Search

Your search keyword '"Anthony T. Sorkin"' showing total 22 results
Start Over Author "Anthony T. Sorkin"
22 results on '"Anthony T. Sorkin"'

1. Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

Author

Guillermo Pechero, Jr., MD, Branden Pfaff, Mayank Rao, David Pogorzelski, Paula McKay, Ella Spicer, Andrea Howe, Haley K. Demyanovich, Debra L. Sietsema, Michael F. McTague, Lolita Ramsey, Martha Holden, Joshua Rudnicki, Jeff Wells, Michelle Medeiros, Gerard P. Slobogean, Sheila Sprague, Jeffrey Wells, Mohit Bhandari, Robert V. O'Toole, Jean-Claude D'Alleyrand, Andrew Eglseder, Aaron Johnson, Christopher Langhammer, Christopher Lebrun, Theodore Manson, Jason Nascone, Ebrahim Paryavi, Raymond Pensy, Andrew Pollak, Marcus Sciadini, Yasmin Degani, Nathan N. O'Hara, Katherine Joseph, Megan Camara, Anthony D. Harris, Daniel C. Mullins, Lehana Thabane, Amber Wood, Gregory J. Della Rocca, Joan Hebden, Kyle J. Jeray, Lucas Marchand, Lyndsay M. O'Hara, Robert Zura, Michael J. Gardner, Jenna Blasman, Jonah Davies, Stephen Liang, Monica Taljaard, P.J. Devereaux, Gordon H. Guyatt, Diane Heels-Ansdell, Debra Marvel, Jana Palmer, Jeff Friedrich, Ms Frances Grissom, I. Leah Gitajn, Saam Morshed, Bradley A. Petrisor, Franca Mossuto, Manjari G. Joshi, Justin Fowler, Jessica Rivera, Max Talbot, Shannon Dodds, Alisha Garibaldi, Silvia Li, Uyen Nguyen, Alejandra Rojas, Taryn Scott, Gina Del Fabbro, Olivia Paige Szasz, Haley Demyanovich, Kelly Little, C. Daniel Mullins, Eric Kettering, Diamond Hale, Brad A. Petrisor, Herman Johal, Bill Ristevski, Dale Williams, Matthew Denkers, Krishan Rajaratnam, Jamal Al-Asiri, Jordan Leonard, Francesc A. Marcano-Fernández, Jodi Gallant, Federico Persico, Marko Gjorgjievski, Annie George, Roman M. Natoli, Greg E. Gaski, Todd O. McKinley, Walter W. Virkus, Anthony T. Sorkin, Jan P. Szatkowski, Joseph R. Baele, Brian H. Mullis, Lauren C. Hill, Andrea Hudgins, Patrick Osborn, Sarah Pierrie, Eric Martinez, Joseph Kimmel, John D. Adams, Michael L. Beckish, Christopher C. Bray, Timothy R. Brown, Andrew W. Cross, Timothy Dew, Gregory K. Faucher, Richard W. Gurich, Jr., David E. Lazarus, S. John Millon, M. Jason Palmer, Scott E. Porter, Thomas M. Schaller, Michael S. Sridhar, John L. Sanders, L. Edwin Rudisill, Jr., Michael J. Garitty, Andrew S. Poole, Michael L. Sims, Clark M. Walker, Robert M. Carlisle, II, Erin Adams Hofer, Brandon S. Huggins, Michael D. Hunter, William A. Marshall, Shea Bielby Ray, Cory D. Smith, Kyle M. Altman, Julia C. Bedard, Markus F. Loeffler, Erin R. Pichiotino, Austin A. Cole, Ethan J. Maltz, Wesley Parker, T. Bennett Ramsey, Alex Burnikel, Michael Colello, Russell Stewart, Jeremy Wise, M. Christian Moody, Stephanie L. Tanner, Rebecca G. Snider, Christine E. Townsend, Kayla H. Pham, Abigail Martin, Emily Robertson, Theodore Miclau, Utku Kandemir, Meir Marmor, Amir Matityahu, R. Trigg McClellan, Eric Meinberg, David Shearer, Paul Toogood, Anthony Ding, Erin Donohoe, Jothi Murali, Tigist Belaye, Eleni Berhaneselase, Alexandra Paul, Kartik Garg, Joshua L. Gary, Stephen J. Warner, John W. Munz, Andrew M. Choo, Timothy S. Achor, Milton L. “Chip” Routt, Guillermo Pechero, Adam Miller, Jennifer E. Hagen, Matthew Patrick, Richard Vlasak, Thomas Krupko, Kalia Sadasivan, Chris Koenig, Daniel Bailey, Daniel Wentworth, Chi Van, Justin Schwartz, Niloofar Dehghan, Clifford B. Jones, J. Tracy Watson, Michael McKee, Ammar Karim, Michael Talerico, Alyse Williams, Tayler Dykes, William T. Obremskey, Amir Alex Jahangir, Manish Sethi, Robert Boyce, Daniel J. Stinner, Phillip Mitchell, Karen Trochez, Andres Rodriguez, Vamshi Gajari, Elsa Rodriguez, Charles Pritchett, Christina Boulton, Jason Lowe, Jason Wild, John T. Ruth, Michel Taylor, Andrea Seach, Sabina Saeed, Hunter Culbert, Alejandro Cruz, Thomas Knapp, Colin Hurkett, Maya Lowney, Michael Prayson, Indresh Venkatarayappa, Brandon Horne, Jennifer Jerele, Linda Clark, Francesc Marcano-Fernández, Montsant Jornet-Gibert, Laia Martínez-Carreres, David Martí-Garín, Jorge Serrano-Sanz, Joel Sánchez-Fernández, Matsuyama Sanz-Molero, Alejandro Carballo, Xavier Pelfort, Francesc Acerboni-Flores, Anna Alavedra-Massana, Neus Anglada-Torres, Alexandre Berenguer, Jaume Cámara-Cabrera, Ariadna Caparros-García, Ferran Fillat-Gomà, Ruben Fuentes-López, Ramona Garcia-Rodriguez, Nuria Gimeno-Calavia, Guillem Graells-Alonso, Marta Martínez-Álvarez, Patricia Martínez-Grau, Raúl Pellejero-García, Ona Ràfols-Perramon, Juan Manuel Peñalver, Mònica Salomó Domènech, Albert Soler-Cano, Aldo Velasco-Barrera, Christian Yela-Verdú, Mercedes Bueno-Ruiz, Estrella Sánchez-Palomino, Ernesto Guerra-Farfan, Jordi Tomas-Hernandez, Jordi Teixidor-Serra, Vicente Molero-Garcia, Jordi Selga-Marsa, Juan Antonio Porcel-Vasquez, Jose Vicente Andres-Peiro, Joan Minguell-Monyart, Yaiza Garcia-Sanchez, Jorge Nuñez-Camarena, Eladia Tauste-Rubio, Marta Gonzalez-Amigo, Nicholas M. Romeo, Heather A. Vallier, Mary A. Breslin, Joanne Fraifogl, Eleanor S. Wilson, Leanne K. Wadenpfuhl, Paul G. Halliday, Darius G. Viskontas, Kelly L. Apostle, Dory S. Boyer, Farhad O. Moola, Bertrand H. Perey, Trevor B. Stone, H. Michael Lemke, Mauri Zomar, Chen “Brenda” Fan, Kyrsten Payne, Kevin Phelps, Michael Bosse, Madhav Karunakar, Laurence Kempton, Stephen Sims, Joseph Hsu, Rachel Seymour, Christine Churchill, Claire Bartel, Robert Miles Mayberry, Maggie Brownrigg, Cara Girardi, Ada Mayfield, Robert A. Hymes, Cary C. Schwartzbach, Jeff E. Schulman, A. Stephen Malekzadeh, Michael A. Holzman, James S. Ahn, Farhanaz Panjshiri, Sharmistha Das, Antoinisha D. English, Sharon M. Haaser, Jaslynn A.N. Cuff, Holly Pilson, Eben A. Carroll, Jason J. Halvorson, Sharon Babcock, J. Brett Goodman, Martha B. Holden, Debra Bullard, Wendy Williams, Thomas F. Higgins, Justin M. Haller, David L. Rothberg, Lucas S. Marchand, Ashley Neese, Mark Russell, Zachary M. Olsen, Marcus Coe, Kevin Dwyer, Devin S. Mullin, Clifford A. Reilly, Peter DePalo, Amy E. Hall, Marilyn Heng, Mitchel B. Harris, R. Malcolm Smith, David W. Lhowe, John G. Esposito, Mira Bansal, Patrick F. Bergin, George V. Russell, Matthew L. Graves, John Morellato, Heather K. Champion, Leslie N. Johnson, Sheketha L. McGee, Eldrin L. Bhanat, Samir Mehta, Derek Donegan, Jaimo Ahn, Annamarie Horan, Mary Dooley, Ashley Kuczinski, Ashley Iwu, David Potter, Robert VanDemark, III, Troy Hollinsworth, Michael J. Weaver, Arvind G. von Keudell, Elizabeth M. Allen, Todd Jaeblon, Robert Beer, Mark J. Gage, Rachel M. Reilly, and Cindy Sparrow

Subjects
Cluster randomized crossover, Stakeholder engagement, Consent, Deferred consent, Trial design, Patient advisors, Medicine (General), R5-920
Abstract

Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. Methods: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Results: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. Discussion: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

