Aims

Unicompartmental and total knee arthroplasty (UKA and TKA) are successful treatments for osteoarthritis, but the solid metal implants disrupt the natural distribution of stress and strain which can lead to bone loss over time. This generates problems if the implant needs to be revised. This study investigates whether titanium lattice UKA and TKA implants can maintain natural load transfer in the proximal tibia.

Aims

The main advantage of 3D-printed, off-the-shelf acetabular implants is the potential to promote enhanced bony fixation due to their controllable porous structure. In this study we investigated the extent of osseointegration in retrieved 3D-printed acetabular implants.

3D printing acetabular cups offers the theoretical advantage of enhanced bony fixation due to greater design control of the porous implant surfaces. Analysing retrieved 3D printed implants can help determine whether this design intent has been achieved. We sectioned 14 off-the-shelf retrieved acetabular cups for histological analysis; 7 cups had been 3D printed and 7 had been conventionally manufactured. Some of the most commonly used contemporary designs were represented in both groups, which were removed due to either aseptic loosening, unexplained pain, infection or dislocation. Clinical data was collected for all implants, including their age, gender, and time to revision. Bone ingrowth was evaluated using microscopic assessment and two primary outcome measures: 1) bone area fraction and 2) extent of bone ingrowth. The additively manufactured cups were revised after a median (IQR) time of 24.9 months (20.5 to 45.6) from patients with a median (IQR) age of 61.1 years (48.4 to 71.9), while the conventional cups had a median (IQR) time to revision of 46.3 months (34.7 to 49.1, p = 0.366) and had been retrieved from patients with a median age of 66.0 years (56.9 to 68.9, p = 0.999). The additively and conventionally manufactured implants had a median (IQR) bone area fraction of 65.7% (36.4 to 90.6) and 33.9% (21.9 to 50.0), respectively (p < 0.001). A significantly greater amount of bone ingrowth was measured into the backside of the additively manufactured acetabular cups, compared to their conventional counterparts (p < 0.001). Bone occupied a median of 60.0% and 5.7% of the porous depth in the additively manufactured and conventional cups, respectively. 3D printed components were found to achieve a greater amount of bone ingrowth than their conventionally manufactured counterparts, suggesting that the complex porous structures generated through this manufacturing technique may encourage greater osteointegration

Ti-6Al-4V is the most common alloy used for orthopaedic implants. Its popularity is due to low density, superior corrosion resistance, good osseointegration and lower elastic modulus when compared to other commonly used alloys such as CoCrMo and stainless steel. In fact, the use of Ti64 has even further increased lately since recent controversy around adverse local tissue reactions and implant failure related to taper corrosion of CoCrMo alloy. However, implants made from Ti64 can fail in some cases due to fatigue fracture, sometimes related to oxide induced stress corrosion cracking or hydrogen embrittlement, or preferential corrosion of the beta phase. Studies performed with Ti-6Al-4V do often not consider that the alloy itself may have a range of characteristics that can vary and could significantly impact the implant properties. These variations are related to the material microstructure which depends not only on chemical composition, but also the manufacturing process and subsequent heat treatments. Different microstructures can occur in implants made form wrought alloys, cast alloys, and more recently, additive manufactured (AM) alloys. Implant alloy microstructure drives mechanical and electrochemical properties. Therefore, this study aims to analyse the microstructure of Ti-6Al-4V alloy of additive manufactured and conventional retrieved orthopaedic implants such as acetabular cups, tibial trays, femoral stem and modular neck by means of electron backscatter diffraction (EBSD). Microstructural features of interest include grains shape and size, phase content and distribution, preferred grain orientation (texture), alloying elements distribution (homogenization) and presence of impurities. Additionally, we demonstrate the direct impact of different microstructural features on hardness. We analysed 17 conventional devices from 6 different manufacturers, 3 additive manufactured devices from 2 different manufactures and 1 control alloy (bar stock). The preliminary results showed that even though all implants have the same chemical composition, their microstructural characteristics vary broadly. Ti64 microstructure of conventional alloys could be categorized in 3 groups: equiaxed grains alloys (Fine and Coarse), bimodal alloys and dendritic alloys. The additive manufactured implants were classified in an additional group on its own which consists of a needle-like microstructures - similar to Widmanstätten patterns, Fig. 1, with a network of β phase along α phase grains. Furthermore, AM alloys exhibited residual grain boundaries from the original β grains from the early stage of the solidification process, Fig. 2. These characteristics may have implication on the fatigue and corrosion behaviour. In addition, it we observed inhomogeneous alloying element distribution in some cases, Fig. 3, especially for the additive manufactured alloys, which also may have consequences on corrosion behaviour. Finally, the hardness testing revealed that the implants with large grain size, such as AM alloys, exhibit low hardness values, as expected, but also the amount of beta phase correlated positively with lower hardness. Grain aspect ratio and beta phase grain size correlated positively with higher hardness. In summary, we found that common Ti64 implants can exhibit a broad variety of different alloy microstructures and the advent of AM alloys introduces an entirely new category. It is imperative to determine the ideal microstructure for specific applications

