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Abstract Background Femoral head avascular necrosis (AVN), or death of femoral head tissue due to a lack of blood supply, is a leading cause of total hip replacement for non-geriatric patients. Core decompression (CD) is an effective treatment to re-establish blood flow for patients with AVN. Techniques aimed at improving its efficacy are an area of active research. We propose the use of 3D printed drill guides to accurately guide therapeutic devices for CD. Methods Using femur sawbones, image processing software, and 3D modeling software, we created a custom-built device with pre-determined drill trajectories and tested the feasibility of the 3D printed drill guides for CD. A fellowship trained orthopedic surgeon used the drill guide to position an 8 ga, 230 mm long decompression device in the three synthetic femurs. CT scans were taken of the sawbones with the drill guide and decompression device. CT scans were processed in the 3D modeling software. Descriptive statistics measuring the angular and needle-tip deviation were compared to the original virtually planned model. Results Compared to the original 3D model, the trials had a mean displacement of 1.440 ± 1.03 mm and a mean angle deviation of 1.093 ± 0.749º. Conclusions The drill guides were demonstrated to accurately guide the decompression device along its predetermined drill trajectory. Accuracy was assessed by comparing values to literature-reported values and considered AVN lesion size. This study demonstrates the potential use of 3D printing technology to improve the efficacy of CD techniques.

Abstract Background The extended trochanteric osteotomy (ETO) is a surgical technique utilized to expose the intramedullary canal of the proximal femur, protect the soft tissues and promote reliable healing. However, imprecise execution of the osteotomy can lead to fracture, soft tissue injury, non-union, and unnecessary morbidity. We developed a technique to create patient specific, 3D-printed cutting guides to aid in accurate positioning of the ETO and improve osteotomy quality and outcomes. Methods Patient specific cutting guides were created based on CT scans using Synopysis Simpleware ScanIP and Solidworks. Custom 3D printed cutting guides were tested on synthetic femurs with foam cortical shells and on cadaveric femurs. To confirm accuracy of the osteotomies, dimensions of the performed osteotomies were compared to the virtually planned osteotomies. Results Use of the patient specific ETO cutting guides resulted in successful osteotomies, exposing the femoral canal and the femoral stem both in synthetic sawbone and cadaveric testing. In cadaveric testing, the guides allowed for osteotomies without fracture and cuts made using the guide were accurate within 6 percent error from the virtually planned osteotomy. Conclusion The 3D-printed patient specific cutting guides used to aid in ETOs proved to be accurate. Through the iterative development of cutting guides, we found that a simple design was key to a reliable and accurate guide. While future clinical trials in human subjects are needed, we believe our custom 3D printed cutting guide design to be effective at aiding in performing ETOs for revision total hip arthroplasty surgeries.

Background: In revision total knee arthroplasty, tibial cones have demonstrated improved longevity and reduced incidence of aseptic loosening. Several currently available “off-the-shelf” (OTS) cone systems may not have sizes to accommodate all patient bone morphologies. Methods: Computed tomographies from one hundred primary total knee arthroplasty patients and dimensions of 4 OTS cones were obtained. Press-fit stems were positioned in 3D tibia models to fit the diaphyseal trajectory. Cones were positioned around the stem at 1, 6, and 13 mm resections measured from the trough of the medial tibial plateau, simulating proximal tibial cuts and bone loss. Tibias were examined for cortical breaching following modeled cone preparation. Results: Increased rate of breaching was observed as size and depth of the cone increased. In 2/49 (4.1%) male and 19/46 (41.3%) female tibias, cones could not be positioned without breaching. No breaches were found in 22/49 (45.0%) male and 5/46 (10.9%) female tibias. For every 1 centimeter increase in patient height, odds of breaching decreased by 12% (odds ratio: 0.88, confidence interval: 0.84, 0.92). For every size increase in cone width, odds of breaching increased by 34% (odds ratio: 1.34, confidence interval: 1.28, 1.47). Placing cones deeper also increased breaching compared to the 1 mm cut. Conclusions: In revision total knee arthroplasty, smaller OTS or custom tibial cones may be needed to fit a patient’s proximal tibial geometry. This is especially true in patients not accommodated by the OTS cone sizes we tested, which impacted shorter patients and/or those with substantial bone loss requiring more tibial resection and deeper cone placement. Use of smaller or custom tibial cones should be considered where indicated.

Three-dimensional (3D) modeling and printing are increasingly used in the field of orthopaedic surgery for both research and patient care. One area where they are particularly helpful is in improving our understanding of the patellofemoral (PF) joint. Heretofore, morphological studies that use 3D models of the PF joint have primarily been based on computed tomography imaging data and thus do not incorporate articular cartilage. Here, we describe a method for creating 3D models of the articular surfaces of the PF joint based on magnetic resonance imaging. Models created using this technique can be used to improve our understanding of the morphology of the articular surfaces of the PF joint and its relationship to joint pathologies. Of particular interest is our finding of articular congruity in printed articular cartilage surfaces of dysplastic PF joints of recurrent patella dislocators.

