Bone age is a radiographical assessment used in pediatric medicine due to its relative objectivity in determining biological maturity compared to chronological age and size.1 Currently, Greulich and Pyle (GP) is one of the most common methods used to determine bone age from hand radiographs.2–4 In recent years, new methods were developed to increase the efficiency in bone age analysis like the shorthand bone age (SBA) and the automated artificial intelligence algorithms. The purpose of this study is to evaluate the accuracy and reliability of these two methods and examine if the reduction in analysis time compromises their accuracy. Two hundred thirteen males and 213 females were selected. Each participant had their bone age determined by two separate raters using the GP (M1) and SBA methods (M2). Three weeks later, the two raters repeated the analysis of the radiographs. The raters timed themselves using an online stopwatch while analyzing the radiograph on a computer screen. De-identified radiographs were securely uploaded to an automated algorithm developed by a group of radiologists in Toronto. The gold standard was determined to be the radiology report attached to each radiograph, written by experienced radiologists using GP (M1). For intra-rater variability, intraclass correlation analysis between trial 1 (T1) and trial 2 (T2) for each rater and method was performed. For inter-rater variability, intraclass correlation was performed between rater 1 (R1) and rater 2 (R2) for each method and trial. Intraclass correlation between each method and the gold standard fell within the 0.8–0.9 range, highlighting significant agreement. Most of the comparisons showed a statistically significant difference between the two new methods and the gold standard; however it may not be clinically significant as it ranges between 0.25–0.5 years. A bone age is considered clinically abnormal if it falls outside 2 standard deviations of the chronological age; standard deviations are calculated and provided in GP atlas.6–8 For a 10-year old female, 2 standard deviations constitute 21.6 months which far outweighs the difference reported here between SBA, automated algorithm and the gold standard. The median time for completion using the GP method was 21.83 seconds for rater 1 and 9.30 seconds for rater 2. In comparison, SBA required a median time of 7 seconds for rater 1 and 5 seconds for rater 2. The automated method had no time restraint as bone age was determined immediately upon radiograph upload. The correlation between the two trials in each method and rater (i.e. R1M1T1 vs R1M1T2) was excellent (κ= 0.9–1) confirming the reliability of the two new methods. Similarly, the correlation between the two raters in each method and trial (i.e. R1M1T1 vs R2M1T1) fell within the 0.9–1 range. This indicates a limited variability between raters who may use these two methods. The shorthand bone age method and an artificial intelligence automated algorithm produced values that are in agreement with the gold standard Greulich and Pyle, while reducing analysis time and maintaining a high inter-rater and intra-rater reliability

Knowledge of the premorbid glenoid shape and the morphological changes the bone undergoes in patients with glenohumeral arthritis can improve surgical outcomes in total and reverse shoulder arthroplasty. Several studies have previously used scapular statistical shape models (SSMs) to predict premorbid glenoid shape and evaluate glenoid erosion properties. However, current literature suggests no studies have used scapular SSMs to examine the changes in glenoid surface area in patients with glenohumeral arthritis. Therefore, the purpose of this study was to compare the glenoid articular surface area between pathologic glenoid cavities from patients with glenohumeral arthritis and their predicted premorbid shape using a scapular SSM. Furthermore, this study compared pathologic glenoid surface area with that from virtually eroded glenoid models created without influence from internal bone remodelling activity and osteophyte formation. It was hypothesized that the pathologic glenoid cavities would exhibit the greatest glenoid surface area despite the eroded nature of the glenoid and the medialization, which in a vault shape, should logically result in less surface area. Computer tomography (CT) scans from 20 patients exhibiting type A2 glenoid erosion according to the Walch classification [Walch et al., 1999] were obtained. A scapular SSM was used to predict the premorbid glenoid shape for each scapula. The scapula and humerus from each patient were automatically segmented and exported as 3D object files along with the scapular SSM from a pre-operative planning software. Each scapula and a copy of its corresponding SSM were aligned using the coracoid, lateral edge of the acromion, inferior glenoid tubercule, scapular notch, and the trigonum spinae. Points were then digitized on both the pathologic humeral and glenoid surfaces and were used in an iterative closest point (ICP) algorithm in MATLAB (MathWorks, Natick, MA, USA) to align the humerus with the glenoid surface. A Boolean subtraction was then performed between the scapular SSM and the humerus to create a virtual erosion in the scapular SSM that matched the erosion orientation of the pathologic glenoid. This led to the development of three distinct glenoid models for each patient: premorbid, pathologic, and virtually eroded (Fig. 1). The glenoid surface area from each model was then determined using 3-Matic (Materialise, Leuven, Belgium). Figure 1. (A) Premorbid glenoid model, (B) pathologic glenoid model, and (C) virtually eroded glenoid model. The average glenoid surface area for the pathologic scapular models was 70% greater compared to the premorbid glenoid models (P < 0 .001). Furthermore, the surface area of the virtual glenoid erosions was 6.4% lower on average compared to the premorbid glenoid surface area (P=0.361). The larger surface area values observed in the pathologic glenoid cavities suggests that sufficient bone remodelling exists at the periphery of the glenoid bone in patients exhibiting A2 type glenohumeral arthritis. This is further supported by the large difference in glenoid surface area between the pathologic and virtually eroded glenoid cavities as the virtually eroded models only considered humeral anatomy when creating the erosion. For any figures or tables, please contact the authors directly

