Retrieval Analysis of Titanium Nitride Coatings for Orthopaedic Implants.

BACKGROUND: The first generation of titanium nitride (TiN) coatings for orthopaedic implants was clinically introduced in the 1990s because of their promising biocompatibility, wear resistance, and corrosion resistance. This study evaluated the in vivo performance of early TiN-coated knee and hip implants, focusing on the bearing surfaces and mechanisms of in vivo damage. METHODS: There were 13 TiN-coated implants (5 knee and 8 hip) retrieved from 8 patients as part of a multi-institutional implant retrieval program. The average implantation time was 4.25 years for knees and 17.5 years for hips. Implant revisions occurred for various reasons, including polyethylene wear, loosening, pain, infection, and instability. Components were examined using a semiquantitative scoring method, and surface roughness measurements were performed using white-light interferometry. Surface morphology, chemistry, and particle characterization were also assessed by scanning electron microscopy. RESULTS: For hips, mild corrosion was found on femoral head tapers, along with severe scratching on certain femoral heads. Knee implants exhibited low burnishing and scratching for both mechanisms. Roughness measurements (Sa) were 37.3 nm (interquartile range = 22.0 to 62.4) for hips and 85.3 nm (interquartile range = 66.3 to 110) for knees. The observed scratch depth in both hip and knee implants due to third-body particles ranged from 0.3 to 1.3 µm. The coating coverage remained intact in the majority of the implants, with 2 cases of small, localized cohesive chipping and substrate exposure. CONCLUSIONS: The results of this study confirm the potential in vivo durability of early TiN coatings and will be useful in benchmarking wear tests for modern TiN-coated orthopaedic implants.

[Development and Challenges of Additive Manufactured Customized Implant].

Additive manufacturing (3D printing) technology aligns with the direction of precision and customization in future medicine, presenting a significant opportunity for innovative development in high-end medical devices. Currently, research and industrialization of 3D printed medical devices mainly focus on nondegradable implants and degradable implants. Primary areas including metallic orthopaedic implants, polyether-ether-ketone (PEEK) bone implants, and biodegradable implants have been developed for clinical and industrial application. Recent research achievements in these areas are reviewed, with a discussion on the additive manufacturing technologies and applications for customized implants. Challenges faced by different types of implants are analyzed from technological, application, and regulatory perspectives. Furthermore, prospects and suggestions for future development are outlined.

Unsupervised registration of 3D knee implant components to biplanar X-ray images.

BACKGROUND: Registration of three-dimensional (3D) knee implant components to radiographic images provides the 3D position of the implants which aids to analyze the component alignment after total knee arthroplasty. METHODS: We present an automatic 3D to two-dimensional (2D) registration using biplanar radiographic images based on a hybrid similarity measure integrating region and edge-based information. More precisely, this measure is herein defined as a weighted combination of an edge potential field-based similarity, which represents the relation between the external contours of the component projections and an edge potential field estimated on the two radiographic images, and an object specificity property, which is based on the distinction of the region-label inside and outside of the object. RESULTS: The accuracy of our 3D/2D registration algorithm was assessed on a sample of 64 components (32 femoral components and 32 tibial components). In our tests, we obtained an average of the root mean square error (RMSE) of 0.18 mm, which is significantly lower than that of both single similarity methods, supporting our hypothesis of better stability and accuracy with the proposed approach. CONCLUSION: Our method, which provides six accurate registration parameters (three rotations and three translations) without requiring any fiducial markers, makes it possible to perform the important analyses on the rotational alignment of the femoral and tibial components on a large number of cases. In addition, this method can be extended to register other implants or bones.

Recent Strategies to Combat Infections from Biofilm-Forming Bacteria on Orthopaedic Implants.

Biofilm-related implant infections (BRII) are a disastrous complication of both elective and trauma orthopaedic surgery and occur when an implant becomes colonised by bacteria. The definitive treatment to eradicate the infections once a biofilm has established is surgical excision of the implant and thorough local debridement, but this carries a significant socioeconomic cost, the outcomes for the patient are often poor, and there is a significant risk of recurrence. Due to the large volumes of surgical procedures performed annually involving medical device implantation, both in orthopaedic surgery and healthcare in general, and with the incidence of implant-related infection being as high as 5%, interventions to prevent and treat BRII are a major focus of research. As such, innovation is progressing at a very fast pace; the aim of this study is to review the latest interventions for the prevention and treatment of BRII, with a particular focus on implant-related approaches.

