Objectives. Bioresorbable orthopaedic devices with calcium phosphate (CaP) fillers are commercially available on the assumption that increased calcium (Ca) locally drives new bone formation, but the clinical benefits are unknown. Electron beam (EB) irradiation of polymer devices has been shown to enhance the release of Ca. The aims of this study were to: 1) establish the biological safety of EB surface-modified bioresorbable devices; 2) test the release kinetics of CaP from a polymer device; and 3) establish any subsequent beneficial effects on bone repair in vivo. Methods. ActivaScrew Interference (Bioretec Ltd, Tampere, Finland) and poly(L-lactide-co-glycolide) (PLGA) orthopaedic screws containing 10 wt% β-tricalcium phosphate (β-TCP) underwent EB treatment. In vitro degradation over 36 weeks was investigated by recording mass loss, pH change, and Ca release. Implant performance was investigated in vivo over 36 weeks using a lapine femoral condyle model. Bone growth and osteoclast activity were assessed by histology and enzyme histochemistry. Results. Calcium release doubled in the EB-treated group before returning to a level seen in untreated samples at 28 weeks. Extensive bone growth was observed around the perimeter of all implant types, along with limited osteoclastic activity. No statistically significant differences between comparative groups was identified. Conclusion. The higher than normal dose of EB used for surface modification did not adversely affect tissue response around implants in vivo. Surprisingly, incorporation of β-TCP and the subsequent accelerated release of Ca had no significant effect on in vivo implant performance, calling into question the clinical evidence base for these commercially available devices. Cite this article: I. Palmer, S. A. Clarke, F. J Buchanan. Enhanced release of calcium phosphate additives from bioresorbable orthopaedic devices using irradiation technology is non-beneficial in a rabbit model: An animal study. Bone Joint Res 2019;8:266–274. DOI: 10.1302/2046-3758.86.BJR-2018-0224.R2

Modular hip prostheses were introduced to optimize the intra-surgical adaptation of the implant design to the native anatomy und biomechanics of the hip. The downside of a modular implant design with an additional modular interface is the potential susceptibility to fretting, crevice corrosion and wear. For testing hip implants with proximal femoral modularity according to ISO & ASTM, sodium chloride solutions are frequently used to determine the fatigue strength and durability of the stem-neck connection. The present study illustrate that the expansion of standard requirements of biomechanical testing is necessary to simulate metal ion release as well as fretting and crevice corrosion by using alternative test fluids. To assess the primary stability of tibial plateaus in vitro, different approaches had been undergone: cement penetration depth analysis, static tension or compression loading until interface failure. However, these test conditions do not reflect the in vivo physiologic loading modes, where the tibial plateau is predominantly subjected to combined compression and shear forces. The objectives were to evaluate the impact of the tibial keel & stem length on the primary stability of a posterior-stabilised tibial plateau under dynamic compression-shear loading conditions in human tibiae.

Regulatory bodies impose stringent pre-market controls to certify the safety and compatibility of medical devices. However, internationally recognized standard tests may be expensive, time consuming and challenging for orthopedic implants because of many possible sizes and configurations. In addition, cost and time of standard testing may endanger the feasibility of custom-device production obtained through innovative manufacturing technologies like 3d printing. Modeling and simulation (M&S) tools could be used by manufactures and at point-of-care to improve design confidence and reliability, accelerate design cycles and processes, and optimize the amount of physical testing to be conducted. We propose an integrated cloud platform to perform in silico testing for orthopedic devices, assessing mechanical safety and electromagnetic compatibility, in line with recognized standards and regulatory guidelines. The . InSilicoTrials.com. platform contains two M&S tools for orthopedic devices: CONSELF and NuMRis. CONSELF (. conself.com. ) uses Salome-Meca 2017 to compute static implant stresses and strains on metallic orthopedic devices, following the requirements and considerations of ASTM F2996-20 for non-modular hip femoral stems and ASTM F3161-16 for total knee femoral components. Simulation results were consistent with those reported in the two standards. NuMRis (. numris.insilicomri.com. ) uses ANSYS HFSS and ANSYS Mechanical 2019R3 to compute radio-frequency energy absorption and induced heating in 1.5T and 3T MRI coils, replicating the ASTM F2182-19e2 Standard Test Method. Simulation results were validated against in vitro measurements. The integrated M&S workflow on the cloud platform allows the user to upload the 3D geometry and the material properties of the orthopedic device to be tested, automatically set up the standard testing scenarios, run simulations and process outcome, with the option to summarize the results in accordance with current FDA guidance on M&S reporting. The easy-to-use interfaces of InSilicoTrials tools run through commercial web browsers, requiring no specific expertise in computational methods or additional on-premise software and hardware resources, since all simulations are run remotely on cloud infrastructure. The integrated cloud platform can be used to evaluate design alternatives, test multi-configuration devices, perform multi-objective design optimization and identify worst-case scenarios within a family of implant sizes, or to assess the safety and compatibility of custom-made orthopedic devices. InSilicoTrials.com. is the first cloud platform offering a collection of M&S tools to perform in silico standard testing for orthopedic devices. The proposed tools allow to assess mechanical safety and electromagnetic compatibility before prototyping, preventing risks and criticalities for the patient, and helping manufacturers and point-of-care to accelerate time and reduce costs during the device development. The proposed platform promotes the broader adoption of digital evidence in preclinical trials, supporting the device submission process and pre-market regulatory evaluation, and helping secure regulatory approval