Introduction. Direct skeletal attachment of prosthetic limbs, commonly known as osseointegration (“OI”), is being investigated by our team with the goal of safely introducing this technology into the United States for human use. OI technology allows for anchorage of prosthetic devices directly to bone using an intramedullary stem. For OI to be effective and secure, bone ingrowth and remodeling around the implant must be achieved. Physicians need an effective way to measure bone remodeling in order to make informed decisions on prescribed loading. This work describes methodology that was developed that utilizes computed tomography (CT) imaging as a tool for analyzing bone remodeling around an osseointegrated implant. Method. A subject implanted with a new Percutaneous Osseointegrated Prosthesis (POP) (DJO Surgical, Austin, TX) had CTs taken of their residual femur at 6-weeks and 12-months post-op in a FDA Early Feasibility Study with Institutional Review Board approval. Three-dimensional models of the femur were created from dicom files of the CT slices using Mimics (v21.0, Materialise, Leuven, Belgium). Each scan was segmented into four objects: cortical bone, medullary cavity, total volume (cortical bone plus the medullary cavity) and endoprosthetic stem (Fig. 1). Following segmentation, models were uploaded to 3-Matic Research (v13.0, Materialise, Leuven, Blegium) in STL format for alignment to a common world coordinate system (Fig. 2). A common origin was set by taking the average distance between planes of the femoral head and the greater trochanter. Once aligned to the coordinate system, biomechanical length (BML) was calculated from the proximal origin to the distal end of the amputated femur. BML and STLs of the aligned medullary cavity and femur volume were entered into custom Matlab code designed to measure cortical and medullary morphology in transverse cross sections of the femur. Morphology data from 6-weeks and 12-month time points were compared in order to determine if bone remodeling around the POP implant could be detected using these methods. Results. Comparing longitudinal data from post-operative visits suggests that important indicators of bone remodeling around the device could be detected (Fig 3). One year after implantation of the POP device the medullary perimeter and area had minimal % differences (−1.5 and 2.2) from the 6-week visit, validating that consistent alignment of the femoral model was achieved between scans from different time points. The cortical area, cortical perimeter, and cortical thickness around the POP implant showed positive percent changes at the 12-months of 19.44%, 4.04% and 14.36% respectively, with the largest increases observed at the the distal end for each parameter. These increases in cortex morphology values indicate bone changes were identified around the endoprosthetic stem of the implant. Discussion/Conclusion. This pilot study utilized CT imaging as a tool for analyzing bone remodeling around a new osseointegrated device. These methods can be performed quickly and accurately and have the potential for use in monitoring bone remodeling. CT scans from additional subjects are being analyzed to further validate and optimize these methods for clinical use. This study described an investigational device, limited by federal law to investigational use. No long-term data exists about its performance. For any figures or tables, please contact the authors directly

In conventional DXA (Dual-energy X-ray Absorptiometry) analysis, pixel bone mineral density (BMD) is often averaged at the femoral neck. Neck BMD constitutes the basis for osteoporosis diagnosis and fracture risk assessment. This data averaging, however, limits our understanding of localised spatial BMD patterns that could potentially enhance fracture prediction. DXA region free analysis (RFA) is a validated toolkit for pixel-level BMD analysis. We have previously deployed this toolkit to develop a spatio-temporal atlas of BMD ageing in the femur. This study aims first to introduce bone age to reflect the overall bone structural evolution with ageing, and second to quantify fracture-specific patterns in the femur. The study dataset comprised 4933 femoral DXA scans from White British women aged 75 years or older. The total number of fractures was 684, of which 178 were reported at the hip within a follow-up period of five years. BMD maps were computed using the RFA toolkit. For each BMD map, bone age was defined as the age for which the L2-norm between the map and the median atlas at that age is minimised. Next, bone maps were normalised for the estimated bone age. A t-test followed by false discovery rate (FDR) analysis was applied to compare between fracture and non-fracture groups. Excluding the ageing effect revealed subtle localised patterns of loss in BMD oriented in the same direction as principal tensile curves. A new score called f-score was defined by averaging the normalised pixel BMD values over the region with FDR q-value less than 1e–6. The area under the curve (AUC) was 0.731 (95% confidence interval (CI)=0.689–0.761) and 0.736 (95% CI=0.694–0.769) for neck BMD and f-score. Combining bone age and f-score improved the AUC significantly by 3% (AUC=0.761, 95% CI=0.756–0.768) over the neck BMD alone (AUC=0.731, 95% CI=0.726–0.737). This technique shows promise in characterizing spatially-complex BMD changes, for which the conventional region-based technique is insensitive. DXA RFA shows promise to further improve fracture prediction using spatial BMD distribution

