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1. The impact of COVID-19 restrictions on participant enrollment in the PREPARE trial

Author

David Pogorzelski, Paula McKay, Michael J. Weaver, Todd Jaeblon, Robert A. Hymes, Greg E. Gaski, Joanne Fraifogl, James S. Ahn, Sofia Bzovsky, Gerard Slobogean, Sheila Sprague, Gerard P. Slobogean, Jeffrey Wells, Mohit Bhandari, Robert V. O'Toole, Jean-Claude D'Alleyrand, Andrew Eglseder, Aaron Johnson, Christopher Langhammer, Christopher Lebrun, Jason Nascone, Raymond Pensy, Andrew Pollak, Marcus Sciadini, Yasmin Degani, Haley K. Demyanovich, Andrea Howe, Nathan N. O'Hara, Heather Phipps, and Eric Hempen

Subjects
COVID-19, Enrollment, Pragmatic trials, PREPARE trial, Medicine (General), R5-920
Abstract

Background: At the initiation of the COVID-19 pandemic, restrictions forced researchers to decide whether to continue their ongoing clinical trials. The PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities) trial is a pragmatic cluster-randomized crossover trial in patients with open and closed fractures. PREPARE was enrolling over 200 participants per month at the initiation of the pandemic. We aim to describe how the COVID-19 research restrictions affected participant enrollment. Methods: The PREPARE protocol permitted telephone consent, however, sites were obtaining consent in-person. To continue enrollment after the initiation of the restrictions participating sites obtained ethics approval for telephone consent scripts and the waiver of a signature on the consent form. We recorded the number of sites that switched to telephone consent, paused enrollment, and the length of the pause. We used t-tests to compare the differences in monthly enrollment between July 2019 and November 2020. Results: All 19 sites quickly implement telephone consent. Fourteen out of nineteen (73.6%) sites paused enrollment due to COVID-19 restrictions. The median length of enrollment pause was 46.5 days (range, 7–121 days; interquartile range, 61 days). The months immediately following the implementation of restrictions had significantly lower enrollment. Conclusion: A pragmatic design allowed sites to quickly adapt their procedures for obtaining informed consent via telephone and allowed for minimal interruptions to enrollment during the pandemic.

Published
2022
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2. 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
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3. 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
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4. Deletion of RBPJK in Mesenchymal Stem Cells Enhances Osteogenic Activity by Up-Regulation of BMP Signaling.

Author

Xifu Shang, Zhengliang Luo, Xudong Wang, Todd Jaeblon, John V Marymont, and Yufeng Dong

Subjects
Medicine, Science
Abstract

Recently we have demonstrated the importance of RBPjk-dependent Notch signaling in the regulation of mesenchymal stem cell (MSC) differentiation during skeletogenesis both in vivo and in vitro. Here we further performed RBPJK loss-of-function experiments to demonstrate for the first time that RBPJK deficient MSC shows enhanced differentiation and osteogenesis acts via up-regulation of the BMP signaling. In the present study, we first compared the spontaneous and osteogenic differentiation in normal and recombination signal binding protein for immunoglobulin kappa J region (RBPJK) deficient human bone marrow-derived mesenchymal stem cells (MSCs). It was found that RBPJK highly expressed in fresh isolated MSCs and its expression was progressing down-regulated during spontaneous differentiation and even greater in osteogenic media inducted differentiation. Deletion of RBPJK in MSCs not only enhances cell spontaneous differentiation, but also significantly accelerates condition media inducted osteogenic differentiation by showing enhanced alkaline phosphatase (ALP) activity, Alizarin red staining, gene expression of Runx2, Osteopontin (OPN), Type I collagen (COL1a1) in culture. Additionally, BMP signaling responsive reporter activity and phosphor-smad1/5/8 expression were also significantly increased upon removal of RBPJK in MSCs. These data proved that inhibition of Notch signaling in MSCs promotes cell osteogenic differentiation by up-regulation of BMP signaling, and RBPJK deficient MSC maybe a better cell population for cell-based bone tissue engineering.