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

The aim of this study was to evaluate whether coating titanium discs with selenium in the form of sodium selenite decreased bacterial adhesion of Staphylococcus aureus and Staph. epidermidis and impeded osteoblastic cell growth.

In order to evaluate bacterial adhesion, sterile titanium discs were coated with increasing concentrations of selenium and incubated with bacterial solutions of Staph. aureus (ATCC 29213) and Staph. epidermidis (DSM 3269) and stained with Safranin-O. The effect of selenium on osteoblastic cell growth was also observed. The adherence of MG-63 cells on the coated discs was detected by staining with Safranin-O. The proportion of covered area was calculated with imaging software.

The tested Staph. aureus strain showed a significantly reduced attachment on titanium discs with 0.5% (p = 0.011) and 0.2% (p = 0.02) selenium coating. Our test strain from Staph. epidermidis showed a highly significant reduction in bacterial adherence on discs coated with 0.5% (p = 0.0099) and 0.2% (p = 0.002) selenium solution. There was no inhibitory effect of the selenium coating on the osteoblastic cell growth.

Selenium coating is a promising method to reduce bacterial attachment on prosthetic material.

Cite this article: Bone Joint J 2013;95-B:678–82.

Introduction. The fixation of press-fit orthopaedic devices depends on the mechanical properties of the bone that is in contact with the implants. During the press-fit implantation, bone is compacted and permanently deformed, finally resulting in the mechanical interlock between implant and bone. For the development and design of new devices, it is imperative to understand these non-linear interactions. One way to investigate primary fixation is by using computational models based on Finite Element (FE) analysis. However, for a successful simulation, a proper material model is necessary that accurately captures the non-linear response of the bone. In the current study, we combined experimental testing with FE modeling to establish a Crushable Foam model (CFM) to represent the non-linear bone biomechanics that influences implant fixation. Methods. Mechanical testing of human tibial trabecular bone was done under uniaxial and confined compression configurations. We examined 62 human trabecular bone samples taken from 8 different cadaveric tibiae to obtain all the required parameters defining the CFM, dependent on local bone mineral density (BMD). The derived constitutive rule was subsequently applied using an in-house subroutine to the FE models of the bone specimens, to compare the model predictions against the experimental results. Results. The crushable foam model provided an accurate simulation of the experimental compression test, and was able to replicate the ultimate compression strength measured in the experiments [Figure 1]. The CFM was able to simulate the post-failure behavior that was observed in the experimental specimens up to strain levels of 50% [Figure 2]. Also, the distribution of yield strains and permanent displacement was qualitatively very similar to the experimental deformation of the bone specimens [Figure 3]. Conclusion. The crushable foam model developed in the current study was able to accurately replicate the mechanical behavior of the human trabecular bone under compression loading beyond the yield point. This advanced bone model enables realistic simulations of the primary fixation of orthopaedic devices, allowing for the analysis of the influence of interference fit and frictional properties on implant stability. In addition, the model is suitable for failure analysis of reconstructions, such as the tibial collapse of total knee arthroplasty. For any figures or tables, please contact the authors directly

