High degree of alignment precision associated with total knee arthroplasty performed using a surgical robot or handheld navigation.

PURPOSE: The purpose of this study was to compare the precision of bony resections during total knee arthroplasty (TKA) performed using different computer-assisted technologies. METHODS: Patients who underwent a primary TKA using an imageless accelerometer-based handheld navigation system (KneeAlign2®, OrthAlign Inc.) or computed tomography-based large-console surgical robot (Mako®, Stryker Corp.) from 2017 to 2020 were retrospectively reviewed. Templated alignment targets and demographic data were collected. Coronal plane alignment of the femoral and tibial components and tibial slope were measured on postoperative radiographs. Patients with excessive flexion or rotation preventing accurate measurement were excluded. RESULTS: A total of 240 patients who underwent TKA using either a handheld (n = 120) or robotic (n = 120) system were included. There were no statistically significant differences in age, sex, and BMI between groups. A small but statistically significant difference in the precision of the distal femoral resection was observed between the handheld and robotic cohorts (1.5° vs. 1.1° difference between templated and measured alignments, p = 0.024), though this is likely clinically insignificant. There were no significant differences in the precision of the tibial resection between the handheld and robotic groups (coronal plane 0.9° vs. 1.0°, n.s.; sagittal plane 1.2° vs. 1.1°, n.s.). There were no significant differences in the rate of overall precision between cohorts (n.s.). CONCLUSIONS: A high degree of component alignment precision was observed for both imageless handheld navigation and CT-based robotic cohorts. Surgeons considering options for computer-assisted TKA should take other important factors, including surgical principles, templating software, ligament balancing, intraoperative adjustability, equipment logistics, and cost, into account. LEVEL OF EVIDENCE: III.

Framework for the Development of Affective and Smart Manufacturing Systems Using Sensorised Surrogate Models.

Human Factor strategy and management have been affected by the incorporation of Key Enabling Technologies (KETs) of industry 4.0, whereby operator 4.0 has been configured to address the wide variety of cooperative activities and to support skills that operate in VUCA (volatile, uncertain, complex, and ambiguous) environments under the interaction with ubiquitous interfaces on real and virtual hybrid environments of cyber-physical systems. Current human Competences-Capacities that are supported by the technological enablers could result in a radically disempowered human factor. This means that in the processes of optimization and improvement of manufacturing systems from industry 4.0 to industry 5.0, it would be necessary to establish strategies for the empowerment of the human factor, which constitute symbiotic and co-evolutionary socio-technical systems through talent, sustainability, and innovation. This paper establishes a new framework for the design and development of occupational environments 5.0 for the inclusion of singularized operators 4.0, such as individuals with special capacities and talents. A case study for workers and their inclusion in employment is proposed. This model integrates intelligent and inclusive digital solutions in the current workspaces of organizations under digital transformation.

Increase in Dissolution Rate of Zotepine via Nanomilling Process - Impact of Dried Nanocrystalline Suspensions on Bioavailability.

Zotepine is an atypical antipsychotic drug used in the treatment of schizophrenia. However, its poor dissolution properties limit its therapeutic efficacy. In this investigation, a series of nanosuspension-containing zotepine were prepared employing media milling method with an aim to improve its dissolution properties and oral bioavailability. Briefly, Box-Behnken design was applied to investigate the influence of various independent variables such as X1- amount of stabilizer, X2- amount of milling agent, and X3- milling time on the performance of the formulation. Dissolution studies revealed enhancement of dissolution rate as compared to pure drug. Solid state characterization (DSC, PXRD, and SEM) studies demonstrated no polymorphic changes in drug after lyophilization of media-milled nanosuspension. In vivo pharmacokinetic studies of lyophilized nanosuspension was carried out in rat and the results exhibited significant improvement in Cmax and AUC0-t, about 450.0 and 287.45%, respectively, suggesting amelioration in oral bioavailability by 2.87-fold higher as compared to pure drug. Accelerated stability studies of the optimized lyophilized formulation at 40°C and 75% RH suggested stability of the nanocrystals for at least a 6-month period. The obtained nanocrystals successfully showed dissolution enhancement and improved oral bioavailability of poorly water-soluble drug, zotepine.