Published
2015
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5. 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
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6. Patients With Cirrhosis Who Have a Model for End-stage Liver Disease Sodium Score of 8 or Greater Are at Increased Risk of Poor Outcomes in Operatively Treated Tibia Fractures

Author

Christopher H, Renninger, Todd, Jaeblon, Gerard P, Slobogean, Robert V, O'Toole, and Nathan N, O'Hara

Subjects
End Stage Liver Disease, Liver Cirrhosis, Tibia, Sodium, Humans, Orthopedics and Sports Medicine, Surgery, Severity of Illness Index, Retrospective Studies
Abstract

The purpose of this study was to compare 30-day readmission rates for cirrhotic and non-cirrhotic patients after tibia fracture fixation by retrospectively identifying all surgically managed tibial plateau, tibial shaft, and pilon fractures from 2010 through 2018 in the National Surgical Quality Improvement Program database (N=14,028). The primary outcome measure was 30-day readmission rates. Secondary outcome measures included 30-day rates of reoperation, length of stay, pulmonary embolism, deep venous thrombosis, and wound complications, including deep or superficial infection. Cirrhotic patients (n=665) and non-cirrhotic patients (n=13,363) were identified using the aspartate aminotransferase to platelet ratio index test. Cirrhotic patients were more likely to have preoperative ascites, renal failure, bleeding disorders, and preoperative transfusions. No differences were reported between the two groups in readmission rate or any of the secondary outcome measures, except that cirrhotic patients' length of stay was longer by 0.5 day. Stratification of the cirrhotic cohort demonstrated that a Model for End-stage Liver Disease sodium (MELD-Na) score of 8 or greater was associated with a 4.1-fold increase in the rate of readmission (5.9% vs 1.5%; P Orthopedics . 2022;45(2):79–85.]

Published
2022
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7. 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

8. Do Fully Threaded Transiliac–Transsacral Screws Improve Mechanical Stability of Vertically Unstable Pelvic Fractures? A Cadaveric Biomechanical Analysis

Author

Li-Qun Zhang, Michael G Schloss, Giovanni Oppizzi, Jared Atchison, Todd Jaeblon, Marcus F. Sciadini, Jason W. Nascone, Steven F Shannon, and Robert V O'Toole

Subjects
Sacrum, Bone density, medicine.medical_treatment, Bone Screws, Osteotomy, Fracture Fixation, Internal, Fractures, Bone, 03 medical and health sciences, 0302 clinical medicine, Cadaver, medicine, Foramen, Humans, Orthopedics and Sports Medicine, Displacement (orthopedic surgery), Pelvic Bones, Pelvis, Fixation (histology), Orthodontics, 030222 orthopedics, business.industry, 030208 emergency & critical care medicine, General Medicine, Biomechanical Phenomena, medicine.anatomical_structure, Surgery, Cadaveric spasm, business
Abstract

OBJECTIVE To determine whether fully threaded transiliac-transsacral (TI-TS) fixation is biomechanically superior to partially threaded TI-TS fixation of vertically unstable transforaminal sacral fractures. METHODS Vertically unstable zone 2 sacral fractures were created in 20 human cadaveric pelves with a unilateral osteotomy and resection of 1 cm of bone through the foramen of the sacrum to represent comminution. Ten specimens received either 2 7.3-mm fully threaded or 2 7.3-mm partially threaded TI-TS screw fixation at the S1 and S2 body, and every specimen received standard 3.5-mm 8-hole parasymphyseal plating anteriorly. Each pelvis was loaded to 250 N at 3 Hz for 100,000 cycles and then loaded to failure. The primary outcome was fracture displacement at the S1 foramen, which was measured at 25,000, 50,000, 75,000, and 100,000 cycles. Secondary outcomes were simulated clinical failure of ≥1 cm displacement at the S1 foramen to determine occurrence probability of failure, and load at failure was defined as 2.5 cm of the linear loading system displacement. Specimens in the fully threaded and partially threaded cohorts were otherwise respectively comparable in regards to age, gender, and bone density. RESULTS Five of the 10 TI-TS partially threaded specimens experienced simulated clinical failure with >1 cm displacement at the S1 foramen compared with 0 of the 10 TI-TS fully threaded cohort (50% vs. 0%, P = 0.03). The mean maximal displacement at the S1 foramen was greater in the partially threaded cohort (9.3 mm) compared with the fully threaded cohort (3.6 mm; P = 0.004). Fully threaded specimens also demonstrated greater mean force to failure than the partially threaded specimens (461 N vs. 288 N; P = 0.0001). CONCLUSIONS Fully threaded TI-TS screw fixation seems to be mechanically superior to partially threaded fixation in a cadaveric vertically unstable transforaminal sacral fracture model with significantly less displacement of the posterior pelvic ring and greater load to failure.

