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

Analysis Of A Clinically Failed, Mechanically Intact, Reconstructive Compression Plate, Bharadwaj Cheruvu, Sunil Karmacharya, Richard T. Laughlin, Tarun Goswami Sep 2015

Analysis Of A Clinically Failed, Mechanically Intact, Reconstructive Compression Plate, Bharadwaj Cheruvu, Sunil Karmacharya, Richard T. Laughlin, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

A reconstructive orthopedic bone plate was submitted for analysis. Traditional failure analysis methods were used to assess the mode of the plate failure. Metallographic investigation of the plate was carried out in this report. Since limited data was available in the literature and clinical data related to subject demography, date of removal as well as reasons for removal unknown, in depth analysis was not possible. However, the plate was received in in-tact condition with minor biological deposits and scratches, it is speculated that the failure of the plate may have been due to biological/clinical reasons, likely infection, rejecting the device …


Velaglucerase Alfa (Vpriv) Enzyme Replacement Therapy In Patients With Gaucher Disease: Long-Term Data From Phase Iii Clinical Trials, Derralynn A. Hughes, Derlis Gonzalez, Elena A. Lukina, Atul Mehta, Madhulika Kabra, Deborah Elstein, Isaac Kisinovsky, Pilar Giraldo, Ashish Bavdekar, Thomas N. Hangartner, Nan Wang, Eric Crombez, Ari Zimran Jul 2015

Velaglucerase Alfa (Vpriv) Enzyme Replacement Therapy In Patients With Gaucher Disease: Long-Term Data From Phase Iii Clinical Trials, Derralynn A. Hughes, Derlis Gonzalez, Elena A. Lukina, Atul Mehta, Madhulika Kabra, Deborah Elstein, Isaac Kisinovsky, Pilar Giraldo, Ashish Bavdekar, Thomas N. Hangartner, Nan Wang, Eric Crombez, Ari Zimran

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Type 1 Gaucher disease is an inherited lysosomal enzyme deficiency with variable age of symptom onset. Common presenting signs include thrombocytopenia, anemia, hepatosplenomegaly, bone abnormalities, and, additionally in children, growth failure. Fifty-seven patients aged 3–62 years at the baseline of two phase III trials for velaglucerase alfa treatment were enrolled in the single extension study. In the extension, they received every-other-week velaglucerase alfa intravenous infusions for 1.2–4.8 years at 60 U/kg, although 10 patients experienced dose reduction. No patient experienced a drug-related serious adverse event or withdrew due to an adverse event. One patient died following a convulsion that was …


Safety And Efficacy Results Of Switch From Imiglucerase To Velaglucerase Alfa Treatment In Patients With Type 1 Gaucher Disease, Deborah Elstein, Atul Mehta, Derralynn A. Hughes, Pilar Giraldo, Joel Charrow, Laurie Smith, Suma P. Shankar, Thomas N. Hangartner, Yune Kunes, Nan Wang, Eric Crombez, Ari Zimran Jul 2015

Safety And Efficacy Results Of Switch From Imiglucerase To Velaglucerase Alfa Treatment In Patients With Type 1 Gaucher Disease, Deborah Elstein, Atul Mehta, Derralynn A. Hughes, Pilar Giraldo, Joel Charrow, Laurie Smith, Suma P. Shankar, Thomas N. Hangartner, Yune Kunes, Nan Wang, Eric Crombez, Ari Zimran

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Gaucher disease (GD) is a lysosomal storage disorder; symptomatic patients with type 1 GD need long-term disease-specific therapy of which the standard of care has been enzyme replacement therapy (ERT). Thirty-eight of 40 patients (aged 9–71 years) clinically stable on ERT with imiglucerase, safely switched to a comparable dose of velaglucerase alfa (units/kg) during TKT034, a 12-month, open-label clinical study, and for 10–50 months in an extension study. The most common adverse events (AEs) judged to be drug-related in the extension were fatigue and bone pain. No drug-related serious AEs were reported. No AEs led to study withdrawal. At 24 …


Toe Joint Replacement Models, Tarun Goswami, Allison L. Van Horn, Alexander O. Sheets Jun 2015

Toe Joint Replacement Models, Tarun Goswami, Allison L. Van Horn, Alexander O. Sheets

Biomedical, Industrial & Human Factors Engineering Faculty Publications

In various embodiments, provided are implantable devices for replacing all or a portion of a metatarsophalangeal joint, comprising (i) a metatarsal component comprising a Substan tially convex bearing Surface; or (ii) a phalanx component comprising a Substantially concave bearing Surface; or (iii) both. In various embodiments, also provided are methods of treating hallux Valgus by replacing all or a portion of a meta tarsophalangeal joint with one or more of the provided implantable devices.


Oculomotor Neurocircuitry, A Structural Connectivity Study Of Infantile Nystagmus Syndrome, Nasser H. Kashou, Angelica R. Zampini Apr 2015

Oculomotor Neurocircuitry, A Structural Connectivity Study Of Infantile Nystagmus Syndrome, Nasser H. Kashou, Angelica R. Zampini

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Infantile Nystagmus Syndrome (INS) is one of the leading causes of significant vision loss in children and affects about 1 in 1000 to 6000 births. In the present study, we are the first to investigate the structural pathways of patients and controls using diffusion tensor imaging (DTI). Specifically, three female INS patients from the same family were scanned, two sisters and a mother. Six regions of interest (ROIs) were created manually to analyze the number of tracks. Additionally, three ROI masks were analyzed using TBSS (Tract-Based Spatial Statistics). The number of fiber tracks was reduced in INS subjects, compared to …


A Probabilistic Fracture Assessment Of Vertebral Cortical Bone, Tarun Goswami, Isaac Mabe Jan 2015

A Probabilistic Fracture Assessment Of Vertebral Cortical Bone, Tarun Goswami, Isaac Mabe

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Cortical bone is a material with a porous structure. The presence of pores creates local stress concentrations and the likelihood of premature failure. Assuming that pores are present in all bone, vertebral endplates, for example, can subside. Subsidence has taken place at rates as high as 77 percent. A computational probabilistic assessment of the pore size distribution and their contribution to the fracture toughness has been presented in this paper. A Monte Carlo simulation was used to develop and assign random pores. Also the model compared crack sizes to the thickness of the cortical bone present as a limiting case. …