cementless knee reconstruction market, worth $1.2B. Furthermore, analysis suggests an additional market of currently untreated younger patients exists, worth £0.8B and growing by 18% annually. Making revision surgery and therefore treatment of younger patients easier would enable access to this market. We aim to offer improved patient treatment via B2B sales of implants to existing orthopaedic manufacturer partners, who would then provide them with instrumentation to hospitals and surgeons. Existing implant materials provide good options for patient treatments, however OSSTEC's porous titanium structures offer unique competitive advantages; combining options for modular design, cementless fixation, initial bone fixation and crucially long term bone maintenance. Speaking to surgeons across global markets shows that many surgeons are keen to pursue bone preserving surgeries and the use of porous implants. Furthermore, there is a growing demand to treat young patients (with 25% growth in patients younger than 65 over the past 10 years) and to use cementless knee treatments, where patient volume has doubled in the past 4 years and is following trends in hip treatments. Our team includes engineers and consultant surgeons who have experience developing multiple orthopaedic implants which have treated over 200,000 patients. To date we have raised £175,000 for the research and development of these implants and we hope to gain insight from industry professionals before further development towards our aim to begin trials for regulatory approval in 2026. OSSTEC implants provide a way to stimulate bone growth after surgery to reduce revision risk. We hope this could allow orthopaedic manufactures to explore high growth markets while meaning surgeons can treat younger patients in a cost effective way and add quality years to patients' lives

Porous surfaces on orthopaedic implants have been shown to promote tissue ingrowth. This study evaluated biological fixation of novel additively manufactured porous implants with and without hydroxyapatite coatings in a canine transcortical model. Laser rapid manufacturing (LRM) Ti6Al4V cylindrical implants were built with a random interconnected architecture mimicking cancellous bone (5.2 mm diameter, 10mm length, 50–60% porous, mean pore size 450μm). Three groups were investigated in this study: as-built with no coating (LRM), as-built coated with solution precipitated hydroxyapatite (LRM-PA), and as-built coated with a plasma sprayed hydroxyapatite (LRM-PSHA). Implants were press-fit into a 5mm unicortical, perpendicular drill hole in the femoral diaphysis of the left and right femurs in 12 canines. Right femora were harvested for histology (SEM, bone ingrowth into implant within cortical region) and left femora for mechanical push-out testing (shear strength of bone-implant interface) at 4 and 12 weeks (N=6, un-paired Student's t-test, p=0.05). For mean bone ingrowth, there was no significant difference between groups at 4 weeks (LRM, LRM-PA, LRM-PSHA: 41.5+8.6%, 51+5.5% and 53.2+11%, respectively) or 12 weeks (LRM, LRM-PA, LRM-PSHA: 64.4+2.8%, 59.9+7.6%, 64.9+6.4%, respectively). LRM and LRM-PA implants had more bone ingrowth at 12 weeks than 4 weeks (p < 0 .05). Mean shear strength of all implants at 12 weeks (LRM, LRM-PA, LRM-PSHA: 39.9+3.6MPa, 33.7+4.6MPa, 36+4.1MPa respectively) were greater than at 4 weeks (LRM, LRM-PA, LRM-PSHA: 21.6+2.8MPa, 20.7+1.1MPa, 20.2+2.5MPa respectively) (p < 0 .05). No significant difference was observed between all groups at 4 or 12 weeks. Overall, this canine study confirmed the suitability of this novel additive manufacturing porous material for biological fixation by bone ingrowth. All implants exhibited high bone ingrowth and mechanical shear strength in this canine model. No difference was observed between uncoated and hydroxyapatite coated implants