INBED: A Highly Specialized System for Bed-Exit-Detection and Fall Prevention on a Geriatric Ward.

OBJECTIVE: In geriatric institutions, the risk of falling of patients is very high and frequently leads to fractures of the femoral neck, which can result in serious consequences and medical costs. With regard to the current numbers of elderly people, the need for smart solutions for the prevention of falls in clinical environments as well as in everyday life has been evolving. METHODS: Hence, in this paper, we present the Inexpensive Node for bed-exit Detection (INBED), a comprehensive, favourable signaling system for bed-exit detection and fall prevention, to support the clinical efforts in terms of fall reduction. The tough requirements for such a system in clinical environments were gathered in close cooperation with geriatricians. RESULTS: The conceptional efforts led to a multi-component system with a core wearable device, attached to the patients, to detect several types of movements such as rising, restlessness and-in the worst case-falling. Occurring events are forwarded to the nursing staff immediately by using a modular, self-organizing and dependable wireless infrastructure. Both, the hardware and software of the entire INBED system as well as the particular design process are discussed in detail. Moreover, a trail test of the system is presented. CONCLUSIONS: The INBED system can help to relieve the nursing staff significantly while the personal freedom of movement and the privacy of patients is increased compared to similar systems.

Integrating multisensor satellite data merging and image reconstruction in support of machine learning for better water quality management.

Monitoring water quality changes in lakes, reservoirs, estuaries, and coastal waters is critical in response to the needs for sustainable development. This study develops a remote sensing-based multiscale modeling system by integrating multi-sensor satellite data merging and image reconstruction algorithms in support of feature extraction with machine learning leading to automate continuous water quality monitoring in environmentally sensitive regions. This new Earth observation platform, termed "cross-mission data merging and image reconstruction with machine learning" (CDMIM), is capable of merging multiple satellite imageries to provide daily water quality monitoring through a series of image processing, enhancement, reconstruction, and data mining/machine learning techniques. Two existing key algorithms, including Spectral Information Adaptation and Synthesis Scheme (SIASS) and SMart Information Reconstruction (SMIR), are highlighted to support feature extraction and content-based mapping. Whereas SIASS can support various data merging efforts to merge images collected from cross-mission satellite sensors, SMIR can overcome data gaps by reconstructing the information of value-missing pixels due to impacts such as cloud obstruction. Practical implementation of CDMIM was assessed by predicting the water quality over seasons in terms of the concentrations of nutrients and chlorophyll-a, as well as water clarity in Lake Nicaragua, providing synergistic efforts to better monitor the aquatic environment and offer insightful lake watershed management strategies.

Novel Surgical Technique for Total Knee Arthroplasty Integrating Kinematic Alignment and Real-Time Elongation of the Ligaments Using the NextAR System.

This study introduces an innovative surgical approach for total knee arthroplasty (TKA) that combines kinematic alignment (KA) principles with real-time elongation of the knee ligaments through the range of motion, using augmented reality (AR). The novelty of the surgical technique lies in the possibility of enhancing the decision-making process to perform the cut on the tibia as for the KA caliper technique developed by Dr. Stephen Howell. The NextAR is a CT-based AR system that offers the possibility of performing three-dimensional surgical preoperative planning and an accurate execution in the surgical room through single-use infrared sensors, smart glasses, and a control unit. During the preoperative planning, the soft tissue is not considered and only the alignment based on bony reference is ensured. Thanks to the possibility of measuring in real time the elongation of the knee collateral lateral ligaments, the system assists the surgeon in optimizing the cut on the tibia after an accurate resurfacing of the femur as described in the KA surgical technique. The implant used in this novel approach is a medial pivot design (Medacta GMK Sphere) that allows the restoration of the physiological behavior of the software tissue and natural knee kinematics. In conclusion, this novel technique offers a promising approach to TKA, allowing personalized treatment tailored to each patient's unique anatomy and soft tissue characteristics. The integration of KA and real-time soft tissue analysis provided by NextAR enhances surgical precision and outcomes, potentially improving patient satisfaction and functional results.

