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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. How many sites should an orthopedic trauma prospective multicenter trial have? A marginal analysis of the Major Extremity Trauma Research Consortium completed trials

Author: Lauren Allen, Robert V. O’Toole, Michael J. Bosse, William T. Obremskey, Kristin R. Archer, Lisa K. Cannada, Jaimie Shores, Lisa M. Reider, Katherine P. Frey, Anthony R. Carlini, Elena D. Staguhn, and Renan C. Castillo
Subjects: Multicenter trials, Research operations, Financial management, Medicine (General), R5-920
Abstract: Abstract Background Multicenter trials in orthopedic trauma are costly, yet crucial to advance the science behind clinical care. The number of sites is a key cost determinant. Each site has a fixed overhead cost, so more sites cost more to the study. However, more sites can reduce total costs by shortening the study duration. We propose to determine the optimal number of sites based on known costs and predictable site enrollment. Methods This retrospective marginal analysis utilized administrative and financial data from 12 trials completed by the Major Extremity Trauma Research Consortium. The studies varied in size, design, and clinical focus. Enrollment across the studies ranged from 1054 to 33 patients. Design ranged from an observational study with light data collection to a placebo-controlled, double-blinded, randomized controlled trial. Initial modeling identified the optimal number of sites for each study and sensitivity analyses determined the sensitivity of the model to variation in fixed overhead costs. Results No study was optimized in terms of the number of participating sites. Excess sites ranged from 2 to 39. Excess costs associated with extra sites ranged from $17K to $330K with a median excess cost of $96K. Excess costs were, on average, 7% of the total study budget. Sensitivity analyses demonstrated that studies with higher overhead costs require more sites to complete the study as quickly as possible. Conclusions Our data support that this model may be used by clinical researchers to achieve future study goals in a more cost-effective manner. Trial registration Please see Table 1 for individual trial registration numbers and dates of registration.
Published: 2024
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3. Venous thromboembolism testing practices after orthopaedic trauma: prophylaxis regimen does not influence testing patterns

Author: Bryce E. Haac, MD, Nathan N. O'Hara, PhD, MHA, Elliott R. Haut, MD, MPH, Theodore T. Manson, MD, Gerard P. Slobogean, MD, Robert V. O'Toole, MD, Deborah M. Stein, MD, MPH, ADAPT Investigators, Herman Johal, Richard Van Besien, Peter Z. Berger, George B. Reahl, Dimitrius Marinos, Yasmin Degani, Daniel Mascarenhas, Daniel Connelly, and Thomas M. Scalea
Subjects: Orthopedic surgery, RD701-811
Abstract: Abstract. Objectives:. To determine venous thromboembolism (VTE) testing patterns in an orthopaedic trauma population and to evaluate for differences in VTE surveillance by prophylaxis regimen through a secondary analysis of the ADAPT trial. Design:. Prospective randomized trial. Setting:. Level I trauma center. Patients:. Three hundred twenty-nine adult (18 years and older) trauma patients presenting with an operative extremity fracture proximal to the metatarsals/carpals or any pelvic or acetabular fracture requiring VTE prophylaxis. Intervention:. VTE imaging studies recorded within 90 days post injury. Main Outcome Measurements:. Percentage of patients tested for VTE were compared between treatment groups using Fisher's exact test. Subsequently, multivariable regression was used to determine patient factors significantly associated with risk of receiving a VTE imaging study. Results:. Sixty-seven patients (20.4%) had VTE tests ordered during the study period. Twenty (29.9%) of these 67 patients with ordered VTE imaging tests had a positive finding. No difference in proportion of patients tested for VTE by prophylaxis regimen (18.8% on aspirin vs. 22.0% on LMWH, P = 0.50) was observed. Factors associated with increased likelihood of VTE testing included White race (adjusted odds ratio [aOR]: 2.61, 95% CI: 1.26–5.42), increased Injury Severity Score (aOR for every 1-point increase: 1.10, 95% CI: 1.05–1.15), and lower socioeconomic status based on the Area Deprivation Index (aOR for every 10-point increase: 1.14, 95% CI: 1.00–1.30). Conclusions:. VTE surveillance did not significantly differ by prophylaxis regimen. Patient demographic factors including race, injury severity, and socioeconomic status were associated with differences in VTE surveillance. Level of Evidence:. Level I, Therapeutic.
Published: 2024
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4. Surgical management and weight-bearing recommendations for geriatric distal femur fractures

Author: Justin M. Haller, MD, Lucas S. Marchand, MD, Thomas F. Higgins, MD, Robert V. O'Toole, MD, and Lisa Reider, PhD
Subjects: Orthopedic surgery, RD701-811
Abstract: Objective:. To investigate current practices among orthopaedic trauma surgeons in treating geriatric distal femur fractures and evaluate current postoperative weight-bearing recommendations. Methods:. A 26-question survey was emailed to Major Extremity Trauma Research Consortium surgeon members to characterize current practice with different fixation methods for distal femur fractures and the surgeon-directed postoperative weight-bearing recommendations for each approach. Results:. Surveys were completed by 123 orthopaedic trauma surgeons with a response rate of 37% (123/332). Retrograde intramedullary nailing (IMN) was commonly performed by 88% of surgeons, and lateral locked plate was commonly performed by 74% of surgeons. Retrograde IMN with a lateral plate was commonly performed by 51% of surgeons. Dual femoral plating was commonly performed by 18% of surgeons and sometimes performed by 39% of surgeons. Surgeons were significantly more likely to allow immediate postoperative weight-bearing for retrograde IMN (P < 0.001), retrograde IMN with lateral plate (P < 0.001), and dual plate (P < 0.001) as compared with locked lateral plate. Most surgeons (79%) would be interested in participating in a randomized controlled trial (RCT) investigating single implant versus dual implant for distal femur fractures and believe that a trial incorporating immediate weight-bearing is important. Conclusion:. A variety of implants are commonly used to treat geriatric distal femur fractures. Patients with distal femur fracture commonly have weight-bearing restrictions in the immediate postoperative period. A large proportion of orthopaedic trauma surgeons have clinical equipoise for an RCT to investigate the impact of surgical construct and weight-bearing on geriatric distal femur fracture patient recovery.
Published: 2024
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5. 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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6. Fix or Replace? Patient Preferences for the Treatment of Geriatric Lower Extremity Fractures: A Discrete Choice Experiment

Author: John T. Richards MD, Nathan N. O’Hara PhD, MHA, Kathleen Healy MD, Nicolas Zingas MD, Natasha McKibben MD, Caroline Benzel MD, Gerard P. Slobogean MD, MPH, Robert V. O’Toole MD, and Marcus F. Sciadini MD
Subjects: Orthopedic surgery, RD701-811, Geriatrics, RC952-954.6
Abstract: Introduction When considering treatment options for geriatric patients with lower extremity fractures, little is known about which outcomes are prioritized by patients. This study aimed to determine the patient preferences for outcomes after a geriatric lower extremity fracture. Materials and Methods We administered a discrete choice experiment survey to 150 patients who were at least 60 years of age and treated for a lower extremity fracture at a Level I trauma center. The discrete choice experiment presented study participants with 8 sets of hypothetical outcome comparisons, including joint preservation (yes or no), risk of reoperation at 6 months and 24 months, postoperative weightbearing status, disposition, and function as measured by return to baseline walking distance. We estimated the relative importance of these potential outcomes using multinomial logit modeling. Results The strongest patient preference was for maintained function after treatment (59%, P < .001), followed by reoperation within 6 months (12%, P < .001). Although patients generally favored joint preservation, patients were willing to change their preference in favor of joint replacement if it increased function (walking distance) by 13% (SE, 66%). Reducing the short-term reoperation risk (12%, P < .001) was more important to patients than reducing long-term reoperation risk (4%, P = .33). Disposition and weightbearing status were lesser priorities to patients (9%, P < .001 and 7%, P < .001, respectively). Discussion After a lower extremity fracture, geriatric patients prioritized maintained walking function. Avoiding short-term reoperation was more important than avoiding long-term reoperation. Joint preservation through fracture fixation was the preferred treatment of geriatric patients unless arthroplasty or arthrodesis provides a meaningful functional benefit. Hospital disposition and postoperative weightbearing status were less important to patients than the other included outcomes. Conclusions Geriatric patients strongly prioritize function over other outcomes after a lower extremity fracture.
Published: 2024
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7. Orthopaedic infections: what have we learned?

Author: Christopher Lee, MD, Erik Mayer, MD, Nicholas Bernthal, MD, Joseph Wenke, PhD, and Robert V. O'Toole, MD
Subjects: Orthopedic surgery, RD701-811
Abstract: Summary:. Orthopaedic infections remain challenging complications to treat, with profound economic impact in addition to patient morbidity. The overall estimates of infection after orthopaedic surgery with internal devices has been estimated at 5%, with hospital costs eight times that of those without fracture-related infections and with significantly poorer functional and pain interference PROMIS scores. Orthopaedic infection interventions have been focused on prevention and treatment options. The creation of new modalities for orthopaedic infection treatment can benefit from the understanding of the temporal relationship between bacterial colonization and host–cell integration, a concept referred to as “the race for the surface.” Regarding prevention, host modulation and antibiotic powder use have been explored as viable options to lower infection rates. Orthopaedic infection treatment has additionally continued to evolve, with PO antibiotics demonstrating equivalent efficacy to IV antibiotics for the treatment of orthopaedic infections in recent studies. In conclusion, orthopaedic infections remain difficult clinical dilemmas, although evolving prevention and treatment modalities continue to emerge.
Published: 2023
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8. Does cumulative topical antibiotic powder use increase the risk of drug induced acute kidney injury in fracture patients?