Development of a Wireless Telemetry Sensor Device to Measure Load and Deformation in Orthopaedic Applications.

Due to sensor size and supporting circuitry, in-vivo load and deformation measurements are currently restricted to applications within larger orthopaedic implants. The objective of this study is to repurpose a commercially available low-power, miniature, wireless, telemetric, tire-pressure sensor (FXTH87) to measure load and deformation for future use in orthopaedic and biomedical applications. The capacitive transducer membrane was modified, and compressive deformation was applied to the transducer to determine the sensor signal value and the internal resistive force. The sensor package was embedded within a deformable enclosure to illustrate potential applications of the sensor for monitoring load. To reach the maximum output signal value, sensors required compressive deformation of 350 ± 24 µm. The output signal value of the sensor was an effective predictor of the applied load on a calibrated plastic strain member, over a range of 35 N. The FXTH87 sensor can effectively sense and transmit load-induced deformations. The sensor does not have a limit on loads it can measure, as long as deformation resulting from the applied load does not exceed 350 µm. The proposed device presents a sensitive and precise means to monitor deformation and load within small-scale, deformable enclosures.

Bacteria Death and Osteoblast Metabolic Activity Correlated to Hydrothermally Synthesised TiO2 Surface Properties.

Orthopaedic surgery comes with an inherent risk of bacterial infection, prolonged antibiotic therapy and revision surgery. Recent research has focused on nanostructured surfaces to improve the bactericidal and osseointegrational properties of implants. However, an understanding of the mechanical properties of bactericidal materials is lacking. In this work, the surface properties of hydrothermal TiO2 nanostructured surfaces are investigated for their effect on bactericidal efficiency and cellular metabolic activity of human osteoblast cells. TiO2 nanostructures, approximately 307 nm in height and 14 GPa stiffness, were the most effective structures against both gram-positive (Staphylococcus aureus) and gram-negative (Pseudomonas aeruginosa) bacteria. Statistical analysis significantly correlated structure height to the death of both bacteria strains. In addition, the surface contact angle and Young's modulus were correlated to osteoblast metabolic activity. Hydrophilic surfaces with a contact angle between 35 and 50° produced the highest cellular metabolic activity rates after 24 hours of incubation. The mechanical tests showed that nanostructures retain their mechanical stability and integrity over a long time-period, reaffirming the surfaces' applicability for implants. This work provides a thorough examination of the surface, mechanical and wettability properties of multifunctional hydrothermally synthesised nanostructured materials, capable of killing bacteria whilst improving osteoblast metabolic rates, leading to improved osseointegration and antibacterial properties of orthopaedic implants.

Surgical Site Infection In Orthopaedic Implants And Its Common Bacteria With Their Sensitivities To Antibiotics, In Open Reduction Internal Fixation.

BACKGROUND: Surgical site infection in orthopaedic implants is a major problem, causing long hospital stay, cost to the patient and is a burden on health care facilities. It increases rate of nonunion, osteomyelitis, implant failure, sepsis, multiorgan dysfunction and even death. Surgical site infection is defined as pain, erythema, swelling and discharge from wound site. Surgical site infection in orthopaedic implants is more challenging to the treating orthopaedic surgeon as the causative organism is protected by a biofilm over the implant's surface. Antibiotics cannot cross this film to reach the bacteria's, causing infection. METHODS: This descriptive case series study includes 132 patients of both genders with ages between 13-60 years conducted at Orthopaedic Unit, Ayub Medical College, Abbottabad from 1st October 2015 to 31st March 2016. Patients with close fractures of long bones were included in the study to determine the frequency of surgical site infection in orthopaedic implants and the type of bacteria involved and their sensitivity to various antibiotics. All implants were of stainless steel. The implants used were Dynamic hip screws, Dynamic compression screws, plates, k-wires, Interlocking nails, SIGN nails, Austin Moore prosthesis and tension band wires. Pre-op and post-op antibiotics used were combination of Sulbactum and Cefoperazone which was given 1 hour before surgery and continued for 72 hours after surgery. Patients were followed up to 4 weeks. Pus was taken on culture stick, from those who developed infection. Results were entered in the pro forma. RESULTS: A total of 132 patients of long bone fractures, who were treated with open reduction and internal fixation, were studied. Only 7 patients developed infection. Staphylococcus Aureus was isolated from all 7 patients. Staphylococcus aureus was sensitive to Linezolid, Fusidic Acid, and vancomycin. Cotrimoxazole, tetracycline, Gentamycin and Clindamycin were partially effective. CONCLUSIONS: Surgical Site Infection is common in orthopaedic implants, occurring in 5.30% cases. Staphylococcus aureus is the common bacteria, causing it.

