Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis after a Fracture.

BACKGROUND: Clinical guidelines recommend low-molecular-weight heparin for thromboprophylaxis in patients with fractures, but trials of its effectiveness as compared with aspirin are lacking. METHODS: In this pragmatic, multicenter, randomized, noninferiority trial, we enrolled patients 18 years of age or older who had a fracture of an extremity (anywhere from hip to midfoot or shoulder to wrist) that had been treated operatively or who had any pelvic or acetabular fracture. Patients were randomly assigned to receive low-molecular-weight heparin (enoxaparin) at a dose of 30 mg twice daily or aspirin at a dose of 81 mg twice daily while they were in the hospital. After hospital discharge, the patients continued to receive thromboprophylaxis according to the clinical protocols of each hospital. The primary outcome was death from any cause at 90 days. Secondary outcomes were nonfatal pulmonary embolism, deep-vein thrombosis, and bleeding complications. RESULTS: A total of 12,211 patients were randomly assigned to receive aspirin (6101 patients) or low-molecular-weight heparin (6110 patients). Patients had a mean (±SD) age of 44.6±17.8 years, 0.7% had a history of venous thromboembolism, and 2.5% had a history of cancer. Patients received a mean of 8.8±10.6 in-hospital thromboprophylaxis doses and were prescribed a median 21-day supply of thromboprophylaxis at discharge. Death occurred in 47 patients (0.78%) in the aspirin group and in 45 patients (0.73%) in the low-molecular-weight-heparin group (difference, 0.05 percentage points; 96.2% confidence interval, -0.27 to 0.38; P<0.001 for a noninferiority margin of 0.75 percentage points). Deep-vein thrombosis occurred in 2.51% of patients in the aspirin group and 1.71% in the low-molecular-weight-heparin group (difference, 0.80 percentage points; 95% CI, 0.28 to 1.31). The incidence of pulmonary embolism (1.49% in each group), bleeding complications, and other serious adverse events were similar in the two groups. CONCLUSIONS: In patients with extremity fractures that had been treated operatively or with any pelvic or acetabular fracture, thromboprophylaxis with aspirin was noninferior to low-molecular-weight heparin in preventing death and was associated with low incidences of deep-vein thrombosis and pulmonary embolism and low 90-day mortality. (Funded by the Patient-Centered Outcomes Research Institute; PREVENT CLOT ClinicalTrials.gov number, NCT02984384.).

Perioperative nutritional status thought to be important, but poorly understood.

OBJECTIVES: Malnutrition has been shown to increase complications and leads to poor outcomes in surgical patients, but it has not been studied extensively in orthopedic trauma. This study's purpose is to determine the perspective and assessment of nutrition by orthopedic traumatologists. METHODS: A survey was created and distributed via REDCap to orthopedic traumatologists at 60 U.S. trauma centers. Out of 183 distributed surveys, 130 surgeons completed the survey (71%). The survey focused on the importance of nutrition and practice patterns in orthopedic trauma. RESULTS: Seventy-five percent of surgeons thought that nutritional status was "very important" to the final outcome of patients with orthopedic trauma injuries, 24% responded "somewhat important" and 1% responded "not important." Furthermore, 88% perform nutritional assessments; most surgeons (77%) utilize nutritional laboratory markers, with the most common markers being albumin, pre-albumin, transferrin and CRP. Additionally, 42% think trending the laboratory markers is important, and 50% are not sure if nutrition markers should be tested at multiple time points. Despite 75% of surgeons believing that nutrition is very important, only 8% discuss it with patients routinely. When asked what is more important for outcomes, nutrition or Vitamin D, almost three times as many surgeons thought nutrition was more important (29% vs 11%, respectively). CONCLUSIONS: While orthopedic traumatologists believe nutrition is an important determinant of patient outcomes, this study shows a clear lack of consensus and variability in practice regarding nutrition among surgeons. Orthopedic trauma surgeons need specific guidelines on how to assess and treat malnutrition in trauma patients.

Do superficial infections increase the risk of deep infections in tibial plateau and plafond fractures?