Collection of 4–5 independent peri-prosthetic tissue samples is recommended for microbiological diagnosis of prosthetic joint infections. Sonication of explanted prostheses has also been shown to increase microbiological yield in some centres. We compared sonication with standard tissue sampling for diagnosis of prosthetic joint and other orthopaedic device related infections. We used standard protocols for sample collection, tissue culture and sonication. Positive tissue culture was defined as isolation of a phenotypically indistinguishable organism from ≥2 samples; and positive sonication culture as isolation of an organism at ≥50 cfu/ml. We compared the diagnostic performance of each method against an established clinical definition of infection (Trampuz 2011), and against a composite clinical and microbiological definition of infection based on international consensus (Gehrke & Parvizi 2013). 350 specimens were received for sonication, including joint prostheses (160), exchangeable components (76), other orthopaedic hardware and cement (104), and bone (10). A median of 5 peri-prosthetic tissue samples were received from each procedure (IQR 4–5). Tissue culture was more sensitive than sonication for diagnosis of prosthetic joint and orthopaedic device related infection using both the clinical definition (66% versus 57%, McNemar's Χ2 test p=0.016) and the composite definition of infection (87% vs 66%, p<0.001). The combination of tissue culture and sonication provided optimum sensitivity: 73% (95% confidence interval 65–79%) against the clinical definition and 92% (86–96%) against the composite definition. Results were similar when analysis was confined to joint prostheses and exchangeable components; other orthopaedic hardware; and patients who had received antibiotics within 14 days prior to surgery. Tissue sampling appears to have higher sensitivity than sonication for diagnosis of prosthetic joint and orthopaedic device infection at our centre. This may reflect rigorous collection of multiple peri-prosthetic tissue samples. A combination of methods may offer optimal sensitivity, reflecting the anatomical and biological spectrum of prosthetic joint and other device related infections

Objectives. Establishing the diagnosis of implant-associated infections is often difficult, because of variable clinical presentations and lack of uniform diagnostic criteria. Sonication of removed orthopedic devices was shown to have superior sensitivity and specificity for infection. We evaluated the value of microcalorimetry as a quick and reliable tool in the diagnosis of infection in sonication fluid from removed implants. Methods. Between 10/2009 and 02/2010 we prospectively included all removed orthopaedic devices at our institution, which were subjected to sonication. Periprosthetic tissue cultures were performed as standard procedure. The removed device was sonicated in Ringer solution (40 kHz, 1 minute) and the resulting fluid was cultured and centrifuged (3000 × g, 10 minutes). The resulting pellet was resuspended in 3 ml tryptic soy broth for isothermal microcalorimetry (sensitivity of 0.25 μW). The detection time until increase of 20 μW was calculated. A 48-channel batch calorimeter (TA Instruments, New Castle, DE, USA) was used to measure the heat flow at 37°C controlled at 0.0001 °C. Results. 39 cases were included (24 males, mean age ± SD was 63 ± 16 years). 29 cases were orthopedic prostheses (14 hip, 11 knee, 1 shoulder and 1 joint spacers) and 10 cases osteosynthetic materials (6 screws, 3 plates, 1 cement-nail). 13 cases (33%) were infected, of which 10 (77%) were positive in sonication culture and 12 (92%) in microcalorimetry. The mean detection time by microcalorimetry was 11.4 h (range, 0.2 h–20.9 h). Examples for microcalorimetric signals can be seen in Fig.1. Conclusions. Microcalorimety of sonication fluid showed superior sensitivity for the diagnosis of infection with detection time of <24 h. This method is a promising diagnostic assay for a rapid and accurate diagnosis of infections associated with orthopedic devices

According to a report by Millennium Research Group in January 2011, the US orthopaedic extremity device market will generate over $4.6 billion in revenue by 2015. 1. With an ageing demographic and increasing demand for better quality of life into old age, there is clearly a commercial drive for the orthopaedic device community to develop new and innovative solutions to bone and joint problems. Devising such solutions is one thing; protecting them, so that research investment can be rewarded, is another. How is such protection achieved? The judicious use of intellectual property rights plays a key role, and this article aims to provide some information about the use of patents to protect innovation