Weibull analysis of ceramics and related materials: A review.

It has been realized throughout the years that an ideal combination of high toughness, hardness and strength is required in many engineering applications that need load-bearing capabilities. Ceramics and related materials have significant constraints for structural and particular non-structural applications due to their low toughness and limited strength while having substantially superior hardness than typical metallic materials. For example, hydroxyapatite (HAp) has gained attention for applications in orthopaedic implants, dental materials, drug delivery, etc. Researchers have continued to strive to produce HAp materials with reliable properties within the acceptable Weibull modulus (m) for load bearing. The Weibull analysis (WA) is a statistical analysis adopted widely in reliability applications to detect failure periods. Researchers have confirmed it to be an effective technique to get results on the reliability of materials at a moderately low rate with assured reliability of the material or component. This review summarizes the WA and the steps in the Weibull method for its reliability analysis to predict the failure rate of ceramics like HAp and other related materials. Also, the applications of WA for these materials were reviewed. From the review, it was discovered that Weibull distribution is proven to confer to the feeblest-link concept. For brittle materials, it was revealed that the Weibull Modulus ranges from 2 to 40, and environment, production processes, and comparative factors are well-thought-out contributing factors for reliability. In addition, the confidence interval can be up to 95 %. The frequently used technique for reliability valuation is to syndicate the Weibull statistics. Also, a very narrow distribution is desirable to offer the expected likelihood. Furthermore, when paired with trials, Monte Carlo simulations prove to be a very helpful tool for forecasting the dependability of different estimate techniques and their optimization. Finally, if the equivalent m is anticipated to be high, it signifies that the material has a high degree of homogeneity of properties and high reliability. WA can find application in predicting the dependability and lifetime of materials, making it widely utilized in engineering and other disciplines. It is especially useful for analysing data in which the likelihood of failure per unit of time varies over time.

Understanding immune-mediated cobalt/chromium allergy to orthopaedic implants: a meta-synthetic review.

BACKGROUND: The frequency of primary joint replacement surgery continues to increase worldwide. While largely considered biologically inert entities, an increasing body of evidence continues to validate a not insignificant incidence of allergic reactions to such implants. Little previous work has explored genuinely immune-mediated reactivity in this context. In the absence of a contemporary published summary on the topic, this paper explored the current state of understanding of cobalt/chromium allergy and proposes a patient management algorithm whereby such immune reactions are clinically suggested. METHODS: A structured, systematic literature review was performed by following PRISMA search principles to provide an updated review of this area. RESULTS: Thirty-six topic-related articles were identified, the majority reflecting lower tiers of scientific evidence with a lack of homogeneous quantitative data to facilitate valid cohort comparisons. Largely, the available literature represented small case series' or expert opinions. CONCLUSIONS: Despite increasing clinical awareness and acknowledgement of true allergy to joint replacement components, this review highlighted that the evidence base underpinning the diagnosis and management of such patients is limited. Both patient-reported metal allergy or skin patch testing are grossly unreliable methods and show almost no correlation with true immune reactivity. Recent studies suggested a potential role for patient-specific in vitro cellular activation testing and/or targeted genetic testing when cobalt/chromium allergy is clinically suspected. However, while likely representing the contemporary "best available" approaches both can be costly undertakings, are not yet universally available, and still require broader validation in non-research settings before wider uptake can be championed.

Cancer-Causing Effects of Orthopaedic Metal Implants in Total Hip Arthroplasty.

BACKGROUND: Metal implants have been preferentially used in THA due to its biocompatibility, mechanical stability and durability. Yet concerns have emerged regarding their potential to release metallic ions, leading to long-term adverse effects, including carcinogenicity. This study aimed to investigate the risk of cancer development in patients with orthopaedic metal implants in total hip arthroplasty (THA). METHODS: Patients with THA conducted at a local tertiary implant centre from 2001-2008 were linked to the local cancer registry and followed up to the end of 2023. Standardized incidence ratios (SIRs) for cancer incidence and its confidence interval by Poisson distribution were calculated. Survival analysis was depicted using the Kaplan-Meier method, and the log-rank test was used to assess the differences across groups. RESULTS: The study cohort included 388 patients and 53 cancers diagnosed during follow-up, at least 5 years post THA. All-site cancer risks were increased in patients with THA (SIR: 1.97; 95% CI: 1.48-2.46), validated with chi-square analysis (chi-square = 15.2551, N = 100,388, p < 0.01). A statistically significant increase in multiple site-specific cancers including haematological cancers were identified. CONCLUSIONS: Patients with THA were found to have an increased risk for cancer compared to the general population during a mean follow-up of 16 years.