Joint Replacement Technology in the Ambulatory Surgery Center: Current and Future Applications.

Total joint replacement (TJR) surgery in the ambulatory surgery centers (ASCs) has grown significantly over the past several years, along with the ability to improve the value of care. Standardization of high-quality, perioperative care is pivotal to the success of a TJR ASC program. As surgeons are experiencing increasing overhead with decreasing reimbursement, technology integration can provide major advantages. In this article, we will therefore highlight several examples of technologies that are changing the field and improving care in the preoperative, intraoperative, and postoperative settings.

The Surgeon Ergonomic Impact of a Tubular-Based Digital Camera to Perform a Seated Posterior Cervical Foraminotomy.

BACKGROUND: Posterior cervical decompression is a common spine procedure that can be performed with the patient in prone or sitting position. The sitting position provides the potential benefits of more facile retraction of surrounding soft tissues, increased operative field and fluoroscopic visualization, and decreased epidural bleeding. However, the surgeon's ergonomics of this positioning can be quite challenging when using the standard operative microscope to perform the procedure and may cause musculoskeletal harm to the surgeon. METHODS: A sterile digital camera was brought into the field to perform a sitting foraminotomy completed through the tube retractor at both C6-7 and C7-T1 levels. For half of the procedure, a typical neurosurgical operative microscope was brought into the field to evaluate surgeon ergonomics using baseline Rapid Entire Body Assessment (REBA) scores for 2 surgeons of differing stature. The digital camera was inserted onto the tubular retractor, and REBA scores were calculated. RESULTS: With a microscope, the surgeon with taller stature scored a 5 on the initial REBA scale, and the surgeon with shorter stature scored a 6, placing both in the medium-risk category. Once the tubular-based camera was placed, repeated REBA score of both surgeons was 3, placing them in the low-risk category. CONCLUSIONS: Using a tubular-based digital camera system, the ergonomics of the surgery are substantially improved. The surgeon can stand closer to the operative field and look directly at a front-facing screen, allowing increased relaxation of the upper extremity and cervical musculature; improving overall ergonomic function.

Factors for Individualization of Therapeutic Exercises for the Design of Health-Enabling Technologies.

Designing health-enabling technologies (HETs) to support individualized physiotherapeutic exercises requires comprehensive knowledge of bio-psycho-social factors to be considered. Therefore, this review identified factors for individualization of therapeutic exercises in patients with musculoskeletal shoulder disorders in peer-reviewed articles searched in MEDLINE. The final full-text analysis included 16 of 335 search results and extracted nineteen main categories of individualization factors. The most frequently identified main categories include progression of exercises, exercise framework, and assessment. An iterative approach with constant reassessments represents the key principle for the process of individualization. Categories that are difficult to standardize were rarely mentioned, but should also be considered. The identified factors can improve the design-process of HETs by sensitizing developers, enable further formal modelling, and support communication between developers, physiotherapists, and patients.

3D PBV-Net: An automated prostate MRI data segmentation method.

