Developing and Testing of Low-cost 3D Printed Prostheses to Restore and Improve Function of Children with Congenital or Traumatic Amputations

The purpose of this investigation was to provide technical considerations and clinical evidence of the possible benefits and obstacles in the use of upper-limb 3D printed prostheses in paediatric populations. This information is crucial for clinicians interested in exploring the use of 3D printed prostheses for their patients. In the present study, children with congenital digit reductions (n=5); absent digits (one traumatic and four congenital) (n=5) and with upper-limb reductions (n=9). The perceived functionality of upper-limbs before the use of the prosthesis and after 4 months of use. In addition, gross dexterity, anthropometric measurements, active range of motion, and strength measurements were assessed before and after 6 month of using a low-cost 3D printed prosthetic hand. Their parents completed a survey at 1 and 3 months asking to quantify the time their child used the prosthesis on a daily basis in addition to the type of activities they performed with the prosthesis. The main finding of our studies is that the initial prosthesis design of the Cyborg Beast was not a functional solution for congenital paediatric patients with remnant opposition and pinch function, but significantly increased forearm circumference (Before=16.70±1.86 cm and After=17.80±1.48 cm), wrist active ROM flexion (Before=54.60±14.48° and After=68.40±14.29°), and active ROM extension (Before=40.40±37.75° and After=47.00±36.42° cm) after 6 months of use and can be incorporated in several activities at home and in school. However, 44% of our research participants reported durability issues and/or malfunctioning of these devices after 3 months of use

Brain lateralization in children with upper‑limb reduction deficiency

Background: The purpose of the current study was to determine the influence of upper-limb prostheses on brain activity and gross dexterity in children with congenital unilateral upper-limb reduction deficiencies (ULD) compared to typically developing children (TD). Methods: Five children with ULD (3 boys, 2 girls, 8.76 ± 3.37 years of age) and five age- and sex-matched TD children (3 boys, 2 girls, 8.96 ± 3.23 years of age) performed a gross manual dexterity task (Box and Block Test) while measuring brain activity (functional near-infrared spectroscopy; fNIRS). Results: There were no significant differences (p = 0.948) in gross dexterity performance between the ULD group with prosthesis (7.23 ± 3.37 blocks per minute) and TD group with the prosthetic simulator (7.63 ± 5.61 blocks per minute). However, there was a significant (p = 0.001) difference in Laterality Index (LI) between the ULD group with prosthesis (LI = − 0.2888 ± 0.0205) and TD group with simulator (LI = 0.0504 ± 0.0296) showing in a significant ipsilateral control for the ULD group. Thus, the major finding of the present investigation was that children with ULD, unlike the control group, showed significant activation in the ipsilateral motor cortex on the non-preferred side using a prosthesis during a gross manual dexterity task. Conclusions: This ipsilateral response may be a compensation strategy in which the existing cortical representations of the non-affected (preferred) side are been used by the affected (non-preferred) side to operate the prosthesis. This study is the first to report altered lateralization in children with ULD while using a prosthesis. Trial registration The clinical trial (ClinicalTrial.gov ID: NCT04110730 and unique protocol ID: IRB # 614-16-FB) was registered on October 1, 2019 (https ://clini caltr ials.gov/ct2/show/NCT04 11073 0) and posted on October 1, 2019. The study start date was January 10, 2020. The first participant was enrolled on January 14, 2020, and the trial is scheduled to be completed by August 23, 2023. The trial was updated January 18, 2020 and is currently recruitin