PURPOSE: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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. LEVEL OF EVIDENCE: Prognostic Level II.

Changes in Opioid Prescribing Following the Implementation of State Policies Limiting Morphine Equivalent Daily Dose in a Commercially Insured Population.

BACKGROUND: Prescription opioid mortality doubled 2002-2016 in the United States. Given the association between high-dose opioid prescribing and opioid mortality, several states have enacted morphine equivalent daily dose (MEDD) policies to limit high-dose prescribing. The study objective is to evaluate the impact of state-level MEDD policies on opioid prescribing among the privately insured. METHODS: Claims data, 2010-2015 from 9 policy states and 2 control states and a comparative interrupted time series design were utilized. Primary outcomes were any monthly opioid use and average monthly MEDD. Stratified analyses evaluated theorized weaker policies (guidelines) and theorized stronger policies (passive alert systems, legislative acts, and rules/regulations) separately. Patient groups explicitly excluded from policies (eg, individuals with cancer diagnoses or receiving hospice care) were also examined separately. Analyses adjusted for covariates, state fixed effects, and time trends. RESULTS: Both guideline and strong policy implementation were both associated with 15% lower odds of any opioid use, relative to control states. However, there was no statistically significant change in the use of high-dose opioids in policy states relative to control states. There was also no difference in direction and significance of the relationship among targeted patient groups. CONCLUSIONS: MEDD policies were associated with decreased use of any opioids relative to control states, but no change in high-dose prescribing was observed. While the overall policy environment in treatment states may have discouraged opioid prescribing, there was no evidence of MEDD policy impact, specifically. Further research is needed to understand the mechanisms through which MEDD policies may influence prescribing behavior.

The Impact of Morphine Equivalent Daily Dose Threshold Guidelines on Prescribed Dose in a Workers' Compensation Population.

BACKGROUND: Prescription opioid overdose has increased markedly and is of great concern among injured workers receiving workers' compensation insurance. Given the association between high daily dose of prescription opioids and negative health outcomes, state workers' compensation boards have disseminated Morphine Equivalent Daily Dose (MEDD) guidelines to discourage high-dose opioid prescribing. OBJECTIVE: To evaluate the impact of MEDD guidelines among workers' compensation claimants on prescribed opioid dose. METHODS: Workers' compensation claims data, 2010-2013 from 2 guideline states and 3 control states were utilized. The study design was an interrupted time series with comparison states and average monthly MEDD was the primary outcome. Policy variables were specified to allow for both instantaneous and gradual effects and additional stratified analyses examined evaluated the policies separately for individuals with and without acute pain, cancer, and high-dose baseline use to determine whether policies were being targeted as intended. RESULTS: After adjusting for covariates, state fixed-effects, and time trends, policy implementation was associated with a 9.26 mg decrease in MEDD (95% confidence interval, -13.96 to -4.56). Decreases in MEDD also became more pronounced over time and were larger in groups targeted by the policies. CONCLUSIONS: Passage of workers' compensation MEDD guidelines was associated with decreases in prescribed opioid dose among injured workers. Disseminating MEDD guidelines to doctors who treat workers' compensation cases may address an important risk factor for opioid-related mortality, while still allowing for autonomy in practice. Further research is needed to determine whether MEDD policies influence prescribing behavior and patient outcomes in other populations.

Reducing High-Dose Opioid Prescribing: State-Level Morphine Equivalent Daily Dose Policies, 2007-2017.