INTRODUCTION. Hip resurfacing offers a more bone conserving solution than total hip replacement (THR) but currently has limited clinical indications related to some poor design concepts and metal ion related issues. Other materials are currently being investigated based on their successful clinical history in THR such as Zirconia Toughened Alumina (ZTA, Biolox Delta, CeramTec, Germany) which has shown low wear rates and good biocompatibility but has previously only been used as a bearing surface in THR. A newly developed direct cementless fixation all-ceramic (ZTA) resurfacing cup offers a new solution for resurfacing however ZTA has a Young's modulus approximately 1.6 times greater than CoCr - such may affect the acetabular bone remodelling. This modelling study investigates whether increased stress shielding may occur when compared to a CoCr resurfacing implant with successful known clinical survivorship. METHODS. A finite element model of a hemipelvis constructed from CT scans was used and virtually reamed to a diameter of 58mm. Simulations were conducted and comparisons made of the ‘intact’ acetabulum and ‘as implanted’ with monobloc cups made from CoCr (Adept®, MatOrtho Ltd, UK) and ZTA (ReCerf ™, MatOrtho Ltd. UK) orientated at 35° inclination and 20° anteversion. The cups were loaded with 3.97kN representing a walking load of 280% for an upper bound height patient with a BMI of 35. The cup-bone interface was assigned a coulomb slip-stick function with a coefficient of friction of 0.5. The percentage change in strain energy density between the intact and implanted states was used to indicate hypertrophy (increase in density) or stress shielding (decrease in density). RESULTS. Implanting both cups changed the strain distribution observed in the hemipelvis, Figure 1. The change in strain distribution was similar between materials and indicated a similar response from the bone, Figure 2. In both implanted cases, the inferior peri-acetabular bone around the implant indicated a reduction in bone strain. The bone remodelling distribution charts show that regardless of threshold remodelling stimulus level (75% in elderly, 50% in younger patients) the CoCr and ZTA cups were expected to produce the same bone response with only a small percentage of the bone in the hemipelvis indicating stress shielding or hypertrophy, Figure 3. DISCUSSION. Currently only metal cups are used for cementless fixation but improvements in design and technology have made it possible to engineer a thin-walled, direct fixation, all-ceramic cup. Both CoCr and ZTA are an order of magnitude greater than the Young's modulus of cortical bone altering the bone strain but changing the material from CoCr to a stiffer ZTA did not change the expected bone remodelling response. Given the clinical history of metal cups without loosening due to bone remodelling, the study indicates that a ZTA cup should not lead to increased stress shielding and is potentially suitable for as a cementless cup for both resurfacing and THR. SIGNIFICANCE. An all-ceramic cup is unlikely to lead to increased stress shielding around the acetabulum due to the change in material. For any figures or tables, please contact the authors directly

Low-energy fractures complications are a major public health issue that make osteoporosis even worse. In sub-Saharan Africa, the prevalence of osteoporosis varies from 18.2% to 65.8%. There was no change in bone mineral density between HIV-infected and non-HIV-infected women in Sub-Saharan Africa, where HIV is widespread. Other investigations that demonstrated that HIV-infected people had poor BMD both before and after starting anti-retroviral treatment did not consistently show a low BMD finding. Inflammation-mediated bone remodelling has been associated with low BMD in HIV-infected patients. Antiretroviral Therapy has been demonstrated to exacerbate bone loss in addition to the pre-existing intrinsic risk of developing osteoporosis. Question: Is there loss of bone in HIV-infected patients before initiating ART?. The patients who were HIV-positive and enrolled in the ADVANCE research were retrospectively reviewed on a desk. All of the 1053 individuals in the ADVANCE research had a DXA scan performed to evaluate BMD as part of the initial screening and recruitment approach. The ADVANCE research enrolled HIV-positive people and randomly assigned them to three ART arms. A total of 400 patients were reviewed. Of these 400 records reviewed, 62.3% were female. 80% of the participants were younger than 40 years old, and 3% were older than 50 years. 82% were virally suppressed with less than 50 viral copies. The prevalence of osteopenia was 25.5% and osteoporosis was 2.8%, observed in predominantly African female participants aged between 30 and 39 years. The findings of this study confirm that there is pre-existing bone loss among HIV-infected ART naïve individuals. Approximately 28.3% in our study had clinically confirmed evidence of bone loss and of these, 2.8% of the entire cohort had osteoporosis. Bone loss was most prevalent in black females who are virologically suppressed

Distal radius fractures are the most common osteoporotic fractures among women. The treatment of these fractures has been shifting from a traditional non-operative approach to surgery, using volar locking plate (VLP) technology. Surgery, however, is not without risk, complications including failure to restore an anatomic reduction, fracture re-displacement, and tendon rupture. The VLP implant is also marked by bone loss due to stress-shielding related to its high stiffness relative to adjacent bone. Recently, a novel internal, composite-based implant, with a stiffness less than the VLP, was designed to eradicate the shortcomings associated with the VLP implant. It is unclear, however, what effect this less-stiff implant will have upon adjacent bone density distributions long-term. The objective of this study was to evaluate the long-term effects of the two implants (the novel surgical implant and the gold-standard VLP) by using subject-specific finite element (FE) models integrated with an adaptive bone formation/resorption algorithm. Specimen: One fresh-frozen human forearm specimen (female, age = 84 years old) was imaged using CT and was used to create a subject-specific FE model of the radius. Finite element modeling: In order to simulate a clinically relevant (unstable) fracture of the distal radius, a wedge of bone was removed from the model, which was approximately 10 mm wide and centered 20 mm proximal to the tip of the radial styloid. Bone remodeling algorithm: A strain-energy density (SED) based bone remodeling theory was used to account for bone remodeling. With this approach, bone density decreased linearly when SED per bone density was less than 67.5 µJ/g and increased when it was more than 232.5 µJ/g. When it was in the lazy zone (67.5 to 232.5 µJ/g), no changes in density occurred. Boundary conditions: A 180 N quasi-static force representing the scaphoid, and a 120 N quasi-static force representing the lunate was applied to the radius. The midshaft of the radius was constrained. FE outcomes: To examine the effects of stress shielding associated with each implant, the long-term changes of bone density within proximal transverse cross-sections of radius were inspected. The regional density analysis focused on three transverse cross-sections. The transverse cross-sections were positioned proximal to the subchondral plate, and were distanced 50 (cross-section A), 57 (cross-section B), and 64 mm (cross-section C) from the subchondral endplate. For both implants in all three cross-sections, cortical bone was reserved completely at the volar side. On the dorsal side, the cortical bone was completely resorbed in the VLP model. In all cross-sections, the averaged resultant density was higher for the “novel implant”. The difference ranged from 33% (cross-section A) to 36% (cross-section C) in favor of the “novel implant”. On average, the density values of the novel implant were 34% higher in transverse cross-sections (A, B, and C). This study showed that the novel implant offered higher density distributions compared to the VLP, which suggests that the novel implant may be superior to the VLP in terms of avoiding stress shielding

