How Many Patients Do We Need? Predictors of Consent to Participate in Clinical Research Studies in Orthopaedic Trauma.

OBJECTIVES: To characterize the recruitment rates at a Level I trauma center enroling for multiple prospective orthopaedic trauma research studies and identify patient-related and study-related predictors of consent. DESIGN: We conducted a case-control study to identify predictors of study consent. The authors categorized studies based on intensity of the study intervention (low, intermediate, or high). A 2-level generalized linear model with random intercept for study was used to predict study consent. SETTING: This analysis includes data from 10 federally funded studies conducted as part of a large, national consortium that were enroling patients in 2013-2014. PATIENTS/PARTICIPANTS: Three hundred thirty-four patients were approached for at least 1 study and included in the analysis. INTERVENTION: N/A. MAIN OUTCOME MEASURES: Consent to participate in the research study. RESULTS: A total of 315 patients consented to be in a study (71% of approached patients). Consent rate varied by study (45%-95%). No patient characteristics (race, age, or sex) were associated with consent. Patients approached for studies of intermediate intensity were 83% less likely to consent (odds ratio = 0.17; 95% confidence interval: 0.04-0.67), and those approached for studies of high intensity were 91% less likely to consent (odds ratio = 0.09; 95% confidence interval: 0.03-0.32). CONCLUSION: Patient factors were not associated with consent. Study intensity is a major driver of consent rates. Studies of higher intensity will require the study team to approach up to twice as many patients as the target enrolment. This study provides a framework that can be used in study planning and determination of feasibility.

Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial.

Importance: Despite the widespread use of systemic antibiotics to prevent infections in surgically treated patients with fracture, high rates of surgical site infection persist. Objective: To examine the effect of intrawound vancomycin powder in reducing deep surgical site infections. Design, Setting, and Participants: This open-label randomized clinical trial enrolled adult patients with an operatively treated tibial plateau or pilon fracture who met the criteria for a high risk of infection from January 1, 2015, through June 30, 2017, with 12 months of follow-up (final follow-up assessments completed in April 2018) at 36 US trauma centers. Interventions: A standard infection prevention protocol with (n = 481) or without (n = 499) 1000 mg of intrawound vancomycin powder. Main Outcomes and Measures: The primary outcome was a deep surgical site infection within 182 days of definitive fracture fixation. A post hoc comparison assessed the treatment effect on gram-positive and gram-negative-only infections. Other secondary outcomes included superficial surgical site infection, nonunion, and wound dehiscence. Results: The analysis included 980 patients (mean [SD] age, 45.7 [13.7] years; 617 [63.0%] male) with 91% of the expected person-time of follow-up for the primary outcome. Within 182 days, deep surgical site infection was observed in 29 of 481 patients in the treatment group and 46 of 499 patients in the control group. The time-to-event estimated probability of deep infection by 182 days was 6.4% in the treatment group and 9.8% in the control group (risk difference, -3.4%; 95% CI, -6.9% to 0.1%; P = .06). A post hoc analysis of the effect of treatment on gram-positive (risk difference, -3.7%; 95% CI, -6.7% to -0.8%; P = .02) and gram-negative-only (risk difference, 0.3%; 95% CI, -1.6% to 2.1%; P = .78) infections found that the effect of vancomycin powder was a result of its reduction in gram-positive infections. Conclusions and Relevance: Among patients with operatively treated tibial articular fractures at a high risk of infection, intrawound vancomycin powder at the time of definitive fracture fixation reduced the risk of a gram-positive deep surgical site infection, consistent with the activity of vancomycin. Trial Registration: ClinicalTrials.gov Identifier: NCT02227446.

Association of COVID-19 With Achieving Time-to-Surgery Benchmarks in Patients With Musculoskeletal Trauma.

Importance: In response to the COVID-19 pandemic, many hospital systems were forced to reduce operating room capacity and reallocate resources. The outcomes of these policies on the care of injured patients and the maintenance of emergency services have not been adequately reported. Objective: To evaluate whether the COVID-19 pandemic was associated with delays in urgent fracture surgery beyond national time-to-surgery benchmarks. Design Setting and Participants: This retrospective cohort study used data collected in the Program of Randomized Trials to Evaluate Preoperative Antiseptic Skin Solutions in Orthopaedic Trauma among at 20 sites throughout the US and Canada and included patients who sustained open fractures or closed femur or hip fractures. Exposure: COVID-19-era operating room restrictions were compared with pre-COVID-19 data. Main Outcomes and Measures: Surgery within 24 hours after injury. Results: A total of 3589 patients (mean [SD] age, 55 [25.4] years; 1913 [53.3%] male) were included in this study, 2175 pre-COVID-19 and 1414 during COVID-19. A total of 54 patients (3.1%) in the open fracture cohort and 407 patients (21.8%) in the closed hip/femur fracture cohort did not meet 24-hour time-to-surgery benchmarks. We were unable to detect any association between time to operating room and COVID-19 era in either open fracture (odds ratio [OR], 1.40; 95% CI, 0.77-2.55; P = .28) or closed femur/hip fracture (OR, 1.01; 95% CI, 0.74-1.37; P = .97) cohorts. In the closed femur/hip fracture cohort, there was no association between time to operating room and regional COVID-19 prevalence (OR, 1.07; 95% CI, 0.70-1.64; P = .76). Conclusions and Relevance: In this cohort study, there was no association between meeting time-to-surgery benchmarks in either open fracture or closed femur/hip fracture during the COVID-19 pandemic compared with before the pandemic. This is counter to concerns that the unprecedented challenges associated with managing the COVID-19 pandemic would be associated with clinically significant delays in acute management of urgent surgical cases and suggests that many hospital systems within the US were able to effectively implement policies consistent with time-to-surgery standards for orthopedic trauma in the context of COVID-19-related resource constraints.