Author: Nathan N. O'Hara, Jessica Carullo, Manjari Joshi, Mary Banoub, Kimberly C. Claeys, Sheila Sprague, Gerard P. Slobogean, and Robert V. O'Toole
Subjects: Vancomycin, Tobramycin, Topical antibiotics, Infection prophylaxis, Acute kidney injury, Acute Kidney Injury, Orthopedic surgery, RD701-811
Abstract: Aims There is increasing evidence to support the use of topical antibiotics to prevent surgical site infections. Although previous research suggests a minimal nephrotoxic risk with a single dose of vancomycin powder, fracture patients often require multiple procedures and receive additional doses of topical antibiotics. We aimed to determine if cumulative doses of intrawound vancomycin or tobramycin powder for infection prophylaxis increased the risk of drug-induced acute kidney injury (AKI) among fracture patients. Methods This cohort study was a secondary analysis of single-centre Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma (PREP-IT) trial data. We included patients with a surgically treated appendicular fracture. The primary outcome was drug-induced AKI. The odds of AKI per gram of vancomycin or tobramycin powder were calculated using Bayesian regression models, which adjusted for measured confounders and accounted for the interactive effects of vancomycin and tobramycin. Results Of the 782 included patients (mean age 48 years (SD 20); 59% male), 83% (n = 648) received at least one vancomycin dose (cumulative range 1 to 12 g). Overall, 45% of the sample received at least one tobramycin dose (cumulative range 1.2 to 9.6 g). Drug-induced AKI occurred in ten patients (1.2%). No association was found between the cumulative dose of vancomycin and drug-induced AKI (odds ratio (OR) 1.08 (95% credible interval (CrI) 0.52 to 2.14)). Additional doses of tobramycin were associated with a three-fold increase in the adjusted odds of drug-induced AKI (OR 3.66 (95% CrI 1.71 to 8.49)). Specifically, the risk of drug-induced AKI rose substantially after 4.8 g of tobramycin powder (7.5% (95% CrI 1.0 to 35.3)). Conclusion Cumulative doses of vancomycin were not associated with an increased risk of drug-induced AKI among fracture patients. While the risk of drug-induced AKI remains less than 4% with three or fewer 1.2 g tobramycin doses, the estimated risk increases substantially to 8% after four cumulative doses. Level of evidence: Therapeutic Level III Cite this article: Bone Jt Open 2022;3(4):284–290.
Published: 2022
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9. Local administration of vancomycin powder in orthopaedic fracture surgery: current practice and trends

Author: Lucas S. Marchand, MD, Sheila Sprague, PhD, Nathan N. O'Hara, PhD, Chuan Silvia Li, MSc, Robert V. O'Toole, MD, Manjari Joshi, MBBS, Darius Viskontas, MD, FRCSC, Nicholas Romeo, DO, Robert A. Hymes, MD, William T. Obremskey, MD, Thomas F. Higgins, MD, Gorden D. Potter, MD, Patrick F. Bergin, MD, Mark Gage, MD, Joshua L. Gary, MD, Mohit Bhandari, MD, PhD, FRCSC, and Gerard P. Slobogean, MD
Subjects: Orthopedic surgery, RD701-811
Abstract: Abstract. Objectives:. Surgical site infections in orthopaedic trauma are a significant problem with meaningful patient and health care system–level consequences. Direct application of antibiotics to the surgical field has many potential benefits in reducing surgical site infections. However, to date, the data regarding the local administration of antibiotics have been mixed. This study reports on the variability of prophylactic vancomycin powder use in orthopaedic trauma cases across 28 centers. Methods:. Intrawound topical antibiotic powder use was prospectively collected within three multicenter fracture fixation trials. Fracture location, Gustilo classification, recruiting center, and surgeon information were collected. Differences in practice patterns across recruiting center and injury characteristics were tested using chi-square statistic and logistic regression. Additional stratified analyses by recruiting center and individual surgeon were performed. Results:. A total of 4941 fractures were treated, and vancomycin powder was used in 1547 patients (31%) overall. Local administration of vancomycin powder was more frequent in open fractures 38.8% (738/1901) compared with closed fractures 26.6% (809/3040) (P < 0.001). However, the severity of the open fracture type did not affect the rate at which vancomycin powder was used (P = 0.11). Vancomycin powder use varied substantially across the clinical sites (P < 0.001). At the surgeon level, 75.0% used vancomycin powder in less than one-quarter of their cases. Conclusions:. Prophylactic intrawound vancomycin powder remains controversial with varied support throughout the literature. This study demonstrates wide variability in its use across institutions, fracture types, and surgeons. This study highlights the opportunity for increased practice standardization for infection prophylaxis interventions. Level of Evidence:. Prognostic—III.
Published: 2023
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10. 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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11. Patients value their own pain over braking safety when deciding when to return to driving: a discrete choice experiment on lower extremity injuries

Author: Genaro A. DeLeon, MS, Nicholas P. Rolle, BS, Cynthia E. Burke, BS, Phillip C. McKegg, MS, Zachary D. Hannan, BS, Qasim M. Ghulam, DO, Jayesh Gupta, BS, Abdulai Bangura, BS, Katherine C. O’Connor, MS, Gerard P. Slobogean, MD, Robert V. O’Toole, MD, and Nathan N. O’Hara, PhD
Subjects: Orthopedic surgery, RD701-811
Abstract: Abstract. Objective:. To quantify patient preferences towards time to return to driving relative to compromised reaction time and potential complication risks. Design:. Cross-sectional discrete choice experiment. Setting:. Academic trauma center. Patients:. Ninety-six adult patients with an operative lower extremity fracture from December 2019 through December 2020. Intervention:. None. Main Outcome Measurement:. Patient completed a discrete choice experiment survey consisting of 12 hypothetical return to driving scenarios with varied attributes: time to return to driving (range: 1 to 6 months), risk of implant failure (range: 1% to 12%), pain upon driving return (range: none to severe), and driving safety measured by braking distance (range: 0 to 40 feet at 60 mph). The relative importance of each attribute is reported on a scale of 0% to 100%. Results:. Patients most valued a reduced pain level when resuming driving (62%), followed by the risk of implant failure (17%), time to return to driving (13%), and braking safety (8%). Patients were indifferent to returning to driving at 1 month (median utility: 28, interquartile range [IQR] −31 to 80) or 2 months (median utility: 59, IQR: 41 to 91) postinjury. Conclusion:. Patients with lower extremity injuries demonstrated a willingness to forego earlier return to driving if it might mean a decrease in their pain level. Patients are least concerned about their driving safety, instead placing higher value on their own pain level and chance of implant failure. The findings of this study are the first to rigorously quantify patient preferences toward a return to driving and heterogeneity in patient preferences. Level of Evidence:. V
Published: 2022
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12. Can financial payments incentivize short-term smoking cessation in orthopaedic trauma patients? Evidence from a discrete choice experiment

Author: Dana Alkhoury, Jared Atchison, Antonio J. Trujillo, Kimberly Oslin, Katherine P. Frey, Robert V. O’Toole, Renan C. Castillo, and Nathan N. O’Hara
Subjects: Medicine (General), R5-920
Abstract: Abstract Background Smoking increases the risk of complications and related costs after an orthopaedic fracture. Research in other populations suggests that a one-time payment may incentivize smoking cessation. However, little is known on fracture patients’ willingness to accept financial incentives to stop smoking; and the level of incentive required to motivate smoking cessation in this population. This study aimed to estimate the financial threshold required to motivate fracture patients to stop smoking after injury. Methods This cross-sectional study utilized a discrete choice experiment (DCE) to elicit patient preferences towards financial incentives and reduced complications associated with smoking cessation. We presented participants with 12 hypothetical options with several attributes with varying levels. The respondents’ data was used to determine the utility of each attribute level and the relative importance associated with each attribute. Results Of the 130 enrolled patients, 79% reported an interest in quitting smoking. We estimated the financial incentive to be of greater relative importance (ri) (45%) than any of the included clinical benefits of smoking cessations (deep infection (ri: 24%), bone healing complications (ri: 19%), and superficial infections (ri: 12%)). A one-time payment of $800 provided the greatest utility to the respondents (0.64, 95% CI: 0.36 to 0.93), surpassing the utility associated with a single $1000 financial incentive (0.36, 95% CI: 0.18 to 0.55). Conclusions Financial incentives may be an effective tool to promote smoking cessation in the orthopaedic trauma population. The findings of this study define optimal payment thresholds for smoking cessation programs.
Published: 2021
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13. Pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solution in open fractures (Aqueous-PREP): the feasibility of a cluster randomized crossover study

Author: Sheila Sprague, Paige Guyatt, Sofia Bzovsky, Uyen Nguyen, Mohit Bhandari, Lehana Thabane, Brad Petrisor, Herman S. Johal, Jordan Leonard, Shannon Dodds, Franca Mossuto, Robert V. O’Toole, Andrea Howe, Haley K. Demyanovich, Megan Camara, Nathan N. O’Hara, Gerard P. Slobogean, and The PREP-IT Investigators
Subjects: Pilot study, Feasibility, Open fractures, Aqueous antiseptic skin solution, Surgical site infection, Cluster crossover, Medicine (General), R5-920
Abstract: Abstract Background Preoperative antiseptic skin solutions are used prior to most surgical procedures; however, there is no definitive research comparing infection-related outcomes following use of the various solutions available to orthopedic trauma surgeons. The objective of this pilot study was to test the feasibility of a cluster randomized crossover trial that assesses the comparative effectiveness of a 10% povidone-iodine solution versus a 4% chlorhexidine gluconate solution for the management of open fractures. Methods Two orthopedic trauma centers participated in this pilot study. Each of these clinical sites was randomized to a starting solution (povidone-iodine solution or chlorhexidine gluconate) then subsequently crossed over to the other treatment after 2 months. During the 4-month enrollment phase, we assessed compliance, enrollment rates, participant follow-up, and accurate documentation of the primary clinical outcome. Feasibility outcomes included (1) the implementation of the interventions during a run-in period; (2) enrollment of participants during two 2-month enrollment phases; (3) application of the trial interventions as per the cluster randomization crossover scheme; (4) participant follow-up; and (5) accurate documentation of the primary outcome (surgical site infection). Feasibility outcomes were summarized using descriptive statistics reported as means (standard deviation) or medians (first quartile, third quartile) for continuous variables depending on their distribution and counts (percentage) for categorical variables. Corresponding 95% confidence intervals (CIs) were also reported. Results All five of the criteria for feasibility were met. During the run-in phase, all 18 of the eligible patients identified at the two clinical sites received the correct cluster-assigned treatment. A total of 135 patients were enrolled across both sites during the 4-month recruitment phase, which equates to 92% (95% CI 85.9 to 96.4%) of eligible patients being enrolled. Compliance with the assigned treatment in the pilot study was 98% (95% CI 93.5 to 99.8%). Ninety-eight percent (95% CI 93.5 to 99.8%) of participants completed the 90-day post-surgery follow-up and the primary outcome (SSI) was accurately documented for 100% (95% CI 96.6 to 100.0%) of the participants. Conclusions These results confirm the feasibility of a definitive study comparing antiseptic solutions using a cluster randomized crossover trial design. Building upon the infrastructure established during the pilot phase, a definitive study has been successfully initiated. Trial registration ClincialTrials.gov , number NCT03385304 . Registered December 28, 2017.
Published: 2021
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14. A patient-centered composite endpoint weighting technique for orthopaedic trauma research