INTRODUCTION. The magnitude of principal strain is indicative of the risks of femoral fracture,. 1,2. while changes in femoral strain energy density (SED) after total hip arthroplasty (THA) have been associated with bone remodeling stimulus. 3. Although previous modeling studies have evaluated femoral strains in the intact and implanted femur under walking loads through successfully predicting physiological hip contact force and femoral muscle forces,. 1,2,3. strains during ‘high load’ activities of daily living have not typically been evaluated. Hence, the objective of this study was to compare femoral strain between the intact and the THA implanted femur under peak loads during simulated walking, stair descent, and stumbling. METHODS. CTs of three cadaveric specimens were used to develop finite element (FE) models of intact and implanted femurs. Implanted models included a commercially-available femoral stem (DePuy Synthes, Warsaw, IN, USA). Young's moduli of the composite bony materials were interpolated from Hounsfield units using a CT phantom and established relationships. 4. Peak hip contact force and femoral muscle forces during walking and stair descent were calculated using a lower extremity musculoskeletal model. 5. and applied to the femur FE models (Fig. 1). While maintaining the peak hip contact forces, muscle forces were further adjusted using an iterative optimization approach in FE models to reduce the femur deflection to the reported physiological range (< 5 mm). 2. Femoral muscle forces during stumbling were estimated utilizing the same optimization approach with literature-reported hip contact forces as input. 6. Maximum and minimum principal strains were calculated for each loading scenario. Changes in SED between intact and THA models were calculated in bony elements around the stem. RESULTS. As expected, high loads during stumbling resulted in the highest peak principal strains along femoral diaphysis (THA: 3179±523 and −4559±629 με; intact: 4232±818 and −5853±204 με) compared to stair descent and typically evaluated gait loads (THA: 1741±363 and −1893±76 με; intact: 2256±887 and −2509±493 με; Fig. 2). Principal strains in THA models peaked close to the tip of the femoral stem across three activities, compared with proximally located peak principal strains in the intact models (Fig. 2). Bony elements located medially and laterally to the femoral stem showed decreased SED after THA, while increased SED was observed in elements distal to the femoral stem (Fig. 3). DISCUSSION. Using appropriately distributed muscle forces, our model predicted similar peak principal strains and SED differences compared with reported values during walking (peak principal strains: ±1500 to ±2000 με. 1,2. ; SED differences: ± 0.02 MPa. 3. ). In addition to the close to failure level principal strains, stumbling showed the most noticeable changes in SED compared with the other two activities. Results suggest iterative bone remodeling simulations should include a composite of activities-of-daily-living loading conditions as well as appropriately distributed muscle forces. For any figures or tables, please contact authors directly

The advantages of unicompartmental knee arthroplasty (UKA) include its bone preserving nature, lower relative cost and superior functional results. Some temporary pain has been reported clinically following this procedure. Could this be related to bone remodeling? A validated bone remodeling algorithm may have the answers…. A 3D geometry of an intact human cadaveric tibia was generated using CT images. An all poly unicompartmental implant geometry was positioned in an inlay and onlay configuration on the tibia and the post-operative models created. An adaptive bone remodeling algorithm was used with finite element modeling to predict the bone remodeling behavior surrounding the implant in both scenarios. Virtual DEXA images were generated from the model and bone mineral density (BMD) was measured in regions of interest in the AP and ML planes. BMD results were compared to clinical results. The bone remodelling algorithm predicted BMD growth in the proximal anterior regions of the tibia, with an inward tendency for both inlay and onlay models. Looking in the AP plane, a maximum of up to 7% BMD growth was predicted and in the ML plane this was as high as 16%. Minimal BMD loss was observed, which suggests minimal disturbance to the natural bone growth following UKA. Positron emission tomography (PET) scans showed active hot spots in the antero- medial regions of the tibia. These results were consistent with the finite element modeling results. Bone remodeling behavior was found to be sensitive to sizing and positioning of the implant. The adaptive bone remodeling algorithm predicted minimal BMD loss and some BMD growth in the anterior region of the tibia following UKA. This is consistent with patient complaint and PET scans

Introduction. A previous computational study on an all-polymer PEEK-on-UHMWPE total knee replacement implant showed improved periprosthetic bone loading, compared to a conventional implant [1]. That study used a simulated gait cycle to determine distal loading, but a patella was not included. Substantial distal decrease of bone remodeling stimulus was found, in accordance with previous reports [2], but it was not consistent with other clinical and post-mortem DEXA results, which found the largest loss of bone stock in the anterior region [3,4]. As patellofemoral forces are relatively low during gait compared to squatting, we simulated a deep squat, expecting that a high-demand activity would provide similar indications of bone loss as literature [3,4]. Consequently, we applied both high tibiofemoral and patellofemoral loads, to provide more insight in the potential benefits of a new PEEK-Optima® femoral component on periprosthetic bone stock. Methods. We adopted a deep squat finite element model from Zelle et al. and included quasi-static deep flexion and load sharing at the posterior condyles [6]. A new implant design was inserted, with three variations in material properties: intact, CoCr and PEEK. The stiffness of the femoral elements was mapped from CT and applied to either the cut femur only (CoCr and PEEK) or the entire femoral construct (intact). The strain energy density (SED) was evaluated in the periprosthetic region as a measure for bone remodeling stimulus. To examine the effects of the entire exercise, SED values were integrated over all increments. Results. During squat the highest SED values were found at the intercondylar region, behind the posterior condyles and behind the anterior flange, extending further inward to the bone. Both the lateral and medial view of the periprosthetic region show markedly different SED patterns from the conventional CoCr implant. Higher values originating proximally extended to lower values in the anterodistal region (Figure 1). However, in the CoCr reconstruction these anterodistal patterns less prominent or even absent. In Figure 2, simulated DEXA images are presented showing the bone remodeling stimulus throughout the periprosthetic volume. Overall, the image for CoCr shows darker areas than PEEK and the reference, further corroborating the findings shown in Figure 1. Moreover, it is visible that the PEEK reconstruction had SED values similar to the reference in the femoral component region. Discussion. This study has corroborated that the influence of the patella in high-demanding tasks is of great importance to the anterior periprosthetic bone stock [4,5]. The loss of bone remodeling stimulus in the CoCr reconstruction is in accordance with literature findings [2–4]. The resemblance of PEEK to the intact reference suggests that the new PEEK-Optima® femoral component could largely retain the integrity of the periprosthetic bone