Background. Additive manufacturing (AM) has created many new avenues for material and manufacturing innovation. In orthopaedics, metal additive manufacturing is now widely used for production of joint replacements, spinal fusion devices, and cranial maxillofacial reconstruction. Plastic additive manufacturing on the other hand, has mostly been utilized for pre-surgical planning models and surgical cutting guides. The addition of pharmaceuticals to additively manufactured plastics is novel, particularly when done at the raw material level. The purpose of this study was to prove the concept of antibiotic elution from additively manufactured polymeric articles and demonstrate feasibility of application in orthopaedics. Methods. Using patented processes, three heat-stable antibiotics commonly used in orthopaedics were combined with six biocompatible polymers (2 bioresorbable) into filament and powder base materials for fused deposition modeling (FDM) and selective laser sintering (SLS) AM processes. Raw materials of 1%, 2%, and 5% antibiotic concentrations (by mass) were produced as well as a blend of all three antibiotics each at 1% concentration. Thin disks of 25 mm diameter were manufactured of each polymer with each antibiotic at all concentrations. Disks were applied to the center of circular petri dishes inoculated with a bacterium as per a standard zone of inhibition, or Kirby-Bauer disk diffusion tests. After 72 hours incubation, the zone of inhibited bacterial growth was measured. Periprosthetic joint infection (PJI) of the knee was selected as the proof-of-concept application in orthopaedics. A series of tibial inserts mimicking those of a common TKR system were manufactured via SLS using a bioresorbable base material (Figure 1). Three prototype inserts were tested on a knee wear simulator for 333,000 cycles following ISO 14242–1:2014 to approximate 2–4 months of in vivo use between surgeries of a 2-stage procedure for PJI. Gravimetric measurement and visual damage assessment was performed. Results. Bacterial growth was inhibited to a mean diameter of 32.3 mm (FDM) and 42.2 mm (SLS) for nearly all combinations of polymers and concentrations of antibiotics. Prototype tibial inserts experienced an average of 200 mg of wear during testing and demonstrated no evidence of cracking, delamination or significant deformation (Figure 2). Conclusion. Bench-level testing of these novel antibiotic-eluting polymers demonstrates feasibility for their application in orthopaedic medicine. In particular, treatment of stubborn PJI with potential for increased and sustained antibiotic elution, patient-specific cocktailing, and maintenance of knee joint structure and function compared to existing PJI products and practices. Subsequent testing for these novel polymers will determine static and dynamic (wear-induced) antibiotic elution rates. For any figures or tables, please contact the authors directly