Author: Ugochukwu N. Udogwu, Andrea Howe, Katherine Frey, Marckenley Isaac, Daniel Connelly, Dimitrius Marinos, Mitchell Baker, Renan C. Castillo, Gerard P. Slobogean, Robert V. O’Toole, and Nathan N. O’Hara
Subjects: Best-worst scaling choice experiment, Orthopaedic trauma, Fracture, Study design, Composite endpoint, Weighting technique, Medicine (General), R5-920
Abstract: Abstract Background This study aimed to address the current limitations of the use of composite endpoints in orthopaedic trauma research by quantifying the relative importance of clinical outcomes common to orthopaedic trauma patients and use those values to develop a patient-centered composite endpoint weighting technique. Methods A Best-Worst Scaling choice experiment was administered to 396 adult surgically-treated fracture patients. Respondents were presented with ten choice sets, each consisting of three out of ten plausible clinical outcomes. Hierarchical Bayesian modeling was used to determine the utilities associated with the outcomes. Results Death was the outcome of greatest importance (mean utility = − 8.91), followed by above knee amputation (− 7.66), below knee amputation (− 6.97), severe pain (− 5.90), deep surgical site infection (SSI) (− 5.69), bone healing complications (− 5.20), and moderate pain (− 4.59). Mild pain (− 3.30) and superficial SSI (− 3.29), on the other hand, were the outcomes of least importance to respondents. Conclusion This study revealed that patients’ relative importance towards clinical outcomes followed a logical gradient, with distinct and quantifiable preferences for each possible component outcome. These findings were incorporated into a novel composite endpoint weighting technique.
Published: 2019
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15. 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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16. 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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17. Fixation Using Alternative Implants for the Treatment of Hip Fractures

Author: Sheila Sprague, PhD, Mohit Bhandari, MD, PhD, FRCSC, Sofia Bzovsky, MSc, Taryn Scott, MSW, MSc, Lehana Thabane, PhD, Diane Heels-Ansdell, MSc, Robert V. O’Toole, MD, Andrea Howe, BS, Greg E. Gaski, MD, Lauren C. Hill, BS, CCRC, Krista M. Brown, MS, CCRC, Darius Viskontas, MD, Mauri Zomar, CCRP, Gregory J. Della Rocca, MD, PhD, FACS, Gerard P. Slobogean, MD, MPH, and FAITH-2 investigators
Subjects: Orthopedic surgery, RD701-811
Abstract: Abstract. Objectives:. To conduct a pilot trial for the Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) protocol to assess feasibility of a definitive trial. Design:. Pilot trial. Setting:. Twenty-five clinical sites across North America and Australia were initiated, but enrolment occurred in only 15 North American sites. Patients/Participants:. Ninety-one randomized adults aged 18 to 60 years with a femoral neck fracture requiring surgical fixation. Intervention:. Eligible patients were randomized to receive surgical treatment (sliding hip screw or cancellous screws) AND nutritional supplementation (4000 IU of vitamin D or placebo) for 6 months postfracture. Main Outcome Measurements:. Feasibility outcomes included: clinical site initiation, participant enrolment rate, proportion of participants with complete 12-month follow-up, level of data quality, and rate of protocol adherence (number of randomization errors, crossovers between treatment groups, and daily supplementation adherence). Results:. Eighty-six of 91 participants randomized into the pilot trial from 15 North American hospitals were deemed eligible. Four of five primary feasibility criteria were not achieved as we were unable to initiate clinical sites outside of North America and Australia due to feasibility constraints, slow participant enrolment (60 participants recruited over 36 mo), low adherence with daily nutritional supplementation at the 6-week (72.1%), 3-month (60.5%), and 6-month (54.7%) follow-up visits, and a high loss to follow-up rate of 22.1% at 12 months. Conclusions:. Despite not meeting key feasibility criteria, we increased our knowledge on the logistics and anticipated barriers when conducting vitamin D supplementation trials in this trauma population, which can be used to inform the design and conduct of future trials on this topic.
Published: 2020
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18. 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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19. The Use of Vancomycin Powder in Tibial Plateau Fractures at Lower Risk of Infection

Author: Nicolas Zingas, Zachary D. Hannan, Kathleen M. Healey, Natasha S. McKibben, Cynthia E. Burke, Phillip C. McKegg, Qasim M. Ghulam, Nathan N. O'Hara, Manjari Joshi, Andrew Dubina, and Robert V. O'Toole
Subjects: Orthopedics and Sports Medicine, Surgery, General Medicine
Published: 2023
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20. Predicting Which Species of Bacteria Will Cause an Infection After Fracture Surgery

Author: Ajinkya Rane, Qasim M. Ghulam, Zachary D. Hannan, Phillip C. McKegg, Kalin Fisher, Manjari Joshi, Nathan N. O'Hara, and Robert V. O'Toole
Subjects: Orthopedics and Sports Medicine, Surgery
Abstract: The aim of this study was to develop and validate risk prediction models for deep surgical site infection (SSI) caused by specific bacterial pathogens after fracture fixation. A retrospective case-control study was conducted at a level I trauma center. Fifteen candidate predictors of the bacterial pathogens in deep SSI were evaluated to develop models of bacterial risk. The study included 441 patients with orthopedic trauma with deep SSI after fracture fixation and 576 control patients. The main outcome measurement was deep SSI cultures positive for methicillin-sensitive Staphylococcus aureus (MSSA), methicillin-resistant S aureus (MRSA), gram-negative rods (GNRs), anaerobes, or polymicrobial infection within 1 year of injury. Prognostic models were developed for five bacterial pathogen outcomes. Mean area under the curve ranged from 0.70 (GNRs) to 0.74 (polymicrobial). Strong predictors of MRSA were American Society of Anesthesiologists (ASA) classification of III or greater (odds ratio [OR], 3.4; 95% CI, 1.6–8.0) and time to fixation greater than 7 days (OR, 3.4; 95% CI, 1.9–5.9). Gustilo type III fracture was the strongest predictor of MSSA (OR, 2.5; 95% CI, 1.6–3.9) and GNRs (OR, 3.4; 95% CI, 2.3–5.0). ASA classification of III or greater was the strongest predictor of polymicrobial infection (OR, 5.9; 95% CI, 2.7–15.5) and was associated with increased odds of GNRs (OR, 2.7; 95% CI, 1.5–5.5). Our models predict the risk of MRSA, MSSA, GNR, anaerobe, and polymicrobial infections in patients with fractures. The models might allow for modification of preoperative antibiotic selection based on the particular pathogen posing greatest risk for this patient population. [ Orthopedics . 202x;4x(x):xx–xx.]
Published: 2023
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21. Financial Toxicity Is Common in Patients After Tibia Fracture

Author: Lily R. Mundy, Nicolas H. Zingas, Natasha McKibben, Kathleen Healey, Nathan N. O'Hara, Robert V. O'Toole, and Raymond A. Pensy
Subjects: Orthopedics and Sports Medicine, Surgery, General Medicine
Published: 2023
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22. Small-Fragment Plate Fixation of Humeral Shaft Fractures

Author: Christopher G. Langhammer, Giuliana Rotunno, Christina Sebastian, Jason W. Nascone, Robert V. O'Toole, W. Andrew Eglseder, and Marcus F. Sciadini
Subjects: Orthopedics and Sports Medicine, Surgery
Abstract: Fixation of humeral shaft fractures is frequently performed with large-fragment (4.5 mm) plates to accommodate immediate weight bearing. Use of small-fragment (3.5 mm) plates as an alternative carries theoretical benefits. We examined nonunion rates and postoperative radial nerve palsy (RNP) rates in a retrospective cohort of patients undergoing open reduction and internal fixation of humeral shaft fractures with 3.5-mm or 4.5-mm plates. Two hundred thirty-six patients with 241 humeral shaft fractures were included. Small 3.5-mm plates were used in 83% of the patients, and large 4.5-mm plates were used in 17% of the patients. Fifty-three percent were made weight bearing as tolerated following surgical fixation. There was a 7% incidence of nonunion and a 10% incidence of RNP in the 3.5-mm plate group. There was a 7% incidence of nonunion and a 15% incidence of RNP in the 4.5-mm plate group. No statistically significant relationship was shown between nonunion or RNP and plate size ( P =.74 and P =.39). No relationship was shown between nonunion and postoperative weight-bearing status ( P =.45). Subgroup analysis according to plate size additionally showed no association of nonunion with postoperative weight bearing in both the 4.5-mm ( P =.55) and the 3.5-mm ( P =.25) cohorts. Small-fragment and large-fragment plating of humeral shaft fractures resulted in comparable union and RNP rates, regardless of postoperative weight-bearing status. Our findings suggest that 3.5-mm plate fixation of humeral shaft fractures is a safe alternative to 4.5-mm plate fixation. [ Orthopedics . 202x;4x(x):xx–xx.]
Published: 2023
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23. Use of the HemaClear™ elastic tourniquet reduces blood loss in operative treatment of humeral shaft fractures

Author: Christopher Domes, Nathan N. O'Hara, Robert V. O'Toole, Michael G. Schloss, Zachary D. Hannan, and Raymond A. Pensy
Subjects: General Earth and Planetary Sciences, General Environmental Science
Abstract: To determine if the use of a narrower elastic tourniquet compared to a standard pneumatic tourniquet reduces operative blood loss in the operative fixation of humeral shaft fractures.This retrospective cohort study was performed at a level I trauma center and included 134 patients, aged 18 to 90 years, with a humeral shaft fracture treated with open reduction internal fixation (ORIF) from January 2007 through June 2018. The primary variable of interest was the application of a HemaClear™ elastic tourniquet versus a standard pneumatic tourniquet during the fixation of a humeral shaft fracture. The primary outcome was estimated blood loss (EBL) during the humerus ORIF surgery as recorded in the operative record. The secondary outcomes were total tourniquet time and operative time. The primary purpose of the study was to compare the above outcomes between the two tourniquet types.Estimated blood loss was 42% lower (95% CI: 11% to 73%, p0.01) in the elastic tourniquet group when compared to the standard pneumatic tourniquet group. The use of the elastic tourniquet was also associated with a 67% increase (95% CI: 35% to 100%, p0.01) in tourniquet time compared to the standard pneumatic tourniquet. No difference in the total operative time between the two groups (difference, -3%; 95% CI: -21 to 14, p = 0.72) was observed.Elastic tourniquet use was associated with 42% less blood loss in the fixation of humeral shaft fractures compared to use of a traditional pneumatic tourniquet, although this may be of unclear clinical importance given the relatively low estimated blood loss in this cohort. The potential benefit of reduced blood loss associated with the narrower elastic tourniquet is likely caused by the increased tourniquet time, without a change in overall operative time.
Published: 2023
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24. Outcomes of Tibiotalocalcaneal Hindfoot Fusion Nails Used for Acute Lower Extremity Trauma in a High-Risk Patient Population

