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Full-Text Articles in Operations Research, Systems Engineering and Industrial Engineering

Understanding Visual Representation Of Imputed Data For Aiding Human Decision-Making, Ryan M. Thompson Jan 2020

Understanding Visual Representation Of Imputed Data For Aiding Human Decision-Making, Ryan M. Thompson

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The effectiveness of representing higher dimensional data on a two-dimensional visualization was required to be studied in the development of a novel data imputation method, Continuous Imputation With Association Rules (CIWAR). When the CIWAR method is used to impute missing data, the method generates additional metadata that increases each imputed data point's dimensionality. Potential use cases for CIWAR include situations where imputed data would be analyzed by individuals with little or no data analytic experience or situations where imputed data would be used to aid high-stress time-critical human decision processes. A study was conducted to assess the effect of the …


Investigation Of Retrieved Cardiac Devices, Anmar Salih, Iosif Papadakis Ktistakis, Spyridon Manganas, Abdul Wase, Tarun Goswami Dec 2019

Investigation Of Retrieved Cardiac Devices, Anmar Salih, Iosif Papadakis Ktistakis, Spyridon Manganas, Abdul Wase, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Damage assessment of lead and pulse generator with various exposure times is important in the development of cardiac devices. Approximately, 92.1 million patients in the US suffer from cardiovascular diseases with an estimated healthcare cost of over $300 billion and at least one million with implantable cardiac devices. These devices are complex and composed on multiple levels and present challenges while assessing the damage. However, the study on the analysis of cardiac devices may lend insight into common damage patterns and improve future cardiac devices design. The objective of this work is to perform a thorough in vivo damage assessment …


Investigation Of A Neuro-Stimulator Retrieved Posthumously, Megan Markl, Rodney J. Gutherie, Tarun Goswami Dec 2019

Investigation Of A Neuro-Stimulator Retrieved Posthumously, Megan Markl, Rodney J. Gutherie, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

A neurostimulator was investigated in this paper posthumously. Device was presented to our anatomical gift program. Investigation was multi-fold and contained visual inspection, using an optical microscope, and mechanical and electrical testing of leads and its insulator. It was concluded that the device could have been damaged during implantation, in vivo, during removal, and/or during transportation to author’s laboratories. The damage observed on the lead insulation is similar to that which can occur due to anchoring of the lead and hardening due to oxidation. Insulation stiffness was determined to be 1/10 of new insulator. The results reported here on the …


Simulation Of Skull Fracture Due To Falls, Anthony Vicini, Tarun Goswami Dec 2019

Simulation Of Skull Fracture Due To Falls, Anthony Vicini, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

This study presents novel predictive equations for von Mises stress values of bones in the frontal and lateral regions of the skull. The equations were developed based on results of a finite element model developed during this research. The model was validated for frontal and lateral loading conditions with input values mimetic to fall scenarios. Using neural network processing of the information derived from the model achieved R2 values of 0.9990 for both the stress and deflection. Based on the outcome of the fall victims, a threshold von Mises stress of 40.9 to 46.6 MPa was found to indicate skull …


Deep Brain Stimulation: Prediction Model For Volume Of Tissue Stimulated, Melissa Jones, Tarun Goswami Nov 2019

Deep Brain Stimulation: Prediction Model For Volume Of Tissue Stimulated, Melissa Jones, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

An attempt has been made to understand deep brain stimulation in humans via marketable devices that are approved by the US Food and Drug Administration. The electrode characteristics were presented to influence the volume of tissue stimulated. Experimental data were digitized and VTS data were presented a function of electrode diameter, aspect ratio, applied current, pulse duration, voltage and frequency. Amongst other trends voltage and VTS were found to exhibit a three-stage relation, where Stage II characteristics were represented by a linear equation. It is in this stage, the VTS was found to be stable and where the most effective …


Stress Shielding In Cemented Hip Implants Assessed From Computed Tomography, Bharadwaj Cheruvu, Indresh Venkatarayappa, Tarun Goswami May 2019