Published
2021
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9. 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

10. The implementation of multiple two-month treatment periods in cluster randomized crossover trial in orthopaedic trauma: The PREP-IT Program

Author

Sheila Sprague, Chuan Silvia Li, Diane Heels-Ansdell, David Pogorzelski, Shannon Dodds, Jordan Leonard, Mohit Bhandari, Michael J. Prayson, Saam Morshed, Mark J. Gage, Michael J. Weaver, Marilyn Heng, Todd Jaeblon, Lehana Thabane, and Gerard Slobogean

Subjects
General Agricultural and Biological Sciences
Published
2021
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11. Medial sided articular impaction in tibial plateau fractures

Author

Steven S. Shannon, Lucas S. Marchand, Todd Jaeblon, Robert V O'Toole, Ian P. McAlister, and Jason W. Nascone

Subjects
Radiography, Computed tomography, 03 medical and health sciences, Quadrant (abdomen), 0302 clinical medicine, Trauma Centers, medicine, Tibial plateau fracture, Humans, Fracture type, General Environmental Science, Retrospective Studies, 030222 orthopedics, geography, Plateau, geography.geographical_feature_category, medicine.diagnostic_test, Impaction, business.industry, Joint surface, 030208 emergency & critical care medicine, medicine.disease, Tibial Fractures, General Earth and Planetary Sciences, Nuclear medicine, business, Tomography, X-Ray Computed
Abstract

Introduction Tibial plateau fractures are a heterogenous group of injuries with a variable amount of articular injury and are commonly associated with lateral sided articular impaction. Previous work has focused on describing the morphology of tibial plateau fractures, but has neglected description of medial sided articular impaction. The aim of this investigation was to assess the morphology of medial sided articular impaction in tibial plateau fractures, with specific attention directed toward the frequency, location, size, and associated fracture patterns. Methods Skeletally mature patients presenting to a Level I trauma center from 2008-2018 with a tibial plateau fracture (AO/OTA 41B-C) were identified retrospectively. Fractures were classified by AO/OTA and Schatzker type. Radiographs and computed tomography (CT) scans were reviewed to identify and localize medial sided articular impaction. The location and surface area of impaction was characterized by creating frequency diagram heat maps from axial CT scans. Descriptive statistics were performed using standard measures. Results Of the 1032 tibial plateau fractures included, 82 (7.9%) were noted to have medial sided articular impaction. Rate of impaction varied by fracture type (p = 0.03): Schatzker II, 2% (7 of 381); Schatzker IV, 21% (19 of 96); and Schatzker VI, 11% (56 of 524). Average total surface area of impaction was 9% of the total and 19% of the medial plateau area. Area of impaction varied by fracture type (p = 0.004): Schatzker II, 6% (95% confidence interval [CI], 4%−7%); Schatzker IV, 11% (95% CI, 9%−13%), and Schatzker VI, 9% (95% CI, 7%−11%). The area of impaction occurred primarily along the lateral aspect of the medial plateau in Schatzker II fractures, in the anteromedial quadrant of Schatzker IV fractures, and was evenly distributed across the medial plateau in Schatzker VI fractures. Conclusions Surgeons should be aware that medial articular impaction is present in approximately 8% of tibial plateau fractures. Schatzker IV fractures are most likely to have medial impaction and a larger proportion of the joint surface involved in these injuries.

Published
2020

12. 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

13. Pediatric Supracondylar Fractures: Variation in Fracture Patterns and the Biomechanical Effects of Pin Configuration

Author

Alan Ogden, Joseph J. Andary, Todd Jaeblon, and Steven Anthony

Subjects
Models, Anatomic, Humeral Fractures, medicine.medical_specialty, High fracture, Bone Nails, Fracture Fixation, Internal, 03 medical and health sciences, 0302 clinical medicine, Humans, Medicine, Orthopedics and Sports Medicine, 030212 general & internal medicine, Child, Ulnar Nerve, Orthodontics, 030222 orthopedics, business.industry, Oblique case, Equipment Design, General Medicine, Humerus, Sagittal plane, Biomechanical Phenomena, Surgery, Transverse plane, medicine.anatomical_structure, Pediatrics, Perinatology and Child Health, Fracture (geology), business, Bone Wires
Abstract