Abstract. Objectives. Additive manufacturing has led to numerous innovations in orthopaedic surgery: surgical guides; surface coatings/textures; and custom implants. Most contemporary implants are made from titanium alloy (Ti-6Al-4V). Despite being widely available industrially and clinically, there is little published information on the performance of this 3D printed material for orthopaedic devices with respect to regulatory approval. The aim of this study was to document the mechanical, chemical and biological properties of selective laser sintering (SLS) manufactured specimens following medical device (TOKA®, 3D Metal Printing LTD, UK) submission and review by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Methods. All specimens were additively manufactured in Ti-6Al-4V ELI (Renishaw plc, UK). Mechanical tests were performed according to ISO6892-1, ISO9585 and ISO12107 for tensile (n=10), bending (n=3) and fatigue (n=16) respectively (University of Bath, UK). Appropriate chemical characterisation and biological tests were selected according to recommendations in ISO10993 and conducted by external laboratories (Wickham Labs, UK; Lucideon, UK; Edwards Analytical, UK) in adherence with Good Lab Practise guidelines. A toxicological review was conducted on the findings (Bibra, UK). Results. The mechanical tests demonstrated that the material performed to the specification for conventionally manufactured titanium alloy of this type (ISO5832-3). The toxicology review concluded that there were no significant concerns for the health of the patients identified in this evaluation and implantation of the TOKA® device would not result in a significant health risk to patients. Conclusions. Reflecting on our MHRA experience, additive manufacture of orthopaedic devices is still considered to be a ‘novel’ process by regulatory bodies, requiring additional safety evidence. Despite this, our findings demonstrate that there is no difference, mechanically or chemically, to the traditionally manufactured alloy material. We hope to support the widening use of 3D printed titanium alloy orthopaedic devices by publishing our route to regulatory approval. Declaration of Interest. (a) fully declare any financial or other potential conflict of interest

Implant loosening is one of the primary mechanisms of failure for hip, knee, ankle and shoulder arthroplasty. Many established implant fixation surfaces exist to achieve implant stability and fixation. More recently, additive manufacturing technology has offered exciting new possibilities for implant design such as large, open, porous structures that could encourage bony ingrowth into the implant and improve long-term implant fixation. Indeed, many implant manufacturers are exploiting this technology for their latest hip or knee arthroplasty implants. The purpose of this research is to investigate if the design freedoms offered by additive manufacturing could also be used to improve initial implant stability – a precursor to successful long-term fixation. This would enable fixation equivalent to current technology, but with lower profile fixation features, thus being less invasive, bone conserving and easier to revise. 250 cylindrical specimens with different fixation features were built in Ti6Al4V alloy using a Renishaw AM250 additive manufacturing machine, along with 14 specimens with a surface roughness similar to a conventional titanium fixation surface. Pegs were then pushed into interference fit holes in a synthetic bone material using a dual-axis materials testing machine equipped with a load/torque-cell (figure 1). Specimens were then either pulled-out of the bone, or rotated about their cylindrical axis before being pulled out to quantify their ability to influence initial implant stability. It was found that additively manufactured fixation features could favourably influence push-in/pull-out stability in one of two-ways: firstly the fixation features could be used to increase the amount pull-out force required to remove the peg from the bone. It was found that the optimum fixation feature for maximising pull-out load required a pull-out load of 320 N which was 6× greater than the least optimum design (54 N) and nearly 3× the maximum achieved with the conventional surface (120 N). Secondly, fixation features could also be used to decrease the amount of force required to insert the implant into bone whilst improving fixation (figure 2). Indeed, for some designs the ratio of push-in to pull-out was as high as 2.5, which is a dramatic improvement on current fixation surface technology, which typically achieved a ratio between 0.3–0.6 depending on the level of interference fit. It was also found that the additively manufactured fixation features could influence the level of rotational stability with the optimum design resisting 3× more rotational torque compared to the least optimum design. It is concluded that additive manufacturing technology could be used to improve initial implant stability either by increasing the anchoring force in bone, or by reducing the force required to insert an implant whilst maintaining a fixed level of fixation. This defines a new set of rules for implant fixation using smaller low profile features, which are required for minimally invasive device design