Published
2021
Full Text
View/download PDF

2. Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial

Author

David Pogorzelski, Uyen Nguyen, Paula McKay, Lehana Thabane, Megan Camara, Lolita Ramsey, Rachel Seymour, J. Brett Goodman, Sheketha McGee, Joanne Fraifogl, Andrea Hudgins, Stephanie L. Tanner, Mohit Bhandari, Gerard P. Slobogean, Sheila Sprague, Jeffrey Wells, Jean-Claude D'Alleyrand, Anthony D. Harris, Daniel C. Mullins, Amber Wood, Gregory J. Della Rocca, Joan Hebden, Kyle J. Jeray, Lucas Marchand, Lyndsay M. O'Hara, Robert Zura, Michael J. Gardner, Jenna Blasman, Jonah Davies, Stephen Liang, Monica Taljaard, P.J. Devereaux, Gordon H. Guyatt, Diane Heels-Ansdell, Debra Marvel, Jana Palmer, Jeff Friedrich, Nathan N. O'Hara, Ms. Frances Grissom, I. Leah Gitajn, Saam Morshed, Robert V. O'Toole, Bradley A. Petrisor, Franca Mossuto, Manjari G. Joshi, Justin Fowler, Jessica Rivera, Max Talbot, Shannon Dodds, Alisha Garibaldi, Silvia Li, Alejandra Rojas, Taryn Scott, Gina Del Fabbro, Olivia Paige Szasz, Andrea Howe, Joshua Rudnicki, Haley Demyanovich, Kelly Little, C. Daniel Mullins, Michelle Medeiros, Eric Kettering, Diamond Hale, Andrew Eglseder, Aaron Johnson, Christopher Langhammer, Christopher Lebrun, Theodore Manson, Jason Nascone, Ebrahim Paryavi, Raymond Pensy, Andrew Pollak, Marcus Sciadini, Yasmin Degani, Haley K. Demyanovich, Katherine Joseph, Brad A. Petrisor, Herman Johal, Bill Ristevski, Dale Williams, Matthew Denkers, Krishan Rajaratnam, Jamal Al-Asiri, Jordan Leonard, Francesc A. Marcano-Fernández, Jodi Gallant, Federico Persico, Marko Gjorgjievski, Annie George, Roman M. Natoli, Greg E. Gaski, Todd O. McKinley, Walter W. Virkus, Anthony T. Sorkin, Jan P. Szatkowski, Joseph R. Baele, Brian H. Mullis, Lauren C. Hill, Patrick Osborn, Sarah Pierrie, Eric Martinez, Joseph Kimmel, John D. Adams, Michael L. Beckish, Christopher C. Bray, Timothy R. Brown, Andrew W. Cross, Timothy Dew, Gregory K. Faucher, Richard W. Gurich, Jr., David E. Lazarus, S. John Millon, M. Jason Palmer, Scott E. Porter, Thomas M. Schaller, Michael S. Sridhar, John L. Sanders, L. Edwin Rudisill, Jr., Michael J. Garitty, Andrew S. Poole, Michael L. Sims, Clark M. Walker, Robert M. Carlisle, II, Erin Adams Hofer, Brandon S. Huggins, Michael D. Hunter, William A. Marshall, Shea Bielby Ray, Cory D. Smith, Kyle M. Altman, Julia C. Bedard, Markus F. Loeffler, Erin R. Pichiotino, Austin A. Cole, Ethan J. Maltz, Wesley Parker, T. Bennett Ramsey, Alex Burnikel, Michael Colello, Russell Stewart, Jeremy Wise, M. Christian Moody, Rebecca G. Snider, Christine E. Townsend, Kayla H. Pham, Abigail Martin, Emily Robertson, Theodore Miclau, Utku Kandemir, Meir Marmor, Amir Matityahu, R. Trigg McClellan, Eric Meinberg, David Shearer, Paul Toogood, Anthony Ding, Erin Donohue, Tigist Belaye, Eleni Berhaneselase, Alexandra Paul, Kartik Garg, Joshua L. Gary, Stephen J. Warner, John W. Munz, Andrew M. Choo, Timothy S. Achor, Milton L. “Chip” Routt, Mayank Rao, Guillermo Pechero, Adam Miller, Jennifer E. Hagen, Matthew Patrick, Richard Vlasak, Thomas Krupko, Kalia Sadasivan, Chris Koenig, Daniel Bailey, Daniel Wentworth, Chi Van, Justin Schwartz, Niloofar Dehghan, Clifford B. Jones, J Tracy Watson, Michael McKee, Ammar Karim, Michael Talerico, Debra L. Sietsema, Alyse Williams, Tayler Dykes, William T. Obremskey, Amir Alex Jahangir, Manish Sethi, Robert Boyce, Daniel J. Stinner, Phillip Mitchell, Karen Trochez, Andres Rodriguez, Vamshi Gajari, Elsa Rodriguez, Charles Pritchett, Christina Boulton, Jason Lowe, Jason Wild, John T. Ruth, Michel Taylor, Andrea Seach, Sabina Saeed, Hunter Culbert, Alejandro Cruz, Thomas Knapp, Colin Hurkett, Maya Lowney, Michael Prayson, Indresh Venkatarayappa, Brandon Horne, Jennifer Jerele, Linda Clark, Francesc Marcano-Fernández, Montsant Jornet-Gibert, Laia Martínez-Carreres, David Martí-Garín, Jorge Serrano-Sanz, Joel Sánchez-Fernández, Matsuyama Sanz-Molero, Alejandro Carballo, Xavier Pelfort, Francesc Acerboni-Flores, Anna Alavedra-Massana, Neus Anglada-Torres, Alexandre Berenguer, Jaume Cámara-Cabrera, Ariadna Caparros-García, Ferran Fillat-Gomà, Ruben Fuentes-López, Ramona Garcia-Rodriguez, Nuria Gimeno-Calavia, Guillem Graells-Alonso, Marta Martínez-Álvarez, Patricia Martínez-Grau, Raúl Pellejero-García, Ona Ràfols-Perramon, Juan Manuel Peñalver, Mònica Salomó Domènech, Albert Soler-Cano, Aldo Velasco-Barrera, Christian Yela-Verdú, Mercedes Bueno-Ruiz, Estrella Sánchez-Palomino, Ernesto Guerra, Yaiza García, Nicholas M. Romeo, Heather A. Vallier, Mary A. Breslin, Eleanor S. Wilson, Leanne K. Wadenpfuhl, Paul G. Halliday, Darius G. Viskontas, Kelly L. Apostle, Dory S. Boyer, Farhad O. Moola, Bertrand H. Perey, Trevor B. Stone, H. Michael Lemke, Mauri Zomar, Ella Spicer, Chen “Brenda” Fan, Kyrsten Payne, Kevin Phelps, Michael Bosse, Madhav Karunakar, Laurence Kempton, Stephen Sims, Joseph Hsu, Christine Churchill, Claire Bartel, Robert Miles Mayberry, Maggie Brownrigg, Cara Girardi, Ada Mayfield, Robert A. Hymes, Cary C. Schwartzbach, Jeff E. Schulman, A. Stephen Malekzadeh, Michael A. Holzman, James S. Ahn, Farhanaz Panjshiri, Sharmistha Das, Antoinisha D. English, Sharon M. Haaser, Jaslynn A.N. Cuff, Holly Pilson, Eben A. Carroll, Jason J. Halvorson, Sharon Babcock, Martha B. Holden, Debra Bullard, Wendy Williams, Thomas F. Higgins, Justin M. Haller, David L. Rothberg, Ashley Neese, Mark Russell, Marcus Coe, Kevin Dwyer, Devin S. Mullin, Clifford A. Reilly, Peter DePalo, Amy E. Hall, Marilyn Heng, Mitchel B. Harris, R. Malcolm Smith, David W. Lhowe, John G. Esposito, Mira Bansal, Patrick F. Bergin, George V. Russell, Matthew L. Graves, John Morellato, Heather K. Champion, Leslie N. Johnson, Sheketha L. McGee, Eldrin L. Bhanat, Samir Mehta, Derek Donegan, Jaimo Ahn, Annamarie Horan, Mary Dooley, Ashley Kuczinski, Ashley Iwu, David Potter, Robert VanDemark, III, Branden Pfaff, Troy Hollinsworth, Michael J. Weaver, Arvind G. von Keudell, Michael F. McTague, Elizabeth M. Allen, Todd Jaeblon, Robert Beer, Mark J. Gage, Rachel M. Reilly, and Cindy Sparrow

Subjects
Sampling, Pragmatic, Cluster crossover, Sampling framework, Work flow, Sampling strategy, Medicine (General), R5-920
Abstract

Introduction: Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow. Methods: Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients. Results: 7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p

Published
2021
Full Text
View/download PDF

3. The impact of heterotopic ossification prophylaxis after surgical fixation of acetabular fractures: national treatment patterns and related outcomes

Author

Adam Boissonneault, Nathan O Hara, David Pogorzelski, Lucas Marchand, Thomas Higgins, Leah Gitajn, Mark J. Gage, Roman M. Natoli, Ishani Sharma, Sarah Pierrie, Robert V O’Toole, Sheila Sprague, Gerard Slobogean, Gerard P. Slobogean, Jeffrey Wells, Mohit Bhandari, Anthony D. Harris, C. Daniel Mullins, Lehana Thabane, Amber Wood, Gregory J. Della Rocca, Joan Hebden, Kyle J. Jeray, Lucas S. Marchand, Lyndsay M. O'Hara, Robert Zura, Christopher Lee, Joseph Patterson, Michael J. Gardner, Jenna Blasman, Jonah Davies, Stephen Liang, Monica Taljaard, PJ Devereaux, Gordon H. Guyatt, Diane Heels-Ansdell, Debra Marvel, Jana Palmer Jeffrey Wells, Jeff Friedrich, Nathan N. O'Hara, Frances Grissom, I. Leah Gitajn, Saam Morshed, Robert V. O'Toole, Bradley A. Petrisor, Franca Mossuto, Manjari G. Joshi, Jean-Claude D'Alleyrand, Justin Fowler, Jessica Rivera, Max Talbot, Shannon Dodds, Silvia Li, Alejandra Rojas, Gina Del Fabbro, Olivia Paige Szasz, Paula McKay, Alexandra Minea, Andrea Howe, Haley Demyanovich, Michelle Medeiros, Genevieve Polk, Eric Kettering, Nirmen Mahal, Andrew Eglseder, Aaron Johnson, Christopher Langhammer, Christopher Lebrun, Jason Nascone, Raymond Pensy, Andrew Pollak, Marcus Sciadini, Yasmin Degani, Haley K. Demyanovich, Heather Phipps, Eric Hempen, Christine Holler, Brad A. Petrisor, Herman Johal, Bill Ristevski, Dale Williams, Matthew Denkers, Krishan Rajaratnam, Jamal Al-Asiri, Jodi Gallant, Kaitlyn Pusztai, Sarah MacRae, Sara Renaud, John D. Adams, Michael L. Beckish, Christopher C. Bray, Timothy R. Brown, Andrew W. Cross, Timothy Dew, Gregory K. Faucher, Richard W. Gurich, David E. Lazarus, S. John Millon, M. Christian Moody, M. Jason Palmer, Scott E. Porter, Thomas M. Schaller, Michael S. Sridhar, John L. Sanders, L. Edwin Rudisill, Michael J. Garitty, Andrew S. Poole, Michael L. Sims, Clark M. Walker, Robert Carlisle, Erin A. Hofer, Brandon Huggins, Michael Hunter, William Marshall, Shea B. Ray, Cory Smith, Kyle M. Altman, Erin Pichiotino, Julia C. Quirion, Markus F. Loeffler, Erin R. Pichiotino, Austin A. Cole, Ethan J. Maltz, Wesley Parker, T. Bennett Ramsey, Alex Burnikel, Michael Colello, Russell Stewart, Jeremy Wise, Matthew Anderson, Joshua Eskew, Benjamin Judkins, James M. Miller, Stephanie L. Tanner, Rebecca G. Snider, Christine E. Townsend, Kayla H. Pham, Abigail Martin, Emily Robertson, Emily Bray, J. Wilson Sykes, Krystina Yoder, Kelsey Conner, Harper Abbott, Todd O. McKinley, Walter W. Virkus, Anthony T. Sorkin, Jan P. Szatkowski, Brian H. Mullis, Yohan Jang, Luke A. Lopas, Lauren C. Hill, Courteney L. Fentz, Maricela M. Diaz, Krista Brown, Katelyn M. Garst, Emma W. Denari, Patrick Osborn, Maria Herrera, Theodore Miclau, Meir Marmor, Amir Matityahu, R. Trigg McClellan, David Shearer, Paul Toogood, Anthony Ding, Jothi Murali, Ashraf El Naga, Jennifer Tangtiphaiboontana, Tigist Belaye, Eleni Berhaneselase, Dmitry Pokhvashchev, William T Obremskey, Amir Alex Jahangir, Manish Sethi, Robert Boyce, Daniel J. Stinner, Phillip Mitchell, Karen Trochez, Elsa Rodriguez, Charles Pritchett, Natalie Hogan, A. Fidel Moreno, Jennifer E. Hagen, Matthew Patrick, Richard Vlasak, Thomas Krupko, Michael Talerico, Marybeth Horodyski, Marissa Pazik, Elizabeth Lossada-Soto, Joshua L. Gary, Stephen J Warner, John W. Munz, Andrew M. Choo, Timothy S. Achor, Milton L. 'Chip' Routt, Michael Kutzler, Sterling Boutte, Ryan J. Warth, Michael Prayson, Indresh Venkatarayappa, Brandon Horne, Jennifer Jerele, Linda Clark, Christina Boulton, Jason Lowe, John T. Ruth, Brad Askam, Andrea Seach, Alejandro Cruz, Breanna Featherston, Robin Carlson, Iliana Romero, Isaac Zarif, Niloofar Dehghan, Michael McKee, Clifford B Jones, Debra L Sietsema, Alyse Williams, Tayler Dykes, Ernesto Guerra-Farfan, Jordi Tomas-Hernandez, Jordi Teixidor-Serra, Vicente Molero-Garcia, Jordi Selga-Marsa, Juan Antonio Porcel-Vazquez, Jose Vicente Andres-Peiro, Ignacio Esteban-Feliu, Nuria Vidal-Tarrason, Jordi Serracanta, Jorge Nuñez-Camarena, Maria del Mar Villar-Casares, Jaume Mestre-Torres, Pilar Lalueza-Broto, Felipe Moreira-Borim, Yaiza Garcia-Sanchez, Francesc Marcano-Fernández, Laia Martínez-Carreres, David Martí-Garín, Jorge Serrano-Sanz, Joel Sánchez-Fernández, Matsuyama Sanz-Molero, Alejandro Carballo, Xavier Pelfort, Francesc Acerboni-Flores, Anna Alavedra-Massana, Neus Anglada-Torres, Alexandre Berenguer, Jaume Cámara-Cabrera, Ariadna Caparros-García, Ferran Fillat-Gomà, Ruben Fuentes-López, Ramona Garcia-Rodriguez, Nuria Gimeno-Calavia, Marta Martínez-Álvarez, Patricia Martínez-Grau, Raúl Pellejero-García, Ona Ràfols-Perramon, Juan Manuel Peñalver, Mònica Salomó Domènech, Albert Soler-Cano, Aldo Velasco-Barrera, Christian Yela-Verdú, Mercedes Bueno-Ruiz, Estrella Sánchez-Palomino, Vito Andriola, Matilde Molina-Corbacho, Yeray Maldonado-Sotoca, Alfons Gasset-Teixidor, Jorge Blasco-Moreu, Núria Fernández-Poch, Josep Rodoreda-Puigdemasa, Arnau Verdaguer-Figuerola, Heber Enrique Cueva-Sevieri, Santiago Garcia-Gimenez, Darius G. Viskontas, Kelly L. Apostle, Dory S. Boyer, Farhad O. Moola, Bertrand H. Perey, Trevor B. Stone, H. Michael Lemke, Ella Spicer, Kyrsten Payne, Robert A. Hymes, Cary C. Schwartzbach, Jeff E. Schulman, A. Stephen Malekzadeh, Michael A. Holzman, Greg E. Gaski, Jonathan Wills, Holly Pilson, Eben A. Carroll, Jason J. Halvorson, Sharon Babcock, J. Brett Goodman, Martha B. Holden, Wendy Williams, Taylor Hill, Ariel Brotherton, Nicholas M. Romeo, Heather A Vallier, Anna Vergon, Thomas F. Higgins, Justin M. Haller, David L. Rothberg, Zachary M. Olsen, Abby V. McGowan, Sophia Hill, Morgan K. Dauk, Patrick F. Bergin, George V. Russell, Matthew L. Graves, John Morellato, Sheketha L. McGee, Eldrin L. Bhanat, Ugur Yener, Rajinder Khanna, Priyanka Nehete, Dr. David Potter, Dr. Robert VanDemark, Kyle Seabold, Nicholas Staudenmier, Marcus Coe, Kevin Dwyer, Devin S. Mullin, Theresa A. Chockbengboun, Peter A. DePalo, Kevin Phelps, Michael Bosse, Madhav Karunakar, Laurence Kempton, Stephen Sims, Joseph Hsu, Rachel Seymour, Christine Churchill, Ada Mayfield, Juliette Sweeney, Todd Jaeblon, Robert Beer, Brent Bauer, Sean Meredith, Sneh Talwar, Christopher M. Domes, Rachel M. Reilly, Ariana Paniagua, JaNell Dupree, Michael J. Weaver, Arvind G. von Keudell, Abigail E. Sagona, Samir Mehta, Derek Donegan, Annamarie Horan, Mary Dooley, Marilyn Heng, Mitchel B. Harris, David W. Lhowe, John G. Esposito, Ahmad Alnasser, Steven F. Shannon, Alesha N. Scott, Bobbi Clinch, Becky Weber, Michael J. Beltran, Michael T. Archdeacon, Henry Claude Sagi, John D. Wyrick, Theodore Toan Le, Richard T. Laughlin, Cameron G. Thomson, Kimberly Hasselfeld, Carol A. Lin, Mark S. Vrahas, Charles N. Moon, Milton T. Little, Geoffrey S. Marecek, Denice M. Dubuclet, John A. Scolaro, James R. Learned, Philip K. Lim, Susan Demas, Arya Amirhekmat, and Yan Marco Dela Cruz

