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1. Predicting deep infection in pilon and tibial plateau fractures: a secondary analysis of the VANCO and OXYGEN trials

Author

Archie L. Overmann, MD, Anthony R. Carlini, MS, Robert V. O'Toole, MD, Renan C. Castillo, PhD, Nathan N. O'Hara, PhD, MHA, METRC, Eben A. Carroll, MD, James Brett Goodman, MBA, Martha B. Holden, AAS, AA, Anna N. Miller, MD, Amanda Spraggs-Hughes, PhD, Michael L. Brennan, MD, Paul Tornetta, III, MD, Patrick M. Osborn, MD, Jessica C. Rivera, MD, PhD, Clinton K. Murray, MD, Joseph E. Kimmel, MS, Michael J. Bosse, MD, Joseph R. Hsu, MD, Madhav A. Karunakar, MD, Laurence B. Kempton, MD, Rachel B. Seymour, PhD, Stephen H. Sims, MD, Christine Churchill, MA, Debra L. Sietsema, PhD, RN, Ida Leah Gitajn, MD, MS, Rachel M. Reilly, MD, Robert D. Zura, MD, Cameron Howes, BA, Hassan Mir, MD, MBA, Michael J. Weaver, MD, Marilyn Heng, MD, MPH, Thuan V. Ly, MD, Emily A. Wagstrom, MD, Jerald R. Westberg, MPH, BA, Brian H. Mullis, MD, Jeffrey O. Anglen, MD, Leilani S. Mullis, MD, Karl D. Shively, MD, Todd O. McKinley, MD, Roman M. Natoli, MD, PhD, Anthony Sorkin, MD, Lauren C. Hill, BS, CCRC, Robert A. Hymes, MD, Greg E. Gaski, MD, A. Stephen Malekzadeh, MD, Lolita Ramsey, PhD, RN, Jeff E. Schulman, MD, Cary C. Schwartzbach, MD, Robert A. Sikorski, MD, Olivia C. Lee, MD, Peter C. Krause, MD, Joshua L. Gary, MD, Timothy S. Achor, MD, Andrew Choo, MD, John W. Munz, MD, Sterling J. Boutte, BS, Matthew C. Galpin, CCRC, H. Michael Frisch, MD, Adam M. Kaufman, MD, C. Michael LeCroy, MD, Christopher S. Smith, MD, Alec C. Stall, MD, MPH, Andrea Horne, MA, CCRP, Manjari Joshi, MBBS, Jason W. Nascone, MD, Marcus F. Sciadini, MD, Gerard P. Slobogean, MD, Andrea L. Howe, BS, Roman Hayda, MD, Andrew R. Evans, MD, Stanislaw P. Stawicki, MD, MBA, Thomas R. Wojda, MD, MBA, Michael J. Gardner, MD, Julius A. Bishop, MD, Saqib Rehman, MD, MBA, Cyrus Caroom, MD, Elizabeth Sheridan, MPH, MACPR, Theodore Miclau, MD, Saam Morshed, MD, PhD, Thomas F. Higgins, MD, Justin M. Haller, MD, Clay A. Spitler, MD, Massimo Max Morandi, MD, FACS, Paul Edward Matuszewski, MD, Arun Aneja, MD, PhD, Patrick F. Bergin, MD, Eldrin Bhanat, MD, MPH, Matt L. Graves, MD, John Morellato, MBBS Hons, David Teague, MD, William Ertl, MD, Jaimo Ahn, MD, PhD, Gele B. Moloney, MD, John C. Weinlein, MD, Boris A. Zelle, MD, Animesh Agarwal, MD, Ravi A. Karia, MD, Ashoke Sathy, MD, Drew Sanders, MD, MPH, David B. Weiss, MD, Seth R. Yarboro, MD, Veronica Lester-Ballard, MSN, Eric D. McVey, MEd, CCRP, Reza Firoozabadi, MD, MA, Arman Dagal, MD, FRCA, Conor P. Kleweno, MD, Julie Agel, MA, Paul S. Whiting, MD, Natasha M. Simske, BS, Alexander B. Siy, BS, William T. Obremskey, MD, MPH, Basem Attum, MD, Eduardo J. Burgos, MD, Vamshi Gajari, MBBS, A. Alex Jahangir, MD, Andres Rodriguez-Buitrago, MD, Manish Sethi, MD, Daniel J. Stinner, MD, PhD, Rajesh R. Tummuru, MBBS, MBA, Karen M. Trochez, MA, BS, Jean-Claude G. D'Alleyrand, MD, MSE, Lauren E. Allen, DrPH, Susan C. Collins, MSc, Yanjie Huang, ScM, and Tara J. Taylor, MPH