The current gold standard bone substitute is still autologous bone, despite the fact that its harvest demands for a second operation site, causes additional pain, discomfort, potential destruction of the grafting site, and is limited in supply. Since newly developed clinical approaches like transplantation of cells are invasive and costly, and osteoinduction by bone morphogenetic proteins is expensive and is associated with mild to severe side effects, the optimization of osteoconduction appears as promising option to realize bone substitute-based bone tissue engineering. In the 90ties of the last century, the holy grail of pore size for scaffolds in bone tissue engineering was set between 0.3 and 0.5 mm. More recent, papers from others and us indicated that the optimal microarchitecture for bone tissue engineering scaffolds in terms of pore size, constrictions, rod thickness, or rod distance is still unknown. Additive manufacturing appears as an ideal tool to study those diverse microarchitecture options since it can generate scaffolds where size and location of pores and connections between pores can be tested. For the production of our test scaffolds, we applied laser sintering of titanium and lithography-based additive manufacturing of ceramics. Histomorphometry of calvarial defects in rabbits revealed that bone formation was significantly increased by scaffolds with pore diameters in the range of 0.7–1.2 mm. Scaffolds with pores of 1.5 and 1.7 mm perform significantly worse. Therefore, pore diameters in osteoconductive bone substitutes should be 1.0–1.2 mm and thus much bigger than previously suggested. In essence, osteoconductive microarchitectures of degradable bone substitutes can be realized by lithography based additive manufacturing and this methodology appears as a promising tool for the production of personalized bone tissue engineering scaffolds to be used in cranio-maxillofacial surgery, dentistry, and orthopedics

Introduction. The number of total hip arthroplasties has been increasing worldwide, and it is expected that revision surgeries will increase significantly in the near future. Although reconstructing normal hip biomechanics with extensive bone loss in the revision surgery remains challenging. The custom−made acetabular component produced by additive manufacturing, which can be fitted to a patient's anatomy and bone defect, is expected to be a predominant reconstruction material. However, there have been few reports on the setting precision and molding precision of this type of material. The purpose of this study was to validate the custom−made acetabular component regarding postoperative three−dimensional positioning and alignment. Methods. Severe bone defects (Paprosky type 3A and 3B) were made in both four fresh cadaveric hip joints using an acetabular reamer mimicking clinical cases of acetabular component loosening or osteolysis in total hip arthroplasty. On the basis of computed tomography (CT) after making the bone defect, two types of custom−made acetabular components (augmented type and tri−flanged type) that adapted to the bone defect substantially were produced by an additive manufacturing machine. A confirmative CT scan was taken after implantation of the component, and then the data were installed in an analysis workstation to compare the postoperative component position and angle to those in the preoperative planning. Results. The mean absolute deviations of the center of the hip joint between preoperative planning and the actual component position in the augmented type were 0.7 ± 0.4 mm for the horizontal position, 0.2 ± 0.1 mm for the vertical position, and 0.5 ± 0.3 mm for the antero−posterior position. The mean absolute deviations of the center of the hip joint in the tri−flanged type in the horizontal, vertical, and antero−posterior positions were 1.0 ± 0.4 mm, 0.4 ± 0.2 mm, 0.3 ± 0.1 mm, respectively. The mean absolute deviations of the component angle were 3.5° ± 0.9° at inclination and 2.0° ± 1.7° at anteversion in the augmented type and 0.6° ± 0.5° at inclination and 0.9° ± 0.3° at anteversion in the tri−flanged type. Conclusion. Since custom−made orthopaedic implants produced by additive manufacturing can support individual anatomy and bone defect, this type of implant is expected to be applied to revision surgery and bone tumor surgery for severe bone defects. The present study demonstrated that preoperative planning of the center of the hip joint was successfully reproduced after the implantation of both types of custom−made acetabular components. In the tri−flanged type, better satisfactory results were provided in the component position and angle by comparing the past CAOS tools such as a surgical navigation system and a patient−specific guide. There is scope for further improvement, but the custom−made acetabular component produced by additive manufacturing may become very useful reconstruction material in hip revision surgeries. Problems to be addressed in the future include the improvement of the reproducibility of the preoperative planning and investigation of long−term clinical results