INTRODUCTION. Total hip arthroplasty (THA) is a very successful orthopaedic treatment with 15 years implant survival reaching 95%, but decreasing age and increasing life expectancy of THA patients ask for much longer lasting solutions. Shorter and more flexible cementless stems are of high interest as these allow to maintain maximum bone stock and reduce adverse long-term bone remodeling.1 However, decreasing stem length and reducing implant stiffness might compromise the initial stability by excessively increasing interfacial stresses. In general, a good balance between implant stability and reduced stress shielding must be provided to obtain durable THA reconstruction.2. This finite element (FE) study aimed to evaluate primary stability and bone remodeling of a new design of short hip implant with solid and U-shaped cross-section. MATERIALS AND METHODS. The long tapered Quadra-H stem and the short SMS implants (Medacta International, Castel San Pietro, Switzerland) were compared in this study (Figure 1). A FE model of a femur was based on calibrated CT data of an 81 year-old male (osteopenic bone quality). Both titanium alloy implants were assigned an elastic modulus of 105 GPa and the Poisson's ratios were set to 0.3. Initial stability simulations included the hip joint force and all muscle loads during a full cycle of normal walking as calculated in AnyBody software (Anybody Technology AS, Denmark), whereas the remodeling simulation used the peak loads from normal walking and stair climbing activities. Initial stability results are presented as micromotions on the implant surface with a threshold of 40 µm.3 Bone remodeling outcomes are represented in a form of simulated Dual X-ray Absorptiometry (DEXA) scans and the quantitative bone mineral density (BMD) changes in 7 periprosthetic zones. RESULTS. The U-shaped SMS implant showed slightly higher micromotions (2.7% surface area exceeding 40 µm) than the Quadra-H stem (0.2%), whereas micromotions of solid SMS were considerably higher (8.4%) (Figure 2). The largest micromotions were found on medial side of all implants. The smallest bone loss one year post-operatively was predicted around the U-shaped SMS implant. Proximal zones (1, 6 and 7) showed the largest bone loss with average of 9.9%, 11.8% and 12.8% for the U-shaped SMS, solid SMS and Quadra-H respectively (Figure 3). The bone remodeling prediction for the Quadra-H stem was in good agreement with clinical DEXA measurements (overall bone loss of 5.5% vs. 5.7). CONCLUSION. The U-shaped SMS implant is clearly superior to its solid version and has potential to provide comparable initial stability as the long Quadra-H stem and considerably better long-term bone stock preservation

Introduction. Trabecular Titanium is a biomaterial characterized by a regular three-dimensional hexagonal cell structure imitating trabecular bone morphology. Components are built via Electron Beam Melting technology in aone- step additive manufacturing process. This biomaterial combines the proven mechanical properties of Titanium with the elastic modulus provided by its cellular solid structure (Regis 2015 MRS Bulletin). Several in vitro studies reported promising outcomes on its osteoinductive and osteoconductive properties: Trabecular Titanium showed to significantly affect osteoblast attachment and proliferation while inhibiting osteoclastogenesis (Gastaldi 2010 J Biomed Mater Res A, Sollazzo 2011 ISRN Mater Sci); human adipose stem cells were able to adhere, proliferate and differentiate into an osteoblast-like phenotype in absence of osteogenic factors (Benazzo 2014 J Biomed Mater Res A). Furthermore, in vivo histological and histomorphometric analysis in a sheep model indicated that it provided bone in-growth in cancellous (+68%) and cortical bone (+87%) (Devine 2012 JBJS). A multicentre prospective study was performed to assess mid-term outcomes of acetabular cups in Trabecular Titanium after Total Hip Arthroplasty (THA). Methods. 89 patients (91 hips) underwent primary cementless THA. There were 46 (52%) men and 43 (48%) women, with a median (IQR) age and BMI of 67 (57–70) years and 26 (24–29) kg/m2, respectively. Diagnosis was mostly primary osteoarthritis in 80 (88%) cases. Radiographic and clinical evaluations (Harris Hip Score [HHS], SF-36) were performed preoperatively and at 7 days, 3, 6, 12, 24 and 60 months. Bone Mineral Density (BMD) was determined by dual-emission X-ray absorptiometry (DEXA) according to DeLee &Charnley 3 Regions of Interest (ROI) postoperatively at the same time-points using as baseline the measureat 1 week. Statistical analysis was carried out using Wilcoxon test. Results. Median (IQR) HHS and SF-36 improved significantly from 48 (39–61) and 49 (37–62) preoperatively to 99 (96–100) and 76 (60–85) at 60 mo. (p≤0.0001). Radiographic analysis showed evident signs of bone remodelling and biological fixation, with presence of superolateral and inferomedial bone buttress, and radial trabeculae in ROI I/II. All cups resulted radiographically stable without any radiolucent lines. The macro-porous structure of this biomaterial generates a high coefficient of friction (Marin 2012 Hip Int), promoting a firm mechanical interlocking at the implant-bone interface which could be already observed in the operating room. BMD initially declined from baseline at 7 days to 6 months. Then, BMD slightly increased or stabilized in all ROIs up to 24 months, while showing evidence of partial decline over time with increasing patient' age at 60 months, although without any clinical significance in terms of patients health status or implant stability. Statistical significant correlations in terms of bone remodeling were observed between groups of patients on the basis of gender and age (p≤0.05). No revision or implant failure was reported. Conclusions. All patients reported significant improvements in quality of life, pain relief and functional recovery. Radiographic evaluation confirmed good implant stability at 60 months. These outcomes corroborate the evidence reported on these cups by orthopaedic registries and literature (Perticarini 2015 BMC Musculoskelet Disord; Bistolfi 2014 Min Ortop)