Local antimicrobial therapy is an integral aspect of treating orthopaedic device related infection (ODRI), which is conventionally administered via polymethylmethacrylate (PMMA) bone cement. PMMA, however, is limited by a suboptimal antibiotic release profile and a lack of biodegradability. In this study, we compare the efficacy of PMMA versus an antibioticloaded hydrogel in a single- stage revision for chronic methicillin-resistant Staphylococcus aureus (MRSA) ODRI in. sheep. Antibiofilm activity of the antibiotic combination (gentamicin and vancomycin) was determined in vitro. Swiss alpine sheep underwent a single-stage revision of a tibial intramedullary nail with MRSA infection. Local gentamicin and vancomycin therapy was delivered via hydrogel or PMMA (n = 5 per group), in conjunction with systemic antibiotic therapy. In vivo observations included: local antibiotic tissue concentration, renal and liver function tests, and quantitative microbiology on tissues and hardware post-mortem. There was a nonsignificant reduction in biofilm with an increasing antibiotic concentration in vitro (p = 0.12), confirming the antibiotic tolerance of the MRSA biofilm. In the in vivo study, four out of five sheep from each treatment group were culture negative. Antibiotic delivery via hydrogel resulted in 10–100 times greater local concentrations for the first 2–3 days compared with PMMA and were comparable thereafter. Systemic concentrations of gentamicin were minimal or undetectable in both groups, while renal and liver function tests were within normal limits. This study shows that a single-stage revision with hydrogel or PMMA is equally effective, although the hydrogel offers certain practical benefits over PMMA, which make it an attractive proposition for clinical use

Currently, there is considerable interest in the role that metal allergy may play in the clinical performance of orthopaedic devices. The extant literature suggests that metal allergy is a real clinical phenomenon, albeit the prevalence and clinical impact are not defined. Degradation products in the form of ionic or particulate debris can complex with local proteins and alter their conformation so that they may not be recognised as self-proteins. This can result in an adaptive immune response. The typical paradigm proposed for such an allergy is that of a delayed type hypersensitivity response (Type 4) whereby the antigenic stimulus interacts with antigen presenting cells and T lymphocytes to elicit a cell mediated immune response. There is some evidence that patients with metal-on-metal bearings and/or high serum metal levels elicit more response to metal antigen challenge measured as either patch test sensitivity or lymphocyte proliferation. Thus, while there is an idiosyncratic aspect of the allergic response, there is also a dose response component. The diagnosis of metal allergy remains a challenge as patch testing has not been shown to correlate well with clinical symptoms. In-vitro assays, such as lymphocyte transformation testing, have promise but await robust clinical validation before they can be considered reliable diagnostic testing modalities. Allergy to implanted metal orthopaedic devices is a rare clinical event, and is a diagnosis of exclusion. Revision surgery should be considered a last resort with the understanding that the outcomes are unpredictable. Given the limitations of current diagnostic modalities, widespread screening of patients for metal allergies prior to TKA is not recommended

Aim. Periprosthetic joint infections (PJI) are a rare, but devastating complication. Diagnostic approaches to PJI vary greatly between different centers. Most commonly tissue biopsies and synovial fluid sampling are recommended for identification pathogens causing PJI. However, sensitivity and specificity of those techniques have been shown to be highly dependent on preanalytical factors like time and conditions of transportation, location of sampling, as well as analytical approaches and prolonged incubation for up to 14days. Sonication of explanted orthopedic devices has been shown to be more than only an addition in the diagnosis of PJI. The goal of this study was to evaluate the diagnostic value of sonication in PJI. Method. Retrospective cohort analysis of orthopedic samples sent for sonication from 29 surgical centers between 06/2014–04/2017. Until 07/2015 samples were plated on Columbia-, MacConkey-, Chocolate- and Schaedler agar*, incubated aerobically and anaerobically for up to 14 days. In 07/2015 an additional enrichment of 10ml per aerobic and anaerobic blood culture bottles* was introduced. The bottles were also incubated up to 14days and plated immediately if growth was detected. Results. We evaluated 698 orthopedic samples sent for sonication, of which resulted in growth of one (n=355) or several (n=15) relevant pathogens. Coagulase negative staphylococci were isolated in 162 cases; Staphylococcus aureus was isolated in 67 cases, Propionibacterium spp. In 23 cases, Streptococcus spp. in 14 cases, Gram negative in 44 cases, Enterococcus spp. also in 14 cases and Candida spp. in 3 cases. The necessary time of incubation to growth was further decreased to 1.8 days (range: 0–13) days after introduction of additional incubation of sonicate fluid in blood-culture bottles. 92.7% of all positive samples showed growth before the 8th day of incubation. Conclusions. Sonication of explanted orthopedic devices and culturing of the sonicate fluid provides a fast reliable tool for diagnosing pathogens of PJI/ODAI potentially without the need for prolonged incubation for up to 14 days. The additional incubation of the sonicate fluid in automated blood-culturing systems further improves the limit of detection and the time to growth. *BioMerieux, Marcy étoile