Stress Shielding In Cemented Hip Implants Assessed From Computed Tomography, Bharadwaj Cheruvu, Indresh Venkatarayappa, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Background: Aseptic loosening is the major cause of revisions for hip replacement. This mode of failure is often caused by stress shielding. Stress shielding in the femur occurs when some of the loads are taken by the prosthesis and shielded from going to the bone. There is little information regarding the stress shielding among cemented hip implants. Purpose: The purpose of this study is to investigate the effect of stress shielding on the proximal femur with a femoral prosthesis. Methods: A patient had undergone open reduction and internal fixation (ORIF) due to a comminuted reversed oblique fracture of the right …


Retail Facility Layout Considering Shopper Path And Door Placement, Sagarkumar D. Hirpara Jan 2019

Retail Facility Layout Considering Shopper Path And Door Placement, Sagarkumar D. Hirpara

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The physical design of a retail store is known to influence the attitude and behavior of shoppers, in turn affecting the store’s performance. While literature in retail design has alluded to the impact of changes in department placements on impulse revenue, it has not accounted for the changes in the path of a shopper due to such modifications. Shopper path changes can alter a department’s visibility to the shoppers as they pass by, and such visibility eventually impacts that department’s impulse revenue. To address this gap, we study the retail facility layout problem by accounting for changes in the shopper …


Joint Determination Of Rack Configuration And Shelf Space Allocation To Maximize Retail Impulse Profit, Uttam Karki Jan 2019

Joint Determination Of Rack Configuration And Shelf Space Allocation To Maximize Retail Impulse Profit, Uttam Karki

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For brick-and-mortar retailers to be successful, it is critical for them to optimally design their rack layout and place products in order to draw attention of shoppers. Literature suggests that racks placed at acute (or obtuse) angles to the main aisle frequented by shoppers can enhance visibility of products compared to racks placed orthogonally (i.e., 90˚). Placing products with high impulse purchase potential in the resulting highly visible locations on the rack can increase shopper impulse purchases. However, placing racks at angles other than 90˚ can increase the required floor space. Additionally, while reducing the height of the racks just …


The Development Of The Human-Automation Behavioral Interaction Task (Habit) Analysis Framework, Isabelle Catherine Baird Jan 2019

The Development Of The Human-Automation Behavioral Interaction Task (Habit) Analysis Framework, Isabelle Catherine Baird

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Complex systems involve the collaboration of automated agents and goal-oriented human operators in a dynamic environment, and dynamic environments required dynamic automation. The implementation of automation fundamentally changes the nature of the cognitive demands by means of changing the role of the human operator. The augmentation of operator situation awareness has become a major design objective in the development of human-automated systems. Extensive literature identified the out-of-the-loop performance problem as a human-automation interaction challenge. This thesis presents the Human-Automation Behavioral Interaction Task (HABIT) Analysis, as a novel approach to assessing human-automation interaction challenges, such as out-of-the-loop consequences. The novel framework …


Agent-Based Simulation Of Artificial-Intelligence-Assisted Transfer Of Care, Paul B. Stone Jan 2019

Agent-Based Simulation Of Artificial-Intelligence-Assisted Transfer Of Care, Paul B. Stone

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This study demonstrates the application of Agent-Based Simulation as a potential training aid for Transfer of Care (ToC) between EMS and a hospital triage department. The specific aim was to develop a simulation to increase the efficiency and accountability of information communication during ToC to test the suitability of Agent-Based Simulation to address training requirements in complex, health provision settings. This paper focuses on the design of the training simulation, including the development of individual agents within the simulation through the user interface elements and the evaluation and verification of the prototype simulator. The primary objective is for the simulation …


A Model To Optimize Major Trauma Network Considering Patient Safety, Monit D. Vaishnav Jan 2019

A Model To Optimize Major Trauma Network Considering Patient Safety, Monit D. Vaishnav

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Trauma is any physical injury that has the potential to cause prolonged disability and death if the appropriate level of care is not administered in a timely fashion. Existing approaches in the literature and by the American College of Surgeons (ACS) to optimize the network of trauma centers are limiting. To address this challenge, we introduce the Trauma Network Design Problem, a bi-objective mathematical model that aims at determining the optimal trauma network by minimizing the weighted sum of mistriages. We use the trauma network data from 2012 for the state of Ohio to illustrate the use of our approach …


Feature-Based Discretization Of A Turbine Disk For Probabilistic Risk Assessment, Michael Thomas, Jace Carter, Lloyd Matson, Tarun Goswami Aug 2018