Transverse pediatric supracondylar fractures through the midolecranon fossa are frequently encountered and modeled in biomechanical studies. Our objective is to investigate the optimal pin configurations for low, sagittal oblique, and high fracture varieties that have not been previously investigated.A total of 100 synthetic composite pediatric humeri were tested. Three groups of 30 were used to simulate 1 of 3 fracture variations. Subgroups of 10 were stabilized with 2 lateral pins (2LP), 3 lateral pins (3LP), or cross K-wires (XP). The 90 fracture and 10 intact models were tested for anterior posterior (AP), medial lateral (ML), and rotational stiffness.In low fractures, AP, ML, and rotational stiffness of 2LP and 3LP were similar to intact. ML stiffness was less using XP. AP and ML stiffness of 2LP and 3LP were significantly greater than XP.In oblique fractures, AP, ML, and rotational stiffness of 2LP was similar to intact but 3LP was significantly less. AP and ML stiffness of XP was significantly less. 2LP demonstrated greater AP, ML, and rotational stiffness than 3LP and XP.In high fractures, all configurations demonstrated significantly less rotational stiffness than intact and AP stiffness similar to intact. Rotational stiffness of 3LP was greater than 2LP and XP. AP and ML stiffness were not different among configurations.2LP are stiffer than 3LP and XP for sagittal oblique fractures. 2LP and 3LP stiffness were similar in low transverse fractures, and both constructs demonstrated greater stiffness than XP configuration. 3LP is preferable for high transverse fractures. XP were never stiffer than the lateral only constructs in any of the patterns tested.All-lateral pin constructs may provide adequate stiffness to maintain reduction of low transverse, sagittal oblique, and high transverse patterns of pediatric supracondylar humerus fractures without risk of injury to the ulnar nerve.

Published
2016
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14. Waist-Hip Ratio Surrogate Is More Predictive Than Body Mass Index of Wound Complications After Pelvic and Acetabulum Surgery

Author

Kevin J Perry, Joseph A Kufera, and Todd Jaeblon

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Body Mass Index, 03 medical and health sciences, Fractures, Bone, Young Adult, 0302 clinical medicine, Waist–hip ratio, Postoperative Complications, Fracture Fixation, Predictive Value of Tests, Risk Factors, medicine, Humans, Orthopedics and Sports Medicine, 030212 general & internal medicine, Pelvis, Aged, Retrospective Studies, Aged, 80 and over, 030222 orthopedics, Receiver operating characteristic, business.industry, Waist-Hip Ratio, Acetabular fracture, Acetabulum, General Medicine, Middle Aged, medicine.disease, Surgery, medicine.anatomical_structure, ROC Curve, Predictive value of tests, Injury Severity Score, Female, business, Body mass index
Abstract

OBJECTIVES To determine whether a novel surrogate of waist-hip ratio (WHR) is more predictive of wound complications after pelvis or acetabulum stabilization than body mass index (BMI) and describe the method of measuring a WHR proxy (WHRp). DESIGN Retrospective review. SETTING One Level 1 Trauma Center. PATIENTS One hundred sixty-one patients after operative repair of pelvis and acetabulum fractures. INTERVENTION Operative stabilization of a pelvic ring injury or acetabular fracture. MAIN OUTCOME MEASUREMENTS Infection (pin, superficial, and deep) and wound healing complication. METHODS We retrospectively reviewed 161 subjects after operative repair of pelvic and acetabular fractures. Primary outcome was any wound complication. BMI was acquired from medical records. WHRp was derived from anteroposterior and lateral computed tomography scout images. BMI and WHRp results were analyzed as continuous and categorical variables. BMI was grouped into high-risk categories of ≥30 and ≥40. WHRp data were grouped utilizing the WHO's high-risk profile for females (>0.85) and males (>0.90). An alternative optimal WHR was also assessed. Covariate analysis included demographic data, Injury Severity Score, mechanism, tobacco use, presence and types of open approach, injury type, associated injuries and comorbidities, failure of fixation, and thromboembolism. RESULTS The mean follow-up was 15.9 months. Twenty-four (15%) patients developed wound complications. Increasing BMI (P < 0.007) and WHRp (P < 0.001) as continuous variables and female sex (P < 0.009) were associated with wound complications. Applying unadjusted continuous data to a receiver operating characteristic curve revealed a greater area under the curve for WHRp than for BMI (P < 0.001). The optimal predictive WHRp was ≥1.0 (P < 0.001, odds ratio 43.11). The receiver operating characteristic curve from adjusted data demonstrated a greater area under the curve for WHRp ≥1.0 (0.93) compared with BMI ≥30 (0.78) or ≥40 (0.75) and WHO WHRp (0.82). Computed tomography generated WHRp demonstrated excellent interrater reliability (0.99). CONCLUSION The WHRp of ≥1.0 was more predictive than BMI of wound complications after operative treatment of pelvis and acetabulum fractures. In our series, WHRp calculated using scout images performed sufficiently well to predict wound complications. LEVEL OF EVIDENCE Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Published
2018