Orthopedic Device-Related Infections (ODRIs) are a major medical challenge, particularly due to the involvement of biofilm-encased and multidrug-resistant bacteria. Current treatments, based on antibiotic administration, have proven to be ineffective. Consequently, there is a need for antibiotic-free alternatives. Antimicrobial peptides (AMPs) are a promising solution due to their broad-spectrum of activity, high efficacy at very low concentrations, and low propensity to induce resistance. We aim to develop a new AMP-based chitosan nanogel to be injected during orthopedic device implantation to prevent ODRIs. Chitosan was functionalized with norbornenes (NorChit) through the reaction with carbic anhydride and then, a cysteine-modified AMP, Dhvar5, a peptide with potent antibacterial activity, even against methicillin-resistant Staphylococcus aureus (MRSA), was covalently conjugated to NorChit (NorChit- Dhvar5), through a thiol-norbornene photoclick chemistry (UV= 365 nm). For NorChit-Dhvar5 nanogels production, the NorChit-Dhvar5 solution (0.15% w/v) and Milli-Q water were injected separately into microfluidic system. The nanogels were characterized regarding size, concentration, and shape, using Transmission Electron Microscopy (TEM), Nanoparticle Tracking Analysis (NTA) and Dynamic light scattering (DLS). The nanogels antibacterial properties were assessed in Phosphate Buffer (PBS) for 6 h, against four relevant microorganisms (Pseudomonas aeruginosa, S. aureus and MRSA, and in Muller- Hinton Broth (MHB), 50% (v/v) in PBS, supplemented with human plasma (1% (v/v)), for 6 and 24 h against MRSA. The obtained NorChit-Dhvar5 nanogels, presented a round-shaped and ∼100 nm. NorChit- Dhvar5 nanogels in a concentration of 10. 10. nanogels/mL in PBS were capable of reducing the initial inoculum of P. aeruginosa by 99%, S. aureus by 99%, and MRSA by 90%. These results were corroborated by a 99% MRSA reduction, after 24 h in medium. Furthermore, NorChit-Dhvar5 nanogels do not demonstrate signs of cytotoxicity against MC3T3-E1 cells (a pre-osteoblast cell line) after 14 days, having high potential to prevent antibiotic-resistant infection in the context of ODRIs