Subjects
General Earth and Planetary Sciences, General Environmental Science
Published
2023
Full Text
View/download PDF

4. Aqueous skin antisepsis before surgical fixation of open fractures (Aqueous-PREP): a multiple-period, cluster-randomised, crossover trial

Author

Gerard P. Slobogean, Sheila Sprague, Jeffrey L. Wells, Mohit Bhandari, Anthony D. Harris, C. Daniel Mullins, Lehana Thabane, Amber Wood, Gregory J. Della Rocca, Joan N. Hebden, Kyle J. Jeray, Lucas S. Marchand, Lyndsay M. O'Hara, Robert D. Zura, Christopher Lee, Joseph T. Patterson, Michael J. Gardner, Jenna Blasman, Jonah Davies, Stephen Liang, Monica Taljaard, PJ Devereaux, Gordon Guyatt, Diane Heels-Ansdell, Debra Marvel, Jana E. Palmer, Jeff Friedrich, Nathan N. O'Hara, Frances Grissom, I. Leah Gitajn, Saam Morshed, Robert V. O'Toole, Bradley Petrisor, Franca Mossuto, Manjari G. Joshi, Jean-Claude G. D'Alleyrand, Justin Fowler, Jessica C. Rivera, Max Talbot, David Pogorzelski, Shannon Dodds, Silvia Li, Gina Del Fabbro, Olivia Paige Szasz, Sofia Bzovsky, Paula McKay, Alexandra Minea, Kevin Murphy, Andrea L. Howe, Haley K. Demyanovich, Wayne Hoskins, Michelle Medeiros, Genevieve Polk, Eric Kettering, Nirmen Mahal, Andrew Eglseder, Aaron Johnson, Christopher Langhammer, Christopher Lebrun, Jason Nascone, Raymond Pensy, Andrew Pollak, Marcus Sciadini, Yasmin Degani, Heather Phipps, Eric Hempen, Herman Johal, Bill Ristevski, Dale Williams, Matthew Denkers, Krishan Rajaratnam, Jamal Al-Asiri, Jodi L. Gallant, Kaitlyn Pusztai, Sarah MacRae, Sara Renaud, John D. Adams, Michael L. Beckish, Christopher C. Bray, Timothy R. Brown, Andrew W. Cross, Timothy Dew, Gregory K. Faucher, Richard W. Gurich Jr, David E. Lazarus, S. John Millon, M. Christian Moody, M. Jason Palmer, Scott E. Porter, Thomas M. Schaller, Michael S. Sridhar, John L. Sanders, L. Edwin Rudisill Jr, Michael J. Garitty, Andrew S. Poole, Michael L. Sims, Clark M. Walker, Robert Carlisle, Erin A. Hofer, Brandon Huggins, Michael Hunter, William Marshall, Shea B. Ray, Cory Smith, Kyle M. Altman, Erin R. Pichiotino, Julia C. Quirion, Markus F. Loeffler, Austin A. Cole, Ethan J. Maltz, Wesley Parker, T. Bennett Ramsey, Alex Burnikel, Michael Colello, Russell Stewart, Jeremy Wise, Matthew Anderson, Joshua Eskew, Benjamin Judkins, James M. Miller, Stephanie L. Tanner, Rebecca G. Snider, Christine E. Townsend, Kayla H. Pham, Abigail Martin, Emily Robertson, Emily Bray, J. Wilson Sykes, Krystina Yoder, Kelsey Conner, Harper Abbott, Roman M. Natoli, Todd O. McKinley, Walter W. Virkus, Anthony T. Sorkin, Jan P. Szatkowski, Brian H. Mullis, Yohan Jang, Luke A. Lopas, Lauren C. Hill, Courteney L. Fentz, Maricela M. Diaz, Krista Brown, Katelyn M. Garst, Emma W. Denari, Patrick Osborn, Sarah N. Pierrie, Bradley Kessler, Maria Herrera, Theodore Miclau, Meir T. Marmor, Amir Matityahu, R. Trigg McClellan, David Shearer, Paul Toogood, Anthony Ding, Jothi Murali, Ashraf El Naga, Jennifer Tangtiphaiboontana, Tigist Belaye, Eleni Berhaneselase, Dmitry Pokhvashchev, William T. Obremskey, Amir Alex Jahangir, Manish Sethi, Robert Boyce, Daniel J. Stinner, Phillip P. Mitchell, Karen Trochez, Elsa Rodriguez, Charles Pritchett, Natalie Hogan, A. Fidel Moreno, Jennifer E. Hagen, Matthew Patrick, Richard Vlasak, Thomas Krupko, Michael Talerico, Marybeth Horodyski, Marissa Pazik, Elizabeth Lossada-Soto, Joshua L. Gary, Stephen J. Warner, John W. Munz, Andrew M. Choo, Timothy S. Achor, Milton L. 'Chip' Routt, Michael Kutzler, Sterling Boutte, Ryan J. Warth, Michael J. Prayson, Indresh Venkatarayappa, Brandon Horne, Jennifer Jerele, Linda Clark, Christina Boulton, Jason Lowe, John T. Ruth, Brad Askam, Andrea Seach, Alejandro Cruz, Breanna Featherston, Robin Carlson, Iliana Romero, Isaac Zarif, Niloofar Dehghan, Michael McKee, Clifford B. Jones, Debra L. Sietsema, Alyse Williams, Tayler Dykes, Ernesto Guerra-Farfan, Jordi Tomas-Hernandez, Jordi Teixidor-Serra, Vicente Molero-Garcia, Jordi Selga-Marsa, Juan Antonio Porcel-Vazquez, Jose Vicente Andres-Peiro, Ignacio Esteban-Feliu, Nuria Vidal-Tarrason, Jordi Serracanta, Jorge Nuñez-Camarena, Maria del Mar Villar-Casares, Jaume Mestre-Torres, Pilar Lalueza-Broto, Felipe Moreira-Borim, Yaiza Garcia-Sanchez, Francesc Marcano-Fernández, Laia Martínez-Carreres, David Martí-Garín, Jorge Serrano-Sanz, Joel Sánchez-Fernández, Matsuyama Sanz-Molero, Alejandro Carballo, Xavier Pelfort, Francesc Acerboni-Flores, Anna Alavedra-Massana, Neus Anglada-Torres, Alexandre Berenguer, Jaume Cámara-Cabrera, Ariadna Caparros-García, Ferran Fillat-Gomà, Ruben Fuentes-López, Ramona Garcia-Rodriguez, Nuria Gimeno-Calavia, Marta Martínez-Álvarez, Patricia Martínez-Grau, Raúl Pellejero-García, Ona Ràfols-Perramon, Juan Manuel Peñalver, Mònica Salomó Domènech, Albert Soler-Cano, Aldo Velasco-Barrera, Christian Yela-Verdú, Mercedes Bueno-Ruiz, Estrella Sánchez-Palomino, Vito Andriola, Matilde Molina-Corbacho, Yeray Maldonado-Sotoca, Alfons Gasset-Teixidor, Jorge Blasco-Moreu, Núria Fernández-Poch, Josep Rodoreda-Puigdemasa, Arnau Verdaguer-Figuerola, Heber Enrique Cueva-Sevieri, Santiago Garcia-Gimenez, Darius G. Viskontas, Kelly L. Apostle, Dory S. Boyer, Farhad O. Moola, Bertrand H. Perey, Trevor B. Stone, H. Michael Lemke, Ella Spicer, Kyrsten Payne, Robert A. Hymes, Cary C. Schwartzbach, Jeff E. Schulman, A. Stephen Malekzadeh, Michael A. Holzman, Greg E. Gaski, Jonathan Wills, Holly Pilson, Eben A. Carroll, Jason J. Halvorson, Sharon Babcock, J. Brett Goodman, Martha B. Holden, Wendy Williams, Taylor Hill, Ariel Brotherton, Nicholas M. Romeo, Heather A. Vallier, Anna Vergon, Thomas F. Higgins, Justin M. Haller, David L. Rothberg, Zachary M. Olsen, Abby V. McGowan, Sophia Hill, Morgan K. Dauk, Patrick F. Bergin, George V. Russell, Matthew L. Graves, John Morellato, Sheketha L. McGee, Eldrin L. Bhanat, Ugur Yener, Rajinder Khanna, Priyanka Nehete, David Potter, Robert VanDemark III, Kyle Seabold, Nicholas Staudenmier, Marcus Coe, Kevin Dwyer, Devin S. Mullin, Theresa A. Chockbengboun, Peter A. DePalo Sr., Kevin Phelps, Michael Bosse, Madhav Karunakar, Laurence Kempton, Stephen Sims, Joseph Hsu, Rachel Seymour, Christine Churchill, Ada Mayfield, Juliette Sweeney, Todd Jaeblon, Robert Beer, Brent Bauer, Sean Meredith, Sneh Talwar, Christopher M. Domes, Mark J. Gage, Rachel M. Reilly, Ariana Paniagua, JaNell Dupree, Michael J. Weaver, Arvind G. von Keudell, Abigail E. Sagona, Samir Mehta, Derek Donegan, Annamarie Horan, Mary Dooley, Marilyn Heng, Mitchel B. Harris, David W. Lhowe, John G. Esposito, Ahmad Alnasser, Steven F. Shannon, Alesha N. Scott, Bobbi Clinch, Becky Weber, Michael J. Beltran, Michael T. Archdeacon, Henry Claude Sagi, John D. Wyrick, Theodore Toan Le, Richard T. Laughlin, Cameron G. Thomson, Kimberly Hasselfeld, Carol A. Lin, Mark S. Vrahas, Charles N. Moon, Milton T. Little, Geoffrey S. Marecek, Denice M. Dubuclet, John A. Scolaro, James R. Learned, Philip K. Lim, Susan Demas, Arya Amirhekmat, and Yan Marco Dela Cruz