Medial opening wedge high tibial osteotomy (MOWHTO) is the workhorse procedure for correcting varus malalignment of the knee. There have been recent developments in the synthetic options to fill the osteotomy gap. The current gold standard for filling this osteotomy gap is autologous bone graft which is associated with donor site morbidity. We would like to introduce and describe the process of utilizing the novel Osteopore® 3D printed, honeycomb structured, Polycaprolactone and β-Tricalcium Phosphate wedge for filling the gap in MOWHTO. In the advent of additive manufacturing and the quest for more biocompatible materials, the usage of the Osteopore® bone wedge in MOWHTO is a promising technique that may improve the biomechanical stability as well the healing of the osteotomy gap

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

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

Critical-sized bone defects remain challenging in the clinical setting. Autologous bone grafting remains preferred by clinicians. However, the use of autologous tissue is associated with donor-site morbidity and limited accessibility to the graft tissue. Advances in the development of synthetic bone substitutes focus on improving their osteoinductive properties. Whereas osteoinductivity has been demonstrated with ceramics, it is still a challenge in case of polymeric composites. One of the approaches to improve the regenerative properties of biomaterials, without changing their synthetic character, is the addition of inorganic ions with known osteogenic and angiogenic properties. We have previously reported that the use of a bioactive composite with high ceramic content composed of poly(ethyleneoxide terephthalate)/poly(butylene terephthalate) (1000PEOT70PBT30, PolyActive, PA) and 50% beta-tricalcium phosphate (β-TCP) with the addition of zinc in a form of a coating of the TCP particles can enhance the osteogenic differentiation of human mesenchymal stromal cells (hMSCs) (3). To further support the regenerative properties of these scaffolds, inorganic ions with known angiogenic properties, copper or cobalt, were added to the coating solution. β-TCP particles were immersed in a zinc and copper or zinc and cobalt solution with a concentration of 15 or 45 mM. 3D porous scaffolds composed of 1000PEOT70PBT30 and pure or coated β-TCP were additively manufactured by 3D fibre deposition. The osteogenic and angiogenic properties of the fabricated scaffolds were tested in vitro through culture with hMSCs and human umbilical vein endothelial cells, respectively. The materials were further evaluated through ectopic implantation in an in vivo mini-pig model. The early expression of relevant osteogenic gene markers (collagen-1, osteocalcin) of hMSCs was upregulated in the presence of lower concentration of inorganic ions. Further analysis will focus on the evaluation of ectopic bone formation and vascularisation of these scaffolds after implantation in a mini-pig ectopic intramuscular model

Developments in the field of additive manufacturing have allowed significant improvements in the design and production of scaffolds with biologically relevant features to treat bone defects. Unfortunately, the workflow to generate personalized scaffolds is source of inaccuracies leading to a poor fit between the implant and patients' bone defects. In addition, scaffolds are often brittle and fragile, uneasing their handling by surgeons, with significant risks of fracture during their insertion in the defect. Consequently, we developed organo-mineral cementitious scaffolds displaying evolutive mechanical properties which are currently being evaluated to treat maxillofacial bone deformities in veterinary clinics. Treatment of dog patients was approved by ethic and welfare committees (CERVO-2022-14-V). To date, 8 puppies with cleft palate/lip deformities received the following treatment. Two weeks prior surgery, CT-scan of patient's skull was performed to allow for surgical planning and scaffold designing. Organo-mineral printable pastes were formulated by mixing an inorganic cement precursor (α-Ca3(PO4)2) to a self-reticulating hydrogel (silanized hyaluronic acid) supplemented with a viscosifier (hydroxymethylpropylcellulose). Scaffolds were produced by robocasting of these pastes. Surgical interventions included the reconstruction of soft tissues, and the insertion of the scaffold soaked with autologous bone marrow. Bone formation was monitored 3 and 6 months after reconstruction, and a biopsy at 6 months was performed for more detailed analyses. Scaffolds displayed great handling properties and were inserted within bone defects without significant issue with a relevant bone edges/scaffold contact. Osteointegration of the scaffolds was observed after 3 months, and regeneration of the defect at 6 months seemed quite promising. Preliminary results have demonstrated a potential of the set-up strategy to treat cleft lip/palate deformities in real, spontaneous clinical setting. Translation of these innovative scaffolds to orthopedics is planned for a near future