Role of Dithiothreitol in Detection of Orthopaedic Implant-Associated Infections.

Orthopaedic implant-associated infections (OIAIs) represent a notable complication of contemporary surgical procedures, exerting a considerable impact on patient outcomes and escalating healthcare expenditures. Prompt diagnosis holds paramount importance in managing OIAIs, with sonication widely acknowledged as the preferred method for detecting biofilm-associated infections. Recently, dithiothreitol (DTT) has emerged as a potential substitute for sonication, owing to its demonstrated ability to impede biofilm formation. This study aimed to compare the efficacy of DTT with sonication in identifying microorganisms within implants. Conducted as a prospective cohort investigation, the study encompassed two distinct groups: patients with suspected infections undergoing implant removal (Group A) and those slated for hardware explantation (Group B). Hardware segments were assessed for biofilm-related microorganisms using both sonication and DTT, with a comparative analysis of the two methods. A total of 115 patients were enrolled. In Group A, no statistically significant disparity was observed between DTT and sonication. DTT exhibited a sensitivity of 89.47% and specificity of 96.3%. Conversely, in Group B, both DTT and sonication fluid cultures yielded negative results in all patients. Consequently, this investigation suggests that DTT holds comparable efficacy to sonication in detecting OIAIs, offering a novel, cost-effective, and readily accessible diagnostic modality for identifying implant-associated infections.

Exploration of microstructural characteristics, mechanical properties, andin vitrobiocompatibility of biodegradable porous magnesium scaffolds for orthopaedic implants.

In this study, porous magnesium (Mg) scaffolds were investigated with varying strontium (Sr) and constant zinc (Zn) concentrations through the powder metallurgy process. All samples were examined at room temperature to evaluate their microstructure, mechanical andin-vitrodegradation behaviour and biological properties. Results indicated that adding Sr was associated with fine average grain size, increased mechanical strength, and a decreased corrosion rate. All samples show tiny isolated and open interconnected pores (porosities: 18%-30%, pores: 127-279 µm) with a suitable surface roughness of less than 0.5 µm. All the provided samples possess mechanical and hemocompatible properties that closely resemble natural bone. Mg-4Zn-2Sr has the highest hardness (102.61 ± 15.1 HV) and compressive strength (24.80 MPa) than Mg-4Zn-0.5Sr (85 ± 8.5 HV, 22.14 MPa) and Mg-4Zn-1Sr (97.71 ± 11.2 HV, 18.06 MPa). Immersion results revealed that samples in phosphate-buffered saline solutions have excellent degradability properties, which makes them a promising biodegradable material for orthopaedic applications. The scaffold with the highest Sr concentration shows the best optimised mechanical and degradation behaviour out of the three porous scaffolds, with a 2.7% hemolysis rate.

Current developments and future perspectives of nanotechnology in orthopedic implants: an updated review.

Orthopedic implants are the most commonly used fracture fixation devices for facilitating the growth and development of incipient bone and treating bone diseases and defects. However, most orthopedic implants suffer from various drawbacks and complications, including bacterial adhesion, poor cell proliferation, and limited resistance to corrosion. One of the major drawbacks of currently available orthopedic implants is their inadequate osseointegration at the tissue-implant interface. This leads to loosening as a result of immunological rejection, wear debris formation, low mechanical fixation, and implant-related infections. Nanotechnology holds the promise to offer a wide range of innovative technologies for use in translational orthopedic research. Nanomaterials have great potential for use in orthopedic applications due to their exceptional tribological qualities, high resistance to wear and tear, ability to maintain drug release, capacity for osseointegration, and capability to regenerate tissue. Furthermore, nanostructured materials possess the ability to mimic the features and hierarchical structure of native bones. They facilitate cell proliferation, decrease the rate of infection, and prevent biofilm formation, among other diverse functions. The emergence of nanostructured polymers, metals, ceramics, and carbon materials has enabled novel approaches in orthopaedic research. This review provides a concise overview of nanotechnology-based biomaterials utilized in orthopedics, encompassing metallic and nonmetallic nanomaterials. A further overview is provided regarding the biomedical applications of nanotechnology-based biomaterials, including their application in orthopedics for drug delivery systems and bone tissue engineering to facilitate scaffold preparation, surface modification of implantable materials to improve their osteointegration properties, and treatment of musculoskeletal infections. Hence, this review article offers a contemporary overview of the current applications of nanotechnology in orthopedic implants and bone tissue engineering, as well as its prospective future applications.