OBJECTIVE: To describe current state-level policies in the United States, January 1, 2007-June 1, 2017, limiting high morphine equivalent daily dose (MEDD) prescribing. METHODS: State-level MEDD threshold policies were reviewed using LexisNexis and Westlaw Next for legislative acts and using Google for nonlegislative state-level policies. The websites of each state's Medicaid agency, health department, prescription drug monitoring program, workers' compensation board, medical board, and pharmacy board were reviewed to identify additional policies. The final policy list was checked against existing policy compilations and academic literature and through contact with state health agency representatives. Policies were independently double-coded on the categories: state, agency/organization, policy type, effective date, threshold level, and policy exceptions. RESULTS: Currently, 22 states have at least one type of MEDD policy, most commonly guidelines (14 states), followed by prior authorizations (four states), rules/regulations (four states), legislative acts (three states), claim denials (two states), and alert systems/automatic patient reports (two states). Thresholds range widely (30-300 mg MEDD), with higher thresholds generally corresponding to more restrictive policies (e.g., claim denial) and lower thresholds corresponding to less restrictive policies (e.g., guidelines). The majority of policies exclude some groups of opioid users, most commonly patients with terminal illnesses or acute pain. CONCLUSIONS: MEDD policies have gained popularity in recent years, but considerable variation in threshold levels and policy structure point to a lack of consensus. This work provides a foundation for future evaluation of MEDD policies and may inform states considering adopting such policies.

Barriers and Facilitators to the Implementation of Injury Prevention Programs: A Qualitative Exploration and Model Development.

BACKGROUND: In 2006, the American College of Surgeons Committee on Trauma mandated implementation of injury prevention programs as a requirement for Level I and II trauma center designation. Little is known about the factors that facilitate or create barriers to establishing evidence-based injury prevention program implementation. The purpose of this research is to generate hypotheses regarding processes used to implement injury prevention programs at trauma centers, identify the factors that facilitate and serve as a barrier to implementation, and develop a model reflecting these factors and relationships. METHODS: This is a qualitative study of injury prevention programs at trauma centers. Study participants were chosen from 24 sites representing trauma centers of different patient volumes, geographic regions, and settings in the United States. Subjects participated in phone interviews based on guides developed from pilot interviews with prevention coordinators. Transcribed interviews from eight subjects were analyzed using a system of member checking to code; analysis informed the identification of factors that influence the establishment of evidence-based injury prevention programs. RESULTS: Five themes emerged from the data analysis: external factors, internal organizational factors, program capacity, program selection, and program success. Analysis revealed that successful program implementation was related to supportive leaders and collaborative, interdepartmental relationships. Additional themes indicated that while organizations were motivated primarily by verification requirements (external factor), strong institutional leadership (internal factor) was lacking. Employee readiness (program capacity) was hindered by limited training opportunities, and programs were often chosen (selection) based on implementation ease rather than evidence base or local data. CONCLUSIONS: Data analysis reveals five emerging themes of program implementation; using these data, we suggest an initial model of barriers and facilitators for implementing evidence-based injury prevention programs that could serve as the springboard for additional research involving a larger representative sample.

A patient-centered composite endpoint weighting technique for orthopaedic trauma research.

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.

Insurance status and health-related quality-of-life disparities after trauma: results from a nationally representative survey in the US.

PURPOSE: To determine whether insurance status modifies the association between injuries and health-related quality of life (HRQOL) in a nationally representative sample of US adults. METHODS: This is a longitudinal, observational study using the pooled 2000-2006 Medical Expenditure Panel Survey (MEPS). A total of 50,225 adults (age ≥ 18) with or without injuries were included in the study. HRQOL was evaluated using the EuroQoL Health Index (EQ-5D), visual analog scale (VAS), and the SF-12 physical component score (PCS) and mental component score (MCS). A categorical variable of injury-insurance combinations was created (not injured-privately insured, not injured-publically insured, not injured-uninsured, injured-privately insured, injured-publically insured, or injured-uninsured) and was included in the linear regression models. Adjustment covariates included age, gender, education, race, diabetes, hypertension, and baseline self-reported health. Healthcare utilization was also examined among the study population by injury status and across insurance groups. RESULTS: Seven hundred and ten individuals reported injuries. Adjusted analyses showed that injured individuals with public insurance had lower EQ-5D (-0.25), VAS (-11.4), PCS (-8.5), and MCS (-4.9) than the privately insured controls, while uninsured had EQ-5D, VAS, PCS and MCS that were, respectively, -0.12, -7.2, -2.6 and -4.1 relative to privately insured controls. With the exception of hospital discharges, healthcare utilization among uninsured individuals was lower than those with public or private insurance. CONCLUSIONS: We found injured individuals to have lower HRQOL than those without injuries, and this effect was exacerbated by insurance status. These findings call for interventions aimed to narrow the outcome disparity among injured in the US.