Introduction. Kienböck's disease is generally defined as the collapse of the lunate bone, and this may lead to early wrist osteoarthritis. Replacing the collapsed lunate with an implant has regained renewed interest with the advancing technology of additive manufacturing, enabling the design of patient-specific implants. The aims of this project are (1) to determine how accurate it is to use the contralateral lunate shape as a template for patient-specific lunate implants, and (2) to study the effects of shape variations wrist kinematics using 4D-computed tomography (CT) scanning. Methods. A 3D statistical shape model (SSM) of the lunate was built based on bilateral CT scans of 54 individuals. Using SMM, shape variations of the lunate were identified and the intra- and inter-subject shape variations were compared by performing an intraclass correlation analysis. A radiolucent motor-controlled wrist-holder was designed to guide flexion/extension and radial/ulnar deviation of ex vivo wrist specimens under 4D-CT scanning. In this pilot, three shape mode variations were tested per specimen in two specimens were. After post-processing each CT, the scapholunate angle (SLA) and capitolunate angle (CLA) were measured. Results. The shape of the lunate was not symmetrical, defined as exceeding the intra-subject variation in five different shape modes. The FE tests show a generalized increase in scapholunate and capitolunate angle when using lunate implants, and comparing variation of shape modes showed that shape mode 3 has a significant effect on the measured angles (p<0.05). Discussion. The design of patient-specific lunate implants may prove to be challenging using a ‘mirror’-design as it will lead to a degree of shape asymmetry. The pilot study, to determine the effects of those shape variations on wrist kinematics suggest that the degree of shape variation observed indeed may alter the wrist kinematics, although this needs to be further investigated in study using more specimens

We present the indications and outcomes of a series of custom 3D printed titanium acetabular implants used over a 9 year period at our institution (Sydney, Australia), in the setting of revision total hip arthroplasty. Individualised image-based case planning with additive manufacturing of pelvic components was combined with screw fixation and off-the-shelf femoral components to treat patients presenting with failed hip arthroplasty involving acetabular bone loss. Retrospective chart review was performed on the practices of three contributing surgeons, with an initial search by item number of the Medicare Benefits Scheme linked to a case list maintained by the manufacturer. An analysis of indications, patient demographics and clinical outcome was performed. The cohort comprised 65.2% female with a median age of 70 years (interquartile range 61–77) and a median follow up of 32.9 months (IQR 13.1 - 49.7). The indications for surgery were infection (12.5%); aseptic loosening (78.1%) and fracture (9.4%), with 65.7% of cases undergoing previous revision hip arthroplasty. A tumour prosthesis was implanted into the proximal femur in 21.9% of cases. Complications were observed in 31.3% of cases, with four cases requiring revision procedures and no deaths reported in this series. Kaplan-Meier analysis of all-cause revision revealed an overall procedure survival of 88.7% at two years (95%confidence interval 69 - 96.2) and 83.8% (95%CI 62 - 93.7) at five years, with pelvic implant-specific survival of 98% (95%CI 86.6 - 99.7) at two and five year follow up. We conclude that an individualised planning approach for custom 3D printed titanium acetabular implants can provide high overall and implant-specific survival at up to five years follow up in complex cases of failed hip arthroplasty and acetabular bone loss