Feature-Based Discretization Of A Turbine Disk For Probabilistic Risk Assessment, Michael Thomas, Jace Carter, Lloyd Matson, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

There is an economic need to extend the useful life of jet engine rotors. Retirement-for-Cause (RFC) is a lifing method that allows for the continued operation of components passed traditional life limits. Under RFC, an extension of damage tolerance, components are deemed safe for a further service interval using non-destructive inspections (NDI) for crack like defe cts. As components are kept in-service beyond their designed service life it is essential that the probability of failure (POF), or risk, of continued service is known. Under current FAA rotor design certification practices the component POF is analyzed using a probabilistic framework focused …


Failure Analysis Of Philos Plate Construct Used For Pantalar Arthrodesis Paper Ii-Screws And Fem Simulations, Farah Hamandi, Richard T. Laughlin, Tarun Goswami Apr 2018

Failure Analysis Of Philos Plate Construct Used For Pantalar Arthrodesis Paper Ii-Screws And Fem Simulations, Farah Hamandi, Richard T. Laughlin, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

A fractured stainless steel 3.5 mm proximal humerus internal locking system (PHILOS) plate and screws were investigated in this paper. This plate was used for ankle arthrodesis of a 68-year-old female with a right ankle deformity. Both the plate and screws were considered in this investigation. Optical and scanning electron microscopes (SEM) were used to document fracture surface characteristics, such as extensive scratching, plastic deformation, rubbed surfaces, discoloration, and pitting, along with cleavage, secondary cracking, deposits of debris, striations, and dimples. Indications of these features show that the plate failed by corrosion fatigue, however, overloading separated the screw(s) in two …


Developing A High-Dimensional Dataset Of The Changes In Ion Channels Expression Level At The Cholinergic Boutons In Amyotrophic Lateral Sclerosis, Joshua Harris Jan 2018

Developing A High-Dimensional Dataset Of The Changes In Ion Channels Expression Level At The Cholinergic Boutons In Amyotrophic Lateral Sclerosis, Joshua Harris

The University Honors Program

ALS, or Amyotrophic Lateral Sclerosis, is a neurodegenerative disease that causes motor neuron degeneration. Affecting nerve cells in the brain and spinal cord, this disease eventually leads to respiratory muscle failure and death. Although ALS is fairly uncommon, our lack of information on how ALS develops drives the need for further study. In the Neuro Engineering, Rehabilitation, and Degeneration laboratory at Wright State University, immunohistochemical data has been collected on a mouse model (SOD1-G93A) throughout their lifespan to better examine the neurological effects of ALS. To better organize and interpret the data, a high-dimensional dataset was created in this project …


Evaluation Of Consumer Drone Control Interface, Thomas William Merrell Jan 2018

Evaluation Of Consumer Drone Control Interface, Thomas William Merrell

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The development and use of consumer grade drones is becoming a larger part of our society for many different applications. There has been a great amount of discussion and constant review of proper operation of consumer drones including proper methods of control. In turn, regulation of such devices has been inconsistent. This study aims to better understand the effects of the three primary control interface methods (line of sight, video aided, and first-person view) on flight performance, situational awareness, and perceived mental workload of the operator. Secondarily, this study aims to provide design recommendations for future interfaces. This study shows …


Augmenting Incident Command System For Improved Emergency Response, Meenakshi Nagarajan Jan 2018

Augmenting Incident Command System For Improved Emergency Response, Meenakshi Nagarajan

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Incident Command System provides a framework for commanders to manage an incident. However, maintaining good situation awareness in an emergency situation is often challenging to the Incident Commander. Stress may result in task fixation which may cause the commander to miss critical information and can eventually lead to poor decisions. The proposed augmented decision support system, with an integrated knowledge base, enhances the commander's decision making and situation awareness by presenting the information that may have been missed. The system has been evaluated to investigate its utility in chemical hazard scenarios. The system was used by experienced Incident Commanders to …


Impact Of Noise Level On Task Performance And Workload And Correlation To Personality, Kaylee Marie Eakins Jan 2018

Impact Of Noise Level On Task Performance And Workload And Correlation To Personality, Kaylee Marie Eakins