While surgeon-industry relationships in orthopaedics have a critical role in advancing techniques and patient outcomes, they also present the potential for conflict of interest (COI) and increased risk of bias in surgical education. Consequently, robust processes of disclosure and mitigation of potential COI have been adopted across educational institutions, professional societies, and specialty journals. The past years have seen marked growth in the use of online video-based surgical education platforms that are commonly used by both trainees and practicing surgeons. However, it is unclear to what extent the same COI disclosure and mitigation principles are adhered to on these platforms. Thus, the purpose of the present study was to evaluate the frequency and adequacy of potential COI disclosure on orthopaedic online video-based educational platforms. We retrospectively reviewed videos from a single, publicly-accessible online peer-to-peer orthopaedic educational video platform (VuMedi) that is used as an educational resource by a large number of orthopaedic trainees across North America. The 25 highest-viewed videos were identified for each of 6 subspecialty areas (hip reconstruction, knee reconstruction, shoulder/elbow, foot and ankle, spine and sports). A standardized case report form was developed based on the COI disclosure guidelines of the American Academy of Orthopaedic Surgery (AAOS) and the Journal of Bone and Joint Surgery. Two reviewers watched and assessed each video for presentation of any identifiable commercial products or brand names, disclosure of funding source for video, and presenter's potential conflict of interest. Additionally, presenter disclosures were cross-referenced against commercial relationships reported in the AAOS disclosure database to determine adequacy of disclosure. Any discrepancies between reviewers were resolved by consensus wherever possible, or with adjudication by a third reviewer when necessary. Out of 150 reviewed videos, only 37 (25%) included a disclosure statement of any kind. Sixty-nine (46%) videos involved the presentation of a readily identifiable commercial orthopaedic device, implant or brand. Despite this, only 13 of these (19%) included a disclosure of any kind, and only 8 were considered adequate when compared to the presenter's disclosures in the AAOS database. In contrast, 83% of the presenters of the videos included in this study reported one or more commercial relationships in the AAOS disclosure database. Videos of presentations given at conferences and/or academic meetings had significantly greater rates of disclosure as compared to those that were not (41% vs 14%; p=0.004). Similarly, disclosures associated with conference/meeting presentations had significantly greater rates of adequacy (21% vs 7%; p=0.018). Even so, less than half of the educational videos originating from a conference or meeting included a disclosure of any kind, and only about half of these were deemed adequate. No differences were seen in the rate of disclosures between orthopaedic subspecialties (p=0.791). Online orthopaedic educational videos commonly involve presentation of specific, identifiable commercial products and brands, and the large majority of presenters have existing financial relationships with potential for conflict of interest. Despite this, the overall rate of disclosure of potential conflict of interest in these educational videos is low, and many of these disclosures are incomplete or inadequate. Further work is needed to better understand the impact of this low rate of disclosure on orthopaedic education both in-training and in practice

Aims: Minor foot amputations in diabetic subjects aim at the preservation of limb length and thus in keeping subject’s ability to walk. Different surgical techniques will be described and clinical 5-years outcome will be presented. Methods: The study comprises subjects with diabetic-neuropathic osteoarthropathy (DNOAP) who underwent minor amputations or resections of the foot between 1996–2001. In all patients post-treatment examination has been performed. Focus was on wound healing, duration of rehabilitation process, walking ability and the use of mobility aids. Results: In 86 diabetic subjects 121 minor amputations of the foot have been carried out. The frequency of reamputations was 56% in the mean with a distinct accumulation in the area of forefoot amputations. For post-surgery treatment in case of forefoot amputations orthopaedic shoes have been prescribed; in case of hindfoot amputations orthopaedic devices were used. The activity pattern according to the criteria of Hoffer revealed walking ability in 92% of the patients. Conclusions: Amputations and resections of the foot have a long lasting tradition and they deserve particular attention. Although a relatively high frequency of reamputations must be admitted, they allow for the preservation of limb length. However, as an essential prerequisite a high standard in the fabrication of orthopaedic shoes and orthopaedic devices must be secured