Prostate cancer is one of the most common deadly diseases in men worldwide, which is seriously affecting people's life and health. Reliable and automated segmentation of the prostate gland in MRI data is exceptionally critical for diagnosis and treatment planning of prostate cancer. Although many automated segmentation methods have emerged, including deep learning based approaches, segmentation performance is still poor due to the large variability of image appearance, anisotropic spatial resolution, and imaging interference. This study proposes an automated prostate MRI data segmentation approach using bicubic interpolation with improved 3D V-Net (dubbed 3D PBV-Net). Considering the low-frequency components in the prostate gland, the bicubic interpolation is applied to preprocess the MRI data. On this basis, a 3D PBV-Net is developed to perform prostate MRI data segmentation. To illustrate the effectiveness of our approach, we evaluate the proposed 3D PBV-Net on two clinical prostate MRI data datasets, i.e., PROMISE 12 and TPHOH, with the manual delineations available as the ground truth. Our approach generates promising segmentation results, which have achieved 97.65% and 98.29% of average accuracy, 0.9613 and 0.9765 of Dice metric, 3.120 mm and 0.9382 mm of Hausdorff distance, and average boundary distance of 1.708, 0.7950 on PROMISE 12 and TPHOH datasets, respectively. Our method has effectively improved the accuracy of automated segmentation of the prostate MRI data and is promising to meet the accuracy requirements for telehealth applications.

Using Digital Health to Support Best Practices: Impact of MRI Ordering Guidelines Embedded Within an Electronic Referral Solution.

BACKGROUND: Between 2003 and 2012, the number of MRIs performed in Canada more than doubled to 1.7 million [1]. According to a 2010 Health Council of Canada report nearly 30% of MRIs were inappropriately ordered [2]. The use of diagnostic imaging referral guidelines has been shown to improve the appropriateness of imaging orders [3, 4]. OBJECTIVES: To identify the number of unnecessary pre-consult MRIs ordered for patients with knee pain. As well, the impact that new evidence-based clinical decision support (DS) guidelines embedded within the referral form has had on the number of unnecessary MRIs was investigated. METHODS: This study employed a retrospective design approach. Charts of all knee pain patients over the age of 55 who were referred for consultation to the 5 participating orthopedic surgeons during the study period were reviewed by three medical students. RESULTS: 270 patient charts were included in this study. MRI was ordered for 60 patients with only 56.7% having had a prior X-ray. Of the 60 ordered MRIs, 50 (84%) were considered inappropriate, while only 10 (16%) were appropriate. Our results were compared to previous results of a quality improvement study implemented at the same clinic. A substantial reduction of 12% in the number of pre-consult MRIs and a 5% increase in the number of ordered X-rays before consultation was demonstrated. CONCLUSION: This work highlights the impact of including DS tools within an electronic referral form to support clinical best practices.

Formulation and performance of Irbesartan nanocrystalline suspension and granulated or bead-layered dried powders - Part I.

Nanocrystalline suspensions offer a promising approach to improve the dissolution rate of BCS Class II/IV drugs and hence oral bioavailability. Irbesartan (crystalline Form B), a poorly soluble drug substance was chosen as a model compound for the study. The objectives of the study were to formulate Irbesartan nanocrystalline suspension via media milling, study the effects of process and formulation variables on particle size reduction, and evaluate bead layering or spray granulation as drying processes. A Design of Experiment approach was utilized to understand the impact of formulation variables on particle size reduction via media milling. Drug concentration and type of stabilizer were found to be significant in particle size reduction. Optimized Irbesartan nanocrystalline suspension (i.e. at 10% w/w with 1% w/w poloxamer 407) showed superior in vitro dissolution profile compared to unmilled suspension. Optimized Irbesartan nanocrystalline suspension was converted into dried powders either by bead layering (with microcrystalline cellulose) or by spray granulation (either with mannitol or microcrystalline cellulose). DSC and PXRD studies revealed that Irbesartan remained crystalline post drying. Microcrystalline cellulose beads layered with Irbesartan nanocrystals showed about 65% drug dissolution within the first 10 min of dissolution study. Mannitol granules containing Irbesartan nanocrystals were fast dissolving (i.e. >90% drug dissolution within 10 min) compared to microcrystalline cellulose granules (i.e. approx. 46% drug dissolution within 10 min). Irbesartan nanocrystalline suspension had the fastest dissolution rates (i.e. >90% drug dissolution in two minutes) followed by mannitol-based granules containing dried Irbesartan nanocrystals (i.e. >90% drug dissolution in ten minutes).