Author: Kalin J, Fisher, Steven F, Shannon, Christina M, Dean, Max A, Coale, Kathleen M, Healey, Robert V, O'Toole, Theodore T, Manson, Nathan N, O'Hara, and Marcus F, Sciadini
Subjects: Orthopedics and Sports Medicine, Surgery, General Medicine
Abstract: To determine the outcomes of high-risk patients treated with tibiotalocalcaneal hindfoot fusion nails.Retrospective case series.Level I trauma center.Between January 2007 and December 2016, 50 patients with significant medical comorbidities treated with a tibiotalocalcaneal hindfoot fusion nail in the setting of acute distal tibia and ankle trauma considered to be limb-threatening.Tibiotalocalcaneal hindfoot fusion nail.Two-year cumulative incidence of unplanned reoperation and estimated survival with limb salvage at 2 years.Of the 50 patients, 20 (38%) had an unplanned reoperation (mean: 2.5 reoperations), including 19 for implant removal, 11 for irrigation and debridement and/or placement of an antibiotic delivery device, and 4 for revision fusion. Three patients required amputation and 3 patients died within 2 years of injury, resulting in an estimated survival with limb salvage at 2 years of 79% (95% confidence interval: 67%-91%). After accounting for the competing risk of death and incomplete follow-up, the 2-year cumulative incidence of unplanned reoperation was 64% (95% confidence interval: 62%-67%).Patients in this series experienced a high rate of return to the operating room but a relatively low rate of amputation. Because patients were indicated for this course of treatment on the basis of comorbidities felt to put them at high risk of loss of limb with traditional treatment, acute hindfoot fusion nailing might represent a viable option in select high-risk patients and injuries. Clinicians should be aware that complications are still common.Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
Published: 2023
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25. The Effect of Surgeon Experience on Short- to Medium-Term Complication Rate Following Operative Fixation of Acetabular Fractures

Author: Bennet A, Butler, Zachary D, Hannan, Qasim M, Ghulam, Genaro A, DeLeon, Nathan, O'Hara, Jason W, Nascone, Marcus F, Sciadini, and Robert V, O'Toole
Subjects: Surgeons, Fracture Fixation, Internal, Fractures, Bone, Open Fracture Reduction, Postoperative Complications, Treatment Outcome, Humans, Acetabulum, Orthopedics and Sports Medicine, Surgery, Clinical Competence, General Medicine, Retrospective Studies
Abstract: Operative management of acetabular fractures is technically challenging, but there is little data regarding how surgeon experience affects outcomes. Previous efforts have focused only on reduction quality in a single surgeon series. We hypothesized that increasing surgeon experience would be associated with improved acetabular surgical outcomes in general.Retrospective cohort study.Urban academic level-I trauma center.Seven hundred ninety-five patients who underwent an open reduction internal fixation for an acetabular fracture.There was a significant association between surgeon experience and certain outcomes, specifically reoperation rate (16.9% overall), readmission rate (13.9% overall), and reduction quality. Deep infection rate (9.7% overall) and secondary displacement rate (3.7% overall) were not found to have a significant association with surgeon experience. For reoperation rate, the time until 50% peak performance was 2.4 years in practice.Surgeon experience had a significant association with reoperation rate, quality of reduction, and readmission rate after open reduction internal fixation of acetabular fractures. Other patient outcomes were not found to be associated with surgeon experience.Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
Published: 2022
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26. Can a Computer-based Force Feedback Hip Fracture Skills Simulator Improve Clinical Task Performance? A Cadaveric Validation Study

Author: Christopher Domes, Max Coale, Annie Weber, Marckenley Isaac, Ugo Udogwu, Nathan N. O'Hara, Matthew Christian, Robert V. O'Toole, and Marcus F. Sciadini
Subjects: Orthopedics and Sports Medicine, Surgery
Published: 2023
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27. Telemedicine and Socioeconomics in Orthopaedic Trauma Patients: A Quasi-Experimental Study During the COVID-19 Pandemic

Author: Ishaq O, Ibrahim, Abdulai, Bangura, Nathan N, O'Hara, Andrew N, Pollak, Gerard P, Slobogean, Robert V, O'Toole, and Christopher G, Langhammer
Subjects: Orthopedics, Socioeconomic Factors, COVID-19, Humans, Orthopedics and Sports Medicine, Surgery, Pandemics, Telemedicine, Retrospective Studies
Abstract: Socioeconomic factors may introduce barriers to telemedicine care access. This study examines changes in clinic absenteeism for orthopaedic trauma patients after the introduction of a telemedicine postoperative follow-up option during the COVID-19 pandemic with attention to patient socioeconomic status (SES).Patients (n = 1,060) undergoing surgical treatment of pelvic and extremity trauma were retrospectively assigned to preintervention and postintervention cohorts using a quasi-experimental design. The intervention is the April 2020 introduction of a telemedicine follow-up option for postoperative trauma care. The primary outcome was the missed visit rate (MVR) for postoperative appointments. We used Poisson regression models to estimate the relative change in MVR adjusting for patient age and sex. SES-based subgroup analysis was based on the Area Deprivation Index (ADI) according to home address.The pre-telemedicine group included 635 patients; the post-telemedicine group included 425 patients. The median MVR in the pre-telemedicine group was 28% (95% confidence interval [CI], 10% to 45%) and 24% (95% CI, 6% to 43%) in the post-telemedicine group. Low SES was associated with a 40% relative increase in MVR (95% CI, 17% to 67%, P0.001) compared with patients with high SES. Relative MVR changes between pre-telemedicine and post-telemedicine groups did not reach statistical significance in any socioeconomic strata (low ADI, -6%; 95% CI, -25% to 17%; P = 0.56; medium ADI, -18%; 95% CI, -35% to 2%; P = 0.07; high ADI, -12%; 95% CI, -28% to 7%; P = 0.20).Low SES was associated with a higher MVR both before and after the introduction of a telemedicine option. However, no evidence in this cohort demonstrated a change in absenteeism based on SES after the introduction of the telemedicine option. Clinicians should be reassured that there is no evidence that telemedicine introduces additional socioeconomic bias in postoperative orthopaedic trauma care.III.
Published: 2022
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28. Microbial Interspecies Associations in Fracture-Related Infection

Author: Ida, Gitajn, Paul, Werth, Robert V, O'Toole, Mandarin, Joshi, David, Jevsevar, Brent, Wise, Ajinya, Rane, Steven, Horton, Emily A, McClure, Benjamin, Ross, and Carey, Nadell
Subjects: Methicillin-Resistant Staphylococcus aureus, Fractures, Bone, Coinfection, Humans, Surgical Wound Infection, Orthopedics and Sports Medicine, Surgery, Microbial Sensitivity Tests, General Medicine, Staphylococcal Infections, Anti-Bacterial Agents, Retrospective Studies
Abstract: Describe co-occurrence or clustering of microbial taxa in fracture-related infections to inform further exploration of infection-related interactions among them.Retrospective review.Level 1 trauma center.Four hundred twenty-three patients requiring surgical intervention for deep surgical site infection between January 2006 and December 2015.None.Connection between microbial taxa.Methicillin-resistant Staphylococcus aureus, methicillin-sensitive Staphylococcus aureus, and coagulase-negative Staphylococcus represented the majority of monomicrobial observations (71%). Gram-negative rods, gram-positive rods, and anaerobes presented more frequently in polymicrobial infections. Enterobacter, vancomycin-sensitive Enterococcus, and Pseudomonas are present in polymicrobial infections with the highest frequencies and represent the top 3 most important nodes within the microorganism framework, with the highest network centrality scores.The present study indicates that there are common microbial taxa (Enterobacter, Enterococcus, and Pseudomonas) that tend to co-occur with other microbes greater than 75% of the time. These commonly co-occurring microbes have demonstrated interactive relationships in other disease pathologies, suggesting that there may be similar important interactions in fracture-related infections. It is possible that these microbial communities play a role in the persistently high failure rate associated with management of infection after trauma. Future studies are needed to study the intermicrobial interactions that explain the frequency at which taxa co-occur. Understanding and potentially disrupting these intermicrobial relationships could inform improvements in the treatment of established infections and in the prevention of infection in high-risk patients.Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.
Published: 2022
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29. 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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30. Are deep infections that present before and after 90 days from orthopaedic trauma different? An analysis of the validity of the recent change in CDC criteria for infections

Author: Michael Rocca, Michael A. Maceroli, Brent T. Wise, Manjari Joshi, Daniel Connelly, Robert V O'Toole, Renan C. Castillo, Yanjie Huang, and Daniel Mascarenhas
Subjects: Male, medicine.medical_specialty, Logistic regression, law.invention, law, Internal medicine, Fracture fixation, medicine, Humans, Surgical Wound Infection, Orthopaedic trauma, Pelvis, Retrospective Studies, General Environmental Science, Univariate analysis, Hip Fractures, business.industry, Acetabulum, Hepatitis C, medicine.disease, Intensive care unit, United States, Orthopedics, medicine.anatomical_structure, General Earth and Planetary Sciences, Centers for Disease Control and Prevention, U.S, business
Abstract: Background In 2016, the Centers for Disease Control and Prevention (CDC) changed the time frame for their definition of deep surgical site infection (SSI) from within 1 year to within 90 days of surgery. We hypothesized that a substantial number of infections in patients who have undergone fracture fixation present beyond 90 days and that there are patient factors that can predict who is more likely to present with SSI after 90 days. Methods A retrospective review yielded 452 deep SSI after fracture fixation. These patients were divided into two groups—those infected within 90 days of surgery (308 patients) and those infected beyond 90 days (144 patients). Data were collected on risk factors for infection. Univariate and multiple logistic regression analyses were performed to compare the two groups. A randomly selected control group was used to build infection prediction models for both outcomes. The two outcomes were then modeled against each other to determine whether differences in predictors for early versus late infection exist. Results Of the 452 infections, 144 occurred beyond 90 days (32%). No statistically significant patient factors were found in univariate analysis between the early and late infection groups. The need for flap coverage was the only injury characteristic that differed significantly between groups, with patients in the late infection group more likely to have needed a flap. In models of early versus late infection, there are no statistically significant predictors. When modeled against the control group and directly comparing the two models, predictors for early infection include male sex and fractures of the pelvis, acetabulum, or hip, whereas predictors of late infection include hepatitis C and/or human immunodeficiency virus (HIV) and admission to the intensive care unit (ICU). Conclusion Use of the recent CDC definition will underestimate the rate of actual postoperative infections when applied to orthopaedic trauma patients. Hepatitis C and/or HIV and ICU admission are predictors of late infection, whereas male sex and pelvis, acetabulum, or hip fractures are predictors of early infection. Patients who receive flap coverage may be more likely to present with late infection.
Published: 2022
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31. Fixed angle device comparison in young femoral neck fractures: Dynamic hip screw vs dynamic helical hip system