Subjects
Adult, Male, Canada, Cross-Over Studies, Chlorhexidine, General Medicine, Antisepsis, Middle Aged, Fractures, Open, Anti-Infective Agents, Local, Humans, Surgical Wound Infection, Female, Povidone-Iodine
Abstract

Chlorhexidine skin antisepsis is frequently recommended for most surgical procedures; however, it is unclear if these recommendations should apply to surgery involving traumatic contaminated wounds where povidone-iodine has previously been preferred. We aimed to compare the effect of aqueous 10% povidone-iodine versus aqueous 4% chlorhexidine gluconate on the risk of surgical site infection in patients who required surgery for an open fracture.We conducted a multiple-period, cluster-randomised, crossover trial (Aqueous-PREP) at 14 hospitals in Canada, Spain, and the USA. Eligible patients were adults aged 18 years or older with an open extremity fracture treated with a surgical fixation implant. For inclusion, the open fracture required formal surgical debridement within 72 h of the injury. Participating sites were randomly assigned (1:1) to use either aqueous 10% povidone-iodine or aqueous 4% chlorhexidine gluconate immediately before surgical incision; sites then alternated between the study interventions every 2 months. Participants, health-care providers, and study personnel were aware of the treatment assignment due to the colour of the solutions. The outcome adjudicators and data analysts were masked to treatment allocation. The primary outcome was surgical site infection, guided by the 2017 US Centers for Disease Control and Prevention National Healthcare Safety Network reporting criteria, which included superficial incisional infection within 30 days or deep incisional or organ space infection within 90 days of surgery. The primary analyses followed the intention-to-treat principle and included all participants in the groups to which they were randomly assigned. This study is registered with ClinicalTrials.gov, NCT03385304.Between April 8, 2018, and June 8, 2021, 3619 patients were assessed for eligibility and 1683 were enrolled and randomly assigned to povidone-iodine (n=847) or chlorhexidine gluconate (n=836). The trial's adjudication committee determined that 45 participants were ineligible, leaving 1638 participants in the primary analysis, with 828 in the povidone-iodine group and 810 in the chlorhexidine gluconate group (mean age 44·9 years [SD 18·0]; 629 [38%] were female and 1009 [62%] were male). Among 1571 participants in whom the primary outcome was known, a surgical site infection occurred in 59 (7%) of 787 participants in the povidone-iodine group and 58 (7%) of 784 in the chlorhexidine gluconate group (odds ratio 1·11, 95% CI 0·74 to 1·65; p=0·61; risk difference 0·6%, 95% CI -1·4 to 3·4).For patients who require surgical fixation of an open fracture, either aqueous 10% povidone-iodine or aqueous 4% chlorhexidine gluconate can be selected for skin antisepsis on the basis of solution availability, patient contraindications, or product cost. These findings might also have implications for antisepsis of other traumatic wounds.US Department of Defense, Canadian Institutes of Health Research, McMaster University Surgical Associates, PSI Foundation.

Published
2022

5. Retrograde intramedullary nailing below a hip arthroplasty prosthesis: a viable fixation option for periprosthetic and interprosthetic femur fractures

Author

Roman M. Natoli, Walter W Virkus, Raveesh D Richard, Anthony T Sorkin, and Greg E. Gaski

Subjects
030203 arthritis & rheumatology, 030222 orthopedics, medicine.medical_specialty, business.industry, medicine.medical_treatment, Nonunion, Periprosthetic, medicine.disease, Prosthesis, Surgery, law.invention, Intramedullary rod, 03 medical and health sciences, Fixation (surgical), 0302 clinical medicine, law, Orthopedic surgery, medicine, Internal fixation, Orthopedics and Sports Medicine, Femur, business
Abstract

Periprosthetic femur fractures (PPFF) distal to a femoral stem are traditionally treated with open reduction and internal fixation (ORIF) with plate and screws. To our knowledge, no studies exist comparing outcomes following ORIF vs retrograde intramedullary nails (RIMN) for this injury. This is a retrospective comparison of PPFFs distal to a femoral stem treated by ORIF (n = 17) vs RIMN (n = 13). The primary outcome was unplanned re-operation. There was no difference in unplanned re-operation (17.6 vs 23.1%, p > 0.99), infection, nonunion, refracture, and alignment between groups. The RIMN group had shorter surgical time (89 vs 157 min, p < 0.01), less blood loss (137 vs 291 ml, p = 0.03), and greater obesity. RIMN is a potential option for operative fixation of PPFF distal to a femoral stem worthy of additional study.

Published
2020
Full Text
View/download PDF

6. Intramedullary Nail Fixation of Intra-articular and Extra-articular Proximal Tibia Fractures

Author

Anokha, Padubidri, Anthony T, Sorkin, Andrew, Gudeman, Roman M, Natoli, and Greg E, Gaski

Subjects
Fracture Healing, Tibial Fractures, Treatment Outcome, Tibia, Humans, Bone Nails, Bone Plates, Fracture Fixation, Intramedullary, Retrospective Studies
Abstract

Recent studies suggest advantages to intramedullary nailing (IMN) of extra-articular proximal tibia fractures compared to plating. To our knowledge, no studies have evaluated IMN treatment of proximal tibia fractures with simple articular extension. We sought to compare rate of reoperation, malalignment, and patient-reported outcomes in patients with intra-articular versus extra-articular proximal tibia fractures treated via IMN. This retrospective cohort study compared patients that underwent IMN of extra-articular proximal tibia fractures (AO/OTA 41A2 and A3; n = 33) to simple intra-articular fractures (AO/OTA 41C1 and C2; n = 20) with minimum 12-month follow-up. With the numbers available, no significant differences were detected between the extra- and intra-articular groups for unplanned reoperation (9/33 vs. 2/20, p = 0.18), infection (4/33 vs. 1/20, p = 0.64), nonunion (4/33 vs. 2/20, p0.99), or malunion (5/30 vs. 3/19, p0.99). IMN of simple intra-articular proximal tibial fractures is a reasonable treatment strategy that may be desirable in certain clinical situations. (Journal of Surgical Orthopaedic Advances 30(1):055-060, 2021).