Introduction. The frequency of revision hip arthroplasty is increasing with the increasing life expectancy and number of individuals treated with joint replacement. Newer porous implants have been introduced which may provide better treatment options for revision arthroplasty. These may require cementation to other prosthesis components and occasionally to bone, however, there is currently no information on how these porous implants interface with cement. Materials and Methods. Cylindrical bone (control group) and porous metal probes with a diameter and height of 10mm were created and subsequently cemented in a standardized setting. These were placed under tensile and torsional loading scenarios. In this experimental study, 10 human femoral heads were used to create 20 cylindrical probes with a diameter and height of 10mm. One side was tapered to 6mm for cementation and interface evaluation. A further set of 20 probes of a porous metal implant (Trabecular Metal®) was created with the same geometry. After the probes were created and lavaged, they were cemented at the tapered surface using a medium viscosity cement at a constant cementation pressure (1.2N/mm2). The setup allowed for comparison of the porous metal/cement interface (group A) with the well-studied control group interface bone/cement (group B). The maximal interface stability of groups A and B were evaluated under tensile and rotational loading scenarios and the cement penetration was measured. Results. Group A showed a significantly decreased cement penetration under the same cementation pressure than group B, yet the interface showed a significantly more stable interface in the measured tests: larger maximum tensile force (effect size 2.7), superior maximum tensile strength (effect size 2.6), greater maximum torsional force (effect size 2.2), and higher rotational stiffness (effect size 1.5). Discussion and Conclusion. The porous metal/cement interface displays substantially more stability than does the bone/cement interface. Although these tests evaluate initial stability in an in-vitro setting, they appear promising with regard to their cemented stability. As a result, a multicomponent porous metal construct with cement interdigitation should not compromise the overall implant primary stability

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

Biodegradable metals as orthopaedic implant materials receive substantial scientific and clinical interest. Marketed cardiovascular products confirm good biocompatibility of iron. Solid iron biodegrades slowly in vivo and has got supra-physiological mechanical properties as compared to bone and porous implants can be optimized for specific orthopaedic applications. We used Direct Metal Printing (DMP)3 to additively manufacture (AM) scaffolds of pure iron with fine-tuned bone-mimetic mechanical properties and improved degradation behavior to characterize their biocompatibility under static and dynamic 3D culture conditions using a spectrum of different cell types. Atomized iron powder was used to manufacture scaffolds with a repetitive diamond unit cell design on a ProX DMP 320 (Layerwise/3D Systems, Belgium). Mechanical characterization (Instron machine with a 10kN load cell, ISO 13314: 2011), degradation behavior under static and dynamic conditions (37ºC, 5% CO2 and 20% O2) for up of 28 days, with μCT as well as SEM/energy-dispersive X-ray spectroscopy (EDS) (SEM, JSM-IT100, JEOL) monitoring under in vivo-like conditions. Biocompatibility was comprehensively evaluated using a broader spectrum of human cells according to ISO 10993 guidelines, with topographically identical titanium (Ti-6Al-4V, Ti64) specimen as reference. Cytotoxicity was analyzed by two-way ANOVA and post-hoc Tukey's multiple comparisons test (α = 0.05). By μCT, as-built strut size (420 ± 4 μm) and porosity of 64% ± 0.2% were compared to design values (400 μm and 67%, respectively). After 28 days of biodegradation scaffolds showed a 3.1% weight reduction after cleaning, while pH-values of simulated body fluids (r-SBF) increased from 7.4 to 7.8. Mechanical properties of scaffolds (E = 1600–1800 MPa) were still within the range for trabecular bone, then. At all tested time points, close to 100% biocompatibility was shown with identically designed titanium (Ti64) controls (level 0 cytotoxicity). Iron scaffolds revealed a similar cytotoxicity with L929 cells throughout the study, but MG-63 or HUVEC cells revealed a reduced viability of 75% and 60%, respectively, already after 24h and a further decreased survival rate of 50% and 35% after 72h. Static and dynamic cultures revealed different and cell type-specific cytotoxicity profiles. Quantitative assays were confirmed by semi-quantitative cell staining in direct contact to iron and morphological differences were evident in comparison to Ti64 controls. This first report confirms that DMP allows accurate control of interconnectivity and topology of iron scaffold structures. While microstructure and chemical composition influence degradation behavior - so does topology and environmental in vitro conditions during degradation. While porous magnesium corrodes too fast to keep pace with bone remodeling rates, our porous and micro-structured design just holds tremendous potential to optimize the degradation speed of iron for application-specific orthopaedic implants. Surprisingly, the biological evaluation of pure iron scaffolds appears to largely depend on the culture model and cell type. Pure iron may not yet be an ideal surface for osteoblast- or endothelial-like cells in static cultures. We are currently studying appropriate coatings and in vivo-like dynamic culture systems to better predict in vivo biocompatibility