Abstract Background Finite element modelling the material behavior of bone in-silico is a powerful tool to predict the best suited surgical treatment for individual patients. Results We demonstrate the development and use of a pre-processing plug-in program with a 3D modelling image processing software suite (Synopsys Simpleware, ScanIP) to assist with identifying, isolating, and defining cortical and trabecular bone material properties from patient specific computed tomography scans. The workflow starts by calibrating grayscale values of each constituent element with a phantom – a standardized object with defined densities. Using an established power law equation, we convert the apparent density value per voxel to a Young’s Modulus. The resulting “calibrated” scan can be used for modeling and in-silico experimentation with Finite Element Analysis. Conclusions This process allows for the creation of realistic and personalized simulations to inform a surgeon’s decision-making. We have made this plug-in program open and accessible as a supplemental file.

Abstract Background Polymethyl methacrylate, or “bone cement,” can be used intraoperatively to replace damaged or diseased bone and to deliver local antibiotics. 3D printed molds allow surgeons to form personalized and custom shapes with bone cement. One factor hindering the clinical utility of anatomically accurate 3D printed molds is that cured bone cement can be difficult to remove due to the strong adhesion between the mold and the bone cement. One way to reduce the adhesion between the 3D printed mold and the cured bone cement is with the use of a surface coating, such as a lubricant. This study sought to determine the optimal surface coating to prevent bone cement adhesion to 3D printed molds that could be utilized within a sterile operating room environment. Methods Hemispheric molds were 3D printed using a stereolithography printer. The molds were coated with four sterile surface coatings available in most operating theatres (light mineral oil, bacitracin ointment, lubricating jelly, and ultrasound transmission gel). Polymethyl methacrylate with tobramycin antibiotic was mixed and poured into the molds. The amount of force needed to “push out” the cured bone cement from the molds was measured to determine the efficacy of each surface coating. Tukey’s multiple comparison test was performed to compare the results of the pushout test. Results The average pushout force for the surface coatings, in increasing order, were as follows (mean ± standard deviation) --- bacitracin ointment: 9.10 ± 6.68 N, mineral oil: 104.93 ± 69.92 N, lubricating jelly: 147.76 ± 63.77 N, control group: 339.31 ± 305.20 N, ultrasound transmission gel 474.11 ± 94.77 N. Only the bacitracin ointment required significantly less pushout force than the control (p = 0.0123). Conclusions The bacitracin ointment was the most effective surface coating, allowing the bone cement to be pushed out of the mold using the least amount of force. In addition, the low standard deviation speaks to the reliability of the bacitracin ointment to reduce mold adhesion compared to the other surface coatings. Given its efficacy as well as its ubiquitous presence in the hospital operating room setting, bacitracin ointment is an excellent choice to prevent adhesion between bone cement and 3D printed molds intraoperatively.

Abstract 3D printing is revolutionizing the medical device landscape through its ability to rapidly create patient-specific anatomic models, surgical instruments, and implants. Recent advances in 3D printing technology have allowed for the creation of point-of-care (PoC) 3D printing centers. These PoC centers blur the line between healthcare provider, medical center, and device manufacturer, creating regulatory ambiguity. The United States Food & Drug Administration (FDA) currently regulates 3D printed devices through existing medical device regulations. However, the FDA is increasingly interested in developing guidelines and regulations specifically for PoC 3D printing due to its rapid adoption across the healthcare institutions. In this article, we review the regulatory framework that governs medical devices, discuss how PoC 3D printing falls within this framework, and describe a novel conceptual framework that the FDA has proposed. Finally, through analysis of the aforementioned regulations and discussions with industry medical 3D printing regulatory experts, we provide recommendations for PoC medical 3D printing best practices so that institutions are best positioned to utilize this revolutionary technology safely and effectively.

Three-dimensional (3D) modeling and printing comprise an important tool for orthopaedic surgeons. One area in which 3D modeling has the potential to dramatically improve our understanding of biomechanical kinematics is pathologies of the patellofemoral joint, in particular trochlear dysplasia. We describe a method for creating 3D printed models of the patellofemoral joint, including computed tomography image acquisition, image segmentation, model creation, and 3D printing. The models created can help surgeons understand and plan surgery for recurrent patellar dislocations.