Subjects
Orthopedic surgery, RD701-811
Abstract

Abstract. Objectives:. To develop and validate a prediction model for a deep surgical site infection (SSI) after fixation of a tibial plateau or pilon fracture. Design:. Pooled data from 2 randomized trials (VANCO and OXYGEN). Setting:. Fifty-two US trauma centers. Patients:. In total, 1847 adult patients with operatively treated tibial plateau or pilon fractures who met criteria for a high risk of infection. Intervention:. We considered 13 baseline patient characteristics and developed and externally validated prediction models using 3 approaches (logistic regression, stepwise elimination, and machine learning). Main Outcomes and Measures:. The primary prediction model outcome was a deep SSI requiring operative debridement within 182 days of definitive fixation. Our primary prognostic performance metric for evaluating the models was area under the receiver operating characteristic curve (AUC) with clinical utility set at 0.7. Results:. Deep SSI occurred in 75 VANCO patients (8%) and in 56 OXYGEN patients (6%). The machine learning model for VANCO (AUC = 0.65) and stepwise elimination model for OXYGEN (AUC = 0.62) had the highest internal validation AUCs. However, none of the external validation AUCs exceeded 0.64 (range, 0.58 to 0.64). Conclusions:. The predictive models did not reach the prespecified clinical utility threshold. Our models' inability to distinguish high-risk from low-risk patients is likely due to strict eligibility criteria and, therefore, homogeneous patient populations.

Published
2024
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2. Deep Surgical Site Infection after Fracture Has a Profound Effect on Functional Outcomes

Author

Ida Leah Gitajn, MD, MS, Paul M. Werth, PhD, Anthony R. Carlini, MS, Michael J. Bosse, MD, Joshua L. Gary, MD, Reza Firoozabadi, MD, MA, William Obremskey, MD, MPH, Todd O. McKinley, MD, Renan C. Castillo, PhD, Robert V. O’Toole, MD, and METRC, Edward R. Westrick, Eben A. Carroll, James Brett Goodman, Martha B. Holden, Anna N. Miller, Amanda Spraggs-Hughes, PhD, Michael L. Brennan, Paul Tornetta, III, Michael J. Weaver, Marilyn Heng, Patrick M. Osborn, Jessica C. Rivera, Clinton K. Murray, Joseph E. Kimmel, Charles Moon, Joseph R. Hsu, Madhav A. Karunakar, Laurence B. Kempton, Rachel B. Seymour, Stephen H. Sims, Christine Churchill, Rachel M. Reilly, Robert D. Zura, Cameron Howes, Hassan Mir, Emily A. Wagstrom, Brian Mullis, Jeffrey O. Anglen, Leilani S. Mullis, Karl D. Shively, Greg E. Gaski, Roman M. Natoli, Anthony Sorkin, Walter Virkus, Robert A. Hymes, Michael A. Holzman, A. Stephen Malekzadeh, Jeff E. Schulman, Cary C. Schwartzbach, Olivia C. Lee, Peter C. Krause, Massimo "Max" Morandi, Andrew Choo, John W. Munz, Sterling Boutte, Matthew C. Galpin, H. Michael Frisch, Adam M. Kaufman, C. Michael LeCroy, Christopher S. Smith, Alec C. Stall, Andrea Horne, Jason W. Nascone, Nathan N. O'Hara, Ebrahim Paryavi, Marcus F. Sciadini, Yasmin Degani, Andrea L. Howe, Roman Hayda, Andrew R. Evans, Debra L. Sietsema, Stanislaw P. Stawicki, Thomas Wojda, Michael J. Gardner, Julius A. Bishop, Saqib Rehman, Cyrus Caroom, Elizabeth Sheridan, Theodore Miclau, Saam Morshed, Thomas F. Higgins, Justin M. Haller, Paul E. Matuszewski, Arun Aneja, Raymond D. Wright, Jr., Patrick F. Bergin, Eldrin Bhanat, Matt L. Graves, John Morellato, Clay A. Spitler, David Teague, William Ertl, Jaimo Ahn, Patrick Hesketh, Gele B. Moloney, John C. Weinlein, Boris A. Zelle, Animesh Agarwal, Ravi A. Karia, Ashoke Sathy, Drew T. Sanders, David B. Weiss, Seth R. Yarboro, Veronica Lester-Ballard, Eric D. McVey, Arman Dagal, Michael Githens, Conor Kleweno, Julie Agel, Paul S. Whiting, Natasha M. Simske, Alexander B. Siy, Basem Attum, Eduardo Burgos, Vamshi Gajari, Andres Rodriguez-Buitrago, Manish Sethi, Rajesh R. Tummuru, Jean-Claude G. D'Alleyrand, Lauren E. Allen, Susan C. Collins, Yanjie Huang, and Tara J. Taylor