15. Improving Pain Management and Long-Term Outcomes Following High-Energy Orthopaedic Trauma (Pain Study)

Author

Daniel O. Scharfstein, Anthony R. Carlini, Tara J. Taylor, Lauren E. Allen, Heather A. Vallier, Renan C. Castillo, Allan Gottschalk, Yingjie Weng, Paul Tornetta, Gregory de Lissovoy, Todd Jaeblon, Brandon J. Goff, Srinivasa N. Raja, Ellen J. MacKenzie, Robert V O'Toole, and Katherine Frey

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Pregabalin, law.invention, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Fracture Fixation, Fracture fixation, medicine, Humans, Pain Management, Orthopedics and Sports Medicine, 030212 general & internal medicine, Longitudinal Studies, Prospective Studies, Adverse effect, Depression (differential diagnoses), Aged, Pain Measurement, Aged, 80 and over, Pain, Postoperative, business.industry, Anti-Inflammatory Agents, Non-Steroidal, Chronic pain, General Medicine, Perioperative, Middle Aged, medicine.disease, Quality Improvement, United States, Analgesics, Opioid, Treatment Outcome, Opioid, Physical therapy, Surgery, Drug Therapy, Combination, Female, Chronic Pain, business, 030217 neurology & neurosurgery, medicine.drug
Abstract

Poor pain control after orthopaedic trauma is a predictor of physical disability and numerous negative long-term outcomes. Despite increased awareness of the negative consequences of poorly controlled pain, analgesic therapy among hospitalized patients after orthopaedic trauma remains inconsistent and often inadequate. The Pain study is a 3 armed, prospective, double-blind, multicenter randomized trial designed to evaluate the effect of standard pain management versus standard pain management plus perioperative nonsteroidal anti-inflammatory drugs or pregabalin in patients of ages 18-85 with extremity fractures. The primary outcomes are chronic pain, opioid utilization during the 48 hours after definitive fixation and surgery for nonunion in the year after fixation. Secondary outcomes include preoperative and postoperative pain intensity, adverse events and complications, physical function, depression, and post-traumatic stress disorder. One year treatment costs are also compared between the groups.

Published
2017

16. Anatomic Relationships After Instrumentation of the Midshaft Clavicle With 3.5-mm Reconstruction Plating: An Anatomic Study

Author

Todd Jaeblon, Jason Reed, Tobin Hanson, and Steven Douglas Werner

Subjects
Male, Bone Screws, Posture, Subclavian Artery, Subclavian Vein, Fracture Fixation, Internal, Fractures, Bone, Cadaver, medicine.artery, Bone plate, medicine, Humans, Brachial Plexus, Orthopedics and Sports Medicine, Subclavian artery, Aged, Aged, 80 and over, business.industry, General Medicine, Anatomy, Middle Aged, Plastic Surgery Procedures, musculoskeletal system, Neurovascular bundle, Clavicle, body regions, medicine.anatomical_structure, Calipers, Female, Surgery, Cadaveric spasm, business, Bone Plates, Brachial plexus
Abstract

OBJECTIVES: To examine the anatomic relationships of the major neurovascular structures at the midshaft clavicle region as they pertain to plate osteosynthesis in the treatment of midshaft clavicle fractures. METHODS: Fifteen fresh cadaveric specimens were dissected at the clavicle region. The shortest distances from the midshaft clavicular fracture lines to the subclavian artery and vein and brachial plexus were measured with a digital caliper with the limb in anatomic position and at 90° of abduction. The mean and range distance values were recorded. The clavicles were then instrumented with eight-hole, 3.5-mm reconstruction plates and screws (Synthes, Paoli PA) placed in superior and anteroinferior positions. The shortest distances from the screw tips to the neurovascular structures were measured at variable plate positions, fracture zones, and limb positions. The incidence of screw tip contact was reported. RESULTS: In 20% (three of 15) of the specimens, screw tip contact with a major neurovascular structure occurred. In these three specimens, two screw tip contacts occurred with the plate in a superior position and two occurred with the plate in an anteroinferior position. In one specimen, screw tip contact occurred with both plate positions. Limb abduction to 90° consistently increased the distance of the neurovascular structures from the clavicle. There was no observable trend in screw contact frequency in respect to limb position or fracture zone. CONCLUSION: Caution must be exercised when instrumenting midshaft clavicle fractures regardless of chosen plate position. Limb abduction to 90° provides an added measure of safety during clavicle instrumentation.

