Výsledky vyhledávání - "S. Raymond Golish"

Akademický článek

Pivotal trials of orthopedic surgical devices in the United States: predominance of two-arm non-inferiority designs

Autor: S. Raymond Golish

Publikováno v: Trials, Vol 18, Iss 1, Pp 1-8 (2017)

Abstract Background The United States Food and Drug Administration (FDA) reviews class III orthopedic devices submitted for premarket approval with pivotal clinical trials. The purpose of this study was to determine the types of orthopedic devices re

Externí odkaz: https://doaj.org/article/2f0bbff559d04649a2224f08e189cdea

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Summary of the FDA virtual public workshop on spinal device clinical review held on September 17, 2021

Autor: Vincent J. Devlin, Ronald Jean, CAPT Raquel Peat, Hongying Jiang, Paul A. Anderson, John C. Benson, Darrel S. Brodke, S. Raymond Golish, Khaled M. Kebaish, A. Noelle Larson, Hassan Serhan

Publikováno v: The spine journal : official journal of the North American Spine Society. 22(9)

The mission of Food and Drug Administration (FDA)'s Center for Devices and Radiological Health is to protect and promote public health. It assures that patients and providers have timely and continued access to safe, effective, and high-quality medic

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ac3d18de379ffb8fa168f6453477acb1
https://pubmed.ncbi.nlm.nih.gov/35460900

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Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of low back pain

Autor: S. Raymond Golish, Ryan A. Tauzell, Daniel R. Perry, Terry Trammell, Gazanfar Rahmathulla, Charles H. Cho, John E. Easa, Anthony J. Lisi, David S. Cheng, Christopher K. Taleghani, Shay Bess, Adam C. Lipson, Kris E. Radcliff, Yakov Vorobeychik, Padma Gulur, Karie A. Rosolowski, Ravi Prasad, Cumhur Kilincer, Richard J. Meagher, Sean Christie, John E. O'Toole, Randall P. Brewer, William C. Watters, Alison A. Stout, Murat Pekmezci, Thiru M. Annaswamy, Paul Dougherty, D. Scott Kreiner, Bernard Allan Cohen, Jonathan N. Sembrano, Simon Dagenais, Paul Park, Jamie L. Baisden, Zoher Ghogawala, Anil K. Sharma, Dennis E. Enix, Charles A. Reitman, Robert L. Rich, Walter S. Bartynski, Jeffrey A. King, Amy M. Yahiro, Paul G. Matz, David A. Provenzano, Norman B. Chutkan, Christopher M. Bono, Daniel S. Robbins, Daniel K. Resnick, Tom E. Reinsel, R. Carter Cassidy, Steven W. Hwang, Gary Ghiselli

Publikováno v: The Spine Journal. 20:998-1024

Background context The North American Spine Society's (NASS) Evidence Based Clinical Guideline for the Diagnosis and Treatment of Low Back Pain features evidence-based recommendations for diagnosing and treating adult patients with nonspecific low ba

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2d9192b569e72b469f53629a3051c5ee
https://doi.org/10.1016/j.spinee.2020.04.006

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Superiority Claims for Spinal Devices: A Systematic Review of Randomized Controlled Trials

Autor: S. Raymond Golish, Michael W. Groff, Jason A Inzana, Ali Araghi

Publikováno v: Global Spine Journal

Study Design:Systematic review.Objectives:Superiority claims for medical devices are commonly derived from noninferiority trials, but interpretation of such claims can be challenging. This study aimed to ( a) establish the prevalence of noninferiorit

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ebceae9080219775c7ccc71a39ff0d60
https://doi.org/10.1177/2192568219841046

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Determination of Work Relative Value Units for Management of Lumbar Spinal Stenosis by Open Decompression and Interlaminar Stabilization

Autor: S. Raymond Golish, Matthew Twetten, Morgan P. Lorio, Delaine Lorio

Publikováno v: Int J Spine Surg

Background: Effective January 1, 2017, open surgical decompression and interlaminar stabilization (ILS) received a Category I Current Procedural Terminology (CPT®) code 22867. The current work relative value units (wRVUs) assigned to the procedure o

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f53aee0d3661c0e201c6da187fb370db
https://europepmc.org/articles/PMC7931742/

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Supplementary_Table_S2 - Superiority Claims for Spinal Devices: A Systematic Review of Randomized Controlled Trials

Autor: S. Raymond Golish, Groff, Michael W., Araghi, Ali, Inzana, Jason A.