Author: Bennet Butler, Nathan N O'Hara, Jason W. Nascone, Phillip McKegg, Gerard M. Slobogean, Christopher T. LeBrun, Marcus F. Sciadini, Robert V O'Toole, Genaro DeLeon, and Lucas S. Marchand
Subjects: Adult, Male, medicine.medical_specialty, Adolescent, medicine.medical_treatment, Bone Screws, Osteotomy, Femoral Neck Fractures, Fracture Fixation, Internal, Young Adult, medicine, Humans, General Environmental Science, Femoral neck, Fixation (histology), Dynamic hip screw, Femur Neck, Hip Fractures, business.industry, Osteonecrosis, Absolute risk reduction, Infant, Middle Aged, Surgery, Treatment Outcome, medicine.anatomical_structure, Cohort, General Earth and Planetary Sciences, business, Complication
Abstract: Introduction Femoral neck fractures in the young patient present a unique challenge. Most surgeons managing these injuries prefer a fixed angle implant, however these devices are fraught with problems. A dynamic hip screw (DHS) is one such fixed angle device that risks malreduction through rotational torque during screw insertion. To avoid this risk some surgeons utilize a dynamic helical hip system (DHHS), however little is known about the complication profile of this device. We hypothesized that the complication rate between these two devices would be similar. Patients and Methods All patients presenting to a single tertiary referral center with a femoral neck fracture were identified from a prospectively collected trauma database over an 11-year period. Patients were included if they were less than 60 years of age, treated with a DHS or DHHS, and had at least 6 months of follow-up. Demographic data, injury characteristics, and post-operative complications were obtained through chart review. Standard statistical comparisons were made between groups. A total of 77 patients met inclusion criteria. Results Average age of patients was 38 years (range: 18–59) and 56 (73%) were male. The DHS was used in 37 (48%) patients and the DHHS was used in 40 (52%) patients. Demographic data including average age, gender, body mass index, and smoking status did not differ between the groups. There were 29 (39%) total complications of interest (femoral neck shortening >5 mm, non-union requiring osteotomy, conversion to THA, and osteonecrosis. There were 19 (51%) complications in the DHS group and 10 (25%) in the DHHS group (p = 0.01, risk difference 25%, 95% CI 7–43). Comparisons of the individual complications about the DHS and DHHS cohort did not reach statistical significance for non-union (8% vs 3%) or THA (16% vs 13%) (p = 0.33, p = 0.64, respectively) but a difference was detected in the rate of shortening (27% vs 10%; p = 0.05). Conclusion This study demonstrates a high risk of complication when managing young femoral neck fractures in line with prior literature. The major complication rate of non-union requiring osteotomy or fixation failure resulting in THA was no different between the two groups, but the rate of shortening was greater the DHS group. This data suggests the DHHS may be a suitable device to manage the young femoral neck fracture and without increased risk of complication.
Published: 2022
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32. Pelvic Ring Injury Mortality: Are We Getting Better?

Author: Aresh Sepehri, Jonathan J. Morrison, Lucas S. Marchand, Zachary D. Hannan, Syed M.R. Zaidi, Gerard P. Slobogean, Abdulai T. Bangura, Nathan N O'Hara, Theodore T. Manson, and Robert V O'Toole
Subjects: medicine.medical_specialty, business.industry, Mortality rate, Absolute risk reduction, General Medicine, Article, Confidence interval, Injury mortality, Fractures, Bone, Injury Severity Score, medicine.anatomical_structure, Trauma Centers, Pelvic ring, Internal medicine, Cohort, Humans, Medicine, Abdomen, Orthopedics and Sports Medicine, Surgery, Pelvic Bones, business, Retrospective Studies
Abstract: To determine if changes in pelvic trauma care and treatment protocols have affected overall mortality rates after pelvic ring injury.Retrospective cohort study.Level I trauma center.A total of 3314 patients with pelvic ring injuries who presented to a single referral center from 1999 to 2018 were included in the study.Pelvic ring management, years 1999-2006 versus years 2007-2018.In hospital mortality. Other examined variables included change in patient demographics, fracture characteristics, date of injury, associated injuries, length of hospital stay, Abbreviated Injury Severity Score.The composite mortality rate was 6.5% (214/3314). The earliest cohort presented a mortality rate of 9.1% [111/1224; 95% confidence interval (CI), 7.6%-10.8%] compared with the more recent cohort mortality rate of 4.9% (103/2090; 95% CI, 4.1%-5.9%). Overall mortality was significantly lower in the more recent period, a risk difference of 4.1% (95% CI, 2.3%-6.1%; P0.01). After adjusting for age and Abbreviated Injury Severity Score of the brain, chest, and abdomen, the mortality reduction was more pronounced with an adjusted risk difference of 6.4% (95% CI, 4.7%-8.1%; P0.01).Significant improvement in the mortality rate of pelvic ring injuries has been demonstrated in recent years (4.9% vs. 9.1%) and the difference is even large when accounting for known confounders. Improvement appears to coincide chronologically with changes in trauma resuscitation and implementation of adjuvant treatments for managing patients with severe hemorrhagic shock. Although the exact benefit of each treatment awaits further research, these data might indicate improved care over time for these difficult patients.Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
Published: 2022
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33. Secondary Bony Defects after Soft Tissue Reconstruction in Limb-Threatening Lower Extremity Injuries: Does the Approach to Flap Elevation Matter?

Author: Cynthia E. Burke, Lily R. Mundy, Jayesh Gupta, Alison L. Wong, Blessing Enobun, Nathan N. O'Hara, Abdulai Bangura, Katherine C. O'Connor, Julio J. Jauregui, Nathan F. Miller, Robert V. O'Toole, and Raymond A. Pensy
Subjects: Surgery
Abstract: Background Limb-threatening lower extremity injuries often require secondary bone grafting after soft tissue reconstruction. We hypothesized that there would be fewer wound complications when performing secondary bone grafting via a remote surgical approach rather than direct flap elevation. Methods A retrospective cohort study was performed at a single Level 1 trauma center comparing complications after secondary bone grafting in patients who had undergone previous soft tissue reconstruction after open tibia fractures between 2006 and 2020. Comparing bone grafting via a remote surgical incision versus direct flap elevation, we evaluated wound dehiscence requiring return to the operating room as the primary outcome. Secondary outcomes were deep infection and delayed amputation. Results We identified 129 patients (mean age: 40 years, 82% male) with 159 secondary bone grafting procedures. Secondary bone grafting was performed via a remote surgical approach in 54% (n = 86) and direct flap elevation in 46% (n = 73) of cases. Wound dehiscence requiring return to the operating room occurred in one patient in the flap elevation group (1%) and none of the patients in the remote surgical approach. The odds of deep wound infection (OR, 1.77; p = 0.31) or amputation (OR, 1.43; p = 0.73) did not significantly differ between surgical approaches. No significant differences were found in complications between the reconstructive surgeon elevating and re-insetting the flap and the orthopaedic trauma surgeon performing the flap elevation and re-inset. Conclusion Direct flap elevation for secondary bone grafting after soft tissue reconstruction for open tibia fractures did not result in more complications than bone grafting via a remote surgical approach. These findings should reassure surgeons to allow other clinical factors to influence the surgical approach for bone grafting.
Published: 2023
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34. Is External Beam Radiation Therapy Really Associated With Low Rates of Heterotopic Ossification After Acetabular Surgery?

Author: Adam Boissonneault, Elizabeth Harkin, Gerard Slobogean, Jayesh Gupta, Caroline Benzel, Nathan O’Hara, and Robert V. O’Toole
Subjects: Orthopedics and Sports Medicine, Surgery, General Medicine
Published: 2023
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35. Poor Agreement Between Next-Generation DNA Sequencing and Bacterial Cultures in Orthopaedic Trauma Procedures

Author: Roman M, Natoli, Dimitrius P, Marinos, Ryan N, Montalvo, Yasmin, Degani, George, Ochenjele, Cullen, Griffith, Anthony, Ding, I Leah, Gitajn, Theodore T, Manson, Aaron J, Johnson, Birthe Veno, Kjellerup, Janette M, Harro, Manjari, Joshi, and Robert V, O'Toole
Subjects: DNA, Bacterial, Orthopedics, Bacteria, Humans, Orthopedics and Sports Medicine, Surgery, Prospective Studies, Sequence Analysis, DNA, General Medicine, Fractures, Closed
Abstract: Next-generation DNA sequencing (NGS) detects bacteria-specific DNA corresponding to the 16S ribosomal RNA gene and can identify bacterial presence with greater accuracy than traditional culture methods. The clinical relevance of these findings is unknown. The purpose of the present study was to compare the results from bacterial culture and NGS in order to characterize the potential use of NGS in orthopaedic trauma patients.A prospective cohort study was performed at a single academic, level-I trauma center. Three patient groups were enrolled: (1) patients undergoing surgical treatment of acute closed fractures (presumed to have no bacteria), (2) patients undergoing implant removal at the site of a healed fracture without infection, and (3) patients undergoing a first procedure for the treatment of a fracture nonunion who might or might not have subclinical infection. Surgical site tissue was sent for culture and NGS. The proportions of culture and NGS positivity were compared among the groups. The agreement between culture and NGS results was assessed with use of the Cohen kappa statistic.Bacterial cultures were positive in 9 of 111 surgical sites (110 patients), whereas NGS was positive in 27 of 111 surgical sites (110 patients). Significantly more cases were positive on NGS as compared with culture (24% vs. 8.1%; p = 0.001), primarily in the acute closed fracture group. No difference was found in terms of the percent positivity of NGS when comparing the acute closed fracture, implant removal, and nonunion groups. With respect to bacterial identification, culture and NGS agreed in 73% of cases (κ = 0.051; 95% confidence interval, -0.12 to 0.22) indicating only slight agreement compared with expected chance agreement of 50%.NGS identified bacterial presence more frequently than culture, but with only slight agreement between culture and NGS. It is possible that the increased frequency of bacterial detection with molecular methods is reflective of biofilm presence on metal or colonization with nonpathogenic bacteria, as culture methods have selection pressure posed by restrictive, artificial growth conditions and there are low metabolic activity and replication rates of bacteria in biofilms. Our data suggest that NGS should not currently substitute for or complement conventional culture in orthopaedic trauma cases with low suspicion of infection.Diagnostic Level II. See Instructions for Authors for a complete description of levels of evidence.
Published: 2022
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36. Open Ankle Fractures: What Predicts Infection? A Multicenter Study