Published
2011
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17. Polymethylmethacrylate: Properties and Contemporary Uses in Orthopaedics

Author

Todd Jaeblon

Subjects
Vertebroplasty, medicine.medical_specialty, Delivery vehicle, business.industry, Arthroplasty, Replacement, Hip, Bone Cements, technology, industry, and agriculture, macromolecular substances, equipment and supplies, Anti-Bacterial Agents, Biomechanical Phenomena, body regions, Hip arthroplasty, Drug Delivery Systems, Orthopedic surgery, medicine, Humans, Polymethyl Methacrylate, Orthopedic Procedures, Orthopedics and Sports Medicine, Surgery, business, Biomedical engineering
Abstract

Polymethylmethacrylate (PMMA) has been used in orthopaedics since the 1940s. Despite the development and popularity of new biomaterials, PMMA remains popular. Although its basic components remain the same, small proprietary and environmental changes create variations in its properties. PMMA can serve as a spacer and as a delivery vehicle for antibiotics, and it can be placed to eliminate dead space. Endogenous and exogenous variables that affect its performance include component variables, air, temperature, and handling and mixing. PMMA is used in hip arthroplasty and vertebral augmentation, notably, vertebroplasty and kyphoplasty. Cardiopulmonary complications have been reported.

Published
2010
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18. Ambulatory Assistive Devices in Orthopaedics: Uses and Modifications

Author

Safi R Faruqui and Todd Jaeblon

Subjects
medicine.medical_specialty, Walkers, Weight-Bearing, Physical medicine and rehabilitation, Muscle action, Crutches, Humans, Medicine, Orthopedics and Sports Medicine, Muscle, Skeletal, Gait, Self-Help Devices, Orthopedic Equipment, business.industry, Equipment Design, Normal gait, Ambulatory, Orthopedic surgery, Canes, Hip Joint, Surgery, business, Cadence, human activities
Abstract

Ambulatory assistive devices (eg, canes, crutches, walkers) provide advantages such as stability, augmentation of muscle action, and reduction of weight-bearing load. Although they are often prescribed, a detailed understanding of these devices is often lacking, which can lead to detrimental consequences. Comprehension of normal gait cadence, as well as the gait patterns used in both reciprocating and swinging gait, allows the orthopaedic surgeon to understand the limitations of the patient with gait abnormalities. Appreciating the types of assistive devices, their modifications, associated gait patterns, physiologic demand, proper fitting, and indications for use is essential in prescribing the proper device.

Published
2010
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19. Residual Hole Orientation After Plate Removal: Effect on the Clavicle

Author

Jeremy James, Debi Mukherjee, Allen Ogden, and Todd Jaeblon

Subjects
Male, medicine.medical_treatment, medicine.disease_cause, Weight-bearing, Weight-Bearing, Fracture Fixation, Internal, Cadaver, Orientation (geometry), Fracture fixation, Bone plate, medicine, Humans, Internal fixation, Orthopedics and Sports Medicine, Device Removal, Reduction (orthopedic surgery), Aged, Aged, 80 and over, Orthodontics, business.industry, Clavicle, medicine.anatomical_structure, Female, Surgery, Stress, Mechanical, business, Bone Plates
Abstract

Clavicle fractures account for 2.6% to 4% of all fractures. Surgical stabilization of this type of injury is becoming more common. Anterior inferior plating and superior plating are 2 popular approaches to open reduction and internal fixation. Reports of plate removal have raised concerns about reinjury. The goal of the current study was to determine whether the orientation of screw holes in clavicles after removal of an anterior inferior plate vs a superior plate have different biomechanical effects on stiffness and load to failure. The medial and lateral ends of 28 matched pairs of fresh clavicles were potted. Pilot holes, 2.5 mm in diameter, were drilled and oriented anterior inferiorly or superiorly, simulating those left after removal of a plate for a middle-third fracture. The clavicles underwent dynamic axial compression and 3-point load to failure, replicating forces associated with reinjury. Clavicles with anterior inferior holes had a statistically significant higher median maximal load difference of 139 N compared with those with superior holes ( P =.013). Anterior inferior holes showed a statistically significant median increase in stiffness of 16.3 N/mm compared with superior holes ( P =.036). Clavicles with anterior inferior holes had a statistically significant increase in median maximal load to failure and an increase in median stiffness compared with those with superior holes. This finding is relevant for patients who undergo hardware removal and return to activities that put them at risk for repeat high-impact injuries to the clavicle. [ Orthopedics. 2015; 38(11):e1034–e1039.]