Early opioid prescription and risk of long-term opioid use among US workers with back and shoulder injuries: a retrospective cohort study.

The number of prescription opioid overdose deaths has increased dramatically in recent years and many prescribers are unsure how to balance treatment of pain with secondary prevention. Guidelines recommend low-severity injury patients not receive opioids early in the course of their care, but evidence supporting this guideline is limited. Data from 123 096 workers' compensation claims with back and shoulder injuries were analysed to evaluate this guideline. Back and shoulder injury claimants with early opioid use (≤1 month after injury) had 33% lower (95% CI 24% to 41% lower) odds and 29% higher (95% CI 6% to 58% higher) odds, respectively, of long-term opioid use (>3 months) than claimants with late opioid use, after adjusting for key covariates. Stratified analyses indicate that early opioid use does not appear to increase the risk of long-term use except in cases where no diagnosis or only the diagnosis of unspecified shoulder pain is given prior to prescription.

Will My Tibial Fracture Heal? Predicting Nonunion at the Time of Definitive Fixation Based on Commonly Available Variables.

BACKGROUND: Accurate prediction of tibial nonunions has eluded researchers. Reliably predicting tibial nonunions at the time of fixation could change management strategies and stimulate further research. QUESTIONS/PURPOSES: We asked (1) whether data from medical records, fracture characteristics, and radiographs obtained at the time of fixation would identify features predictive of tibial fracture nonunion; and (2) whether this information could be used to create a model to assess the chance of nonunion at the time of intramedullary (IM) nail fixation of the tibia. METHODS: We retrospectively reviewed all tibial shaft fractures treated at our center from 2007 to 2014. We conducted a literature review and collected data on 35 factors theorized to contribute to delayed bone healing. Patients were followed to fracture healing or surgery for nonunion. Patients with planned prophylactic nonunion surgery were excluded because their nonunions were anticipated and our focus was on unanticipated nonunions. Our cohort consisted of 382 patients treated with IM nails for tibial shaft fractures (nonunion, 56; healed, 326). Bivariate and multivariate regression techniques and stepwise modeling approaches examined the relationship between variables available at definitive fixation. Factors were included in our model if they were identified as having a modest to large effect size (odds ratio > 2) at the p < 0.05 level. RESULTS: A multiple variable logistic regression model was developed, including seven factors (p < 0.05; odds ratio > 2.0). With these factors, we created the Nonunion Risk Determination (NURD) score. The NURD score assigns 5 points for flaps, 4 points for compartment syndrome, 3 points for chronic condition(s), 2 points for open fractures, 1 point for male gender, and 1 point per grade of American Society of Anesthesiologists Physical Status and percent cortical contact. One point each is subtracted for spiral fractures and for low-energy injuries, which were found to be predictive of union. A NURD score of 0 to 5 had a 2% chance of nonunion; 6 to 8, 22%; 9 to 11, 42%; and > 12, 61%. CONCLUSIONS: The proposed nonunion prediction model (NURDS) seems to have potential to allow clinicians to better determine which patients have a higher risk of nonunion. Future work should be directed at prospectively validating and enhancing this model. LEVEL OF EVIDENCE: Level III, diagnostic study.

Analgesic Access for Acute Abdominal Pain in the Emergency Department Among Racial/Ethnic Minority Patients: A Nationwide Examination.

