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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.

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.

Abstract. Objectives:. Patient engagement in the design and implementation of clinical trials is necessary to ensure that the research is relevant and responsive to patients. The PREP-IT trials, which include 2 pragmatic trials that evaluate different surgical preparation solutions in orthopaedic trauma patients, followed the patient-centered outcomes research (PCOR) methodology throughout the design, implementation, and conduct. We conducted a substudy within the PREP-IT trials to explore participants' experiences with trial participation. Methods:. At the final follow-up visit (12 months after their fracture), patients participating in the PREP-IT trials were invited to participate in the substudy. After providing informed consent, participants completed a questionnaire that asked about their experience and satisfaction with participating in the PREP-IT trials. Descriptive statistics are used to report the findings. Results:. Four hundred two participants participated in the substudy. Most participants (394 [98%]) reported a positive experience, and 376 (94%) participants felt their contributions were appreciated. The primary reasons for participation were helping future patients with fracture (279 [69%]) and to contribute to science (223 [56%]). Two hundred seventeen (46%) participants indicated that their decision to participate was influenced by the minimal time commitment. Conclusions:. Most participants reported a positive experience with participating in the PREP-IT trials. Altruism was the largest motivator for participating in this research. Approximately half of the participants indicated that the pragmatic, low-participant burden design of the trial influenced their decision to participate. Meaningful patient engagement, a pragmatic, and low-burden protocol led to high levels of participant satisfaction.

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.

Abstract. Bone devitalization is believed to be a critical determinant of complications such as infection or nonunion. However, intraoperative assessment of bone devitalization, particularly in open fractures and infections, remains highly subjective resulting in variation in treatment. Optical imaging tools, particularly dynamic contrast-enhanced fluorescence imaging, can provide real-time, intraoperative assessment of bone and soft tissue perfusion, which informs the tissues' ability to heal and fight infection. We describe a novel technique to apply indocyanine green–based fluorescence imaging, using a device that is frequently used in the operating room to assess skin or flap perfusion in plastic surgery, to assess bone and deep tissue perfusion in three pertinent cases: (1) a chronic infection/nonunion after a Gustilo type 3A tibia fracture (patient 1), (2) an acute Gustilo type 3C tibia open fracture with extensive degloving/soft tissue stripping (patient 2), and (3) an atrophic nonunion of the humerus (patient 3). In all three cases, fluorescence imaging (both time-specific fluorescence and maximum fluorescence) and derived kinetic maps of time-to-peak, ingress slope, and egress slope demonstrated clear spatial variation in perfusion that corresponded to the patient pathogenesis. The impact of this information on patient outcome will need to be evaluated in future clinical trials; however, these cases demonstrate in principle that optical imaging information has the potential to inform surgical practice, reduce the variation in treatment, and improve outcomes observed in these challenging patients.

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

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.

Abstract. Introduction:. Prescription opioid use and misuse has accelerated rapidly in the United States over the past 2 decades. Orthopaedic surgeons are the third highest prescribers of opioids, and thus are contributing to this problem at a significant rate. Despite a surge in the number of publications on this issue, there has been little emphasis in the literature on disentangling the various factors contributing to opioid use and misuse among fracture patients. The goal of this study was to describe areas of focus and identify knowledge gaps present in the current literature on this important issue. Methods:. We employed a scoping review technique due to its ability to successfully address a broad research question. In order to better understand the type of information deemed relevant by opioid researchers, we further analyzed our search results by sorting the publications into the following categories: consumer-focused, provider-focused, focus on substitutes, industry-focused, and focus on regulations (at the institution, profession, and government level). Results:. The search strategies generated 8760 citations; of these, 1166 publications satisfied our inclusion criteria. Around 607 of these final abstracts were marked as “extremely relevant” (52%) and the other 559 (48%) were marked “relevant.” About 36.4% of the total included articles applied to the providers and 19.6% provided information on the consumer. A total of 25.2% of the included papers concerned substitutes for opioids, 15.7% focused on regulatory power in the opioid industry, and 14% considered opioids as an industry, including power of both current stakeholders and potential new entrants. Discussion:. The present study provides a thorough summary of existing literature on opioid use and misuse relevant to musculoskeletal trauma patients. Furthermore, the categorical division of the literature provides a unique perspective into the drivers contributing to the opioid epidemic, and may assist in development of effective interventions to reduce excessive opioid use following traumatic injuries. Our review allowed us to identify important aspects of the opioid industry and various drivers of abuse that were absent from the literature including involvement of the pharmaceutical industry on the opioid epidemic, the involvement of insurance companies in opioid distribution, and the use of nonopioid alternative medications such as nonsteroidal anti-inflammatory drugs (NSAIDs).