Published
2015
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20. Notch activation enhances mesenchymal stem cell sheet osteogenic potential by inhibition of cellular senescence

Author

Ye Tian, Chen Longgang, John V. Marymont, Shi Bin, Todd Jaeblon, Chao Xie, Yufeng Dong, Bing Shu, Massimo Max Morandi, Ying Xu, and Xue Taiyang

Subjects
0301 basic medicine, Senescence, Cancer Research, Cell cycle checkpoint, Callus formation, Immunology, Mesenchymal Stem Cell Transplantation, Mice, 03 medical and health sciences, Cellular and Molecular Neuroscience, Osteogenesis, Animals, Humans, Regeneration, HES1, Cells, Cultured, Cellular Senescence, Receptors, Notch, Chemistry, Mesenchymal stem cell, Mesenchymal Stem Cells, Cell Cycle Checkpoints, Cell Biology, Cell biology, Mice, Inbred C57BL, Transplantation, 030104 developmental biology, Transcription Factor HES-1, Original Article, Stem cell, Cell aging, Jagged-1 Protein
Abstract

Our previous studies have confirmed the therapeutic effects of mesenchymal stem cell (MSC) monolayer sheet transplantation on allograft repair. A limiting factor in their application is the loss of MSC multi-potency as a result of high density sheet culture-induced senescence. In the study reported in this article, we tested whether Notch activation could be used to prevent or delay sheet culture-induced cell aging. Our results showed that, during in vitro long-term (5-day) cell sheet culture, MSCs progressively lose their progenitor characteristics. In contrast, Notch activation by Jagged1 in MSC sheet culture showed reduced cellular senescence and cell cycle arrest compared with control MSCs without Notch activation. Importantly, knockdown of Notch target gene Hes1 totally blocked the inhibition effect of Jagged1 on cellular senescence. Finally, the in vivo allograft transplantation data showed a significant enhanced callus formation and biomechanical properties in Notch activation cultured long-term sheet groups when compared with long-term cultured sheet without Notch activation. Our results suggest that Notch activation by Jagged1 could be used to overcome the stem cell aging caused by high density sheet culture, thereby increasing the therapeutic potential of MSC sheets for tissue regeneration.

Published
2017
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21. A Case of Ipsilateral Both Bone Forearm Fracture and Acute Distal Biceps Rupture

Author

Todd Jaeblon

Subjects
Male, Rupture, medicine.medical_specialty, Multiple Trauma, business.industry, Forearm Injuries, Recovery of Function, General Medicine, Middle Aged, Compartment Syndromes, Ulna Fractures, Biceps, Surgery, Tendon Injuries, Acute Disease, Humans, Patient Compliance, Medicine, Orthopedics and Sports Medicine, Radius Fractures, business, Forearm fracture, Compartment (pharmacokinetics), Patient compliance
Abstract

There have been no reports in the English literature of an acute distal biceps rupture with a diaphyseal forearm fracture. This report describes a case of the combined injuries associated with a compartment syndrome.

Published
2011
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22. The effect of drill bit, pin, and wire tip design on drilling

Author

Bryce M. Fincham and Todd Jaeblon

Subjects
musculoskeletal diseases, education, ComputingMethodologies_IMAGEPROCESSINGANDCOMPUTERVISION, Mechanical engineering, Bone Nails, Hole opener, Bone and Bones, Breakage, Hardware_INTEGRATEDCIRCUITS, ComputingMilieux_COMPUTERSANDEDUCATION, otorhinolaryngologic diseases, Drill bit, Medicine, Humans, Orthopedics and Sports Medicine, ComputingMethodologies_COMPUTERGRAPHICS, Drill, business.industry, Thermal necrosis, ComputingMilieux_PERSONALCOMPUTING, Temperature, Drilling, Penetration (firestop), Equipment Design, equipment and supplies, Surgical Instruments, Roller reamer, Internal Fixators, Surgery, business, Bone Wires
Abstract

Successful penetration of bone is dependent on several factors, including bone quality, drill bit and pin design, and drilling technique. Wires are also used in bone drilling, and the tip configuration can affect the efficiency of bone penetration. Incorrect use of drill bits, pins, and wires may result in complications such as thermal necrosis and hardware breakage.