Introduction. In total joint replacement devices, material loss from the taper junctions is a clinical concern. Previous studies of explanted orthopedic devices have relied on visual scoring methods to quantify the fretting-corrosion damage on the component interfaces. Previous research has shown that visual fretting-corrosion evaluation is correlated to the volume of material loss [1], but scoring is semi-qualitative and does not provide a quantitative measure of the amount of material removed from the surface. The purpose of this study was to develop and validate a quantitative method for measuring the volume of material lost from the surfaces of explanted devices at the taper-trunnion junction. Methods. 10 new exemplar taper adapter sleeves (Ceramtec, Plochingen, Germany) were used for method validation. By using exemplar devices we were able to create clinically realistic taper damage in a controlled and repeatable manner using machining tools. Taper surfaces were measured before and after in vitro material removal using a roundness machine (Talyrond 585, Taylor Hobson, UK). Axial traces were measured on each taper surface using a diamond stylus. The mass of artificially removed material was also measured gravimetrically using a microgram balance (Sartorius, CPA225D, accuracy = ± 0.00003g). Surface profiles were analyzed using a custom MatLab script and Talymap software was used to provide 3D visualizations of the pattern of material loss. Calculated volumetric material loss was compared to the gravimetric value. A sensitivity analysis was conducted to determine the optimum number of traces to characterize the material loss from taper junctions. Results. Our calculations of material loss predicted over 99% of the variation in gravimetric material loss (Figure 1, r2 = 0.9962). Examples of the pattern of material removal from explanted components resembled the patterns reported in explants (Figure 2). The sensitivity analysis showed that a minimum of 24 axial profiles are required for measurements to stay within 2% of the volume calculated with 144 traces for cases with an axisymmetric wear pattern. Discussion. We have developed and validated a quantitative method for the material loss from taper junctions in orthopedic devices. Our sensitivity analysis showed that a minimum of 24 profiles are required to calculate volumetric material loss accurately, however a further sensitivity analysis is required to establish the minimum number of profiles required to accurately characterize “asymmetric” wear patterns. The measurement of 24 profiles takes approximately 20 minutes. The validation thus far has comprised material loss in an axisymmetric pattern. Work is underway to validate the evaluation of tapers with an asymmetric wear pattern. The axisymmetric and asymmetric patterns are realistic representations of wear patterns seen in explanted taper surfaces. This validated method of estimating material loss from taper junctions will be used in our ongoing research program to understand the mechanisms of fretting-corrosion in retrieved orthopaedic tapers

Orthopaedic implants are often fixed into place using bone cement. The degradation of the cement mantle has been implicated as playing a major role in the loosening of these implants, and this often necessitates revision surgery. The present work has used the non-destructive acoustic emission (AE) technique to monitor the initiation and evolution of fatigue damage in bone cement constructs. Using this technique, it should be possible to gain an understanding of failure progression in cemented orthopaedic devices. Previous work in this area has focused on AE activity originating from the eventual failure location in order to identify those signatures associated with critical fatigue cracks. This usually involves analysing AE signatures associated with the final stages of failure; however, there have been limited investigations that have looked at the damage that takes up most of the crack propagation life of the sample, (i.e. microcracking formation and development), that occurs away from the failure site, but could still play a role in final failure. In this study, dog-bone-shaped specimens of bone cement were subjected to uniaxial tensile fatigue loading, with damage monitored along the length of specimens using AE. Where specimens exhibited AE activity at locations away from the fracture site, they were sectioned and subjected to synchrotron tomography, which enabled high resolution images of these regions to be obtained. Microcracks of the order of 20 microns were observed in areas where AE had identified early, non-critical damage; in contrast, no microcracking was observed in areas that either remained unloaded or exhibited no AE. To further corroborate these observations, and characterise the damage mechanisms involved, scanning electron microscopy (SEM) was applied to the sectioned samples. In those locations where significant yet non-critical AE occurred, there was evidence of crack-bridging, suggesting that crack closure mechanisms may have slowed down or even arrested crack propagation within the bone cement. These findings further validate the use of AE as a passive non-destructive method for the identification and understanding of damage evolution in cemented orthopaedic devices

Introduction: Standard therapy for orthopedic device infections includes a two-stage exchange and prolonged antimicrobial therapy. In a subgroup of patients, retention of the device seems to be an effective alternative. Methods: In a prospective study we evaluated treatment efþcacy of orthopedic device infections with implant retention. Inclusion criteria were: early manifestation, stable implant, known pathogen, susceptibility of staphylococci to quinolones and rifampin, good condition of soft tissue. Initially, intravenous antimicrobial therapy was given for 2 weeks, followed by oral treatment for 10 weeks (knee prostheses for 6 months). Results: From January 1999 through June 2002, 19 patients were included: hip prosthesis (9), knee prostheses (6) and internal þxation devices (4). Isolated pathogens were: staphylococci (14), streptococci (4), enterococci (1), and Propionibacterium acnes (1). Open debridement with device retention was performed in 13 patients; the remaining 6 patients were treated with antibiotics only. After initial 2-week intravenous therapy, staphylococcal infections were treated with oral ciproßoxacin 750 mg bid + rifampin 450 mg bid, streptococcal and enterococcal infections with oral amoxicillin 750 mg tid and the P. acnes-infection with oral clindamycin 600 mg tid. 12 of 16 patients were followed for at least 24 months. 10 (83%) had no symptoms or signs of infection at follow-up, 2 (17%) had a relapse Conclusion: In carefully selected patients, device retention with antimicrobial treatment for 3–6 months may be an effective approach