Purpose. Durable fixation may be difficult to achieve when significant bone loss is present, as it occurs in pelvic sarcoma resection and revision surgery of tumor implants. Purpose of this study was to review clinical results of primary and revision surgery of the pelvis and lower extremity in the setting of severe bone loss following limb salvage procedures for bone sarcoma using modular porous tantalum implants. Method. Retrospective study of 15 patients (nine females, six males) undergoing primary or revision pelvic reconstruction (five patients) or revision surgery of a tumor implant of the hip (five patients), knee (four patients), and ankle (one patient) using porous tantalum implants was undertaken. Reason for the tumor implant was resection of bone sarcoma in 13 cases and tumor-like massive bone loss in the remaining two cases. Cause for revision was aseptic failure (nine patients) or deep infection (six patients); average age at the time of surgery was 31 years (16–61 yrs). Revision was managed in a staged fashion in all the six infected cases. All patients presented severe combined segmental and cavitary bone defects. Bone loss was managed in all patients using porous tantalum implants as augmentation of residual bone stock and associated with a megaprosthesis in eight cases (five proximal femur, two distal femur, one proximal tibia). Average follow-up was 4.5 years for hip/knee implants and 2.5 yrs for pelvic reconstructions (range 1–6.8 yrs). Minimum follow-up of two years was available in 11 cases. Results. Infection recurred in one of the six cases managed for infection, requiring further treatment but allowing retention of the porous tantalum implant. All the patients showed well-fixed and functioning implants at latest follow-up. Conclusion. Porous tantalum has been very successful at early follow-up in patients with severe bone loss following primary and revision tumor-related surgery of the pelvis and lower extremity. Longer follow-up is required to appreciate long-term shortcomings

As the number of patients who have undergone total hip arthroplasty rises, the number of patients who require surgery for a failed total hip arthroplasty is also increasing. It is estimated that 183,000 total hip replacements were performed in the United States in the year 2000 and that 31,000 of these (17%) were revision procedures. Reconstruction of the failed femoral component in revision total hip arthroplasty can be challenging from both a technical perspective and in preoperative planning. With multiple reconstructive options available, it is helpful to have a classification system which guides the surgeon in selecting the appropriate method of reconstruction. A classification of femoral deficiency has been developed and an algorithmic approach to femoral reconstruction is presented. An extensively coated, diaphyseal filling component reliably achieves successful fixation in the majority of revision femurs. The surgical technique is straightforward and we continue to use this type of device in the majority of our revision total hip arthroplasties. However, in the severely damaged femur (Type IIIB and Type IV), other reconstructive options may provide improved results. Based on our results, the following reconstructive algorithm is recommended for femoral reconstruction in revision total hip arthroplasty. Type I: In a Type I femur, there is minimal loss of cancellous bone with an intact diaphysis. Cemented or cementless fixation can be utilised. If cemented fixation is selected, great care must be taken in removing the neo-cortex often encountered to allow for appropriate cement intrusion into the remaining cancellous bone. Type II: In a Type II femur, there is extensive loss of the metaphyseal cancellous bone and thus, fixation with cement is unreliable. In this cohort of patients, successful fixation was achieved using a diaphyseal fitting, extensively porous coated implant. However, as the metaphysis is supportive, a cementless implant that achieves primary fixation in the metaphysis can be utilised. Type IIIA: In a Type IIIA femur, the metaphysis is non-supportive and an extensively coated stem of adequate length is utilised to ensure that more than 4cm of scratch fit is obtained in the diaphysis. Type IIIB: Based on the poor results obtained with a cylindrical, extensively porous coated implant (with 4 of 8 reconstructions failing), our present preference is a modular, cementless, tapered stem with flutes for obtaining rotational stability. Type IV: The isthmus is completely non-supportive and the femoral canal is widened. Cementless fixation cannot be reliably used in our experience, as it is difficult to obtain adequate initial implant stability that is required for osseointegration. Reconstruction can be performed with impaction grafting if the cortical tube of the proximal femur is intact. However, this technique can be technically difficult to perform, time consuming and costly given the amount of bone graft that is often required. Although implant subsidence and peri-prosthetic fractures have been associated with this technique, it can provide an excellent solution for the difficult revision femur where cementless fixation cannot be utilised. Alternatively, an allograft-prosthesis composite can be utilised for younger patients in an attempt to reconstitute bone stock and a proximal femoral replacing endoprosthesis used for more elderly patients