Downstream processing of irbesartan nanocrystalline suspension and mini-tablet development - Part II.

The objectives of this study were to evaluate the impact of formulation variables on the drying of nanocrystalline suspensions either via bead layering or spray granulation and develop mini-tablets from the dried nanocrystalline powders. Irbesartan (crystalline Form B), a poorly soluble drug substance was chosen as a model compound. An optimized irbesartan nanocrystalline suspension with a mean particle size of 300 nm was utilized for the downstream processing. Irbesartan nanocrystalline suspension was dried either by layering onto the microcrystalline cellulose beads (i.e. 200 or 500 µm) or by granulation (mannitol or microcrystalline cellulose as substrates) at two different drug loadings (i.e. 10% or 30% w/w). Smaller size beads layered with nanocrystals resulted in faster dissolution profiles compared to larger size beads at both the studied drug loadings (i.e. 10 and 30% w/w). Mannitol granules containing irbesartan nanocrystals resulted in faster dissolution profiles compared to microcrystalline cellulose granules. Microcrystalline cellulose beads and mannitol granules containing irbesartan nanocrystals (i.e. 30% w/w drug loading) were further compressed into mini-tablets. Mini-tablets retained fast drug dissolution characteristics of the dried powders. The results from this study indicated that the spray granulation is a superior drying approach compared to bead layering for drying of irbesartan nanocrystalline suspension and mini-tablet development.

[Enabling technologies in synthetic biology--DNA synthesis, assembly and editing].

Synthetic biology is an emerging discipline, which aims at creating artificial lives or remolding the present organisms to generate new features. To achieve these goals, synthetic biologists need to design and synthesize new genes, pathways, modules or even whole genomes. As these enabling technologies (e.g. gene synthesis, DNA assembly and genome editing) are very important for the progress of synthetic biology, we will focus on the development of these technologies in this review.

The Connecting South West Ontario (cSWO) Benefits Model: An Approach for the Collaborative Capture of Value of Electronic Health Records and Enabling Technology.

This paper explains the benefits model developed and deployed by the connecting South West Ontario (cSWO) program. The cSWO approach is founded on the principles of enabling clinical and organizational value and the recognition that enabling requires a collaborative approach that can include several perspectives. We describe our approach which is aimed at creating a four-part harmony between change management and adoption, best practice research and quality indicators, data analytics and clinical value production.

Cell based advanced therapeutic medicinal products for bone repair: Keep it simple?

The development of cell based advanced therapeutic medicinal products (ATMPs) for bone repair has been expected to revolutionize the health care system for the clinical treatment of bone defects. Despite this great promise, the clinical outcomes of the few cell based ATMPs that have been translated into clinical treatments have been far from impressive. In part, the clinical outcomes have been hampered because of the simplicity of the first wave of products. In response the field has set-out and amassed a plethora of complexities to alleviate the simplicity induced limitations. Many of these potential second wave products have remained "stuck" in the development pipeline. This is due to a number of reasons including the lack of a regulatory framework that has been evolving in the last years and the shortage of enabling technologies for industrial manufacturing to deal with these novel complexities. In this review, we reflect on the current ATMPs and give special attention to novel approaches that are able to provide complexity to ATMPs in a straightforward manner. Moreover, we discuss the potential tools able to produce or predict 'goldilocks' ATMPs, which are neither too simple nor too complex.

Enabling technologies in synthetic biology--DNA synthesis, assembly and editing / 生物工程学报

Synthetic biology is an emerging discipline, which aims at creating artificial lives or remolding the present organisms to generate new features. To achieve these goals, synthetic biologists need to design and synthesize new genes, pathways, modules or even whole genomes. As these enabling technologies (e.g. gene synthesis, DNA assembly and genome editing) are very important for the progress of synthetic biology, we will focus on the development of these technologies in this review.