BACKGROUND: Prior studies of acute abdominal pain provide conflicting data regarding the presence of racial/ethnic disparities in the emergency department (ED). OBJECTIVE: To evaluate race/ethnicity-based differences in ED analgesic pain management among a national sample of adult patients with acute abdominal pain based on a uniform definition. RESEARCH DESIGN/SUBJECTS/MEASURES: The 2006-2010 CDC-NHAMCS data were retrospectively queried for patients 18 years and above presenting with a primary diagnosis of nontraumatic acute abdominal pain as defined by the American Association for the Surgery of Trauma. Independent predictors of analgesic/narcotic-specific analgesic receipt were determined. Risk-adjusted multivariable analyses were then performed to determine associations between race/ethnicity and analgesic receipt. Stratified analyses considered risk-adjusted differences by the level of patient-reported pain on presentation. Secondary outcomes included: prolonged ED-LOS (>6 h), ED wait time, number of diagnostic tests, and subsequent inpatient admission. RESULTS: A total of 6710 ED visits were included: 61.2% (n=4106) non-Hispanic white, 20.1% (n=1352) non-Hispanic black, 14.0% (n=939) Hispanic, and 4.7% (n=313) other racial/ethnic group patients. Relative to non-Hispanic white patients, non-Hispanic black patients and patients of other races/ethnicities had 22%-30% lower risk-adjusted odds of analgesic receipt [OR (95% CI)=0.78 (0.67-0.90); 0.70 (0.56-0.88)]. They had 17%-30% lower risk-adjusted odds of narcotic analgesic receipt (P<0.05). Associations persisted for patients with moderate-severe pain but were insignificant for mild pain presentations. When stratified by the proportion of minority patients treated and the proportion of patients reporting severe pain, discrepancies in analgesic receipt were concentrated in hospitals treating the largest percentages of both. CONCLUSIONS: Analysis of 5 years of CDC-NHAMCS data corroborates the presence of racial/ethnic disparities in ED management of pain on a national scale. On the basis of a uniform definition, the results establish the need for concerted quality-improvement efforts to ensure that all patients, regardless of race/ethnicity, receive optimal access to pain relief.

Frequency and cost of claims by injury type from a state workers' compensation fund from 1998 through 2008.

OBJECTIVE: To determine which work-related injuries are the most frequent and costly. DESIGN: Secondary analysis of workers' compensation claims data. SETTING: Data were provided by a large, Maryland workers' compensation insurer from 1998 through 2008. PARTICIPANTS: Not applicable. INTERVENTIONS: None. MAIN OUTCOMES MEASURES: For 45 injury types, the number of claims and compensation amount was calculated for total compensation and for medical and indemnity compensation separately. RESULTS: Back and knee injuries were the most frequently occurring single injury types, whereas heart attack and occupational disease were the most expensive in terms of mean compensation. When taking into account both the frequency and cost of injury (mean cost × number occurrences), back, knee, and shoulder injuries were the most expensive single injury types. CONCLUSIONS: Successful prevention and management of back, knee, and shoulder injuries could lead to a substantial reduction in the burden associated with work-related injuries.

Psychological treatments for the management of pain after musculoskeletal injury: a systematic review and meta-analysis.

ABSTRACT: Musculoskeletal injury is a leading cause of pain and disability worldwide; 35% to 75% of people experience persistent pain for months and years after injury. Psychological treatments can reduce pain, functional impairment, and psychological distress but are not widely used after injury. This systematic review and meta-analysis (PROSPERO ID: CRD42021236807) aimed to synthesize the literature testing psychological treatments for pain after musculoskeletal injury. We searched EMBASE, MEDLINE, PubMed, PsycINFO, and CENTRAL from inception to May 2022. We extracted participant, treatment, and injury characteristics and primary (eg, pain intensity, functional impairment, depression, anxiety, and PTSD symptoms) and secondary (treatment feasibility and acceptability) outcomes. Twenty-four randomized controlled trials (N = 1966) were included. Immediately posttreatment, people who received psychological treatments (versus any control) reported lower pain intensity (standardized mean differences [SMD] = -0.25, 95% confidence interval [-0.49, -0.02]), functional impairment (SMD = -0.32 [-0.55, -0.09]), and symptoms of depression (SMD = -0.46 [-0.64, -0.29]), anxiety (SMD = -0.34 [-0.65, -0.04]), and PTSD (SMD = -0.43 [-0.70, -0.15]); at 6-month follow-up, only depression symptoms were significantly lower. Included trials varied widely in treatment and injury characteristics. The certainty of evidence was low or very low for most effects and heterogeneity moderate to substantial. Most studies had risk of bias domains judged to be high or unclear. Owing to very low certainty of results, we are unsure whether psychological therapies reduce pain and functional impairment after musculoskeletal injury; they may result in improved depression immediately posttreatment and at follow-up. More research is needed to identify treatments that result in enduring effects.