Introduction Geriatric patients who suffer femoral neck fractures have high morbidity and mortality. Prophylactic fixation of the femoral neck is a potential avenue to reduce the incidence of femoral neck fractures. We studied 3 different implants traditionally used to stabilize the femoral neck: 6.5 mm cannulated screws (CANN), the femoral neck system (FNS) (Depuy Synthes), and the dynamic hip screw (DHS) (Depuy Synthes). Materials and Methods Five osteoporotic Sawbone femurs were used for each model and a control group. Two scenarios were investigated: single leg stance to measure construct stiffness and lateral impact to measure construct stiffness, energy to fracture, and qualitative examination of fracture patterns. Stiffness for each femur and energy to fracture for the lateral impact scenario were calculated and compared between groups using one-way ANOVA. Results DHS showed significantly higher stiffness than the other 2 implants and the control in single leg stance. In the lateral impact scenario, the DHS and CANN were significantly stiffer FNS and the control. Femurs implanted with CANN tended to fracture at the greater trochanter while FNS fractured in a transverse subtrochanteric pattern, and DHS fractured obliquely in the subtrochanteric region. Discussion FNS and DHS experienced fracture patterns less amenable to surgical correction. CANN and DHS proved better able to resist external forces in the lateral fall scenario. CANN also proved better able to resist external forces in the single leg stance scenario and experienced a more amenable fracture pattern in the lateral fall scenario. Conclusions FNS was less able to resist external forces compared with the other implants. This work informs the potential implications between the choice of implants that, although historically have not been used prophylactically, may be considered in the future for prophylactic stabilization of the femoral neck. Cadaveric study and clinical trials are recommended for further study.

Introduction Hip fractures cause significant morbidity and mortality for geriatric patients, and incidence is increasing as the population ages. Following a primary hip fracture, up to 20% may suffer a contralateral hip fracture within 5 years despite fracture risk reduction measures, including fall prevention and osteoporosis pharmacologic treatment. The aim of this study is to assess whether insertion of the Femoral Neck System (Depuy Synthes, West Chester, PA) into the contralateral proximal femur may strengthen the bone and decrease the incidence of contralateral hip fractures. Materials and Methods ScanIP, an image processing software was used to produce 3-dimensional models of a cadaver femur with the implanted device. Models were meshed and exported to Abaqus for finite element analysis to evaluate the device’s ability to reduce stress in the proximal femur. Results were analyzed for element-wise volume and von-Mises stresses. Results The implant reduced peak stress and bone failure at all levels of bone quality. Specifically in osteoporotic bone, the implant decreased peak stress by 27%, proximal femur trabecular bone failure by 5% and cortical bone failure by 100% in the femoral neck. Conclusions Our results from computer generated finite element analyses indicate that the Femoral Neck System may strengthen an osteoporotic proximal femur in the event of a lateral fall. Further investigation with expanded finite element analysis and cadaveric biomechanical studies are needed to validate these results.

Osteoporosis GWAS faces two challenges, causal gene discovery and a lack of phenotypic diversity. Here, the authors use the Diversity Outbred mouse population to inform human GWAS using networks and map genetic loci for 55 bone traits, identifying new potential bone strength genes.

Introduction The frequency of hip fractures, a major cause of morbidity and mortality for geriatric patients, is expected to increase exponentially in the next few decades. The aim of this study is to assess the ability of stainless-steel cannulated screws to reduce the risk of a femoral neck fracture, if placed prophylactically prior to a fall. Materials and Methods We created finite element models from computed tomography (CT) scan-based 3D models of a geriatric patient through 3D-image processing and model generation software. We used linear finite element simulations to analyze the effect of cannulated screws in the proximal femur in single-leg stance and lateral fall, which were processed for peak von Mises stresses and element failure. Findings Prophylactically placed cannulated screws significantly reduced failure in an osteoporotic proximal femur undergoing lateral fall. Three implanted screws in an inverted triangle formation decreased proximal femoral trabecular failure by 21% and cortical failure by 5%. This reduction in failure was achieved with a 55% decrease in femoral neck failure and 14% in lateral cortex failure. Conclusion Our results indicate that cannulated hip screws in an inverted triangle formation may strengthen an osteoporotic proximal femur in the event of a lateral fall. Mechanical testing on cadaveric or composite models is required to validate these results.

ABSTRACT Degenerative osteoarthritis (OA) is recognized as an early‐onset comorbidity of X‐linked hypophosphatemia (XLH), contributing to pain and stiffness and limiting range of motion and activities of daily living. Here, we extend prior findings describing biochemical and cellular changes of articular cartilage (AC) in the phosphate‐wasting environment of XLH to determine the impact of these changes on the biomechanical properties of AC in compression and potential role in the etiology of OA. We hypothesize that despite increased proteoglycan biosynthesis, disruption of the mineralized zone of AC impacts the mechanical properties of cartilage that function to accommodate loads and that therapeutic restoration of this zone will improve the mechanical properties of AC. Data were compared between three groups: wild type (WT), Hyp, and Hyp mice treated with calcitriol and oral phosphate. EPIC microCT confirmed AC mineral deficits and responsiveness to therapy. MicroCT of the Hyp subchondral bone plate revealed that treatment improved trabecular bone volume (BV/TV) but remained significantly lower than WT mice in other trabecular microstructures (p