DEVELOPMENT AND TESTING OF NOVEL ANTIMICROBIAL MATERIALS FOR ADDITIVE MANUFACTURING WITH APPLICATION IN SPACE

PURPOSE: The purpose of the study was twofold: (i) develop and test the antimicrobial properties of a polylactic acid- and a polyurethane-based filament, and (ii) use these filaments to manufacture a socket-based prosthesis to verify printability and longevity of the antimicrobial properties. It was hypothesized that the formulation of a novel biocidal copper-based nanocomposite with a biocompatible 3D printing polymer/copolymer can be used for the development of antimicrobial medical devices to mitigate microbial risks during long space flight missions [1, 2, 3]. METHODS: Polylactic Acid-based Filament Development-The development of a polylactic acid-based filament involved several processes, such as fermentation (corn to Lactic Acid), condensation (Lactide) and polymerization (Polylactic acid; PLA). The addition of copper antimicrobial nanocomposite additive to pellets at different concentrations facilitated the development of a multipurpose antimicrobial filament. The addition of a treated carbon fiber and natural fibers nanocomposites our team create a high strength polylactic acid-based filament (Zuniga, 2018). Polyurethane-based Filament Development-The current polyurethane-based filament is a versatile non-toxic biocompatible flexible filament with a wide variety of applications. To confer biocidal activity to this filament, the inorganic copper-based nanocomposite additive was immobilized physically by embedment in the polyurethane-based filament structure. The additive use zeolites as carriers. The metallic ions contained in zeolite are replaced by copper ions with biocidal properties through ionic exchange. The use of nanoparticles effectively increased the concentration of copper within the zeolites maximizing the antimicrobial behavior. The result was a polyurethane-based flexible filament with high biocidal activity, better action spectrum and longer duration. Antimicrobial testing-Antimicrobial effectiveness and longevity of the filaments was tested by an independent laboratory following standard procedures for ISO 22196 before and after a heat-based accelerating aging agent for a period of 1 month equivalent to 1 year period of aging (Situ Biosciences LLC, wheeling, IL, Chicago, USA). The antimicrobial longevity was tested using a heat-based accelerating aging agent (50°C) using a standard oven heat accelerated aging protocol for standard environmental conditions. Six flat test samples (5 cm x 5cm x 1cm) of each material was manufactured and tested. The ISO 22196 is designed to measure the antimicrobial properties of a solid plastic surface incubated with bacteria, such as two strains of Staphylococcus Aureus (Methicillin-resistant and standard strain) and Escherichia Coli. RESULTS: The bacterial analysis showed that both, the acid- and polyurethane-based filaments with 1% antibacterial nanoparticles additives was up to 99.99% effective against two strains of Staphylococcus Aureus (Methicillin-resistant and standard strain) and Escherichia Coli. The materials showed a 98.99% reduction after one year of simulated aging. The printability of the device was similar o standard polylactic acid and thermoplastic polyurethane filaments. The extrusion process did not affect the antimicrobial properties of the filaments [2]. CONCLUSIONS: A recent study [3] found that 28 astronauts experienced an altered immune response during their six-month mission aboard the International Space Station [3]. The direct cause of this altered immune behavior has not been identified, but may be linked to radiation, microbes, stress, microgravity, altered sleep cycles and isolation 1. In a prolonged space mission, these factors could cause increased susceptibility to illness and, in turn, limitations to human space exploration [1, 3]. The unprecedented accessibility of additive manufacturing technology and the development of 3D printing “Active Materials” have several medical applications and have the potential to revolutionize the manufacturing of medical devices. Promising applications include developing medical devices in austere environments such as space (i.e., International Space Station and inflight medical conditions) as a preventive countermeasure to mitigate microbial risks during long space flight missions [1]. REFERENCES: [1] Zuniga JM, Thompson M. Application of 3D Printing Materials in Space. Journal of 3D Printing in Medicine. 3(1):5-9, 2019 [2] Zuniga, J.. 3D Printed Antibacterial Prostheses. Applied Sciences, 8(9), 1651, 2018. [3] Crucian BE, Choukèr A, Simpson RJ, et al. Immune System Dysregulation During Spaceflight: Potential Countermeasures for Deep Space Exploration Missions. Frontiers in immunology. 2018;9:1437-1437