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

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.

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

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.

Risk-stratified thromboprophylaxis effects of aspirin versus low-molecular-weight heparin in orthopedic trauma patients: A secondary analysis of the PREVENT CLOT trial.

BACKGROUND: The PREVENT CLOT trial concluded that thromboprophylaxis with aspirin was noninferior to low-molecular-weight heparin (LMWH) in preventing death after orthopedic trauma. However, it was unclear if these results applied to patients at highest risk of thrombosis. Therefore, we assessed if the effect of aspirin versus LMWH differed based on patients' baseline risk of venous thromboembolism (VTE). METHODS: The PREVENT CLOT trial enrolled 12,211 adult patients with fractures. This secondary analysis stratified the study population into VTE risk quartiles: low (<1%) to high (>10%) using the Caprini score. We assessed stratum-specific treatment effects using the win ratio method, in which each patient assigned to aspirin was paired with each assigned to LMWH. In each pair, we compared outcomes hierarchically, starting with death, then pulmonary embolism, deep vein thrombosis, and bleeding. The secondary outcome added patients' medication satisfaction as a fifth composite component. RESULTS: In the high-risk quartile (n = 3052), 80% had femur fracture, pelvic, or acetabular fractures. Thoracic (47%) and head (37%) injuries were also common. In the low risk quartile (n = 3053), most patients had a tibia fracture (67%), 5% had a thoracic injury, and less than 1% had head or spinal injuries. Among high risk patients, thromboembolic events did not differ statistically between aspirin and LMWH (win ratio, 0.94; 95% confidence interval [CI], 0.82-1.08, p = 0.42). This result was consistent in the low (win ratio, 1.15; 95% CI, 0.90-1.47, p = 0.27), low-medium (win ratio, 1.05; 95% CI, 0.85-1.29, p = 0.68), and medium-high risk quartiles (win ratio, 0.94; 95% CI, 0.80-1.11, p = 0.48). When medication satisfaction was considered, favorable outcomes were 68% more likely with aspirin (win ratio, 1.68; 95% CI, 1.60-1.77; p < 0.001). CONCLUSION: Thromboembolic outcomes were similar with aspirin or LMWH, even among patients at highest risk of VTE. Aspirin was favored if medication satisfaction was also considered. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level II.

Minimal Clinically Important Difference (MCID) for the Short Musculoskeletal Function Assessment (SMFA) in Severe Lower Extremity Trauma: Pooled Data from 7 Multicenter, Prospective Clinical Trials.

BACKGROUND: The Short Musculoskeletal Function Assessment (SMFA) is a well validated, widely used patient-reported outcome (PRO) measure for orthopaedic patients. Despite its widespread use and acceptance, this measure does not have an agreed upon minimal clinically important difference (MCID). The purpose of the present study was to create distributional MCIDs with use of a large cohort of research participants with severe lower extremity fractures. METHODS: Three distributional approaches were used to calculate MCIDs for the Dysfunction and Bother Indices of the SMFA as well as all its domains: (1) half of the standard deviation (one-half SD), (2) twice the standard error of measurement (2SEM), and (3) minimal detectable change (MDC). In addition to evaluating by patient characteristics and the timing of assessment, we reviewed these calculations across several injury groups likely to affect functional outcomes. RESULTS: A total of 4,298 SMFA assessments were collected from 3,185 patients who had undergone surgical treatment of traumatic injuries of the lower extremity at 60 Level-I trauma centers across 7 multicenter, prospective clinical studies. Depending on the statistical approach used, the MCID associated with the overall sample ranged from 7.7 to 10.7 for the SMFA Dysfunction Index and from 11.0 to 16.8 for the SMFA Bother Index. For the Dysfunction Index, the variability across the scores was small (<5%) within the sex and age subgroups but was modest (12% to 18%) across subgroups related to assessment timing. CONCLUSIONS: A defensible MCID can be found between 7 and 11 points for the Dysfunction Index and between 11 and 17 points for the Bother Index. The precise choice of MCID may depend on the preferred statistical approach and the population under study. While differences exist between MCID values based on the calculation method, values were consistent across the categories of the various subgroups presented. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

The VANCO Trial Findings Are Generalizable to a North American Trauma Registry.