The interest in osteolysis has waned largely due to the impact of crosslinked polyethylene and the “rarity” of this phenomenon. However, the basic process still remains: particles, motion observed with unstable implants and host specific factors all play a role in bone loss around implants. There are 2 predominant patterns of lysis: Linear versus Expansile. Linear Lysis: is focal bone loss at the interface as seen in the bone cement interface in when using acrylic or at the implant-host interface with porous ingrowth/ongrowth implants. Expansile Lysis: is observed in less contained regions such as the retro- and supra-acetabular regions around the socket. These lesions can also be quite extensive yet may be subtle in appearance. Imaging is essential in identifying the extent and magnitude of osteolysis. Available modalities include plain radiographs although they can be of limited value in that even with oblique views, they often underestimate the degree of bone loss. CT scans are useful but can be limited by artifact. Several centers have explored the role of MRI in assessing lysis. It can be useful for bone loss and provides excellent assessment for soft tissue: abductors, neurovascular structures. Metal artifact reduction sequencing is required to maximise information obtainable. Management of osteolysis: Identification and monitoring periprosthetic osteolysis is a crucial element of patient care. Progressive bone loss leading to loss of fixation and the potential risk for periprosthetic fracture is a real possibility and early recognition and intervention is a priority. The basic Guiding Principles of management are centered around several key elements including the source of osteolysis and degree, the fixation of implant, the location of lysis, the track record of implant system, the presence of patient symptoms (if any), and finally the patient age, activity level, and general health. Specifics of treatment of osteolysis around the acetabulum: With cemented sockets, lysis is typically seen late and frequently at the bone-cement interface. It is often associated with a loose implant and the prime indication for surgery may be pain. Treatment involves implant removal and revision with an uncemented cup and bone grafting or augmentation as needed. With uncemented sockets in the setting of osteolysis, there are several factors to consider. These have been stratified by Rubash, Maloney, and Paprosky. The treatment of these sockets has been summarised as follows: for Type I and Type II with limited lysis, lesional treatment such as debridement and bone grafting with head and polyethylene exchange has been suggested. WATCH for impingement!!!! Graft defects via trap-doors can be performed but make the door big enough to graft. Small doors and grafting through screw holes is at best marginal. In instances of compromised locking mechanisms, consider cementing the liner into the shell. For Type II and Type III implants, revision of the component is recommended. With the currently available cementless cup extraction tools, I rarely hesitate to remove a cup with moderate lysis and a broken locking mechanism: better access to lytic areas, better grafting achieved. CAVEAT #1: the disadvantage of implant removal is that it is clearly a bigger procedure and fixation of the new implant may be more difficult. Risks vs. rewards. CAVEAT #2: Socket revision in the setting of failed MOM implants has some unique “issues”. In the Vancouver series, almost 25% of the revision cups failed to achieve biologic fixation. As such, recommendation for using “enhanced” porous implants during revision seems prudent. Additionally, despite the use of larger diameter heads, instability rates remain high

Major bone loss involving the acetabulum can be seen during revision THA due to component loosening, migration or osteolysis and can also occur as a sequela of infected THA. Uncemented porous ingrowth components can be used for reconstruction of the vast majority of revision cases, where smaller segmental or cavitary defects are typically present. But when stable structural support on host bone is lacking, highly porous metal acetabular augments have been described as an alternative to large structural allograft, avoiding the potential for later graft resorption and the resulting loss of mechanical support that can follow. The fundamental concept behind these acetabular augments is the provision of critical additional fixation, structural support and increased contact area against host bone over the weeks following surgery while the desired ingrowth into porous implant surfaces is occurring. Three separate patterns of augment placement have been utilised in our practice since the development of these implants a decade ago: Type 1 – augment screwed onto the superolateral acetabular rim in a “flying buttress” configuration for treatment of a segmental rim defect, Type 2 – augment placed superiorly against host and then fixed (with cement) to the acetabular component adjacent to the cup to fill a mainly elliptical cavitary defect, and Type 3 – augment(s) placed medial to the cup to fill a protrusio type cavitary or combined cavitary segmental defect of the superomedial or medial wall, and allow peripheral cup placement against the still intact acetabular rim. In all cases the acetabular component and augment interface is fixed together with cement, with care to prevent any cement extrusion between any implant and the bone. When possible, we now prefer to place the acetabular component first and fix it provisionally with 2 or more screws, and then place the augments second as this is technically quicker and easier. This order of insertion is only possible though in type 1 and a few select type 2 cases. Type 3 cases always require placement of one or more augments first, before cup insertion. Supplemental cancellous bone graft is used routinely, but the need for structural bone is avoided. Highly porous metal acetabular augments are an infrequently needed, but extremely valuable, versatile and reliable adjunctive fixation method for use with uncemented acetabular components during complex revision THA associated with major bone deficiency. Smaller (often female) patients are more likely to require this approach as reaming away defects to allow insertion of a jumbo cup is more difficult in small patients with a smaller AP dimension to the acetabular columns and less local bone for implant support. Intermediate term durability and apparent radiographic incorporation has been very good despite the complex reconstructions originally required. This technique can allow the avoidance of structural bone grafting for even the most massive of bone defect problems, but additional followup is needed to see how durable these encouraging results are over the longer term