Introduction. The surgical treatment of critical-sized bone defects with complex three-dimensional (3D) geometries is a challenge for the treating surgeon. Additive manufacturing such as 3D printing enables the production of highly individualized bone implants meeting the shape of the patient's bone defect and including a tunable internal structure. In this study, we showcase the design process for patient-specific implants with critical-sized tibia defects. Methods. Two clinical cases of patients with critical tibia defects (size 63×20×21 mm and 50×24×17 mm) were chosen. Brainlab software was used for segmentation of CT data generating 3D models of the defects. The implant construction involves multiple stages. Initially, the outer shell is precisely defined. Subsequently, the specified volume is populated with internal structures using Voronoi, Gyroid, and NaCl crystal structures. Variation in pore size (1.6 mm and 1.0 mm) was accomplished by adjusting scaffold size and material thickness. Results. An algorithmic design process in Rhino and Grasshopper was successfully applied to generate model implants for the tibia from Ct data. By integrating a precise mesh into an outer shell, a scaffold with controlled porosity was designed. In terms of the internal design, both Voronoi and Gyroid form macroscopically homogeneous properties, while NaCl, exhibits irregularities in density and consequently, in the strength of the structure. Data implied that Voronoi and Gyroid structures adapt more precisely to complex and irregular outer shapes of the implants. Conclusion. In proof-of-principle studies customized tibia implants were successfully generated and printed as model implants based on resin. Further studies will include more patient data sets to refine the workflows and digital tools for a broader spectrum of bone defects. The algorithm-based design might offer a tremendous potential in terms of an automated design process for 3D printed implants which is essential for clinical application

Critical-sized bone defects can result from trauma, inflammation, and tumor resection. Such bone defects, often have irregular shapes, resulting in the need for new technologies to produce suitable implants. Bioprinting is an additive manufacturing method to create complex and individualised bone constructs, which can already include vital cells. In this study, we established an extrusion-based printing technology to produce osteoinductive scaffolds based on polycaprolactone (PCL) combined with calcium phosphate, which is known to induce osteogenic differentiation of stem cells. The model was created in python based on the signed distance functions. The shape of the 3D model is a ring with a diameter of 20 mm and a height of 10 mm with a spongiosa-like structure. The interconnected irregular pores have a diameter of 2 mm +/− 0.2 mm standard deviation. Extrusion-based printing was performed using the BIO X6. To produce the bioink, PCL (80 kDa) was combined with calcium phosphate nanopowder (> 150 nm particle size) under heating. After printing, 5 × 10. 6. hMSC were seeded on the construct using a rotating incubator. We were able to print a highly accurate ring construct with an interconnected pore structure. The PCL combined with calcium phosphate particles resulted in a precise printed construct, which corresponded to the 3D model. The bioink containing calcium phosphate nanoparticles had a higher printing accuracy compared to PCL alone. We found that hMSC cultured on the construct settled in close proximity to the calcium phosphate particles. The hMSC were vital for 22 days on the construct as demonstrated by life/dead staining. The extrusion printing technology enables to print a mechanically stable construct with a spongiosa-like structure. The porous PCL ring could serve as an outer matrix for implants, providing the construct the stability of natural bone. To extend this technology and to improve the implant properties, a biologised inner structure will be integrated into the scaffold in the future