Published
2011

23. Pressure ulcers in orthopaedics

Author

D Trey Remaley and Todd Jaeblon

Subjects
Pressure Ulcer, Restraint, Physical, medicine.medical_specialty, Rehabilitation, business.industry, medicine.medical_treatment, Incidence, medicine.disease, Risk Assessment, Severity of Illness Index, digestive system diseases, Casts, Surgical, Orthopedic surgery, Severity of illness, medicine, Humans, Orthopedics and Sports Medicine, Surgery, business, Cognitive impairment, Intensive care medicine, Risk assessment, Complication, Cost of care, Spinal cord injury
Abstract

Pressure ulcers can be a devastating complication in the care of orthopaedic patients. Their presence leads to increased morbidity, mortality, and cost of care. Therapy and rehabilitation cannot progress on a normal postoperative course in the patient with a pressure ulcer. Risk factors for the development of pressure ulcers include spinal cord injury, advanced age, and cognitive impairment. Several grading scales have been developed for the assessment of pressure ulcer. Frequent patient turning, close monitoring, and frequent skin checks are important factors in the prevention of pressure ulcer.

Published
2010

24. Deletion of RBPJK in Mesenchymal Stem Cells Enhances Osteogenic Activity by Up-Regulation of BMP Signaling

Author

Zhengliang Luo, Xifu Shang, Xudong Wang, John V. Marymont, Todd Jaeblon, and Yufeng Dong

Subjects
Male, Cellular differentiation, Blotting, Western, Population, Notch signaling pathway, lcsh:Medicine, Apoptosis, Real-Time Polymerase Chain Reaction, Bone Morphogenetic Protein 1, Immunoenzyme Techniques, 03 medical and health sciences, 0302 clinical medicine, Osteogenesis, Humans, RNA, Messenger, Osteopontin, lcsh:Science, education, Cells, Cultured, Aged, Cell Proliferation, 030304 developmental biology, Regulation of gene expression, 0303 health sciences, education.field_of_study, Multidisciplinary, biology, Reverse Transcriptase Polymerase Chain Reaction, Cell growth, lcsh:R, Mesenchymal stem cell, Cell Differentiation, Mesenchymal Stem Cells, Middle Aged, Flow Cytometry, Molecular biology, Cell biology, RUNX2, Gene Expression Regulation, Immunoglobulin J Recombination Signal Sequence-Binding Protein, 030220 oncology & carcinogenesis, biology.protein, lcsh:Q, Female, Research Article
Abstract

Recently we have demonstrated the importance of RBPjk-dependent Notch signaling in the regulation of mesenchymal stem cell (MSC) differentiation during skeletogenesis both in vivo and in vitro. Here we further performed RBPJK loss-of-function experiments to demonstrate for the first time that RBPJK deficient MSC shows enhanced differentiation and osteogenesis acts via up-regulation of the BMP signaling. In the present study, we first compared the spontaneous and osteogenic differentiation in normal and recombination signal binding protein for immunoglobulin kappa J region (RBPJK) deficient human bone marrow-derived mesenchymal stem cells (MSCs). It was found that RBPJK highly expressed in fresh isolated MSCs and its expression was progressing down-regulated during spontaneous differentiation and even greater in osteogenic media inducted differentiation. Deletion of RBPJK in MSCs not only enhances cell spontaneous differentiation, but also significantly accelerates condition media inducted osteogenic differentiation by showing enhanced alkaline phosphatase (ALP) activity, Alizarin red staining, gene expression of Runx2, Osteopontin (OPN), Type I collagen (COL1a1) in culture. Additionally, BMP signaling responsive reporter activity and phosphor-smad1/5/8 expression were also significantly increased upon removal of RBPJK in MSCs. These data proved that inhibition of Notch signaling in MSCs promotes cell osteogenic differentiation by up-regulation of BMP signaling, and RBPJK deficient MSC maybe a better cell population for cell-based bone tissue engineering.

Published
2015
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25. Biomechanics of Far Cortical Locking

Author

Todd Jaeblon

Subjects
business.industry, Bone Screws, Biomechanics, Humans, Medicine, Orthopedics and Sports Medicine, Surgery, General Medicine, Bone Diseases, Bony Callus, business, Risk Assessment, Neuroscience
Published
2011
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