Major bone loss involving the acetabulum can be seen during revision THA due to component loosening, migration or osteolysis and can also occur as a sequela of infected THA. Uncemented porous ingrowth components can be used for reconstruction of the vast majority of revision cases, where smaller segmental or cavitary defects are typically present. But when stable structural support on host bone is lacking, highly porous metal acetabular augments have been described as an alternative to large structural allograft, avoiding the potential for later graft resorption and the resulting loss of mechanical support that can follow. The fundamental concept behind these acetabular augments is the provision of critical additional fixation, structural support and increased contact area against host bone over the weeks following surgery while the desired ingrowth into porous implant surfaces is occurring. Technique: Three separate patterns of augment placement have been utilised in our practice since the development of these implants: Type 1 - augment screwed onto the superolateral acetabular rim in a “flying buttress” configuration for treatment of a segmental rim defect, Type 2 – augment placed superiorly against host and then fixed (with cement) to the acetabular component adjacent to the cup to fill a mainly elliptical cavitary defect, and Type 3 – augment(s) placed medial to the cup to fill a protrusio type cavitary or combined cavitary segmental defect of the superomedial or medial wall, and allow peripheral cup placement against the still intact acetabular rim. In all cases the acetabular component and augment interface is fixed together with cement, with care to prevent any cement extrusion between any implant and the bone. When possible, we now prefer to place the acetabular component first and fix it provisionally with 2 or more screws, and then place the augments second as this is technically quicker and easier. This order of insertion is only possible though in type 1 and a few select type 2 cases. Type 3 cases always require placement of one or more augments first, before cup insertion. Supplemental cancellous bone graft is used routinely. Results: From 2000 through 2007, porous tantalum acetabular augments were used very selectively in 85 revision THA procedures out of total of 1,789 revision hip cases performed at our institution in that time frame. All cases had associated massive acetabular deficiency precluding stable mechanical support for a cup alone. Fifty-eight hips had complete radiographic as well as clinical follow at minimum 5 years. The majority of patients had either Paprosky type 3A defects (28/58, 48%) or 3B defects (22/58, 38%). Ten out of 58 had pre-operative pelvic discontinuities. At 5 years, 2/58 (3%) were revised for aseptic loosening and another 6/58 demonstrated incomplete radiolucencies between the acetabular shell and zone 3. One of the revised cups and 5 of 6 of the cups with radiolucencies had an associated pelvic discontinuity. Summary: Highly porous metal acetabular augments are an infrequently needed, but extremely valuable, versatile and reliable adjunctive fixation method for use with uncemented acetabular components during complex revision THA associated with major bone deficiency. Intermediate term durability and apparent radiographic incorporation has been very good despite the complex reconstructions originally required. This technique can allow the avoidance of structural bone grafting for even the most massive of bone defect problems, but additional followup is needed to see how durable these encouraging results are over the longer term