The success of cementless orthopaedic implants relies on bony ingrowth and active bone remodelling. Much research effort is invested to develop implants with controllable surface roughness and internal porous architectures that encourage these biological processes. Evaluation of these implants requires long-term and costly animal studies, which do not always yield the desired outcome requiring iteration. The aim of our study is to develop a cost-effective method to prescreen design parameters prior to animal trials to streamline implant development and reduce live animal testing burden. Ex vivo porcine cancellous bone cylinders (n=6, Ø20×12mm) were extracted from porcine knee joints with a computer-numerically-controlled milling machine under sterile conditions within 4 hours of animal sacrifice. The bone discs were implanted with Ø6×12mm additive manufactured porous titanium implants and were then cultured for 21days. Half underwent static culture in medium (DMEM, 10% FBS, 1% antibiotics) at 37°C and 5% CO. 2. The rest were cultured in novel high-throughput stacked configuration in a bioreactor that simulated physiological conditions after surgery: the fluid flow and cyclic compression force were set at 10ml/min and 10–150 N (1Hz,5000 cycles/day) respectively. Stains were administered at days 7 and 14. Samples were evaluated with widefield microscopy, scanning electron microscopy (SEM) and with histology. More bone remodelling was observed on the samples cultured within the bioreactor: widefield imaging showed more remodelling at the boundaries between the implant-bone interface, while SEM revealed immature bone tissue integration within the pores of the implant. Histological analysis confirmed these results, with many more trabecular struts with new osteoid formation on the samples cultured dynamically compared to static ones. Ex vivo bone can be used to analyse new implant technologies with lower cost and ethical impact than animal trial. Physiological conditions (load and fluid flow) promoted bone ingrowth and remodelling

Background. It is known that severe cases of intervertebral disc (IVD) disease may lead to the loss of natural intervertebral height, which can cause radiating pain throughout the lower back and legs. To this point, surgeons perform lumbar fusion using interbody cages, posterior instrumentation and bone graft to fuse adjacent vertebrae together, thus restoring the intervertebral height and alleviating the pain. However, this surgical procedure greatly decreases the range of motion (ROM) of the treated segment, mainly caused by high cage stiffness. Additive manufacturing can be an interesting tool to reduce the cage's elastic modulus (E), by adding porosity (P) in its design. A porous cage may lead to an improved osteointegration since there is more volume in which bone can grow. This work aims to develop a finite element model (FEM) of the L4-L5 functional spinal unit (FSU) and investigate the loss of ROM induced by solid and porous cages. Materials and Methods. The Intact-FEM of L4-L5 was created, which considered the vertebrae, IVD and ligaments with their respective material properties. 1. The model was validated by comparing its ROM with that of other studies. Moments of 10 Nm were applied on top of L4 while the bottom of L5 was fixed to simulate flexion, extension, lateral bending and axial rotation. 2. The lumbar cages, posterior instrumentation and bone graft were then modelled to create the Cage-FEMs. Titanium was chosen for the instrumentation and cages. Cages with different stiffness were considered to represent porous structures. The solid cage had the highest modulus (E. 0. =110 GPa, P. 0. =0%) whereas the porous cages were simulated by lowering the modulus (E. 1. =32.8 GPa, P. 1. =55%; E. 2. =13.9 GPa, P. 2. =76%; E. 3. =5.52 GPa, P. 3. =89%; E. 4. =0.604 GPa, P. 4. =98%), following the literature. 3. The IVD was removed in Cage-FEMs to allow the implant's insertion [Fig. 1] and the previous loading scenarios were simulated to assess the effects of cage porosity on ROM. Results. The Intact-FEM presents acceptable ROM according to experimental and numerical studies, as shown by the red line in Figure 2. After insertion, lower ROM values in Cage-FEMs are measured for each physiological movement [Fig. 3]. In addition, highly porous cages have greater ROM, especially in axial rotation. Discussion. Significant reduction of ROM is expected after cage insertion because the main goal of interbody fusion is to allow bone growth. As such, the procedure's success is highly dependent on segmental stability, which is achieved by using cages in combination with bone graft and posterior instrumentation. Furthermore, higher cage porosities seem to affect the FSU. In fact, ROM increases more as the cage modulus approaches that of the cancellous bone (E. canc-bone. =0.2 GPa. 1. ). Next step will be to assess the effects of cage design on the L4-L5 FSU mechanical behavior and stress distribution. To conclude, additive manufacturing offers promising possibilities regarding implant optimization, being able to create porous cages, thus reducing their stiffness. For any figures or tables, please contact the authors directly