MOXIMED KineSpring® Knee Implant System is an Orthopaedic device designed for younger or highly active patients with osteoarthritis. The device is placed under the skin, is attached to the tibia and femur, and contains springs which help limit some of the forces that are transmitted through the knee during activities such as walking or running and thereby relieve pain that may be experienced by patients with early arthritis of the knee. The aim of this study is to determine the long term safety and efficacy of the KineSpring knee implant system. This is a prospective case series involving two centres in Glasgow. 29 patients (mean age of 45.1 years and range 18-65 years) were recruited into the study between 2011 and 2016. The Primary outcome measure was Oxford knee score (OKS) at 2, 5 and 10 years post-operatively. Secondary outcome measures include device related complications and survival, patient reported functional outcome measures, patient satisfaction, pain levels and change in radiographic classification of osteoarthritis. At 2-year follow-up, 7 implants were removed (74.1% survival). Complications include deep infection, requiring removal in 1 patient, 2 implant failures requiring removal and one spring breakage. In comparison to pre-operative measures there was an improvement in the pain (3.58 vs. 5.20, p=0.02), stiffness (4.16 vs. 4.47, p=0.6) and OKS (32.4 vs. 36.9, p=0.03). The KineSpring improves overall pain, stiffness and functional outcome at 2 years following surgery, however there was a high rate of removal and further long-term follow up analysis is required regarding its effectiveness

For decades, universities and research centers have been applying modeling and simulation (M&S) to problems involving health and medicine, coining the expression in silico clinical trials. However, its use is still limited to a restricted pool of specialists. It is here proposed an easy-to-use cloud-based platform that aims to create a collaborative marketplace for M&S in orthopedics, where developers and model creators are able to capitalize on their work while protecting their intellectual property (IP), and researcher, surgeons and medical device companies can use M&S to accelerate time and to reduce costs of their research and development (R&D) processes. Digital libraries on . InSilicoTrials.com. are built on collaborations among first-rate research center, model developers, software, and cloud providers (partners). Their access is provided to life science and healthcare companies, clinical centers, and research institutes (users), offering them with several solutions for the different steps of the orthopedics and medical devices R&D process. The platform is built using the Microsoft Azure cloud services, conforming to global standards of security and privacy for healthcare, ensuring that clinical data is properly managed, protected, and kept private. The environment protects the IP of partners against the downloading, copying, and changing of their M&S solutions; while providing a safe environment for users to seamlessly upload their own data, set up and run simulations, analyze results, and produce reports in conformity with regulatory requirements. The proposed platform allows exploitation of M&S through a Software-as-a-Service delivery model. The pay-per-use pricing: 1. provide partners with a strong incentive to commercialize their high-quality M&S solutions; 2. enable users with limited budget, such as small companies, research centers and hospitals, to use advanced M&S solutions. Pricing of the M&S tools is based on specific aspects, such as particular features and computational power required, in agreement with the developing partner, and is distinct for different types of customers (i.e., academia or industry). The first medical devices application hosted on . InSilicoTrials.com. is NuMRis (Numerical Magnetic Resonance Implant Safety), implemented in collaboration with the U.S. F.D.A. Center for Devices and Radiological Health, and ANSYS, Inc. The automatic tool allows the investigation of radiofrequency (RF)-induced heating of passive medical implants, such as orthopedic devices (e.g., rods and screws), pain management devices (e.g., leads), and cardiovascular devices (e.g., stents), following the ASTM F2182-19e2 Standard Test Method. NuMRis promotes the broader adoption of digital evidence in preclinical trials for RF safety analysis, supporting the device submission process and pre-market regulatory evaluation. InSilicoTrials.com. aims at defining a new collaborative framework in healthcare, engaging research centers to safely commercialize their IP, i.e., model templates, simulation tools and virtual patients, by helping clinicians and healthcare companies to significantly expedite the pre-clinical and clinical development phases, and to move across the regulatory approval and HTA processes