INTRODUCTION: As the number of patients who have undergone total hip arthroplasty rises, the number of patients who require surgery for a failed total hip arthroplasty is also increasing. It is estimated that 183,000 total hip replacements were performed in the United States in the year 2000 and that 31,000 of these (17%) were revision procedures. Reconstruction of the failed femoral component in revision total hip arthroplasty can be challenging from both a technical perspective and in pre-operative planning. With multiple reconstructive options available, it is helpful to have a classification system which guides the surgeon in selecting the appropriate method of reconstruction. DISCUSSION: An extensively coated, diaphyseal filling component reliably achieves successful fixation in the majority of revision femurs. The surgical technique is straightforward and we continue to use this type of device in the majority of our revision total hip arthroplasties. However, in the severely damaged femur (Type IIIB and Type IV), other reconstructive options may provide improved results. Based on our results, the following reconstructive algorithm is recommended for femoral reconstruction in revision total hip arthroplasty: TYPE I: In a Type I femur, there is minimal loss of cancellous bone with an intact diaphysis. Cemented or cementless fixation can be utilised. If cemented fixation is selected, great care must be taken in removing the neo-cortex often encountered to allow for appropriate cement intrusion into the remaining cancellous bone. TYPE II: In a Type II femur, there is extensive loss of the metaphyseal cancellous bone and thus fixation with cement is unreliable. In this cohort of patients, successful fixation was achieved using a diaphyseal fitting, extensively porous coated implant in 26 of 29 cases (90%) However, as the metaphysis is supportive, a cementless implant that achieves primary fixation in the metaphysis can be utilized. TYPE III A: In a Type IIIA femur, the metaphysis is non-supportive and an extensively coated stem of adequate length is utilised to ensure that more than 4 cm of scratch fit is obtained in the diaphysis. TYPE III B: Based on the poor results obtained with a cylindrical, extensively porous coated implant, our present preference is a modular, cementless, tapered stem with flutes for obtaining rotational stability. Excellent results have been reported with this type of implant and by virtue of its tapered design, excellent initial axial stability can be obtained even in femurs with a very short isthmus. Subsidence has been reported as a potential problem with this type of implant and they can be difficult to insert. However, with the addition of modularity to many systems that employ this concept of fixation, improved stability can be obtained by impacting the femoral component as far distally as needed while then building up the proximal segment to restore appropriate leg length. TYPE IV: In a Type IV femur, the isthmus is completely non-supportive and the femoral canal is widened. Cementless fixation cannot be reliably used in our experience, as it is difficult to obtain adequate initial implant stability that is required for osseointegration. Reconstruction can be performed with impaction grafting if the cortical tube of the proximal femur is intact. However, this technique can be technically difficult to perform, time consuming and costly given the amount of bone graft that is often required. Although implant subsidence and peri-prosthetic fractures have been associated with this technique, it can provide an excellent solution for the difficult revision femur where cementless fixation cannot be utilised. Alternatively, an allograft-prosthesis composite can be utilised for younger patients in an attempt to reconstitute bone stock and a proximal femoral replacing endoprosthesis used for more elderly patients

Major bone loss involving the acetabulum can be seen during revision THA due to component loosening, migration or osteolysis and can also occur as a sequela of infected THA. Uncemented porous ingrowth components can be used for reconstruction of the vast majority of revision cases, where smaller segmental or cavitary defects are typically present. But when stable structural support on host bone is lacking, highly porous metal acetabular augments have been described as an alternative to large structural allograft. The fundamental concept behind these acetabular augments is the provision of critical additional fixation, structural support and increased contact area against host bone over the weeks following surgery while the desired ingrowth into porous implant surfaces is occurring. Three separate patterns of augment placement have been utilised in our practice since the development of these implants a decade ago: Type 1 - augment screwed onto the superolateral acetabular rim in a “flying buttress” configuration for treatment of a segmental rim defect, Type 2 – augment placed superiorly against host and then fixed to the acetabular component adjacent to the cup to fill a mainly elliptical cavitary defect, and Type 3 – augment(s) placed medial to the cup to fill a protrusio type cavitary or combined cavitary segmental defect of the superomedial or medial wall, and allow peripheral cup placement against the still intact acetabular rim. In all cases the acetabular component and augment interface is fixed together with cement, with care to prevent any cement extrusion between any implant and the bone. When possible, we now prefer to place the acetabular component first and fix it provisionally with 2 or more screws, and then place the augments second as this is technically quicker and easier. This order of insertion is only possible in type 1 and a few select type 2 cases. Type 3 cases always require placement of one or more augments first, before cup insertion. Supplemental cancellous bone graft is used routinely, but the need for structural bone is avoided. From 2000 through 2007, porous tantalum acetabular augments were used very selectively in 85 revision THA procedures out of total of the 1,789 revision hip cases performed at our institution. All cases had associated massive acetabular deficiency precluding stable mechanical support for a cup alone. Fifty-eight hips had complete radiographic and clinical follow at minimum 5 years. The majority of patients had either Paprosky type 3A defects (28/58, 48%) or 3B defects (22/58, 38%). Ten out of 58 had pre-operative pelvic discontinuities. Three separate patterns of augment placement were utilised: Type 1 - augment screwed onto the superolateral acetabular rim (21%), Type 2 – augment fixed to the acetabular component adjacent to the cup to fill a mainly elliptical cavitary defect (34%), and Type 3 – augment(s) placed medial to the cup to fill a protrusio type cavitary or combined cavitary segmental defect of the superomedial medial wall (45%). At 5 years, 2/58 (3%) were revised for aseptic loosening and another 6/58 demonstrated incomplete radiolucencies between the acetabular shell and zone 3. One of the revised cups and 5 of 6 of the cups with radiolucencies had an associated pelvic discontinuity. Highly porous metal acetabular augments are an infrequently needed, but extremely valuable, versatile and reliable adjunctive fixation method for use with uncemented acetabular components during complex revision THA associated with major bone deficiency. Smaller patients are more likely to require this approach as reaming away defects to allow insertion of a jumbo cup is more difficult with a smaller AP dimension to the acetabular columns and less local bone for implant support. Intermediate term durability and apparent radiographic incorporation has been very good despite the complex reconstructions originally required. This technique can allow the avoidance of structural bone grafting for even the most massive of bone defect problems, but additional followup is needed to see how durable these encouraging results are over the longer term