OBJECTIVES: To estimate the generalizability of treatment effects observed in the VANCO trial to a broader population of patients with tibial plateau or pilon fractures. METHODS: Design and Setting: Clinical trial data from 36 United States trauma centers and Trauma Quality Programs registry data from more than 875 Level I-III trauma centers in the United States and Canada.Patient Selection Criteria: Patients enrolled in the VANCO trial treated with intrawound vancomycin powder from January 2015 to June 2017 and 31,924 VANCO-eligible TQP patients admitted in 2019 with tibial plateau and pilon fractures.Outcome Measure and Comparisons: Deep surgical site infection and gram-positive deep surgical site infection estimated in the TQP sample weighed by the inverse probability of trial participation. RESULTS: The 980 patients in the VANCO trial were highly representative of 31,924 TQP VANCO-eligible patients (Tipton generalizability index 0.96). It was estimated that intrawound vancomycin powder reduced the odds of deep surgical infection by odds ratio (OR) = 0.46 (95% confidence interval [CI] 0.25-0.86) and gram-positive deep surgical infection by OR = 0.39 (95% CI, 0.18-0.84) within the TQP sample of VANCO-eligible patients. For reference, the trial average treatment effects for deep surgical infection and gram-positive deep surgical infection were OR = 0.60 (95% CI, 0.37-0.98) and OR = 0.44 (95% CI, 0.23-0.80), respectively. CONCLUSIONS: This generalizability analysis found that the inferences of the VANCO trial generalize and might even underestimate the effects of intrawound vancomycin powder when observed in a wider population of patients with tibial plateau and pilon fractures. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Does Topical Vancomycin Powder Use in Fracture Surgery Change Bacteriology and Antibiotic Susceptibilities? An Analysis of the VANCO Trial.

OBJECTIVE: To determine whether intrawound vancomycin changes the bacteriology of surgical site infection pathogens and investigate the emergence of antibiotic-resistant pathogens. DESIGN: Secondary analysis of phase III, prospective, randomized clinical trial. SETTING: Thirty-six US trauma centers. PATIENT SELECTION CRITERIA: Patients who became infected after fixation of tibial plateau or pilon fracture. OUTCOME MEASURES AND COMPARISONS: Pathogen types and bacterial susceptibilities as determined from routine clinical culture in the operating room. RESULTS: Seventy-four patients were studied who were 67.5% male with a mean age of 48.6 years. A lower proportion of gram-positive cocci was observed in the vancomycin powder compared with the standard-of-care group (3.7% vs. 8.0%, P = 0.01). Methicillin-resistant Staphylococcus aureus infection incidence was comparable in both the vancomycin powder and the standard-of-care groups, but rates of methicillin-susceptible S. aureus infections were lower in the treatment group (1.4% vs. 4.8%, P = 0.01). The incidence of coagulase-negative Staphylococci and gram-negative rod infections were similar in both groups. There was no significant difference in susceptibilities between groups in rates of vancomycin-resistant enterococcus. CONCLUSIONS: Topical vancomycin powder decreases the likelihood of gram-positive infections consistent with the biologic activity of vancomycin. Fewer methicillin-susceptible S. aureus and coagulase-negative Staphylococci infections were observed in the group treated with vancomycin powder. An effect of vancomycin powder on methicillin-resistant S. aureus infection risk was not detected given the low incidence in both the intrawound vancomycin and the standard-of-care groups. There was no emergence of gram-negative rod infections or increased resistance patterns observed. Use of topical vancomycin powder does not seem to produce infections in these patients with greater antibiotic resistance than would have occurred without its use. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.