Published
2021

7. Patient and stakeholder engagement learnings: PREP-IT as a case study

Author

Michelle Medeiros, T Rosie Love, Gerard P. Slobogean, Sheila Sprague, Eleanor M. Perfetto, Nathan N. O'Hara, C. Daniel Mullins, Jeffrey Wells, Mohit Bhandari, Jean-Claude D'alleyrand, Anthony Harris, Daniel C. Mullins, Lehana Thabane, Amber Wood, Gregory J. Della Rocca, Joan Hebden, Kyle J. Jeray, Lucas Marchand, Lyndsay M. O'Hara, Robert Zura, Michael J. Gardner, Jenna Blasman, Jonah Davies, Stephen Liang, Monica Taljaard, PJ Devereaux, Gordon H. Guyatt, Dianne Heels-Ansdell, Debra Marvel, Jana Palmer, Jeff Friedrich, Nathan O'Hara, Frances Grissom, Leah Gitajn, Saam Morshed, Robert O'Toole, Bradley A. Petrisor, Megan Camara, Franca Mossuto, Manjari G. Joshi, Justin Fowler, Jessica Rivera, Max Talbot, Shannon Dodds, Alisha Garibaldi, Silvia Li, Uyen Nguyen, David Pogorzelski, Alejandra Rojas, Taryn Scott, Gina Del Fabbro, Olivia Page Szasz, Paula McKay, Andrea Howe, Joshua Rudnicki, Haley Demyanovich, Kelly Little, Adam Boissonneault, Michellic Medeiros, Eric Kettering, Diamond Hale, Nirmen Mahal, Andrew Eglseder, Aaron Johnson, Christopher Langhammer, Christopher Lebrun, Theodore Manson, Jason Nascone, Ebrahim Paryavi, Raymond Pensy, Andrew Pollack, Marcus Sciadini, Yasmin Degani, Katherine Joseph, Lucas S. Marchand, Heather Phipps, Eric Hempen, Herman Johal, Bill Risteyski, Dale Williams, Matthew Denkers, Krishan Rajaratnam, Jamal Al-Asiri, Jordan Leonard, Francesc A. Marcano-Fernández, Jodi Gallant, Federico Persico, Marko Gjorgjievski, Annie George, Sarah M. McGaugh, Kaitlyn Pusztai, Sarah Piekarski, Mavis Lyons, Julia Gennaccaro, Roman M. Natoli, Greg E. Gaski, Todd O. McKinley, Walter W. Virkus, Anthony T. Sorkin, Jan P. Szatkowski, Joseph R. Baele, Brian H. Mullis, Yohan Jang, Luke A. Lopas, Lauren C. Hill, Andrea Hudgins, Courteney L. Fentz, Maricela M. Diaz, Katelyn M. Garst, Emma W. Denari, Patrick Osborn, Sarah Pierrie, Eric Martinez, Joseph Kimmel, Maria Herrera, John D. Adams, Michael Beckish, Christopher Bray, Timothy R. Brown, Andrew W. Cross, Timothy Dew, Gregory Faucher, Richard W. Gurich Jr, David E. Lazarus, S. John Millon, M. Jason Palmer, Scott E. Porter, Thomas M. Schaller, Michael S. Sridhar, John L. Sanders, Edwin L. Rudisill Jr, Michael J. Garitty, Andrew S. Poole, Michael L. Sims, Clark M. Walker, Robert M. Carlisle II, Erin Adams Hofer, Brandon S. Huggins, Michael D. Hunter, William A. Marshall, Shea Bielby Ray, Cory D. Smith, Kyle M. Altman, Julia C. Bedard, Markus F. Loeffler, Erin R. Pichiotino, Austin A. Cole, Ethan J. Maltz, Wesley Parker, T. Bennett Ramsey, Alex Burnikel, Michael Colello, Russell Stewart, Jeremy Wise, M. Christian Moody, Matthew Anderson, Joshua Eskew, Benjamin Judkins, James M. Miller, Stephanie L. Tanner, Rebecca G. Snider, Christine E. Townsend, Kayla H. Pham, Abigail Martin, Emily Robertson, John Wilson Sykes, Theodore Miclau, Utku Kandemir, Meir Marmor, Amir Matityahu, R. Trigg McClellan, Eric Meinberg, David Shearer, Paul Toogood, Anthony Ding, Erin Donohue, Jothi Murali, Ashraf El Naga, Jennifer Tangtiphaiboontana, Tigist Belaye, Eleni Berhaneselase, Alexandra Paul, Kartik Garg, Dmitry Pokhvashchev, Joshua L. Gary, Stephen J. Warner, John W. Munz, Andrew M. Choo, Timothy Achor, Milton L. \\'Chip\\' Routt, Mayank Rao, Guillermo Pechero, Adam Miller, Michael Kutzler, Sterling Boutte, Ryan J. Warth, Jennifer E. Hagen, Matthew Patrick, Richard Vlasak, Thomas Krupko, Kalia Sadasivan, Michael Talerico, Marybeth Horodyski, Chris Koenig, Daniel Bailey, Daniel Wentworth, Chi Van, Justin Schwartz, Marissa Pazik, Elizabeth Lossada-Soto, Niloofar Dehghan, Clifford B. Jones, J. Tracy Watson, Michael McKee, Ammar Karim, Debra L. Sietsema, Alyse William, Tayler Dykes, William T. Obremskey, Amir Alex Jahangir, Manish Sethi, Robert Boyce, Daniel J. Stinner, Phillip Mitchell, Karen Trochez, Andres Rodriguez, Vamshi Gajari, Elsa Rodriguez, Chris Pritchett, Natalie Hogan, Fidel A. Moreno, Christina Boulton, Jason Lowe, Jason Wild, John T. Ruth, Michel Taylor, Brad Askam, Andrea Seach, Sabina Saeed, Hunter Culbert, Alejandro Crus, Thomas Knapp, Colin Hurkett, Maya Lowney, Breanna Featherston, Robin Carlson, Iliana Romero, Isaac Zarif, Michael Prayson, Indresh Venkatarayappa, Brandon Horne, Jennifer Jerele, Linda Clark, Francesc Marcano-Fernández, Montsant Jornet-Gibert, Laia Martínez-Carreres, David Martí-Garín, Jorge Serrano-Sanz, Joel Sánchez-Fernández, Matsuyama Sanz-Molero, Alejandro Carballo, Xavier Pelfort, Francesc Acerboni-Flores, Anna Alavedra-Massana, Neus Anglada-Torres, Alexandre Berenguer, Jaume Cámara-Cabrera, Ariadna Caparros-García, Ferran Fillat-Gomà, Ruben Fuentes-López, Ramona Garcia-Rodriguez, Nuria Gimeno-Clavia, Guillem Graells-Alonso, Marta Martínez-álvarez, Patricia Martínez-Grau, Raúl Pellejero-García, Ona Ràfols-Perramon, Juan Manuel Peñalver, Mònica Salomò Domènech, Albert Soler-Cano, Aldo Velasco-Barrera, Christian Yela-Verdú, Mercedes Bueno-Ruiz, Estrella Sánchez-Palomino, Vito Andriola, Matilde Molina-Corbacho, Yeray Maldonado-Sotoca, Alfons Gasset-Teixidor, Jorge Blasco-Moreu, Núria Fernández-Poch, Josep Rodoreda-Puigdemasa, Arnau Verdaguer-Figuerola, Heber Enrique Cueva-Sevieri, Santiago Garcia-Gimenez, Ernesto Guerra-Farfán, Jordi Tomas-Hernandez, Jordi Teixidor-Serra, Vicente Molero-Garcia, Jordi Selga-Marsa, Juan Antonio Porcel-Vazquez, Jose Vicente Andres-Peiro, Joan Minguell-Monyart, Jorge Nuñez-Camarena, Maria del Mar Villar-Casares, Jaume Mestre-Torres, Pilar Lalueza-Broto, Felipe Moreira-Borim, Yaiza García, Nicholas M. Romeo, Heather A. Vallier, Mary A. Breslin, Joanne Fraifogl, Eleanor S. Wilson, Leanne K Wadenpfuhl, Paul G. Halliday, Isabella Heimke, Darius G. Viskontas, Kelly L. Apostle, Dory S. Boyer, Farhad O. Moola, Bertrand H. Perey, Trevor B. Stone, H. Michael Lemke, Mauri Zomar, Ella Spicer, Chen \\'Brenda\\' Fan, Kyrsten Payne, Kevin Phelps, Michael Bosse, Madhav Karunakar, Laurence Kempton, Stephen Sims, Joseph Hsu, Rachel Seymour, Christine Churchill, Claire Bartel, Robert Miles Mayberry, Maggie Brownrigg, Cara Girardi, Ada Mayfield, Juliette Sweeney, Hannah Pollock, Robert A. Hymes, Cary C. Schwartzbach, Jeff E. Schulman, A. Stephen Malekzadeh, Michael A. Holzman, Jonathan Wills, Lolita Ramsey, James S. Ahn, Farhanaz Panjshiri, Sharmistha Das, Antoinisha D. English, Sharon M. Haaser, Jaslynn A.N. Cuff, Holly Pilson, Eben A. Carroll, Jason J. Halvorson, Sharon Babcock, J. Brett Goodman, Martha B. Holden, Debra Bullard, Wendy Williams, Taylor Hill, Ariel Brotherton, Thomas F. Higgins, Justin M. Haller, David L. Rothberg, Ashley Neese, Mark Russell, Zachary M. Olsen, Abby V. McGowan, Sophia Hill, Marcus Coe, Kevin Dwyer, Devin S. Mullin, Clifford A Reily, Peter DePalo, Amy E. Hall, Rebecca E. Dabrowski, Theresa A. Chockbengboun, Marilyn Heng, Mitchel B. Harris, R. Malcolm Smith, David W. Lhowe, John Esposito, Mira Bansal, Michael McTague, Ahmad Alnasser, Patrick F. Bergin, George V. Russell, Matthew L. Graves, John Morellato, Heather K. Champion, Leslie N. Johnson, Skeketha L. McGee, Eldrin L. Bhanat, Josny Thimothee, Jackie Serrano, Samir Mehta, Derek Donegan, Jaimo Ahn, Annamarie Horan, Mary Dooley, Ashley Kuczinski, Ashley Iwu, David Potter, Robert VanDemark II, Branden Pfaff, Troy Hollinsworth, Kristi Atkins, Michael J. Weaver, Arvind G. von Keudel, Michael F. McTague, Elizabeth M. Allen, Abigail E. Sagona, Todd Jaeblon, Robert Beer, Brent Bauer, Sean Meredith, Autumn Stone, Mark J. Gage, Rachel M. Reilly, Cindy Sparrow, Ariana Paniagua, Christopher M. Domes, Kristina P. Johnson, Steven F. Shannon, Alesha N. Scott, Bobbi Clinch, Carol A. Lin, Mark S. Vrahas, Charles N. Moon, Geoffrey S. Marecek, Denice Dubuclet, John A. Scolaro, James R. Learned, Philip K. Lim, Susan Demas, Michael J. Beltran, Michael T. Archdeacon, Henry Claude Sagi, John D. Wyrick, Theodore Toan Le, Richard T. Laughlin, and Cameron G. Thomson

Subjects
Patient Outcome Assessment, Medical education, business.industry, Stakeholder Participation, Health Policy, Patient-Centered Care, Stakeholder engagement, Medicine, Humans, Multi stakeholder, business, Patient centered
Published
2021

8. Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial

Author

Michael J. Bosse, Joanne Donnelly, Robert D. Zura, Heather A. Vallier, William T. Obremskey, Reza Firoozabadi, Yasmin Degani, Christine Churchill, Peter Z. Berger, Lauren C. Hill, Christina L. Boulton, Rachel B. Seymour, M. J. Crisco, Seth R. Yarboro, Jerald R. Westberg, Christopher M. McAndrew, Christina Riggsbee, Carrie Schoonover, Joshua L. Gary, Marcus F. Sciadini, Vamshi Gajari, Jason J. Halvorson, John C. Weinlein, Greg Osgood, Gele B. Moloney, Babar Shafiq, Sterling J. Boutte, Daniel O. Scharfstein, Olivia C. Lee, Thomas M. Large, Daniel Connelly, David L. Rothberg, Angela Mullins, Walter W Virkus, Drew Sanders, Christopher S. Smith, Cyrus Caroom, William M. Ricci, Animesh Agarwal, Vaishali Laljani, Thomas R Wojda, Medardo Maroto, Josie M. Hydrick, Lisa K. Schroder, Colette Hilliard, Joseph Kimmel, Boris A. Zelle, Stanislaw P Stawicki, Matthew L Graves, Mary A. Breslin, Ravi A. Karia, Susan C J Collins, Lauren E. Allen, James Brett Goodman, Debra L. Sietsema, Eric D. McVey, Anthony R. Carlini, Emily Wagstrom, Yanjie Huang, Patrick M. Osborn, Cara J. Rowe, Elizabeth Sheridan, Roman A. Hayda, Cameron Howes, Christopher T. LeBrun, Mary Zadnik, Laura S. Phieffer, Jessica C. Rivera, Andrew R. Evans, Sharon Haaser, Andrew M Choo, Greg E. Gaski, Justin M. Haller, Jeff E. Schulman, Jaslynn A.N. Cuff, J. Spence Reid, David Teague, Basem Attum, Tara J. Taylor, Cesar S. Molina, Julius A. Bishop, Peter C. Krause, Laurence B. Kempton, Timothy S. Achor, Colin V. Crickard, Lindsay E. Hickerson, Clay A. Spitler, Hassan R. Mir, Veronica Lester-Ballard, Michael L. Brennan, Ryan N Montalvo, Theodore T. Manson, Jason W. Nascone, Chinenye O. Nwachuku, Anna N. Miller, Rachel M. Reilly, Timothy Costales, A. Stephen Malekzadeh, Renan C. Castillo, Kathy Ringenbach, Paul S. Whiting, A. Alex Jahangir, Michael D. Holzman, Michael J. Gardner, Andres Rodriguez-Buitrago, Andrew N. Pollak, George V Russell, Gerald J. Lang, Massimo Max Morandi, Gerard P. Slobogean, John W. Munz, Brigham Au, Andrea Howe, Clinton K. Murray, Saqib Rehman, Ashoke K. Sathy, Alexander B. Siy, Daniel Mascarenhas, Adam M. Kaufman, Anthony T. Sorkin, Stephen H. Sims, Karen M. Trochez, Gabriela Gonzales, H. Michael Frisch, Manjari Joshi, Thomas F. Higgins, G Bradley Reahl, Roman M. Natoli, C. Michael Lecroy, William J.J. Ertl, Nathan N O'Hara, Madhav A. Karunakar, Patrick F. Bergin, Sandy Vang, Joseph R. Hsu, Martha B. Holden, Eduardo J. Burgos, Lolita Ramsey, David B. Weiss, Amanda Spraggs-Hughes, Clifford B. Jones, Mark D. Jenkins, Michael J. Weaver, Robert A. Hymes, David C. Goodspeed, Robert V O'Toole, and Dimitrius Marinos

Subjects
Adult, Male, medicine.medical_specialty, Time Factors, Intra-Articular Fractures, 030230 surgery, Pilon fracture, law.invention, 03 medical and health sciences, Fracture Fixation, Internal, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Vancomycin, Post-hoc analysis, Fracture fixation, Surgical Wound Dehiscence, medicine, Infection control, Humans, Surgical Wound Infection, Prospective Studies, Gram-Positive Bacterial Infections, Probability, Wound dehiscence, business.industry, Absolute risk reduction, Middle Aged, medicine.disease, Surgery, Anti-Bacterial Agents, Tibial Fractures, 030220 oncology & carcinogenesis, Fractures, Ununited, Female, Powders, business, Gram-Negative Bacterial Infections, medicine.drug
Abstract