A resorbable, antibiotic-eluting bone void filler (AEBVF) was developed to address device-related infections. The AEBVF provides two functions: osteoconductive matrix for bone restoration, and local antibiotic delivery to treat device-related infections. In vitro evaluations of this AEBVF demonstrated antimicrobial activity to 7 weeks against Staphylococcus aureus (S. aureus).1 Subsequent rabbit studies demonstrated bactericidal capacity2 of the AEBVF against 105 CFU S. aureus and osteoconductivity.1 We hypothesized that the AEBVF would restore bone volume while eliminating 105 CFU S. aureus in a pilot sheep femoral condyle defect model. Four groups (n=2/group) were utilized to assess osteoconductivity (Group A-commercial ProOsteon & B-AEBVF) and antimicrobial activity (Group C-ProOsteon with 105 CFU S. aureus & D-AEBVF with 105 CFU S. aureus). AEBVF devices comprised degradable polymers (PCL, PEG, PLGA), ProOsteon (Biomet, USA), CaCl2, and tobramycin.3 Devices (1.5cc ProOsteon or 6 AEBVF croutons) were implanted into rectangular defects in the medial face of each sheep femoral condyle. Defects were evaluated using backscatter electron microscopy, mineral apposition rate (MAR) analysis, and light microscopy with Sanderson's Rapid Bone Stain (SRBS). All animals in Groups A, B, and D survived to the 12-week endpoint. In contrast, Group C animals were euthanized 11 days post-op. MAR and SRBS demonstrated comparable bone remodeling and defect restoration after 12 weeks in Groups A, B, and D. Notably, implant volumes of Groups A and D were greatly diminished (0.16±0.1%; 0.35%) after 12 weeks, compared to Group A (13.23±3.2%) and Time “0” (16.8%). These data show the AEBVF device's ability to: eliminate 105 CFU S. aureus, promote bone remodeling comparable to known bone void filler, and degrade at rates that do not interfere with bone remodeling

Background. Stemless prostheses are recognized to be an effective solution for anatomic total shoulder arthroplasty (TSA) while providing bone preservation and shortest operating time. Reverse shoulder arthroplasty (RSA) with stemless has not showed the same effectiveness, as clinical and biomechanical performances strongly depend on the design. The main concern is related to stability and bone response due to the changed biomechanical conditions; few studies have analyzed these effects in anatomic designs through Finite Element Analysis (FEA), however there is currently no study analyzing the reverse configuration. Additionally, most of the studies do not consider the effect of changing the neck-shaft angle (NSA) resection of the humerus nor the proper assignment of spatial bone properties to the bone models used in the simulations. The aim of this FEA study is to analyze bone response and primary stability of the SMR Stemless prosthesis in reverse with two different NSA cuts and two different reverse angled liners, in bone models with properties assigned using a quantitative computed tomography (QCT) methodology. Methods. Sixteen fresh-frozen cadaveric humeri were modelled using the QCT-based finite element methodology. The humeri were CT-scanned with a hydroxyapatite phantom to allow spatial bone properties assignment [Fig. 1]. Two implanted SMR stemless reverse configurations were considered for each humerus: a 150°-NSA cut with a 0° liner and a 135°-NSA cut with a 7° sloped liner [Fig. 2]. A 105° abduction loading condition was simulated on both the implanted reverse models and the intact (anatomic) humerus; load components were derived from previous dynamic biomechanical simulations on RSA implants for the implanted stemless models and from the OrthoLoad database for the intact humeri. The postoperative bone volume expected to resorb or remodel [Fig. 3a] in the implanted humeri were compared with their intact models in sixteen metaphyseal regions of interest (four 5-mm thick layers parallel to the resection and four anatomical quadrants) by means of a three-way repeated measures ANOVA followed by post hoc tests with Bonferroni correction. In order to evaluate primary stability, micromotions at the bone-Trabecular Titanium interface [Fig. 3b] were compared between the two configurations using a Wilcoxon matched-pairs signed-rank test. The significance level α was set to 0.05. Results. With the exception of the most proximal layer (0.0 – 5.0 mm), the 150°-NSA configuration showed overall a statistically significant lower bone volume expected to resorb (p = 0.011). In terms of bone remodelling, the 150°-NSA configuration had again a better response, but fewer statistically significant differences were found. Regarding micromotions, there was a median decrease (Mdn = 3.2 μm) for the 135°-NSA configuration (Mdn = 40.3 μm) with respect to the 150°-NSA configuration (Mdn = 43.5 μm) but this difference was non-significant (p = 0.464). Conclusions. For the analyzed SMR Stemless configurations, these results suggest a reduction in the risk of bone resorption when a 0° liner is implanted with the humerus cut at 150°. The used QCT-based methodology will allow further investigation, as this study was limited to one single design and load case. For any figures or tables, please contact the authors directly