Salivary gland dysfunction markers in type 2 diabetes mellitus patients

Background: Diabetes mellitus (DM) is a chronic disease of the carbohydrate metabolism that, when not rigorously controlled, compromises systemic and organ integrity, thereby causing renal diseases, blindness, neuropathy, arteriosclerosis, infections, and glandular dysfunction, including the salivary glands. The aim of this study was to determine the relationship between the qualitative and quantitative parameters of salivary alteration, which are indicators of salivary gland dysfunction, and the level of metabolic control of type 2 diabetes patients. Material and Methods: A convenience sample of 74 voluntary patients with type 2 DM was selected, each of whom donated a sample of unstimulated saliva. Salivary parameters such as salivary flow rate, protein concentration, pH, and xerostomia were studied. Results: There is a positive relationship between the level of metabolic control measured with HbA1 and the protein concentration in saliva (Spearman rho = 0.329 and p = 0.004). The same assay showed an inverse correlation between HbA1 and pH (Spearman rho = -0.225 and p = 0.05). Conclusions: The protein concentration in saliva and, to a lesser extent, the pH may be useful as glandular dysfunction indicators in DM2 patients

Impact of COVID-19 on cardiovascular testing in the United States versus the rest of the world

Objectives: This study sought to quantify and compare the decline in volumes of cardiovascular procedures between the United States and non-US institutions during the early phase of the coronavirus disease-2019 (COVID-19) pandemic. Background: The COVID-19 pandemic has disrupted the care of many non-COVID-19 illnesses. Reductions in diagnostic cardiovascular testing around the world have led to concerns over the implications of reduced testing for cardiovascular disease (CVD) morbidity and mortality. Methods: Data were submitted to the INCAPS-COVID (International Atomic Energy Agency Non-Invasive Cardiology Protocols Study of COVID-19), a multinational registry comprising 909 institutions in 108 countries (including 155 facilities in 40 U.S. states), assessing the impact of the COVID-19 pandemic on volumes of diagnostic cardiovascular procedures. Data were obtained for April 2020 and compared with volumes of baseline procedures from March 2019. We compared laboratory characteristics, practices, and procedure volumes between U.S. and non-U.S. facilities and between U.S. geographic regions and identified factors associated with volume reduction in the United States. Results: Reductions in the volumes of procedures in the United States were similar to those in non-U.S. facilities (68% vs. 63%, respectively; p = 0.237), although U.S. facilities reported greater reductions in invasive coronary angiography (69% vs. 53%, respectively; p < 0.001). Significantly more U.S. facilities reported increased use of telehealth and patient screening measures than non-U.S. facilities, such as temperature checks, symptom screenings, and COVID-19 testing. Reductions in volumes of procedures differed between U.S. regions, with larger declines observed in the Northeast (76%) and Midwest (74%) than in the South (62%) and West (44%). Prevalence of COVID-19, staff redeployments, outpatient centers, and urban centers were associated with greater reductions in volume in U.S. facilities in a multivariable analysis. Conclusions: We observed marked reductions in U.S. cardiovascular testing in the early phase of the pandemic and significant variability between U.S. regions. The association between reductions of volumes and COVID-19 prevalence in the United States highlighted the need for proactive efforts to maintain access to cardiovascular testing in areas most affected by outbreaks of COVID-19 infection

Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

Colombian consensus recommendations for diagnosis, management and treatment of the infection by SARS-COV-2/ COVID-19 in health care facilities - Recommendations from expert´s group based and informed on evidence

La Asociación Colombiana de Infectología (ACIN) y el Instituto de Evaluación de Nuevas Tecnologías de la Salud (IETS) conformó un grupo de trabajo para desarrollar recomendaciones informadas y basadas en evidencia, por consenso de expertos para la atención, diagnóstico y manejo de casos de Covid 19. Estas guías son dirigidas al personal de salud y buscar dar recomendaciones en los ámbitos de la atención en salud de los casos de Covid-19, en el contexto nacional de Colombia