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An ideal work environment supports a culture of high performance, low mental workload, and quick turnarounds. The impact of noise on three types of tasks in a lab work environment were examined while attempting to identify correlations between a subject's personality and their tolerance to noise. Neuroticism, agreeableness, conscientiousness, and extroversion correlated significantly with subjective (NASA-TLX) and physiological mental workload measures (heart rate variability and eye-tracking). The results show that task type impacts the performance, task duration, and mental workload. Although the physiological workload measures showed significant impact, the parameters standard deviation of R-R intervals and LF/HF ratio agreed with …


Demonstrating The Functionality And Efficacy Of Blockchain-Based System In Healthcare Using Simulation Tools, Jad S. Mubaslat Jan 2018

Demonstrating The Functionality And Efficacy Of Blockchain-Based System In Healthcare Using Simulation Tools, Jad S. Mubaslat

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Blockchain and cryptocurrencies have been a rapidly growing industry and area of academic research since Bitcoin's launch in early 2009. Blockchains have already been applied in spaces outside of finance, such as healthcare. This work explores the Bitcoin blockchain and a blockchain-based care coordination system through the use of modeling and simulation tools. Two agent based models are constructed: one to represent the Bitcoin blockchain, and a second to represent a blockchain-based care coordination system, MDChain. Insight is provided that is relevant to current issues within the Bitcoin community and predictions are made as to its future. The feasibility of …


Exploring Feedback Modalities Using Wearable Device For Complex Systems Training Programs, Layla Akilan Jan 2018

Exploring Feedback Modalities Using Wearable Device For Complex Systems Training Programs, Layla Akilan

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This study examined the effectiveness of a wearable device in delivering various feedback modalities in an attempt to improve performance outcomes in complex systems. Secondarily this study looked at performance when feedback type was matched to preferred learning style according to VARK Learning Styles Inventory results. Participants were required to perform system monitoring and correct for system failures through key presses. Feedback was delivered through a smart watch and was based on response time performance. Feedback modalities included visual, auditory, and haptic feedback. Subjective ratings of situation awareness and mental workload were also examined. Results indicated that auditory feedback condition …


Utilizing Functional Near-Infrared Spectroscopy For Prediction Of Cognitive Workload In Noisy Work Environments, Ryan Gabbard, Mary E. Fendley, Irfaan A. Dar, Rik Warren, Nasser H. Kashou Oct 2017

Utilizing Functional Near-Infrared Spectroscopy For Prediction Of Cognitive Workload In Noisy Work Environments, Ryan Gabbard, Mary E. Fendley, Irfaan A. Dar, Rik Warren, Nasser H. Kashou

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Occupational noise frequently occurs in the work environment in military intelligence, surveillance, and reconnaissance operations. This impacts cognitive performance by acting as a stressor, potentially interfering with the analysts’ decision-making process. We investigated the effects of different noise stimuli on analysts’ performance and workload in anomaly detection by simulating a noisy work environment. We utilized functional near-infrared spectroscopy (fNIRS) to quantify oxy-hemoglobin (HbO) and deoxy-hemoglobin concentration changes in the prefrontal cortex (PFC), as well as behavioral measures, which include eye tracking, reaction time, and accuracy rate. We hypothesized that noisy environments would have a negative effect on the participant in …


Macrodamage Accumulation Model For A Human Femur, Farah Hamandi, Tarun Goswami Aug 2017

Macrodamage Accumulation Model For A Human Femur, Farah Hamandi, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

The objective of this study was to more fully understand the mechanical behavior of bone tissue that is important to find an alternative material to be used as an implant and to develop an accurate model to predict the fracture of the bone. Predicting and preventing bone failure is an important area in orthopaedics. In this paper, the macrodamage accumulation models in the bone tissue have been investigated. Phenomenological models for bone damage have been discussed in detail. In addition, 3D finite element model of the femur prepared from imaging data with both cortical and trabecular structures is delineated using …


Brain Lesions Among Orally Fed And Gastrostomy-Fed Dysphagic Preterm Infants: Can Routine Qualitative Or Volumetric Quantitative Magnetic Resonance Imaging Predict Feeding Outcomes?, Nasser H. Kashou, Irfaan Akram Dar, Mohamed A. El-Mahdy, Charles Pluto, Mark Smith, Ish K. Gulati, Warren Lo, Sudarshan R. Jadcherla Apr 2017