Author: Timothy Costales, Stephen Kottmeier, Andrew H. Schmidt, Michael J. Bosse, David S Sanders, Saam Morshed, Douglas S. Weinberg, Reza Firoozabadi, Ifeanyi Nzegwu, Megan R Dillman, Tigist Belaye, Paul Tornetta, Heather A. Vallier, Jerald R. Westberg, Timothy B. Alton, Rashad H. Usmani, C. D. Jones, Margaret E. Cooke, Daniel Leas, Robert V O'Toole, Max Coale, Brian Mullis, Michael T. Archdeacon, Rafael Kakazu, Kenneth A. Egol, Daniel S. Horwitz, David Teague, Harish Kempegowda, and Anna N. Miller
Subjects: Adult, Male, medicine.medical_specialty, Adolescent, Nonunion, Acute infection, Ankle Fractures, Fracture Fixation, Internal, Fractures, Open, Young Adult, Diabetes mellitus, Humans, Medicine, Orthopedics and Sports Medicine, Malunion, Aged, Retrospective Studies, Aged, 80 and over, business.industry, Implant failure, General Medicine, Evidence-based medicine, Middle Aged, medicine.disease, Surgery, Tibial Fractures, Treatment Outcome, medicine.anatomical_structure, Multi center study, Female, Ankle, business
Abstract: OBJECTIVE To identify the patient, injury and treatment factors associated with an acute infection during the treatment of open ankle fractures in a large multi-center retrospective review. To evaluate the effect of infectious complications on the rates of nonunion, malunion, and loss of reduction. DESIGN Multi-center Retrospective Review. SETTING Sixteen Trauma Centers. PATIENTS One thousand and three consecutive skeletally mature patients (514 men and 489 women) with open ankle fractures. MAIN OUTCOME MEASURES Fracture-related infection (FRI) in open ankle fractures. RESULTS The charts of 1,003 consecutive patients were reviewed and 712 patients (357 women and 355 men) had at least 12 weeks of clinical follow-up. Their average age was 50 years (range 16-96), and average BMI was 31; they sustained OTA/AO types 44A (12%), 44B (58%), and 44C (30%) open ankle fractures. The rate FRI rate was 15%. A multivariable regression analysis identified male sex, diabetes, smoking, immunosuppressant use, time to wound closure, and wound location as independent risk factors for infection. There were 77 cases of malunion, nonunion, loss of reduction and/or implant failure; FRI was associated with higher rates of these complications (p=0.01). CONCLUSION Several patient, injury and surgical factors were associated with fracture-related infection in the treatment of open ankle fractures. LEVEL OF EVIDENCE Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.
Published: 2022
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37. Patient-Specific Precision Injury Signatures to Optimize Orthopaedic Interventions in Multiply Injured Patients (PRECISE STUDY)

Author: Todd O. McKinley, Greg E. Gaski, Timothy R. Billiar, Yoram Vodovotz, Krista M. Brown, Eric A. Elster, Greg M. Constantine, Seth A. Schobel, Henry T. Robertson, Ashley D. Meagher, Reza Firoozabadi, Joshua L. Gary, Robert V. O'Toole, Arun Aneja, Karen M. Trochez, Laurence B. Kempton, Scott D. Steenburg, Susan C. Collins, Katherine P. Frey, and Renan C. Castillo
Subjects: Orthopedics and Sports Medicine, Surgery, General Medicine
Published: 2022
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38. Streamlining Trauma Research Evaluation With Advanced Measurement (STREAM) Study: Implementation of the PROMIS Toolbox Within an Orthopaedic Trauma Clinical Trials Consortium

Author: Anthony R. Carlini, Susan C. Collins, Elena D. Staguhn, Katherine P. Frey, Robert V. O'Toole, Kristin R. Archer, William T. Obremskey, Julie Agel, Conor P. Kleweno, Saam Morshed, Michael J. Weaver, Thomas F. Higgins, Michael J. Bosse, Joseph F. Levy, Albert W. Wu, and Renan C. Castillo
Subjects: Orthopedics, Humans, Orthopedics and Sports Medicine, Surgery, Patient Reported Outcome Measures, General Medicine, Article
Abstract: The Patient-Reported Outcomes Measurement Information System (PROMIS) has developed item banks, short forms and computer-adaptive tests (CATs) to help standardize measurement for important patient reported outcome (PRO) domains. These tools have the potential to revolutionize outcome measurement in clinical research through greater assessment precision while reducing response burden. Perceived implementation challenges include the need for CAT software, mobile technology and internet access. Here, we present preliminary results examining the feasibility of using PROMIS tools within a large, multi-center clinical trials consortium. The assessment of 10 PROMIS domains was incorporated into the longitudinal data collection of six ongoing orthopaedic trauma clinical trials for participants being evaluated at 3, 6 and 12 months following an orthopaedic injury. Twelve-month assessments included both CAT assessments as well as completion of full item banks for a subset of domains. Data were collected for 1,000 trauma patients at 43 trauma centers using a custom-built application which included an interface with our primary data capture system. Paper short forms were available as backup instruments and used infrequently. Six and 12-month study assessments were conducted for 83% and 77% of patients, respectively. It was feasible to use PROMIS tools in a large multi-center, trauma orthopaedics research setting. The ability to efficiently assess a wide spectrum of domains is critically important to the successful completion of future large-scale trials.
Published: 2022
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39. Assessing Soft Tissue Perfusion Using Laser-Assisted Angiography in Tibial Plateau and Pilon Fractures: A Pilot Study

Author: Jared Atchison, Aaron J. Johnson, Ida Leah Gitajn, Marcus F. Sciadini, John A. Scolaro, Raymond A. Pensy, Joshua Rudnicki, Gerard P. Slobogean, Jason W. Nascone, Robert V O'Toole, Christopher T. LeBrun, Phillip McKegg, Aresh Sepehri, Jonathan T. Elliott, and Nathan N O'Hara
Subjects: medicine.medical_specialty, External Fixators, medicine.medical_treatment, Pilot Projects, Article, Pilon fracture, Fracture Fixation, Internal, Fracture fixation, medicine, Tibial plateau fracture, Humans, Internal fixation, Orthopedics and Sports Medicine, Prospective Studies, Retrospective Studies, Fixation (histology), business.industry, Lasers, Angiography, Soft tissue, General Medicine, medicine.disease, Surgery, Perfusion, Tibial Fractures, Treatment Outcome, Soft tissue injury, business
Abstract: OBJECTIVES: Laser-assisted Indocyanine Green Angiography (LA-ICGA) is a novel method for objectively quantifying soft tissue perfusion. The primary aim of this study was to determine whether skin perfusion surrounding tibial plateau and pilon fractures is associated with the Tscherne classification for severity of soft tissue injury. The secondary aim was to determine if soft tissue perfusion improves from the time of injury to the time of definitive fracture fixation in fractures treated using a staged protocol. DESIGN: Prospective cohort study SETTING: Academic trauma centre PATIENTS: Eight pilon fracture patients and 19 tibial plateau fracture patients that underwent open reduction internal fixation MAIN OUTCOME MEASUREMENTS: Skin perfusion (fluorescence units) as measured by LA-ICGA RESULTS: Six patients were classified as Tscherne grade 0, nine as grade 1, ten as grade 2, and two as grade 3. Perfusion decreased by 14 fu (95% CI: −21, −6, p
Published: 2021
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40. Single-Stage Versus 2-Stage Bilateral Intramedullary Nail Fixation in Patients With Bilateral Femur Fractures: A Multicenter Retrospective Review

Author: Natasha M Simske, Lauren M. Tatman, Mary A. Breslin, Patrick Davis, Joseph T. Labrum, Sandy Vang, Julie Titter, Cyril Mauffrey, William T. Obremskey, Jason Nadeau, Robert V O'Toole, Robert N. Matar, Reuben C. Lufrano, Jared Atchison, Ilexa R. Flagstad, Erik A. Lund, Daniel Connelly, Jesse C. Hahn, Harsh R. Parikh, Emily Wagstrom, Andrew H. Schmidt, Hassan R. Mir, Brian P. Cunningham, David J. Hak, Danielle Ries de Chaffin, Roy Sanders, Melissa Albersheim, Tegan Schmidt, Andres Rodriguez-Buitrago, Austin Heare, Paul S. Whiting, Alexander B. Siy, Nichole Shaw, Shawn Feinstein, Heather A. Vallier, and Jerald R. Westberg
Subjects: medicine.medical_specialty, law.invention, Intramedullary rod, law, Fracture fixation, medicine, Humans, Orthopedics and Sports Medicine, Femur, Prospective Studies, Prospective cohort study, Retrospective Studies, business.industry, Glasgow Coma Scale, Retrospective cohort study, General Medicine, medicine.disease, Polytrauma, Fracture Fixation, Intramedullary, Surgery, Treatment Outcome, Injury Severity Score, business, Femoral Fractures
Abstract: Objective To evaluate rates of complications in patients with bilateral femur fractures treated with intramedullary nailing (IMN) during either 1 single procedure or 2 separate procedures. Design A multicenter retrospective review of patients sustaining bilateral femur fractures, treated with IMN in single or 2-stage procedure, from 1998 to 2018 was performed at 10 Level-1 trauma centers. Setting Ten Level-1 trauma centers. Patients/participants Two hundred forty-six patients with bilateral femur fractures. Interventions Intramedullary nailing. Main outcome measures Incidence of complications. Results A total of 246 patients were included, with 188 single-stage and 58 two-stage patients. Gender, age, injury severity score, abbreviated injury score, secondary injuries, Glasgow coma scale, and proportion of open fractures were similar between both groups. Acute respiratory distress syndrome (ARDS) occurred at higher rates in the 2-stage group (13.8% vs. 5.9%; P value = 0.05). When further adjusted for age, gender, injury severity score, abbreviated injury score, Glasgow coma scale, and admission lactate, the single-stage group had a 78% reduced risk for ARDS. In-hospital mortality was higher in the single-stage cohort (2.7% compared with 0%), although this did not meet statistical significance (P = 0.22). Conclusions This is the largest multicenter study to date evaluating the outcomes between single- and 2-stage IMN fixation for bilateral femoral shaft fractures. Single-stage bilateral femur IMN may decrease rates of ARDS in polytrauma patients who are able to undergo simultaneous definitive fixation. However, a future prospective study with standardized protocols in place will be required to discern whether single- versus 2-stage fixation has an effect on mortality and to identify those individuals at risk. Level of evidence Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
Published: 2021
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41. Quantitative Evaluation of Embolic Load in Femoral and Tibial Shaft Fractures Treated With Reamed Intramedullary Fixation