In vitro calibration and in vivo validation of phenomenological corrosion models for resorbable magnesium-based orthopaedic implants.

Metallic bioresorbable orthopaedic implants based on magnesium, iron and zinc-based alloys that provide rigid internal fixation without foreign-body complications associated with permanent implants have great potential as next-generation orthopaedic devices. Magnesium (Mg) based alloys exhibit excellent biocompatibility. However, the mechanical performance of such implants for orthopaedic applications is contingent on limiting the rate of corrosion in vivo throughout the bone healing process. Additionally, the surgical procedure for the implantation of internal bone fixation devices may impart plastic deformation to the device, potentially altering the corrosion rate of the device. The primary objective of this study was to develop a computer-based model for predicting the in vivo corrosion behaviour of implants manufactured from a Mg-1Zn-0.25Ca ternary alloy (ZX10). The proposed corrosion model was calibrated with an extensive range of mechanical and in vitro corrosion testing. Finally, the model was validated by comparing the in vivo corrosion performance of the implants during preliminary animal testing with the corrosion performance predicted by the model. The proposed model accurately predicts the in vitro corrosion rate, while overestimating the in vivo corrosion rate of ZX10 implants. Overall, the model provides a "first-line of design" for the development of new bioresorbable Mg-based orthopaedic devices. STATEMENT OF SIGNIFICANCE: Biodegradable metallic orthopaedic implant devices have emerged as a potential alternative to permanent implants, although successful adoption is contingent on achieving an acceptable degradation profile. A reliable computational method for accurately estimating the rate of biodegradation in vivo would greatly accelerate the development of resorbable orthopaedic implants by highlighting the potential risk of premature implant failure at an early stage of the device development. Phenomenological corrosion modelling approach is a promising computational tool for predicting the biodegradation of implants. However, the validity of the models for predicting the in vivo biodegradation of Mg alloys is yet to be determined. Present study investigates the validity of the phenomenological modelling approach for simulating the biodegradation of resorbable metallic orthopaedic implants by using a porcine model that targets craniofacial applications.

The effects on bone cells of metal ions released from orthopaedic implants. A review.

The increasing use of orthopedic implants and, in particular, of hip and knee joint replacements for young and active patients, has stimulated interest and concern regarding the chronic, long-term effects of the materials used. This review focuses on the current knowledge of the adverse biologic reactions to metal particles released from orthopaedic implants in vivo and in vitro. More specifically, the purpose of this article is to provide an overview of the current literature about the adverse effects of metal particles on bone cells and peri-implant bone.

The effect of nodal connectivity and strut density within stochastic titanium scaffolds on osteogenesis.

Modern orthopaedic implants use lattice structures that act as 3D scaffolds to enhance bone growth into and around implants. Stochastic scaffolds are of particular interest as they mimic the architecture of trabecular bone and can combine isotropic properties and adjustable structure. The existing research mainly concentrates on controlling the mechanical and biological performance of periodic lattices by adjusting pore size and shape. Still, less is known on how we can control the performance of stochastic lattices through their design parameters: nodal connectivity, strut density and strut thickness. To elucidate this, four lattice structures were evaluated with varied strut densities and connectivity, hence different local geometry and mechanical properties: low apparent modulus, high apparent modulus, and two with near-identical modulus. Pre-osteoblast murine cells were seeded on scaffolds and cultured in vitro for 28 days. Cell adhesion, proliferation and differentiation were evaluated. Additionally, the expression levels of key osteogenic biomarkers were used to assess the effect of each design parameter on the quality of newly formed tissue. The main finding was that increasing connectivity increased the rate of osteoblast maturation, tissue formation and mineralisation. In detail, doubling the connectivity, over fixed strut density, increased collagen type-I by 140%, increased osteopontin by 130% and osteocalcin by 110%. This was attributed to the increased number of acute angles formed by the numerous connected struts, which facilitated the organization of cells and accelerated the cell cycle. Overall, increasing connectivity and adjusting strut density is a novel technique to design stochastic structures which combine a broad range of biomimetic properties and rapid ossification.

Assessment of fracture healing in orthopaedic trauma.