Importance Despite the widespread use of systemic antibiotics to prevent infections in surgically treated patients with fracture, high rates of surgical site infection persist. Objective To examine the effect of intrawound vancomycin powder in reducing deep surgical site infections. Design, Setting, and Participants This open-label randomized clinical trial enrolled adult patients with an operatively treated tibial plateau or pilon fracture who met the criteria for a high risk of infection from January 1, 2015, through June 30, 2017, with 12 months of follow-up (final follow-up assessments completed in April 2018) at 36 US trauma centers. Interventions A standard infection prevention protocol with (n = 481) or without (n = 499) 1000 mg of intrawound vancomycin powder. Main Outcomes and Measures The primary outcome was a deep surgical site infection within 182 days of definitive fracture fixation. A post hoc comparison assessed the treatment effect on gram-positive and gram-negative-only infections. Other secondary outcomes included superficial surgical site infection, nonunion, and wound dehiscence. Results The analysis included 980 patients (mean [SD] age, 45.7 [13.7] years; 617 [63.0%] male) with 91% of the expected person-time of follow-up for the primary outcome. Within 182 days, deep surgical site infection was observed in 29 of 481 patients in the treatment group and 46 of 499 patients in the control group. The time-to-event estimated probability of deep infection by 182 days was 6.4% in the treatment group and 9.8% in the control group (risk difference, –3.4%; 95% CI, –6.9% to 0.1%;P = .06). A post hoc analysis of the effect of treatment on gram-positive (risk difference, –3.7%; 95% CI, –6.7% to –0.8%;P = .02) and gram-negative-only (risk difference, 0.3%; 95% CI, –1.6% to 2.1%;P = .78) infections found that the effect of vancomycin powder was a result of its reduction in gram-positive infections. Conclusions and Relevance Among patients with operatively treated tibial articular fractures at a high risk of infection, intrawound vancomycin powder at the time of definitive fracture fixation reduced the risk of a gram-positive deep surgical site infection, consistent with the activity of vancomycin. Trial Registration ClinicalTrials.gov Identifier:NCT02227446

Published
2021

9. A Prospective Clinical Trial Comparing Surgical Fixation versus Nonoperative Management of Minimally Displaced Complete Lateral Compression Pelvis Fractures

Author

Roman M. Natoli, Theodore T. Manson, Nathan N O'Hara, Robert V O'Toole, Blessing Enobun, Joshua Rudnicki, Walter W Virkus, Greg E. Gaski, Todd O. McKinley, Krista M. Brown, Marcus F. Sciadini, Gerard P. Slobogean, Jeff Gill, Anthony T Sorkin, Jason W. Nascone, Andrea Howe, and Christopher T. LeBrun

Subjects
Adult, medicine.medical_specialty, medicine.medical_treatment, Pelvis, Fracture Fixation, Internal, Fractures, Bone, Fractures, Compression, medicine, Humans, Orthopedics and Sports Medicine, Displacement (orthopedic surgery), Prospective Studies, Nonoperative management, Brief Pain Inventory, Reduction (orthopedic surgery), Fixation (histology), business.industry, Bayes Theorem, General Medicine, Lateral compression, Surgery, Clinical trial, Treatment Outcome, medicine.anatomical_structure, business
Abstract

OBJECTIVE To compare the early pain and functional outcomes of operative fixation versus nonoperative management for minimally displaced complete lateral compression (LC; OTA/AO 61-B1/B2) pelvic fractures. DESIGN Prospective clinical trial. SETTING Two academic trauma centers. PATIENTS Forty-eight adult patients with LC pelvic ring injuries with

Published
2021
Full Text
View/download PDF

10. Retrograde intramedullary nailing below a hip arthroplasty prosthesis: a viable fixation option for periprosthetic and interprosthetic femur fractures

Author

Raveesh D, Richard, Roman M, Natoli, Anthony T, Sorkin, Walter W, Virkus, and Greg E, Gaski

Subjects
Fracture Fixation, Internal, Treatment Outcome, Hip Fractures, Arthroplasty, Replacement, Hip, Humans, Femur, Bone Nails, Periprosthetic Fractures, Femoral Fractures, Fracture Fixation, Intramedullary, Retrospective Studies
Abstract

Periprosthetic femur fractures (PPFF) distal to a femoral stem are traditionally treated with open reduction and internal fixation (ORIF) with plate and screws. To our knowledge, no studies exist comparing outcomes following ORIF vs retrograde intramedullary nails (RIMN) for this injury.This is a retrospective comparison of PPFFs distal to a femoral stem treated by ORIF (n = 17) vs RIMN (n = 13). The primary outcome was unplanned re-operation.There was no difference in unplanned re-operation (17.6 vs 23.1%, p0.99), infection, nonunion, refracture, and alignment between groups. The RIMN group had shorter surgical time (89 vs 157 min, p0.01), less blood loss (137 vs 291 ml, p = 0.03), and greater obesity.RIMN is a potential option for operative fixation of PPFF distal to a femoral stem worthy of additional study.

Published
2020

11. Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial

Author

David Pogorzelski, Uyen Nguyen, Paula McKay, Lehana Thabane, Megan Camara, Lolita Ramsey, Rachel Seymour, J. Brett Goodman, Sheketha McGee, Joanne Fraifogl, Andrea Hudgins, Stephanie L. Tanner, Mohit Bhandari, Gerard P. Slobogean, Sheila Sprague, Jeffrey Wells, Jean-Claude D'Alleyrand, Anthony D. Harris, Daniel C. Mullins, Amber Wood, Gregory J. Della Rocca, Joan Hebden, Kyle J. Jeray, Lucas Marchand, Lyndsay M. O'Hara, Robert Zura, Michael J. Gardner, Jenna Blasman, Jonah Davies, Stephen Liang, Monica Taljaard, P.J. Devereaux, Gordon H. Guyatt, Diane Heels-Ansdell, Debra Marvel, Jana Palmer, Jeff Friedrich, Nathan N. O'Hara, Ms. Frances Grissom, I. Leah Gitajn, Saam Morshed, Robert V. O'Toole, Bradley A. Petrisor, Franca Mossuto, Manjari G. Joshi, Justin Fowler, Jessica Rivera, Max Talbot, Shannon Dodds, Alisha Garibaldi, Silvia Li, Alejandra Rojas, Taryn Scott, Gina Del Fabbro, Olivia Paige Szasz, Andrea Howe, Joshua Rudnicki, Haley Demyanovich, Kelly Little, C. Daniel Mullins, Michelle Medeiros, Eric Kettering, Diamond Hale, Andrew Eglseder, Aaron Johnson, Christopher Langhammer, Christopher Lebrun, Theodore Manson, Jason Nascone, Ebrahim Paryavi, Raymond Pensy, Andrew Pollak, Marcus Sciadini, Yasmin Degani, Haley K. Demyanovich, Katherine Joseph, Brad A. Petrisor, Herman Johal, Bill Ristevski, Dale Williams, Matthew Denkers, Krishan Rajaratnam, Jamal Al-Asiri, Jordan Leonard, Francesc A. Marcano-Fernández, Jodi Gallant, Federico Persico, Marko Gjorgjievski, Annie George, Roman M. Natoli, Greg E. Gaski, Todd O. McKinley, Walter W. Virkus, Anthony T. Sorkin, Jan P. Szatkowski, Joseph R. Baele, Brian H. Mullis, Lauren C. Hill, Patrick Osborn, Sarah Pierrie, Eric Martinez, Joseph Kimmel, John D. Adams, Michael L. Beckish, Christopher C. Bray, Timothy R. Brown, Andrew W. Cross, Timothy Dew, Gregory K. Faucher, Richard W. Gurich, David E. Lazarus, S. John Millon, M. Jason Palmer, Scott E. Porter, Thomas M. Schaller, Michael S. Sridhar, John L. Sanders, L. Edwin Rudisill, Michael J. Garitty, Andrew S. Poole, Michael L. Sims, Clark M. Walker, Robert M. Carlisle, Erin Adams Hofer, Brandon S. Huggins, Michael D. Hunter, William A. Marshall, Shea Bielby Ray, Cory D. Smith, Kyle M. Altman, Julia C. Bedard, Markus F. Loeffler, Erin R. Pichiotino, Austin A. Cole, Ethan J. Maltz, Wesley Parker, T. Bennett Ramsey, Alex Burnikel, Michael Colello, Russell Stewart, Jeremy Wise, M. Christian Moody, Rebecca G. Snider, Christine E. Townsend, Kayla H. Pham, Abigail Martin, Emily Robertson, Theodore Miclau, Utku Kandemir, Meir Marmor, Amir Matityahu, R. Trigg McClellan, Eric Meinberg, David Shearer, Paul Toogood, Anthony Ding, Erin Donohue, Tigist Belaye, Eleni Berhaneselase, Alexandra Paul, Kartik Garg, Joshua L. Gary, Stephen J. Warner, John W. Munz, Andrew M. Choo, Timothy S. Achor, Milton L. 'Chip' Routt, Mayank Rao, Guillermo Pechero, Adam Miller, Jennifer E. Hagen, Matthew Patrick, Richard Vlasak, Thomas Krupko, Kalia Sadasivan, Chris Koenig, Daniel Bailey, Daniel Wentworth, Chi Van, Justin Schwartz, Niloofar Dehghan, Clifford B. Jones, J Tracy Watson, Michael McKee, Ammar Karim, Michael Talerico, Debra L. Sietsema, Alyse Williams, Tayler Dykes, William T. Obremskey, Amir Alex Jahangir, Manish Sethi, Robert Boyce, Daniel J. Stinner, Phillip Mitchell, Karen Trochez, Andres Rodriguez, Vamshi Gajari, Elsa Rodriguez, Charles Pritchett, Christina Boulton, Jason Lowe, Jason Wild, John T. Ruth, Michel Taylor, Andrea Seach, Sabina Saeed, Hunter Culbert, Alejandro Cruz, Thomas Knapp, Colin Hurkett, Maya Lowney, Michael Prayson, Indresh Venkatarayappa, Brandon Horne, Jennifer Jerele, Linda Clark, Francesc Marcano-Fernández, Montsant Jornet-Gibert, Laia Martínez-Carreres, David Martí-Garín, Jorge Serrano-Sanz, Joel Sánchez-Fernández, Matsuyama Sanz-Molero, Alejandro Carballo, Xavier Pelfort, Francesc Acerboni-Flores, Anna Alavedra-Massana, Neus Anglada-Torres, Alexandre Berenguer, Jaume Cámara-Cabrera, Ariadna Caparros-García, Ferran Fillat-Gomà, Ruben Fuentes-López, Ramona Garcia-Rodriguez, Nuria Gimeno-Calavia, Guillem Graells-Alonso, Marta Martínez-Álvarez, Patricia Martínez-Grau, Raúl Pellejero-García, Ona Ràfols-Perramon, Juan Manuel Peñalver, Mònica Salomó Domènech, Albert Soler-Cano, Aldo Velasco-Barrera, Christian Yela-Verdú, Mercedes Bueno-Ruiz, Estrella Sánchez-Palomino, Ernesto Guerra, Yaiza García, Nicholas M. Romeo, Heather A. Vallier, Mary A. Breslin, Eleanor S. Wilson, Leanne K. Wadenpfuhl, Paul G. Halliday, Darius G. Viskontas, Kelly L. Apostle, Dory S. Boyer, Farhad O. Moola, Bertrand H. Perey, Trevor B. Stone, H. Michael Lemke, Mauri Zomar, Ella Spicer, Chen 'Brenda' Fan, Kyrsten Payne, Kevin Phelps, Michael Bosse, Madhav Karunakar, Laurence Kempton, Stephen Sims, Joseph Hsu, Christine Churchill, Claire Bartel, Robert Miles Mayberry, Maggie Brownrigg, Cara Girardi, Ada Mayfield, Robert A. Hymes, Cary C. Schwartzbach, Jeff E. Schulman, A. Stephen Malekzadeh, Michael A. Holzman, James S. Ahn, Farhanaz Panjshiri, Sharmistha Das, Antoinisha D. English, Sharon M. Haaser, Jaslynn A.N. Cuff, Holly Pilson, Eben A. Carroll, Jason J. Halvorson, Sharon Babcock, Martha B. Holden, Debra Bullard, Wendy Williams, Thomas F. Higgins, Justin M. Haller, David L. Rothberg, Ashley Neese, Mark Russell, Marcus Coe, Kevin Dwyer, Devin S. Mullin, Clifford A. Reilly, Peter DePalo, Amy E. Hall, Marilyn Heng, Mitchel B. Harris, R. Malcolm Smith, David W. Lhowe, John G. Esposito, Mira Bansal, Patrick F. Bergin, George V. Russell, Matthew L. Graves, John Morellato, Heather K. Champion, Leslie N. Johnson, Sheketha L. McGee, Eldrin L. Bhanat, Samir Mehta, Derek Donegan, Jaimo Ahn, Annamarie Horan, Mary Dooley, Ashley Kuczinski, Ashley Iwu, David Potter, Robert VanDemark, Branden Pfaff, Troy Hollinsworth, Michael J. Weaver, Arvind G. von Keudell, Michael F. McTague, Elizabeth M. Allen, Todd Jaeblon, Robert Beer, Mark J. Gage, Rachel M. Reilly, and Cindy Sparrow