THE EFFECT OF A TRAINING INTERVENTION ON BIMANUAL SYNCHRONY AND MUSCULAR CO-CONTRACTION DURING USE OF AN UPPER LIMB PROSTHESIS

An estimated 35-58% of children with upper limb reductions (ULR) reject their prosthesis due to various factors including weight, discomfort, and lack of functionality [1-2]. This study was designed to assess the impact of training on functionality as measured by bimanual synchrony and muscular co-contractions with a body-powered prosthesis. A 19-year-old female with a congenital left hand ULR was recruited for the case study. Her bimanual synchrony and muscular co-contraction were measured before and after an 8-week training intervention. The home intervention included activities of daily living such as cutting pieces of paper, using utensils, and holding a tray. Co-contraction values were expressed as a Coactivation Index (CI) and calculated as a percentage of antagonist over agonist activity during maximal voluntary contraction. Bimanual synchrony was calculated as the difference in time between the limbs. During MVC for flexion, the CI for the affected limb (M ± SD) were 31.10 ± 1.54 at Baseline and 23.11 ± 9.98 at Follow-Up. During extension, the CI for the unaffected limb were 17.33 ± 1.50 and 25.43 ± 1.94 respectively. The CI values for the affected hand indicate that the participant has a higher percentage of flexor activity following the training. At Baseline, task synchrony between hands was -0.03 ± 0.04 seconds. At Follow-Up, synchrony was 0.04 ± 0.08 seconds, indicating a tendency to lead with the non-affected hand during tasks. Further assessment of functionality should assess participant perceived functionality with the prosthetic

FUNCTIONAL AND COORDINATION OUTCOMES OF AN 8-WEEK INTERVENTION USING A 3D PRINTED PROSTHESIS

By the year 2050, it is expected that 3.6 million people will have upper limb amputations. Despite the increase in functionality provided by prostheses, a recent study found that 45% of children with upper limb deficiencies reject their prosthetic device. Training paradigms for acquired amputees and stroke survivors focus on interlimb transfer paradigms to transfer motor repertoires from the non-affected limb to the affected limb, consequently, increasing the use of the affected limb in day-to-day life. Thus, the purpose of this study is to assess the temporal synchrony of hand movement during a reaching task and gross manual dexterity after completing an 8-week home intervention. We hypothesized that bimanual coordination will be more synchronous and there will be an increase in unilateral gross manual dexterity after the completion of 8-week home intervention. The research subjects were given a 3D printed prosthesis which was designed and scaled to be as proportional and symmetric to the length and circumference of the participant’s non-affected limb. Box and Block and bimanual coordination assessments were performed at baseline and three months after the start of the study. Six subjects were given instructions to practice using their prosthetic at home for two hours a week while five were enrolled in an 8-week home intervention program. The home interventions consisted of two virtual-home visits per week where a training protocol was administered. The 8-week intervention program will ensure repetition of reaching movements and will create better outcomes in bimanual and gross manual dexterity motor assessments

The impact of seawater with calcium and magnesium removal for the flotation of copper-molybdenum sulphide ores

The use of seawater in the flotation of copper-molybdenum sulphide ores is becoming increasingly important. However, the complex chemistry by the presence of calcium and magnesium hydroxyl-complexes interferes with the recovery of molybdenite. This study analyzes the impact of pre-treated seawater with calcium and magnesium removal on the floatability of copper-molybdenum sulphide ores. The pretreatment was carried out by a mixture of NaCO and CaO, which promotes the precipitation of calcium and magnesium ions. Three different conditions were compared, (i) flotation in seawater at pH 11.5; (ii) flotation in pretreated seawater with calcium and magnesium removal at pH 11.5; and (iii) flotation in seawater at natural pH, i.e. pH\ua0≈\ua07.6. While the copper recovery was similar in all cases, the recovery of molybdenum at high alkaline condition was notably increased when seawater harness was reduced. On the other hand, a high pyrite depression was reached because the oxidizing atmosphere at pH 11.5 allows Fe(OH) formation