Subjects
Orthopedic surgery, RD701-811
Abstract

Background:. Fracture-related infection is one of the most challenging complications in orthopaedic trauma surgery. However, the effect of infection on functional and pain-related outcomes has not been well established. The aims of this study were to evaluate functional recovery for patients with fracture and a deep surgical site infection compared with patients with fracture without infection and to evaluate whether pain severity, social support, and preinjury mental health have a moderating effect on the magnitude and direction of the relationship between deep surgical site infection and functional recovery. Methods:. This is a secondary retrospective cohort study using prospectively collected data from the VANCO trial (Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection) and the OXYGEN (Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery) trial. In this study, 2,116 patients with tibial plateau, pilon, or calcaneal fractures at high risk for infection were included. Patients were divided into cohorts of patients who experienced a deep surgical site infection and those who did not. The primary outcome measure was the functional outcome using the Veterans RAND 12-Item Health Survey (VR-12). Results:. After controlling for covariates, deep surgical site infection was independently associated with functional outcome, with a 3.3-point reduction in the VR-12 Physical Component Score, and pain severity was independently associated with functional outcome, with a 2.5-point reduction in the VR-12 Physical Component Score. Furthermore, the Brief Pain Inventory pain severity demonstrated an important moderating effect on the relationship between infection and functional outcome. In patients with lower pain scores, infection had a large negative impact on functional outcome, whereas, in patients with higher pain scores, infection had no significant impact on functional outcome. Furthermore, the functional outcome in the entire cohort remains at only 61% of baseline. Conclusions:. This study documents the negative impact of postoperative infection on functional recovery after injury, as well as the novel finding of pain severity as an important moderating factor. This study emphasizes not only the importance of developing effective interventions designed to reduce postoperative infection, but also the role that factors that moderate pain severity plays in limiting recovery of physical function. Level of evidence:. Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Published
2024
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3. 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

4. Unreamed Intramedullary Nailing Versus External Fixation for the Treatment of Open Tibial Shaft Fractures in Uganda: A Randomized Clinical Trial

Author

Daniel K. Kisitu, Nathan N. O'Hara, Gerard P. Slobogean, Andrea L. Howe, Piotr A. Blachut, Peter J. O'Brien, and David J. Stockton

Subjects
Fracture Healing, External Fixators, Tibia, General Medicine, Fracture Fixation, Intramedullary, Tibial Fractures, Fractures, Open, Treatment Outcome, Fracture Fixation, Quality of Life, Humans, Orthopedics and Sports Medicine, Surgery, Uganda
Abstract

To compare unreamed intramedullary nailing versus external fixation for the treatment of Gustilo-Anderson type II and IIIA open tibial fractures admitted to a hospital in rural Uganda.Randomized clinical trial.Regional referral hospital in Uganda.Fifty-five skeletally mature patients with a Gustilo-Anderson type II or IIIA open tibia shaft fracture treated within 24 hours of injury between May 2016 and December 2019.Unreamed intramedullary nailing (n = 31) versus external fixation (n = 24).The primary outcome was function within 12 months of injury, measured using the Function IndeX for Trauma (FIX-IT) score. Secondary outcomes included health-related quality of life (HRQoL) using the 3-level version of the 5-dimension EuroQol instrument (EQ-5D-3L), radiographic healing using the Radiographic Union Scale for Tibia (RUST) fractures score, and clinical complications.Treatment with an intramedullary nail resulted in a 1.0-point higher [95% credible intervals (CrI), 0.1 to 1.9] FIX-IT score compared with external fixation. Results were similar for the secondary patient-reported outcomes, EQ-5D-3L and the visual analog scale component of the EuroQol instrument (EQ-VAS). RUST scores were not different between groups at any time point. Treatment with an intramedullary nail was associated with a 22.1% (95% CrI, -42.6% to 1.7%) lower rate of malunion and a 20.8% (95% CrI, -44.0% to 2.9%) lower rate of superficial infection.In rural Uganda, treatment of open tibial shaft fractures with an unreamed intramedullary nail results in marginal clinically important improvements in functional outcomes, although there is likely an important reduction in malunion and superficial infection.Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Published
2022

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