Brain Lesions Among Orally Fed And Gastrostomy-Fed Dysphagic Preterm Infants: Can Routine Qualitative Or Volumetric Quantitative Magnetic Resonance Imaging Predict Feeding Outcomes?, Nasser H. Kashou, Irfaan Akram Dar, Mohamed A. El-Mahdy, Charles Pluto, Mark Smith, Ish K. Gulati, Warren Lo, Sudarshan R. Jadcherla

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Introduction: The usefulness of qualitative or quantitative volumetric magnetic resonance imaging (MRI) in early detection of brain structural changes and prediction of adverse outcomes in neonatal illnesses warrants further investigation. Our aim was to correlate certain brain injuries and the brain volume of feeding-related cortical and subcortical regions with feeding method at discharge among preterm dysphagic infants.

Materials and methods: Using a retrospective observational study design, we examined MRI data among 43 (22 male; born at 31.5 ± 0.8 week gestation) infants who went home on oral feeding or gastrostomy feeding (G-tube). MRI scans were segmented, and volumes of brainstem, …


Probabilistic Analysis Of Wear Of Polymer Material Used In Medical Implants, V. Perel, Tarun Goswami Jan 2017

Probabilistic Analysis Of Wear Of Polymer Material Used In Medical Implants, V. Perel, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Probabilistic methods are applied to the study of fatigue wear of sliding surfaces. A variance of time to failure (to occurrence of maximum allowable wear depth) is evaluated as a function of a mean wear rate of normal wear and a size of wear particles. A method of estimating probability of failure-free work during a certain time interval (reliability) is presented. An effect of the bedding-in phase of wear on the reliability is taken into account. Experimental data for Ultra High Molecular Weight Polyethylene (UHMWPE) cups of artificial hip implants is used to make numerical calculations.


Implicit Leadership And Followership Theories: Does Congruency Matter?, Daniel Bashore Jan 2017

Implicit Leadership And Followership Theories: Does Congruency Matter?, Daniel Bashore

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Leadership research largely has ignored the extent to which followers influence leaders and the leadership process. Even fewer studies have examined the effect of Implicit Leadership Theories (ILTs) and Implicit Followership Theories (IFTs) on performance and affective outcomes. In prior research, there is an implicit assumption that ILTs and IFTs are compatible, but little research has examined the presence of incongruent ILTs and IFTs and potential effects incongruence might have on organizational outcomes. The current study examined the effect of ILT/IFT congruence on organizational outcomes (performance, satisfaction, and perceived leader effectiveness) in two different samples: a student sample (N = …


Assessing Effectiveness Of Information Presentation Using Wearable Augmented Display Device For Emergency Response, Sriram Raju Chandran Jan 2017

Assessing Effectiveness Of Information Presentation Using Wearable Augmented Display Device For Emergency Response, Sriram Raju Chandran

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Small screen wearable devices are becoming ubiquitous in the medical field; especially in the fields of surgery and trauma care. Technological intervention that supports data transfer of sending summary of the patient vitals through the transfer of care would be of great benefit to trauma care department. This research focuses on information presentation for wearable augmented reality device to improve human decision making during transfer of care for emergency response, and to improve user experience and reduce cognitive workload. Google Glass ™ device acts as heads up display for users, in this case being medical responders in hospital trauma care. …


A Framework For Centralizing Inventory In Pharmaceutical Supply Chains, Kerry Kathleen Ward Jan 2017

A Framework For Centralizing Inventory In Pharmaceutical Supply Chains, Kerry Kathleen Ward

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Effectively choosing the location of inventory in a pharmaceutical supply chain is central to the mission of pharmaceutical distributors. These supply chains are a critical backbone to the healthcare delivery process: the distributors must deliver products to pharmacies, hospitals and retailers at low cost and with a high level of reliability. This thesis provides a method for analyzing demand data to gain insight on the value of centralizing the inventory into either a hub-and-spoke or national network for a pharmaceutical distribution company. Demand data is analyzed using an off-the-shelf analysis tool as well as a new tool developed in SQL …


Evaluating Mobile Information Display System In Transfer Of Care, Katelyn Berberich Jan 2017