For amputated patients, direct attachment of upper leg prosthesis to the skeletal system by a percutaneous implant is an alternative solution to the traditional socket fixation. Currently available implants, the OPRA system (Integrum AB, Göteborg, Sweden) and the ISP Endo/Exo prosthesis (ESKA Implants AG, Lübeck, Germany) [1-2] allow overcoming common soft tissue problems of conventional socket fixation and provide better control of the prosthetic limb [3], higher mobility and comfort [2, 4]. However, restraining issues such as soft-tissue infections, peri-prosthetic bone fractures [3, 5–8] and considerable bone loss around the stem [9], which might lead to implant's loosening, are present. Finally, a long a residual limb is required for implant fitting. In order to overcome the limiting biomechanical issues of the current designs, a new concept of the direct intramedullary fixation was developed. The aim was to restore the natural load transfer in the femur and allow implantations in short femur remnants (Figure 1). We hypothesize that the new design will reduce the peri-prosthetic bone failure risk and adverse bone remodeling. Generic CT-based finite element models of an intact femoral bone and amputated bones implanted with 3 analyzed implants were created for the study. Models were loaded with two loading cases from a normal walking obtained from the experimental measurements with the OPRA device [10-11]. Periprosthetic bone failure risk was evaluated by considering the von Mises stress criterion [12-14]. Subsequently the strain adaptive bone remodeling theory was used to predict long-term changes in bone mineral density (BMD) around the implants. The bone mineral content (BMC) change was measured around implants and the results were visualized in the form of DXA scans. The OPRA and the ISP implants induced the high stress concentration in the proximal region decreasing in the distal direction to values below physiological levels as compared with the intact bone. The stresses around the new design were more uniformly distributed along the cortex and resembled better the intact case. Consequently, the bone failure risk was reduced as compared to the OPRA and the ISP implants. The adaptive bone remodeling simulations showed high bone resorption around distal parts of the OPRA and the ISP implants in the distal end of the femur (on average −75% ISP to −78% OPRA after 60 months). The bone remodeling simulation did not reveal any bone loss around the new design, but more bone densification was seen (Figure 2). In terms of total bone mineral content (BMC) the OPRA and the ISP implants induced only a short-term bone densification in contrast to the new design, which provoked a steady increase in the BMC over the whole analyzed period (Figure 3). In conclusion, we have seen that the new design offers much better bone maintenance and lower failure probability than the current osseointegrated trans-femoral prostheses. This positive outcome should encourage further developments of the presented concept, which in our opinion has a potential to considerably improve safety of the rehabilitation with the direct fixation implants and allow treatment of patients with short stumps

Interestingly, recent studies have shown promising outcomes in elderly. To the best of our knowledge there are no reports available assessing sequential bone remodelling around DCPD (dicalcium phosphate dehydrate) coated short metaphyseal loading stem using serial radiography. Hence we report the unique patterns of bone remodelling in patients 70 years and older and whether these patterns were different from those seen in younger patients. A total of 41 consecutive primary hip arthroplasties were performed in patients with averaged age of 78.3 years using short stem. The presence and patterns of radiolucent lines, radio-opaque lines, calcar rounding, proximal bone resorption, spot welds, cortical hypertrophy, and intramedullary bone formation around the distal tip were assessed at serial radiography up to averaged follow up of 24.5 months. In early stage of stability, the radio-opaque line appeared in lateral aspect of stem which might means the tension force of stem. On the contrary to this findings, the medial side of stem mainly showed the spot welds due to compression on calcar support. The sequential radiographic bone remodelling in 70 years and older showed the different pattern from those of 30 to 50 year-old. Formation of new endosteal trabeculation (spot welds) were seen only in 55.6% of stems among the elderly study group where as all patients showed spot welds in the younger group. Calcar resorption was often observed in younger group but the degree of calcar resorption was less. The other findings in elderly patients was not different compared to those of younger patients

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

Background and aim. Despite good survivorship analysis for most uncemented tapered straight stems, new proposals modifying stem design in total hip replacement (THR) are being introduced in order to facilitate femoral revision surgery. We have evaluated the clinical and radiological results of four different designs of uncemented tapered straight stems implanted in our institution in order to assess: operative complications, clinical results, survivorship analysis for aseptic loosening and radiographic findings. Methods. 1008 hips implanted from 1998 to 2006 were prospectively followed for a mean of 12 years (range, 10 to 17). Four uncemented femoral designs employing a tapered straight stem were included: 209 Alloclassic stems, 420 Cerafit, 220 SL-Plus and 159 Summit. All hips had a 28 or 32 mm femoral head, and polyethylene (PE)-on metal or ceramic-on-ceramic bearing surface. Radiological femoral type, stem position, femoral canal filling at three levels and the possible appearance of loosening and other bone remodelling changes were recorded in all hips. Results. The rate of intra- and post-operative peri-prosthetic fractures ranged from 0 to 2.5%. No thigh pain was reported in unrevised patients. Among all groups, a total of 15 stems were revised for any cause. The revision rates for any cause at 12 years ranged from 97.1 to 99.3%. (p=0.1). 10 femoral components were revised for aseptic loosening: 6 Alloclassic stems with PE liner sterilized by Nitrogen and 3 SL-Plus stems with standard PE. No revision for aseptic loosening was found in the other designs. The survival rate for stem aseptic loosening was 97.1% (95% CI 95.6–100) for the Alloclassic group at 17 years and 98.2% (95% CI 96.2–100) for the SL-Plus at 14 years. The percentage with a neutral stem position was lower in the Alloclassic and SL-Plus groups (p=0.04). We found that femoral canal filling depended on stem group and stem position at three levels A, B and C (p<0.001). Femoral canal filling was greater in the SL-Plus group at three levels than the others (p<0.001). Bone remodelling changes were more frequent in the SL-Plus group, radiolucent lines (p<0.001) and cortical hypertrophy (p<0.001). Conclusion. Uncemented tapered straight stems consistently provide excellent clinical outcome and bone fixation. Newer proposals must consider these results, avoiding changing successful characteristics and concentrate on improving the less successful aspects