Subjects
Pragmatic, medicine.medical_specialty, Comparative effectiveness research, Pharmacy, Sampling framework, Cluster crossover, Sampling strategy, Article, Odds, 03 medical and health sciences, 0302 clinical medicine, Health care, medicine, 030212 general & internal medicine, Sampling, Pharmacology, lcsh:R5-920, Descriptive statistics, business.industry, Sampling (statistics), General Medicine, Test (assessment), Work flow, Family medicine, business, lcsh:Medicine (General), 030217 neurology & neurosurgery
Abstract

Author(s): Pogorzelski, David; Nguyen, Uyen; McKay, Paula; Thabane, Lehana; Camara, Megan; Ramsey, Lolita; Seymour, Rachel; Goodman, J Brett; McGee, Sheketha; Fraifogl, Joanne; Hudgins, Andrea; Tanner, Stephanie L; Bhandari, Mohit; Slobogean, Gerard P; Sprague, Sheila; PREP-IT Investigators Executive Committee:; Steering Committee; Adjudication Committee; Data and Safety Monitoring Committee; Research Methodology Core; Patient Centred Outcomes Core; Orthopaedic Surgery Core; Operating Room Core; Infectious Disease Core; Military Core; McMaster University Methods Center; University of Maryland School of Medicine Administrative Center; University of Maryland School of Pharmacy, The PATIENTS Program; PREP-IT Clinical Sites: Lead Clinical Site (Aqueous-PREP and PREPARE); Aqueous-PREP and PREPARE; Aqueous-PREP; PREPARE; PREP-IT Investigators Executive Committee | Abstract: IntroductionPragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.MethodsGiven the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients.Results7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p l 0.001).ConclusionsImplementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.

Published
2020

12. Intramedullary Nailing of Lower-Extremity Periarticular Fractures

Author

R D Richard, Roman M. Natoli, N R Sardesai, Greg E. Gaski, Anthony T Sorkin, and Walter W. Virkus

Subjects
Orthodontics, Arthrotomy, 030222 orthopedics, Preoperative planning, business.industry, medicine.medical_treatment, Complex fracture, 030229 sport sciences, law.invention, Intramedullary rod, 03 medical and health sciences, Fixation (surgical), 0302 clinical medicine, Fixed angle, law, Short segment, Medicine, Orthopedics and Sports Medicine, Surgery, Reamer, business, Key Procedures
Abstract

Intramedullary nailing is used to stabilize distal femoral, proximal tibial, and distal tibial periarticular fractures with short proximal or distal segments, as well as some intra-articular fractures in which a stable articular block can be created. Intramedullary nailing may be beneficial in complex fracture patterns with diaphyseal extension, segmental injuries, or patients who might benefit from a decreased incision burden. Step 1: Preoperative planning. Review imaging and make sure there is a nail with adequate interlocks. Consider the use of adjunctive techniques to obtain and maintain alignment, and how intra-articular fracture lines will be stabilized. Step 2: Position and prepare the patient. Step 3: Exposure for nailing via suprapatellar, infrapatellar, or knee arthrotomy approaches. Limited exposure of fracture planes may also be necessary for adjunctive techniques. Step 4: Convert an OTA/AO C-type fracture to an A-type fracture if needed. Step 5: Obtain appropriate starting point and trajectory with the nail starting wire and use the opening reamer. Step 6: Obtain reduction, if not yet done, and pass the ball-tipped reaming wire across the fracture. Step 7: Ream while holding reduction. Step 8: Pass nail. Step 9: Verify reduction is maintained and correct if needed. Step 10: Place interlocks, preferably multiplanar, in the short segment. Create a fixed angle construct if desired and convert adjunctive techniques/provisional fixation to definitive fixation as needed. Step 11: Perform final checks. Step 12: Closure. Step 13: Postoperative plan. For extra-articular fractures, one may expect healing with maintained alignment from what was present at the case end intraoperatively in the vast majority of cases. For intra-articular fractures, development of posttraumatic arthritis is an additional concern.

Published
2020

13. Significant Improvement in the Value of Surgical Treatment of Tibial Plateau Fractures Through Surgeon Practice Standardization

Author

Walter W. Virkus, Krista M. Brown, Christopher A Schneble, Anthony T. Sorkin, and Laurence B. Kempton

Subjects
Male, medicine.medical_specialty, Nonunion, Osteoarthritis, 03 medical and health sciences, 0302 clinical medicine, Cost Savings, Fracture Fixation, medicine, Tibial plateau fracture, Humans, Orthopedics and Sports Medicine, Prospective Studies, Practice Patterns, Physicians', Surgical treatment, Prospective cohort study, Quality of Health Care, 030222 orthopedics, business.industry, Visual Analog Pain Scale, Surgical care, 030229 sport sciences, Orthopedic Surgeons, Middle Aged, medicine.disease, Surgery, Tibial Fractures, Treatment Outcome, Observational study, Female, business
Abstract

INTRODUCTION It is unclear whether cost-based decisions to improve the value of surgical care (quality:cost ratio) affect patient outcomes. Our hypothesis was that surgeon-directed reductions in surgical costs for tibial plateau fracture fixation would result in similar patient outcomes, thus improving treatment value. METHODS This was a prospective observational study with retrospective control data. Surgically treated tibial plateau fractures from 2013 to October 2014 served as a control (group 1). Material costs for each case were calculated. Practices were modified to remove allegedly unnecessary costs. Next, cost data were collected on similar patients from November 2014 through 2015 (group 2). Costs were compared between groups, analyzing partial articular and complete articular fractures separately. Minimum follow-up (f/u) was 1-year. Outcomes data collected include Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF) and pain interference domains, Western Ontario and McMaster Universities Osteoarthritis Index, visual analog pain scale, infection, nonunion, unplanned return to surgery, demographics, injury characteristics, and comorbidities. RESULTS Group 1 included 57 partial articular fractures and 57 complete articular fractures. Group 2 included 37 partial articular fractures and 32 complete articular fractures. Median cost of partial articular fractures decreased from $1,706 to $1,447 (P = 0.025), and median cost of complete articular fractures decreased from $2,681 to $2,220 (P = 0.003). Group 1 had 55 patients who consented to clinical f/u, and group 2 had 39. Median PROMIS PF score was 40 for group 1 and was 43 for group 2 (P = 0.23). There were no significant differences between the groups for any clinical outcomes, demographics, injury characteristics, or comorbidities. Median f/u in group 1 was 31 months compared with 15 months in group 2 (P < 0.0001). DISCUSSION We have demonstrated that surgeons can improve value of surgical care by reducing surgical costs while maintaining clinical outcomes.

Published
2020

14. Association Between 6-Week Postdischarge Risk Classification and 12-Month Outcomes After Orthopedic Trauma

Author

A. Alex Jahangir, Susan C J Collins, Andrea Howe, Mary A. Breslin, Clifford B. Jones, Corey Henderson, Daniel S. Chan, Anjan R. Shah, Andrew M Choo, Daniel O. Scharfstein, Madhav A. Karunakar, Martha B. Holden, Katherine Frey, Stephen T. Wegener, Lauren C. Hill, Kristin R. Archer, Stephen H. Sims, Todd O. McKinley, Eben A. Carroll, Danielle Yemiola Drye, Manish K. Sethi, Andrew N. Pollak, Katherine Ordonio, Joseph R. Hsu, Robert H. Boyce, Walter W. Virkus, Cesar S. Molina, Timothy S. Achor, Susan W. Vanston, Eileen Flores, John W. Munz, Sarah B Hendrickson, Hassan R. Mir, Rachel B. Seymour, Jerald R. Westberg, Debra L. Sietsema, Robert A. Hymes, Barbara Steverson, Anna B. Newcomb, Greg E. Gaski, Melissa Porrey, Anthony T. Sorkin, Michael J. Bosse, Ellen J. MacKenzie, Robert V. O’Toole, Laurence B. Kempton, David J. Hak, Joshua L. Gary, William T. Obremskey, Heather A. Vallier, Yanjie Huang, Christine Churchill, Timothy J. Zerhusen, Elizabeth Wysocki, and Renan C. Castillo

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Health Status, Population, Alcohol abuse, 030230 surgery, Anxiety, 03 medical and health sciences, Social support, Young Adult, 0302 clinical medicine, Postoperative Complications, Trauma Centers, Risk Factors, medicine, Humans, Prospective Studies, education, Prospective cohort study, Musculoskeletal System, Depression (differential diagnoses), Original Investigation, education.field_of_study, Pain, Postoperative, business.industry, Depression, Middle Aged, medicine.disease, Latent class model, Patient Discharge, United States, Treatment Outcome, 030220 oncology & carcinogenesis, Case-Control Studies, Physical therapy, Surgery, Observational study, Female, business, Psychosocial
Abstract

Importance Numerous studies have demonstrated that long-term outcomes after orthopedic trauma are associated with psychosocial and behavioral health factors evident early in the patient’s recovery. Little is known about how to identify clinically actionable subgroups within this population. Objectives To examine whether risk and protective factors measured at 6 weeks after injury could classify individuals into risk clusters and evaluate whether these clusters explain variations in 12-month outcomes. Design, Setting, and Participants A prospective observational study was conducted between July 16, 2013, and January 15, 2016, among 352 patients with severe orthopedic injuries at 6 US level I trauma centers. Statistical analysis was conducted from October 9, 2017, to July 13, 2018. Main Outcomes and Measures At 6 weeks after discharge, patients completed standardized measures for 5 risk factors (pain intensity, depression, posttraumatic stress disorder, alcohol abuse, and tobacco use) and 4 protective factors (resilience, social support, self-efficacy for return to usual activity, and self-efficacy for managing the financial demands of recovery). Latent class analysis was used to classify participants into clusters, which were evaluated against measures of function, depression, posttraumatic stress disorder, and self-rated health collected at 12 months. Results Among the 352 patients (121 women and 231 men; mean [SD] age, 37.6 [12.5] years), latent class analysis identified 6 distinct patient clusters as the optimal solution. For clinical use, these clusters can be collapsed into 4 groups, sorted from low risk and high protection (best) to high risk and low protection (worst). All outcomes worsened across the 4 clinical groupings. Bayesian analysis shows that the mean Short Musculoskeletal Function Assessment dysfunction scores at 12 months differed by 7.8 points (95% CI, 3.0-12.6) between the best and second groups, by 10.3 points (95% CI, 1.6-20.2) between the second and third groups, and by 18.4 points (95% CI, 7.7-28.0) between the third and worst groups. Conclusions and Relevance This study demonstrates that during early recovery, patients with orthopedic trauma can be classified into risk and protective clusters that account for a substantial amount of the variance in 12-month functional and health outcomes. Early screening and classification may allow a personalized approach to postsurgical care that conserves resources and targets appropriate levels of care to more patients.