Evaluating Mobile Information Display System In Transfer Of Care, Katelyn Berberich

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Transfer of care continuum is highly dynamic in nature and there are multiple complexities associated with man-man interaction and man-machine interaction. During transfer of patient care, which occurs from an emergency medical team (EMT) to an emergency department, adequate information related to the patient must be communicated very quickly and precisely. Challenges EMTs and emergency department personnel face are communicating and obtaining all the essential information to ensure the patient receives the best care. Providing the receiving emergency department with patient vitals and pre-hospital procedures that occurred en route could allow for enhanced preparation and improved communication during the transfer …


Somatic Stimulation Causes Frontoparietal Cortical Changes In Neonates: A Functional Near-Infrared Spectroscopy Study, Nasser H. Kashou, Irfaan Akram Dar, Kathryn Hasenstab, Ramzi W. Nahhas, Sudarshan R. Jadcherla Aug 2016

Somatic Stimulation Causes Frontoparietal Cortical Changes In Neonates: A Functional Near-Infrared Spectroscopy Study, Nasser H. Kashou, Irfaan Akram Dar, Kathryn Hasenstab, Ramzi W. Nahhas, Sudarshan R. Jadcherla

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Palmar and plantar grasp are the foremost primitive neonatal reflexes and functions. Persistence of these reflexes in infancy is a sign of evolving cerebral palsy. Our aims were to establish measurement feasibility in a clinical setting and to characterize changes in oxyhemoglobin (HbO) and deoxyhemoglobin (HbD) concentration in the bilateral frontoparietal cortex in unsedated neonates at the crib-side using functional near-infrared spectroscopy (fNIRS). We hypothesized that bilateral concentration changes will occur upon somatic central and peripheral somatic stimulation. Thirteen preterm neonates (five males) underwent time 1, and six (two males) returned for time 2 (mean PMA ¼ 41.6 and 47.0 …


Quantitative Analysis Of Retrieved Glenoid Liners, Katelyn Childs, Lynn Crosby, Tarun Goswami Feb 2016

Quantitative Analysis Of Retrieved Glenoid Liners, Katelyn Childs, Lynn Crosby, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Revision of orthopedic surgeries is often expensive and involves higher risk from complications. Since most total joint replacement devices use a polyethylene bearing, which serves as a weak link, the assessment of damage to the liner due to in vivo exposure is very important. The failures often are due to excessive polyethylene wear. The glenoid liners are complex and hemispherical in shape and present challenges while assessing the damage. Therefore, the study on the analysis of glenoid liners retrieved from revision surgery may lend insight into common wear patterns and improve future product designs. The purpose of this pilot study …


Long-Term Velaglucerase Alfa Treatment In Children With Gaucher Disease Type 1 Naïve To Enzyme Replacement Therapy Or Previously Treated With Imiglucerase, Laurie Smith, William Rhead, Joel Charrow, Suma P. Shankar, Ashish Bavdekar, Nicola Longo, Rebecca Mardach, Paul Harmatz, Thomas N. Hangartner, Hak-Myung Lee, Eric Crombez, Gregory M. Pastores Feb 2016

Long-Term Velaglucerase Alfa Treatment In Children With Gaucher Disease Type 1 Naïve To Enzyme Replacement Therapy Or Previously Treated With Imiglucerase, Laurie Smith, William Rhead, Joel Charrow, Suma P. Shankar, Ashish Bavdekar, Nicola Longo, Rebecca Mardach, Paul Harmatz, Thomas N. Hangartner, Hak-Myung Lee, Eric Crombez, Gregory M. Pastores

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Background

Gaucher Disease type 1 (GD1) often manifests in childhood. Early treatment with enzyme replacement therapy (ERT) may prevent disease complications. We report the assessment of velaglucerase alfa ERT in pediatric GD1 patients who participated in a long-term extension study (HGT-GCB-044, ClinicalTrials.gov Identifier NCT00635427).

Methods

Safety and efficacy were evaluated in pediatric patients receiving velaglucerase alfa 30–60 U/kg by intravenous infusion every other week. In addition to key hematological and visceral efficacy assessments, exploratory assessments conducted specifically in pediatric patients included evaluation of height, bone age, bone marrow burden, and Tanner stage of puberty.

Results

The study included 24 …