Author: Mary Hyder, Nathan N O'Hara, Joshua Rudnicki, Christopher Lee, Daniel Connelly, Robert V O'Toole, Bianca Conti, Andrew N. Pollak, Aresh Sepehri, Mitchell Baker, and Zachary D. Hannan
Subjects: medicine.medical_specialty, Femoral shaft, Bone Nails, law.invention, Intramedullary rod, law, Humans, Medicine, Orthopedics and Sports Medicine, Femur, Guide-wire placement, Tibia, Fixation (histology), business.industry, Trauma center, General Medicine, Confidence interval, Fracture Fixation, Intramedullary, Surgery, Tibial Fractures, Treatment Outcome, business, Femoral Fractures
Abstract: OBJECTIVES To compare the volume of embolic load during intramedullary fixation of femoral and tibial shaft fractures. Our hypothesis was that tibial intramedullary nails (IMNs) would be associated with less volume of intravasation of marrow than IM nailing of femur fractures. DESIGN Prospective observational study. SETTING Urban Level I trauma center. PATIENTS/PARTICIPANTS Twenty-three patients consented for the study: 14 with femoral shaft fractures and 9 with tibial shaft fractures. INTERVENTION All patients underwent continuous transesophageal echocardiography, and volume of embolic load was evaluated during 5 distinct stages: postinduction, initial guide wire, reaming (REAM), nail insertion, and postoperative. MAIN OUTCOME MEASUREMENTS Volume of embolic load was measured based on previously described luminosity scores. The embolic load based on fracture location and procedure stage was evaluated using a mixed effects model. RESULTS The IMN procedure increased the embolic load by 215% (-12% to 442%, P = 0.07) in femur patients relative to tibia patients after adjusting for baseline levels. Of the 5 steps measured, REAM was associated with the greatest increase in embolic load relative to the guide wire placement and controlling for fracture location (421%, 95% confidence interval: 169%-673%, P < 0.01). CONCLUSIONS Femoral shaft IMN fixation was associated with a 215% increase in embolic load in comparison with tibial shaft IMN fixation, with the greatest quantitative load during the REAM stage; however, both procedures produce embolic load. LEVEL OF EVIDENCE Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
Published: 2021
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42. Factors influencing management of bilateral femur fractures: A multicenter retrospective cohort of early versus delayed definitive Fixation

Author: Jason Nadeau, Melissa Albersheim, Joseph T. Labrum, Reuben C. Lufrano, Robert V. O’Toole, Harsh R. Parikh, Danielle Ries de Chaffin, Patrick Davis, Ilexa R. Flagstad, Daniel Connelly, Hassan R. Mir, Barbara Steverson, Tegan Schmidt, Natasha M Simske, Shawn Feinstein, Arthur J. Only, David J. Hak, Lauren M. Tatman, Brian P. Cunningham, Paul S. Whiting, Jerald R. Westberg, Claude Sagi, Julie Titter, Andres Rodriguez-Buitrago, Jared Atchison, Erik A. Lund, Nichole Shaw, Andrew H. Schmidt, Alexander B. Siy, Heather A. Vallier, Emily Wagstrom, Austin Heare, Mary A. Breslin, Jesse C. Hahn, Cyril Mauffrey, William T. Obremskey, and Sandy Vang
Subjects: medicine.medical_specialty, Femoral shaft, 03 medical and health sciences, Injury Severity Score, 0302 clinical medicine, Trauma Centers, medicine, Humans, Femur, In patient, Statistical analysis, Retrospective Studies, General Environmental Science, Fixation (histology), 030222 orthopedics, Multiple Trauma, business.industry, 030208 emergency & critical care medicine, Retrospective cohort study, Evidence-based medicine, Surgery, General Earth and Planetary Sciences, business, Femoral Fractures
Abstract: The purpose of our study was to evaluate the factors that influence the timing of definitive fixation in the management of bilateral femoral shaft fractures and the outcomes for patients with these injuries.Patients with bilateral femur fractures treated between 1998 to 2019 at ten level-1 trauma centers were retrospectively reviewed. Patients were grouped into early or delayed fixation, which was defined as definitive fixation of both femurs within or greater than 24 hours from injury, respectively. Statistical analysis included reversed logistic odds regression to predict which variable(s) was most likely to determine timing to definitive fixation. The outcomes included age, sex, high-volume institution, ISS, GCS, admission lactate, and admission base deficit.Three hundred twenty-eight patients were included; 164 patients were included in the early fixation group and 164 patients in the delayed fixation group. Patients managed with delayed fixation had a higher Injury Severity Score (26.8 vs 22.4; p0.01), higher admission lactate (4.4 and 3.0; p0.01), and a lower Glasgow Coma Scale (10.7 vs 13; p0.01). High-volume institution was the most reliable influencer for time to definitive fixation, successfully determining 78.6% of patients, followed by admission lactate, 64.4%. When all variables were evaluated in conjunction, high-volume institution remained the strongest contributor (XIn this study, high-volume institution was the strongest predictor of timing to definitive fixation in patients with bilateral femur fractures. This study demonstrates an opportunity to create a standardized care pathway for patients with these injuries.Level III.
Published: 2021
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43. Author response for 'Effect of Vitamin <scp> D 3 </scp> Supplementation on Acute Fracture Healing: A Phase <scp>II</scp> Screening Randomized <scp>Double‐Blind</scp> Controlled Trial'

Author: null Gerard P. Slobogean, null Sofia Bzovsky, null Nathan N. O'Hara, null Lucas S. Marchand, null Zachary D. Hannan, null Haley K. Demyanovich, null Daniel W. Connelly, null Jonathan D. Adachi, null Lehana Thabane, null Sheila Sprague, null Mohit Bhandari, null Michael F. Holick, null Nicole Simunovic, null Kim Madden, null Taryn Scott, null Andrew Duong, null Diane Heels‐Ansdell, null Joshua Rudnicki, null Andrew N. Pollak, null Robert V. O'Toole, null Christopher LeBrun, null Jason W. Nascone, null Marcus F. Sciadini, null Yasmin Degani, null Raymond Pensy, null Theodore Manson, null W. Andrew Eglseder, null Christopher G. Langhammer, null Aaron J. Johnson, null Haley Demyanovich, null Andrea Howe, null Dimitrius Marinos, null Daniel Mascarenhas, null George Reahl, null Katherine Ordonio, null Marckenley Isaac, null Ugochukwu Udogwu, null Mitchell Baker, null Alexandra Mulliken, null Jared Atchison, null Michael G. Schloss, null Syed M. R. Zaidi, null Phillip C. McKegg, null Genaro A. DeLeon, null Qasim M. Ghulam, null Megan Camara, and null the Vita‐Shock Investigators
Published: 2022
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44. Do superficial infections increase the risk of deep infections in tibial plateau and plafond fractures?

Author: Joseph T, Patterson, Nathan N, O'Hara, Daniel O, Scharfstein, Renan C, Castillo, Robert V, O'Toole, Reza, Firoozabadi, and Mary, Zadnik
Abstract: Open reduction internal fixation of tibial plateau and pilon fractures may be complicated by deep surgical site infection requiring operative debridement and antibiotic therapy. The management of superficial surgical site infection is controversial. We sought to determine whether superficial infection is associated with an increased risk of deep infection requiring surgical debridement after fixation of tibial plateau and pilon fractures.This is a secondary analysis of data from the VANCO trial, which included 980 adult patients with a tibial plateau or pilon fracture at elevated risk of infection who underwent open reduction internal fixation with plates and screws with or without intrawound vancomycin powder. An association of superficial surgical site infection with deep surgical site infection requiring debridement surgery and antibiotics was explored after matching on risk factors for deep surgical site infection.Of the 980 patients, we observed 30 superficial infections (3.1%) and 76 deep infections (7.8%). Among patients who developed a superficial infection, the unadjusted incidence of developing a deep infection within 90 days was 12.8% (95% confidence interval [CI] 1.3-24.2%). However, after a 3:1 match on infection risk factors, the 90-day marginal probability of a deep surgical site infection after sustaining a superficial infection was 6.0% (95% CI - 6.5-18.5%, p = 0.35).Deep infection after superficial infection is uncommon following operative fixation of tibial plateau and pilon fractures. Increased risk of subsequent deep infection attributable to superficial infection was inconclusive in these data.Prognostic Level II.
Published: 2022

45. Smoking Cessation

Author: Paul E. Matuszewski, David Zuelzer, and Robert V. O'Toole
Published: 2021
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46. Pelvic fracture-related hypotension: A review of contemporary adjuncts for hemorrhage control

Author: Jennifer Mooney, Meghan Keville, Demetrios Demetriades, Nicole L Werner, Bellal Joseph, Melike Harfouche, Jonathan J. Morrison, Charles J. Fox, Todd W. Costantini, Joseph J. DuBose, Gerard P. Slobogean, Robert V O'Toole, Clay Cothren Burlew, Elizabeth Benjamin, and Lucas S. Marchand
Subjects: medicine.medical_specialty, business.industry, MEDLINE, Emergent care, Level iv, Evidence-based medicine, Critical Care and Intensive Care Medicine, medicine.disease, Trauma care, Pelvic fracture, Medicine, Hemorrhage control, Surgery, business, Intensive care medicine
Abstract: Major pelvic hemorrhage remains a considerable challenge of modern trauma care associated with mortality in over a third of patients. Efforts to improve outcomes demand continued research into the optimal employment of both traditional and newer hemostatic adjuncts across the full spectrum of emergent care environments. The purpose of this review is to provide a concise description of the rationale for and effective use of currently available adjuncts for the control of pelvic hemorrhage. In addition, the challenges of defining the optimal order and algorithm for employment of these adjuncts will be outlined. LEVEL OF EVIDENCE Review, level IV.
Published: 2021
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47. Prospective Randomized Trial on Smoking Cessation in Orthopaedic Trauma Patients: Results From the Let’s STOP (Smoking in Trauma Orthopaedic Patients) Now Trial