Fracture healing is a complex physiologic process, relying on the crucial interplay between biological and mechanical factors. It is generally assessed using imaging modalities, including conventional radiology, CT, MRI and ultrasound (US), based on the fracture and patient features. Although these techniques are routinely used in orthopaedic clinical practice, unfortunately, they do not provide any information about the biomechanical status of the fracture site. Therefore, in recent years, several non-invasive techniques have been proposed to assess bone healing using ultrasonic wave propagation, changes in electrical properties of bones and callus stiffness measurement. Moreover, different research groups are currently developing smart orthopaedic implants (plates, intramedullary nails and external fixators), able to provide information about the fracture healing process. These devices could significantly improve orthopaedic and trauma clinical practice in the future and, at the same time, reduce patients' exposure to X-rays. This study aims to define the role of traditional imaging techniques and emerging technologies in the assessment of the fracture healing process.

A coupled computational framework for bone fracture healing and long-term remodelling: Investigating the role of internal fixation on bone fractures.

In this study, a coupled computational modelling framework for bone fracture repair is presented that enables predictions of both healing and remodelling phases of the fracture region and is used to investigate the role of an internal fixation plate on the long-term healing performance of a fracture tibia under a range of different conditions. It was found that introduction of a titanium plate allowed the tibia to undergo successful healing at higher loading conditions and fracture gaps, compared with the non-plated versions. While these plated cases showed faster rates of repair in the healing phase, their performance was substantially different once they entered the remodelling phase, with substantial regions of stress shielding predicted. This framework is one of the few implementations of both fracture healing and remodelling phases of bone repair and includes several innovative approaches to smoothing, time-averaging and time incrementation in its implementation, thereby avoiding any unwanted abrupt changes between tissue phenotypes. This provides a better representation of tissue development in the fracture site when compared with fracture healing models alone and provides a suitable platform to investigate the long-term performance of orthopaedic fixation devices. This would enable the more effective design of permanent fixation devices and optimisation of the spatial and temporal performance of bioabsorbable implants.

[Research progress of antibacterial modification of orthopaedic implants surface].

Objective: To summarize the related research progress of antibacterial modification of orthopaedic implants surface in recent years. Methods: The domestic and foreign related literature in recent years was extensively consulted, the research progress on antibacterial modification of orthopaedic implants surface was discussed from two aspects of characteristics of infection in orthopedic implants and surface anti-infection modification. Results: The orthopaedic implants infections are mainly related to aspects of bacterial adhesion, decreased host immunity, and surface biofilm formation. At present, the main antimicrobial coating methods of orthopaedic implants are antibacterial adhesion coating, antibiotic coating, inorganic antimicrobial coating, composite antimicrobial coating, nitric oxide coating, immunomodulation, three-dimensional printing, polymer antimicrobial coating, and "smart" coating. Conclusion: The above-mentioned antibacterial coating methods of orthopedic implants can not only inhibit bacterial adhesion, but also solve the problems of low immunity and biofilm formation. However, its mechanism of action and modification are still controversial and require further research.

Optimising soft tissue in-growth in vivo in additive layer manufactured osseointegrated transcutaneous implants.

Osseointegrated transcutaneous implants could provide an alternative and improved means of attaching artificial limbs for amputees, however epithelial down growth, inflammation, and infections are common failure modalities associated with their use. To overcome these problems, a tight seal associated with the epidermal and dermal adhesion to the implant is crucial. This could be achieved with specific biomaterials (that mimic the surrounding tissue), or a tissue-specific design to enhance the proliferation and attachment of dermal fibroblasts and keratinocytes. The intraosseous transcutaneous amputation prosthesis is a new device with a pylon and a flange, which is specifically designed for optimising soft tissue attachment. Previously the flange has been fabricated using traditional machining techniques, however, the advent of additive layer manufacturing (ALM) has enabled 3-dimensional porous flanges with specific pore sizes to be used to optimise soft tissue integration and reduce failure of osseointegrated transcutaneous implants. The study aimed to investigate the effect of ALM-manufactured porous flanges on soft tissue ingrowth and attachment in an in vivo ovine model that replicates an osseointegrated percutaneous implant. At 12 and 24 weeks, epithelial downgrowth, dermal attachment and revascularisation into ALM-manufactured flanges with three different pore sizes were compared with machined controls where the pores were made using conventional drilling. The pore sizes of the ALM flanges were 700, 1000 and 1250 µm. We hypothesised that ALM porous flanges would reduce downgrowth, improve soft tissue integration and revascularisation compared with machined controls. The results supported our hypothesis with significantly greater soft tissue integration and revascularisation in ALM porous flanges compared with machined controls.