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

It is very important to fix implant to bone. Bioactive materials as hydroxyapatite or glass-ceramics have bone-bonding ability. Hydroxyapatite-coating is applied to cementless THA or TKA. I and coworkers investigated bone-bonding mechanism of bioactive material and found that bone-like apatite formation play key role for bonding. If the surface of metal is changed to form apatite on it in body, the inert metal changes into bone-bonding material. We developed alkaline and heat treatment of titanium to change titanium to bone –bonding material as follows. At first, titanium is dipped in 5N NaOH solution for 24 hours, at second the metal is washed in pure water and finally it is sintered in 500 degree C for 2 hours. The treated surface has bioactivity, bone bonding ability like hydroxyapatite. The advantage of this treatment over hydroxyapatite-coating procedure is to treat the porous surface without any change of pore figures. As to hydroxyapatite-coating procedure, pore of the small diameter is filled with hydroxyapatite and pore figures are change. We applied this alkaline and heat treatment to cementless THA and its good results of more than ten years was reported. Porous titanium can be changed to bioactive material by alkaline and heat treatment. This bioactive porous titanium was found to have a property of material-induced osteoinduction, that is, the bone formation in pore of porous titanium implanted in canine back muscle. They can be used for bone substitute for big bone defect. We used two procedures to make porous titanium, sintering of titanium powder with spacer particle of ammonium sulfate and selective lazar melting. The latter procedure can produce any type of pore structure of titanium. Selective laser melting was employed to fabricate porous Ti implants (diameter 3.3 mm, length 15 mm) with a channel structure comprising four longitudinal square channels, representing pores, of different diagonal widths, 500, 600, 900, and 1200 micrometer. These were then subjected to chemical and heat treatments to induce bioactivity. Significant osteoinduction was observed in widths 500 and 600 micrometer, with the highest observed osteoinduction occurring at 5 mm from the end of the implants. A distance of 5 mm probably provides a favorable balance between blood circulation and fluid movement. New bioactive bone cement is another topic of the application of bioactive titanium in this lecture. The bone cement contains barium sulphate for radiocontrast. We developed a procedure to replace barium sulphate with bioactive titanium powder. This new bone cement has not only better biocompatibility than conventional cement but also bone bonding ability. It is potent material for the fixation of implant to bone. I will speak the evaluation of this cement using canine model of THA