Aim. A gentamicin-eluting biocomposite consisting of hydroxyapatite and calcium sulfate. 1. can provide effective dead space management in chronic osteomyelitis. However, radiographic follow-up after implantation of this novel material has consistently shown evidence of several unique imaging features previously not described with other comparable bone graft substitutes. Conclusive interpretation of these newly described imaging features is difficult as long term follow-up and histological correlation is not yet available. The aim of this study was to establish a large animal model, closely simulating the clinical situation in order to permit further analysis of imaging features in correlation with histological progression of bone remodelling. Method. Standardised bone defects were created in ten Merino-wool sheep (age: two to four years). Large drill holes (diameter 2.5cm, depth 2cm, volume approx. 10ml) were placed in the medial femoral condyles of both hind legs and filled with a gentamicin antibiotic eluting bone graft substitute. *. Initially surgery was carried out on the right hind leg. Three months later, an identical intervention was performed on the contralateral side. With sacrifice planned after six or twelve months, bone voids three, six, nine and twelve months post-implantation are obtained for evaluation. The study was approved by the Animal Care Committee of Thuringia, Germany. Results. We present our preliminary radiographic results after a follow-up of six months. The bio-composite was clearly visible on all initial post-operative radiographs, showing intimate contact to the surrounding cancellous bone of the distal femur. At one month, a radio-dense ring around the bone void (the so called “halo sign”) was found in four of six bone voids treated with the biocomposite. From 2 months onwards this “halo” typically appeared to progress towards the centre of the treated defects, where spherical remnants of the composite often become increasingly apparent. This pattern has been termed “marble sign” and often appears in combination with the halo-sign. Between three to six months bone remodelling appears to continue, halo- and marble sign increasingly disappear and the composite becomes more and more indistinct from surrounding cancellous bone. Conclusions. We have established a large animal model, which appears to mimic the clinical situation very well and reproduces comparable radiographic post implantation features previously observed and described in clinical cases (including the “halo” and the “marble” sign). We expect that this model will provide valuable information regarding the correlation between histological and basic & advanced imaging features (including MRI, CT and Dexa scans) in the future

Despite the generally inferior clinical performance of acetabular prostheses as compared to the femoral implants, the causes of acetabular component loosening and the extent to which mechanical factors play a role in the failure mechanism are not clearly understood yet. The study was aimed at investigating the load transfer and bone remodelling around the uncemented acetabular prosthesis. The 3-D FE model of a natural right hemi-pelvis was developed using CT-scan data. The same bone was implanted with two uncemented hemispherical acetabular components, one metallic (CoCrMo alloy) and the other ceramic (Biolox delta), with 54 mm outer diameter and 48 mm bearing diameter. The FE models of the implanted pelvis (containing ∼116000 quadratic tetrahedrals) were generated using a submodelling approach, which were based on an overall full model of implanted pelvis (containing ∼217600 quadratic tetrahedrals) acted upon by hip joint force and twenty one muscle forces. The apparent density (ρ in g cm. −3. ) of each cancellous bone element was calculated using linear calibration of CT numbers of bone, from which the Young's modulus (E in MPa) was determined using the relationship, E = 2017.3 ρ. 2.46. [1]. Implant-bone interface conditions, fully bonded and debonded with friction coefficient μ = 0.5, were simulated using contact elements. Applied loading conditions consist of two load cases during a gait cycle, corresponding to 13% and 52% of the walking cycle. Fixed constraints were prescribed at the pubis and at the sacroiliac joint. The bone remodelling algorithm was based on strain energy based site-specific formulation [2]. The FE analysis, in combination with the bone remodelling simulation, was performed using ANSYS FE software. The predicted changes in peri-prosthetic bone density were similar for the metallic and the ceramic implant. For debonded implant-bone interface, stress shielding led to ∼20% reductions in bone density at supero-anterior, infero-anterior and posterior part of the acetabulum (Fig. 1). However, bone apposition was observed at the supero-posterior part of the acetabulum, where implantation led to ∼60% increase in bone density (Fig. 1). The effect of bone resorption was higher for the fully bonded implant-bone interface, wherein bone density reductions of 20–50% were observed in the cancellous bone underlying the implant (Fig. 1), which is indicative of implant loosening over time. However, implantation led to an increase in bone density around the acetabular rim for both the interface conditions (Fig. 1). These results are well corroborated by the earlier studies [3, 4]. Implantation with a ceramic component resulted in 2–7% increase in bone density at supero-posterior part of the acetabulum as compared to the metallic component, for the debonded interface condition. Considering better wear resistant properties and absence of metal ion release, results of this study suggest that the ceramic component might be a viable alternative to the metallic prosthesis