Author: K. J. Joseph, Nathan N O'Hara, Robert V O'Toole, Paul E. Matuszewski, and Carlo C. DiClemente
Subjects: Counseling, medicine.medical_specialty, Referral, medicine.medical_treatment, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, medicine, Humans, Orthopedics and Sports Medicine, Prospective Studies, 030222 orthopedics, business.industry, Smoking, Trauma center, 030208 emergency & critical care medicine, General Medicine, Evidence-based medicine, Odds ratio, Confidence interval, Orthopedics, Quitline, Physical therapy, Smoking cessation, Smoking Cessation, Surgery, business
Abstract: OBJECTIVES Determine if extended inpatient counseling increases smoking cessation. DESIGN Prospective randomized trial. SETTING Level I trauma center. PATIENTS/PARTICIPANTS Current smokers with an operative fracture. INTERVENTION Randomly assigned to control (no counseling), brief counseling (inpatient counseling), or extended counseling (brief counseling plus follow-up counseling) groups in a 1:3:3 ratio. MAIN OUTCOME MEASUREMENTS Smoking cessation confirmed by exhaled carbon monoxide at 3 and 6 months. Secondary outcomes are proportion accepting services from a nationally based quitline. RESULTS Overall, 266 patients participated, with 40, 111, and 115 patients in the control and 2 treatment groups, respectively. At 3 months, 17% of control patients versus 11% in the brief counseling and 10% in the extended counseling groups quit smoking, respectively (P = 0.45, 0.37). At 6 months, 15% of control, and 10% and 5% of the respective counseling groups quit (P = 0.45, 0.10). Extended counseling patients were 3 times more likely to accept referral to a quitline [odds ratio (OR), 3.1; 95% confidence interval (CI), 1.4-6.9], and brief counseling patients were more than 2 times as likely to accept referral (OR, 2.3; 95% CI, 1.0-5.1) than the control group. Extended counseling (OR, 8.2; 95% CI, 1.0-68.5) and brief counseling (OR, 5.3; 95% CI, 0.6-44.9) patients were more likely to use quitline services than the control group. CONCLUSION Increasing levels of inpatient counseling can improve successful referral to a smoking quitline, but it does not seem to influence quit rates among orthopaedic trauma patients. Extended counseling does not appear to provide substantial benefit over brief counseling. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Published: 2021
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48. Immediate Weight Bearing of Plated Both-Bone Forearm Fractures Using Eight Cortices Proximal and Distal to the Fracture in the Polytrauma Patient Is Safe

Author: Alexandra Mullike, W. Andrew Eglseder, Ritu Goel, Lucas S. Marchand, Nicole Krum, Raymond A. Pensy, George Ochenjele, Steven Horton, Robert V O'Toole, and Nathan N O'Hara
Subjects: Adult, Male, medicine.medical_specialty, Nonunion, medicine.disease_cause, Weight-bearing, Weight-Bearing, Fracture Fixation, Internal, 03 medical and health sciences, 0302 clinical medicine, Forearm, Fracture fixation, Bone plate, Humans, Medicine, Orthopedics and Sports Medicine, Retrospective Studies, Fracture Healing, 030222 orthopedics, Multiple Trauma, business.industry, Trauma center, 030229 sport sciences, medicine.disease, Polytrauma, Surgery, Treatment Outcome, medicine.anatomical_structure, Female, business, Complication, Bone Plates
Abstract: Introduction Rehabilitation of trauma patients is facilitated by surgical stabilization permitting weight bearing (WB) of the fractured extremity. Both-bone forearm fracture (BBFx) plate osteosynthesis is an accepted technique with high union and low complication rates; yet, postoperative WB protocols have not been adequately investigated. There exists concern for increased complications in plated BBFx fractures for patients prescribed immediate WB. We hypothesized that immediate WB of surgically treated BBFxs results in acceptable rates of complications. Methods Patients presenting to a Level-1 trauma center from 2007 to 2016 with a BBFx were identified retrospectively. Patients were skeletally mature, surgically treated with prescribed immediate WB protocol, and followed for 6 months or to fracture union. Collected data included demographics, fracture characteristics, associated injuries, and WB protocols for all extremities. Complications recorded included nonunion, hardware failure, and infection. Standard statistical comparisons were used to evaluate the risk of complication in polytrauma patients with modified lower extremity WB protocols (polytrauma group) and patients with no lower extremity WB restrictions (isolated group). Results Two hundred thirteen patients were included with 75 (35%) females and 138 (65%) males. Mean age was 40 years and mean follow-up was 46 weeks. There were 142 (67%) patients in the poly-trauma and 71 (33%) patients in the isolated groups. In the poly-trauma group 21 (10%) patients had bilateral lower extremity WB restrictions. There were 11 (6%) complications noted: 2 non-unions, 4 hardware failures, and 5 infections. Demographics did not vary between the two groups. There was no difference in complications in the isolated (5.7%) versus poly-trauma groups (5.0%) (P = 0.75). Conclusion Immediate WB rehabilitation after BBFx plate osteosynthesis seems to be safe and associated with low nonunion and complication rates. Our results demonstrate that polytrauma patients using ambulatory aids for lower extremity injuries can immediately WB without increased risk compared with isolated BBFx patients.
Published: 2021
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49. Analysis of Computed Tomography–Based Technique for Measuring Femoral Anteversion: Implications for Measuring Rotation After Femoral Intramedullary Nail Insertion

Author: Christopher Langhammer, Nathan N O'Hara, Robert V O'Toole, Lucas S. Marchand, Ian P. McAlister, Steven S. Shannon, Matthew D. Riedel, Marcus F. Sciadini, Christopher T. LeBrun, Jason W. Nascone, and Joshua K. Napora
Subjects: Rotation, Interobserver reliability, Intraclass correlation, Computed tomography, law.invention, Intramedullary rod, 03 medical and health sciences, 0302 clinical medicine, law, Humans, Medicine, Orthopedics and Sports Medicine, Femur, 030222 orthopedics, medicine.diagnostic_test, business.industry, Reproducibility of Results, 030208 emergency & critical care medicine, General Medicine, Confidence interval, Cross-Sectional Studies, Pooled variance, Surgery, Level iii, Tomography, X-Ray Computed, business, Nuclear medicine, Intraobserver reproducibility
Abstract: Objectives To assess the reliability of the current computed tomography (CT) based technique for determining femoral anteversion, and quantify the prevalence and magnitude of side-to-side differences. Design Cross-sectional cohort study. Setting Academic trauma center. Patients We reviewed CT scans from 120 patients with bilateral full-length axial cuts of both femurs. Two hundred forty femurs with no fractures or other identifying features in their femora were included. Ten unique data sets were created to measure anteversion of the left and right sides. Main outcome measurements Intraobserver and interobserver reliability were calculated using intraclass correlation coefficients (ICC) and pooled absolute differences. The mean absolute difference between the sides was determined using a fixed-effects model. Results Interobserver reliability was high (ICC: 0.85, 95% confidence interval [CI]: 0.83-0.88). The pooled mean absolute magnitude of variation between reviewers was small at 1.6 degrees (95% CI: 1.4-1.8 degrees) per scan. The intraobserver reproducibility was high (ICC: 0.91, 95% CI: 0.88-0.93) with a mean error of 2.7 degrees (95% CI: 2.2-3.1 degrees) per repeat viewing of the same scan by the same person. The magnitude of side-to-side variation was 2.0 degrees (95% CI: 1.5-2.6 degrees). Twenty-one subjects (18%, 95% CI: 12-25%) had a mean side-to-side calculated femoral anteversion difference of ≥10 degrees, while 6 (5%, 95% CI: 2-10) subjects had a calculated mean side-to-side difference ≥15 degrees. Conclusions CT based femoral anteversion measurement techniques demonstrate good precision. Only 1 in 20 patients had side-to-side differences of 15 degrees or more. Level of evidence Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
Published: 2021
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50. What Is the Long-Term Impact of an Implant Stewardship Program on Orthopaedic Trauma Implant Pricing?

Author: John Morellato, Mitchell Baker, Robert V O'Toole, Nathan N O'Hara, and Andrew N. Pollak
Subjects: medicine.medical_specialty, External Fixators, law.invention, Proximal tibia, Intramedullary rod, 03 medical and health sciences, 0302 clinical medicine, law, medicine, Humans, Orthopedics and Sports Medicine, Orthopaedic trauma, health care economics and organizations, 030222 orthopedics, business.industry, Trauma center, 030208 emergency & critical care medicine, Prostheses and Implants, General Medicine, Confidence interval, Fracture Fixation, Intramedullary, Surgery, Orthopedics, Costs and Cost Analysis, Implant, Level iii, business, Cost containment
Abstract: Objectives To analyze the effectiveness of an implant stewardship program on implant cost containment and to estimate surgeon responsiveness to implant price changes. Design Interrupted time series. Setting Level I trauma center. Patients/participants Monitored usage of 5 trauma constructs by 10 surgeons over a 5-year period. Intervention Red-Yellow-Green (RYG) implant pricing comparison chart. Main outcome measurements Primary outcomes were changes in the mean price, minimum price, and the number of price changes. The secondary outcome was surgeon responsiveness to RYG/cost changes. Results The study consisted of 2468 procedures. A mean construct price decrease of $66 per year (95% confidence interval [CI], $-170 to $-151), with distal femoral plates demonstrating the largest mean annual price decline ($486; 95% CI, $-540 to $-432). The minimum construct price decreased by $131 per year (95% CI, $-155 to $-111), with the largest reductions observed for distal femoral plates (-$436 per year; 95% CI, $-516 to $-354) and external fixators (-$122 per year; 95% CI, $-258 to $-136). The median price decrease was $407 (range: $6 to $2491), or 12.5% of the previous price. Positive changes in RYG levels increased surgeon usage of tibial nails by 115%, femoral nails by 106%, and external fixators by 104%. Surgeon implant selection was insensitive to RYG changes for distal femoral plates (RYG elasticity [ERYG]: -0.74) and proximal tibia plates (ERYG: -0.21). Conclusions The implant stewardship program was associated with substantial implant price reductions. Surgeon implant selection was especially sensitive to price changes for intramedullary nails and external fixators. Level of evidence Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
Published: 2021
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