Supplementary_Table_S2 for Superiority Claims for Spinal Devices: A Systematic Review of Randomized Controlled Trials by S. Raymond Golish, Michael W. Groff, Ali Araghi and Jason A. Inzana in Global Spine Journal

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0201ed39ecb2dd75aa7d8e0b4f9eaac1

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Supplemental Material, Appendices - Superiority Claims for Spinal Devices: A Systematic Review of Randomized Controlled Trials

Autor: S. Raymond Golish, Groff, Michael W., Araghi, Ali, Inzana, Jason A.

Supplemental Material, Appendices for Superiority Claims for Spinal Devices: A Systematic Review of Randomized Controlled Trials by S. Raymond Golish, Michael W. Groff, Ali Araghi and Jason A. Inzana in Global Spine Journal

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::db5eb62e171ada217756e3e135ac914e

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Corrigendum to 'Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of low back pain' [The Spine Journal 20/7 (2020) p 998-1024]

Autor: David S. Cheng, Paul Dougherty, Sean Christie, Steven W. Hwang, Kris E. Radcliff, S. Raymond Golish, Cumhur Kilincer, Walter S. Bartynski, Alison A. Stout, Ryan A. Tauzell, Padma Gulur, Ravi Prasad, D. Scott Kreiner, Anthony J. Lisi, Dennis E. Enix, Tom E. Reinsel, Terry Trammell, John E. O'Toole, Daniel K. Resnick, Charles A. Reitman, Jamie L. Baisden, Richard J. Meagher, Zoher Ghogawala, Shay Bess, Adam C. Lipson, Christopher K. Taleghani, Jeffrey A. King, Daniel R. Perry, Paul G. Matz, Norman B. Chutkan, Christopher M. Bono, David A. Provenzano, R. Carter Cassidy, Daniel S. Robbins, Gary Ghiselli, Randall P. Brewer, Yakov Vorobeychik, Anil K. Sharma, John E. Easa, William C. Watters, Amy M. Yahiro, Karie A. Rosolowski, Bernard Allan Cohen, Jonathan N. Sembrano, Simon Dagenais, Murat Pekmezci, Paul Park, Robert L. Rich, Thiru M. Annaswamy, Gazanfar Rahmathulla, Charles H. Cho

Publikováno v: The Spine Journal. 21:726-727

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::5124a77491df3be6f775fdc5b9dff202
https://doi.org/10.1016/j.spinee.2021.02.006

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Spinal devices in the United States—investigational device exemption trials and premarket approval of class III devices

Autor: S. Raymond Golish, Michael L. Reed

Publikováno v: The Spine Journal. 17:150-157

Background Context Recently, there has been increased public awareness of regulatory actions by the United States Food and Drug Administration (FDA) on spinal devices. There has also been increased scrutiny of the pivotal clinical trials of these dev

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f8d823add61e765ddfb86e5962d4584b
https://doi.org/10.1016/j.spinee.2016.09.015

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Introduction to Additive Manufacturing and Three-Dimensional Printing in Orthopaedics

Autor: Adam E, Jakus, William M, Mihalko, S Raymond, Golish, Paul A, Anderson, Wellington, Hsu

Publikováno v: Instructional course lectures. 67

Additive manufacturing involves the construction of devices via the layer-by-layer deposition of materials. Additive manufacturing, which also is referred to as three-dimensional printing, is different from traditional machining, which involves the s

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::3e4b6180ee1a9351482abea19d2f0bc9
https://pubmed.ncbi.nlm.nih.gov/31411441

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