Clearly uncemented hip stems are becoming more popular. They are working relatively well and avoiding the step of cementation is easier and much quicker. However, this speaker feels that well designed femoral stems with 25–30 years of proven successful fixation are perfectly good for elderly patients with 10, 15, and 20 year life expectancies. They are good for several reasons. They seal off bleeding from the femur essentially completely—particularly helpful in high anticoagulation patients. Also, addition of antibiotic cement would be expected to have a lower infection rate, and cases of gross osteopenia can be less likely to have fractures or undesired subsidence. There are a few basic points which can make a big difference in the quality of hip stem cementation. These points are: (1) After ordinary broaching, loose, mechanically incompetent bone needs to be removed. This is well done with canal brushes and large angled curettes. (2) The canal must be plugged distally a centimeter or two beyond the tip of the femoral prosthesis. (3) The femoral cavity needs to be as dry as possible at the time of cement introduction. This is one of the more difficult tasks to achieve perfectly. First is pulse lavage with an intramedullary nozzle. Next, I use epinephrine soaked sponges pulled completely out to length and introduced to fill the cavity completely—filling retrograde and packing tightly. Shortly before the cement is to be introduced, the epi sponges are changed to dry ones with the same type of firm, retrograde filling. The canal is commonly dried twice occasionally three times. Cement introduction: (1) A cement gun with long intramedullary nozzle is mandatory. (2) The cement must not be too runny, i.e. of too low a viscosity. You will have more trouble maintaining pressurisation with liquid runny cement, and you risk bleeding from the bone into the cement cavity significantly compromising the cementation. (3) The cement must be introduced retrograde with complete filling i.e. no voids, and not running out of cement to inject before the tip of the nozzle has reached the introitus, the entry point to the femoral cavity. Otherwise you wind up pulling out the nozzle itself out, leaving a void. (4) “Pressurisers,” that is, almost all that I have seen, do not really facilitate pressurisation. Once the canal is completely full with cement and the cement is getting stiffer, pressurisation by pushing at the introitus using your thumb over a lap pad creates tremendous pressurisation that can push cement beyond most cement plugs!. Introducing the femoral component: (1) Last, the femoral component is introduced rather slowly so that one maintains constant pressurisation by virtue of the volume displacement as the component goes to its proper level. Ideally the femoral component reaches its proper level just before the cement is really hard. You really can do this as you get the component 0.5 to1.0 cm. from the final level and impact it slowly as the cement comes to nearly complete hardness. The two worst things you can do— . 1. Have the prosthesis reach its desired level with the cement relatively runny and have the bone bleed into the cement and degrade the quality of the cement interdigitation. 2. Being too slow getting the prosthesis down to the desired level and having it stuck to high. Consistent, optimum cementation of the femoral component is difficult, but achievable and worth it! You have a component with good stress transfer, no undesired proximal stress shielding like some porous implants have; less bleeding from the canal; good 20+ year fixation, etc., etc

Aim. Implant-associated infection remains one of the biggest challenges facing orthopaedics and there is an urgent clinical need to develop new prophylactic strategies. We have previously shown that CSA-90, a broad-spectrum antimicrobial, prevented infection in an infected open fracture model. In this study we developed a novel model of implant-associated infection, in which to further test the potential of CSA-90 as a prophylactic agent. Method. All studies were approved by the local animal ethics committee. 3D-printed porous titanium implants were implanted into the distal femora of 18 week-old male Wistar rats under general anaesthesia. The treatment groups' (n=10) implants were pre-coated with 500μg CSA-90 in saline. Staphylococcus aureus* was inoculated either directly around the implant (1×104 CFU) or injected intravenously immediately post-operatively (1×105 CFU). No systemic antibiotic prophylaxis was used. The study ran for six weeks and animals were reviewed daily for signs of infection. An independent, blinded veterinarian reviewed twice-weekly radiographs, and rats demonstrating osteolysis and/or declining overall health were culled early at their instruction. The primary outcome was implant infection, incorporating survival, microbiological, radiological, and histological measures. Results. All untreated animals inoculated with S. aureus developed clinical and radiographic evidence of implant infection and were culled within 14 days of surgery (Figure 1A). CSA-90 treatment significantly increased median survival in groups inoculated with S. aureus (p<0.001). Swab culture demonstrated that CSA-90 treated implants had a significantly reduced rate of infection compared to untreated implants in both the local (p< 0.01) and systemic (p<0.001) groups (Figure 1B). Conclusions. This study demonstrates clinical potential for CSA-90 as a novel prophylactic antimicrobial for orthopaedics. Further in vivo evaluation is required in conjunction with existing systemic antibiotic prophylaxis. Acknowledgements. This work was funded by NHMRC grant 1106982. Implants and CSA-90 were donated in kind support from Stryker and N8 Medical respectively. For any figures and tables, please contact authors directly (click on ‘Info & Metrics’ tab above for contact details)