Published
2018

15. Intramedullary Nailing of Periarticular Fractures

Author

Anthony T Sorkin, Walter W. Virkus, Greg E. Gaski, and Laurence B. Kempton

Subjects
musculoskeletal diseases, medicine.medical_specialty, Intra-Articular Fractures, law.invention, Intramedullary rod, Proximal tibia, Contraindications, Procedure, 03 medical and health sciences, Fixation (surgical), Distal femur, 0302 clinical medicine, law, Fracture fixation, medicine, Humans, Orthopedics and Sports Medicine, Surgical treatment, Plate fixation, 030222 orthopedics, business.industry, 030208 emergency & critical care medicine, Distal tibia, Surgery, Fracture Fixation, Intramedullary, Tibial Fractures, Treatment Outcome, business, Femoral Fractures
Abstract

Plate fixation has historically been the preferred surgical treatment method for periarticular fractures of the lower extremity. This trend has stemmed from difficulties with fracture reduction and concerns of inadequate fixation with intramedullary implants. However, the body of literature on management of periarticular fractures of the lower extremities has expanded in recent years, indicating that intramedullary nailing of distal femur, proximal tibia, and distal tibia fractures may be the preferred method of treatment in some cases. Intramedullary nailing reliably leads to excellent outcomes when performed for appropriate indications and when potential difficulties are recognized and addressed.

Published
2018

16. Costs and Radiographic Outcomes of Rotational Ankle Fractures Treated by Orthopaedic Surgeons With or Without Trauma Fellowship Training

Author

Jeffrey S. Cheesman, Lauren C. Hill, Anthony T Sorkin, Robert J. Wetzel, Laurence B. Kempton, Todd O. McKinley, and Walter W. Virkus

Subjects
Adult, Reoperation, medicine.medical_specialty, Adolescent, Radiography, medicine.medical_treatment, Ankle Fractures, 03 medical and health sciences, Fracture Fixation, Internal, Young Adult, 0302 clinical medicine, Fracture fixation, Medicine, Humans, Orthopedics and Sports Medicine, 030212 general & internal medicine, Fellowships and Scholarships, Fellowship training, Reduction (orthopedic surgery), Aged, Aged, 80 and over, 030222 orthopedics, business.industry, Evidence-based medicine, Middle Aged, Internal Fixators, Surgery, Open Fracture Reduction, medicine.anatomical_structure, Orthopedics, Traumatology, Cost analysis, Costs and Cost Analysis, Level iii, Clinical Competence, Ankle, business
Abstract

Introduction We evaluated the radiographic outcomes and surgical costs of surgically treated rotational ankle fractures in our health system between providers who had completed a trauma fellowship and those who had not. Methods We grouped patients into those treated by trauma-trained orthopaedic surgeons (TTOS) and non-trauma-trained orthopaedic surgeons (NTTOS). We graded the quality of fracture reductions and calculated implant-related costs of treatment. Results A total of 208 fractures met the inclusion criteria, with 119 in the TTOS group and 89 in the NTTOS group. Five patients lost reduction during the follow-up period. The adequacy of fracture reduction at final follow-up did not differ (P = 0.29). The median surgical cost was $2,940 for the NTTOS group and $1,233 for the TTOS group (P Discussion We found no notable differences in radiographic outcomes between the TTOS and NTTOS groups. Cost analysis demonstrated markedly higher implant-related costs for the NTTOS group, with the median surgical cost being more than twice that for the TTOS group. Level of evidence Level III.

Published
2018

17. Insertion-related pain with intramedullary nailing

Author

Anthony T Sorkin, Laurence B. Kempton, Yohan Jang, and Todd O. McKinley

Subjects
medicine.medical_specialty, Humeral Fractures, Long bone, Iatrogenic Disease, Bone Nails, law.invention, Intramedullary rod, 03 medical and health sciences, 0302 clinical medicine, law, Long term outcomes, medicine, Humans, 030212 general & internal medicine, General Environmental Science, Randomized Controlled Trials as Topic, Fracture Healing, 030222 orthopedics, Pain, Postoperative, Ossification, business.industry, Ossification, Heterotopic, Biomechanics, Soft tissue, Surgery, Fracture Fixation, Intramedullary, Radiography, Tibial Fractures, medicine.anatomical_structure, Treatment Outcome, General Earth and Planetary Sciences, Implant, medicine.symptom, business, Bone Plates, Femoral Fractures
Abstract

The use of intramedullary nails for the treatment of long bone fractures has become increasingly frequent over the last decade with gradually expanding indications and technological advances. Improved biomechanics relative to plates and less direct fracture exposure are some of the potential benefits of intramedullary nails. However, persistent insertion-related pain is common and may limit satisfactory long term outcomes. The etiologies of this phenomenon remain unclear. Proposed theories for which there is a growing body of supporting evidence include hardware prominence, suboptimal nail entry points leading to soft tissue irritation and structural compromise, local heterotrophic ossification, implant instability with persistent fracture micromotion, and poorly defined insertional strain. Many factors that lead to insertion-related pain are iatrogenic, and careful attention to detail and refined surgical techniques will optimize outcomes.

Published
2017

18. Response to Letter to the Editor

Author

Walter W. Virkus, Laurence B. Kempton, Anthony T. Sorkin, Todd O. McKinley, Robert J. Wetzel, Lauren C. Hill, and Jeffery S. Cheeseman

Subjects
030203 arthritis & rheumatology, 030222 orthopedics, medicine.medical_specialty, Letter to the editor, business.industry, Radiography, General surgery, Orthopedic Surgeons, Ankle Fractures, 03 medical and health sciences, 0302 clinical medicine, medicine.anatomical_structure, Orthopedics, Traumatology, medicine, Humans, Orthopedics and Sports Medicine, Surgery, Ankle, Fellowships and Scholarships, business, Fellowship training
Published
2018
Full Text
View/download PDF

19. Results of the T2 humeral nailing system with special focus on compression interlocking

Author

Anthony T. Sorkin, M. Diefenbeck, M. Goebel, Claudia Beimel, Thomas Mückley, and Volker Bühren

Subjects
Adult, Male, Humeral Fractures, medicine.medical_specialty, Elbow, Bone Nails, Health Status Indicators, Humans, Medicine, Humerus, Interlocking, Aged, General Environmental Science, Aged, 80 and over, Fracture Healing, Orthodontics, integumentary system, business.industry, Significant difference, Stiffness, Recovery of Function, Middle Aged, Compression (physics), Fracture Fixation, Intramedullary, Surgery, Radiography, Treatment Outcome, medicine.anatomical_structure, Humeral shaft, General Earth and Planetary Sciences, Equipment Failure, Female, Stress, Mechanical, medicine.symptom, business, Physical score, Follow-Up Studies
Abstract

Summary Background The outcome of interlocking nailing of humeral shaft fractures is controversial. Variations in implants, operative technique and follow-up parameters hinder comparative studies. The aim of this investigation was to evaluate the T2 humeral nailing system according to clinical results, and to recognise advantages and disadvantages of compression interlocking. Methods A total of 36 consecutive humeral shaft fractures were treated with an interlocking humeral nail. In 23 cases the antegrade and in 14 cases the retrograde approach was used. Compression locking was performed in 21 and static locking in 15 cases. Results At 22-month follow-up, bone consolidation was present in 35 cases; in 5 cases complications developed. There was no significant difference between compression and static locking nor between the antegrade and retrograde approach regarding complications, Constant shoulder score, mean Morrey elbow score, SF-12 physical score or SF-12 mental score. Conclusion Antegrade and retrograde interlocking nailing of humeral shaft fractures with the T2 nailing system can result in good functional outcome and unimpaired quality of life. Compression interlocking can minimise the fracture gap and increase the biomechanical stiffness. Potential disadvantages of compression interlocking include possible bending or loosening of the locking screw in the dynamic oblong hole. An additional static locking screw should be used on the humerus after compression interlocking.

Published
2008
Full Text
View/download PDF

21. Surgical technique: static intramedullary nailing of the femur and tibia without intraoperative fluoroscopy

Author

Neil J. White, Geoffrey Konopka, Anthony T. Sorkin, and Todd O. McKinley

Subjects
medicine.medical_specialty, education, law.invention, Intramedullary rod, Intraoperative Period, law, Fracture fixation, Medicine, Fluoroscopy, Humans, Orthopedics and Sports Medicine, Femur, Kirschner wire, Tibia, Surgical Technique, health care economics and organizations, Fractures, Comminuted, medicine.diagnostic_test, business.industry, Hip Fractures, social sciences, General Medicine, Surgery, Fracture Fixation, Intramedullary, Tibial Fractures, Orthopedic surgery, Radiology, business, Femoral Fractures, Bone Wires
Abstract

On a recent mission directed at definitive care for victims of the Haitian earthquake, the orthopaedic team developed a technique for freehand distal locking of femoral and tibial nails without intraoperative fluoroscopy or proximally mounted targeting jigs.After performing open antegrade or retrograde nailing by standard techniques, the freehand lock must be obtained before doing standard outrigger locking. This allows the surgeon to control the nail and deliver the locking hole in the nail to a unicortical drill hole in the femur. Before nail insertion, the distance of the desired locking hole is measured from the outrigger in a standard way such that it can be reproduced after the nail is inserted. Through a unicortical drill hole, the nail is palpated with the tip of a Kirschner wire and systematic maneuvers allow the Kirschner wire to palpate and fall into the locking hole. The Kirschner wire is tapped across the second cortex before drilling. The screw is inserted, and the ball-tipped insertion guidewire is placed back into the nail to palpate the crossing screw confirming position.We treated 16 patients with 18 long bone fractures using the described technique. We assessed patients clinically and radiographically immediately postoperatively.A total of 19 blind freehand interlocks were attempted, and 17 were successful as assessed by direct intraoperative observations and by postoperative radiographs.We describe a simple technique for performing static locked intramedullary nailing of the femur and tibia without fluoroscopy. This technique was successful in most cases and is intended for use with any nailing system only when fluoroscopy or specialized systems for nailing without fluoroscopy are not available.

Published
2010

22. Osteogenic protein-1 (bone morphogenic protein-7) combined with various adjuncts in the treatment of humeral diaphyseal nonunions

Author

Matthew R, Bong, Edward L, Capla, Kenneth A, Egol, Anthony T, Sorkin, Michael, Distefano, Rosemary, Buckle, Robert W, Chandler, and Kenneth J, Koval

Subjects
Adult, Aged, 80 and over, Male, Humeral Fractures, Bone Morphogenetic Protein 7, Bone Nails, Middle Aged, Combined Modality Therapy, Recombinant Proteins, Neuroprotective Agents, Transforming Growth Factor beta, Fractures, Ununited, Bone Morphogenetic Proteins, Humans, Female, Prospective Studies, Bone Plates, Aged
Abstract

A prospective study was conducted to determine the efficacy of using recombinant BMP-7 (rhOP-1) as an adjuvant in the treatment of diaphyseal humeral nonunions. Twenty-three consecutive patients with atrophic humeral diaphyseal nonunions were treated at seven separate institutions. All nonunions were fixed with either a compression plate or an intramedullary nail in conjunction with various bone grafting techniques. Recombinant OP-1 was delivered to the fracture site in a Type I collagen carrier at the time of fixation. All fractures went on to eventual union. There were no serious complications and no adverse reactions to the rhOP-I implant. Our study suggests that rhOP-1 may be a safe and effective adjuvant for the treatment of humeral diaphyseal nonunions.

Published
2006

Catalog

Books, media, physical & digital resources
See catalog results