Defining the volume of consultations for musculoskeletal infection encountered by pediatric orthopaedic services in the United States.

OBJECTIVE: Adequate resources are required to rapidly diagnose and treat pediatric musculoskeletal infection (MSKI). The workload MSKI consults contribute to pediatric orthopaedic services is unknown as prior epidemiologic studies are variable and negative work-ups are not included in national discharge databases. The hypothesis was tested that MSKI consults constitute a substantial volume of total consultations for pediatric orthopaedic services across the United States. STUDY DESIGN: Eighteen institutions from the Children's ORthopaedic Trauma and Infection Consortium for Evidence-based Study (CORTICES) group retrospectively reviewed a minimum of 1 year of hospital data, reporting the total number of surgeons, total consultations, and MSKI-related consultations. Consultations were classified by the location of consultation (emergency department or inpatient). Culture positivity rate and pathogens were also reported. RESULTS: 87,449 total orthopaedic consultations and 7,814 MSKI-related consultations performed by 229 pediatric orthopaedic surgeons were reviewed. There was an average of 13 orthopaedic surgeons per site each performing an average of 154 consultations per year. On average, 9% of consultations were MSKI related and 37% of these consults yielded positive cultures. Finally, a weak inverse monotonic relationship was noted between percent culture positivity and percent of total orthopedic consults for MSKI. CONCLUSION: At large, academic pediatric tertiary care centers, pediatric orthopaedic services consult on an average of ~3,000 'rule-out' MSKI cases annually. These patients account for nearly 1 in 10 orthopaedic consultations, of which 1 in 3 are culture positive. Considering that 2 in 3 consultations were culture negative, estimating resources required for pediatric orthopaedic consult services to work up and treat children based on culture positive administrative discharge data underestimates clinical need. Finally, ascertainment bias must be considered when comparing differences in culture rates from different institution's pediatric orthopaedics services, given the variability in when orthopaedic physicians become involved in a MSKI workup.

Pre-Hip Fracture Falls: A Missed Opportunity for Intervention.

INTRODUCTION: The purpose of this study is to examine utilization of acute care services in the year prior to hip fracture to inform development and implementation of an intervention to prevent subsequent falls and hip fracture that targets high-risk patients. METHODS: Elderly patients (age >55) with hip fractures managed at a level one trauma center during 1 year (n = 134) were included. All "preadmissions," defined as an emergency department (ED) visit or inpatient admission within our hospital system in the year before fall with fracture, were documented. Proportion of patients with a "preadmission," reason for "preadmission," demographic characteristics, medical comorbidities, history of falls with fracture, cause of fracture, and time between preadmission and fracture were documented and described. RESULTS: Of all, 45.5% of patients (n = 61) had a preadmission. Falls was the reason for presentation in 27.5% of the preadmission encounters, and the median interval between preadmission and fracture was 217 days. Only 8% of the patients presenting for falls in the ED received falls counseling. Patients who experienced preadmission were younger, had a higher Charlson Comorbidity Index, and were more likely to be male. Seventy-nine percent were community dwelling at the time of preadmission, and 68% were discharged home. DISCUSSION: Nearly half of hip fracture patients were seen in a high acuity care environment in the year prior to fracture. A quarter presented for falls, supporting previous findings that history of falls is an important risk factor for future falls and injury. However, very few received falls counseling, documenting a major missed opportunity to address falls prevention in the acute care setting. CONCLUSIONS: Preventing subsequent falls and hip fractures in a targeted, high-risk population in the year prior to potential hip fracture has important implications for improving individual morbidity and mortality and population health. Community-based falls prevention programs are a viable option for this high-risk, community-dwelling population. Collaborative interventions are needed to actively link patients to evidence-based community resources.

Does formal vs home-based physical therapy predict outcomes after ankle fracture or ankle fracture-dislocation?

Background: Ankle fractures are among the most common injuries treated by orthopaedic surgeons. Various postoperative rehabilitation strategies have been promoted, but the ability to improve patient-reported functional outcome has not been clearly demonstrated. We aim to evaluate outcomes associated with clinic-based, physical therapist-supervised rehabilitation (Formal-PT) compared to surgeon-directed rehabilitation (Home-PT). Methods: This prospective observational study included patients with operative bimalleolar or trimalleolar ankle fractures with or without dislocation (n = 80) at a Level I trauma center. Patients were prescribed PT per the surgeon's practice pattern. Patient-reported functional outcomes at 6 months and complication rates were compared between groups. Results: Of the 80 patients, 38 (47.5%) patients received Formal-PT; the remaining received Home-PT. Thirty-four patients (89.5%) attended ≥1 PT session. Number of sessions attended ranged from 1 to 36 (mean = 16). Receipt of Formal-PT did not differ by injury characteristics or demographics. Of patients with private insurance, 57% were prescribed Formal-PT vs 7% of uninsured patients (P = .033). FAAM and Combination SMFA scores at 6 months were similar between groups (Formal-PT: 69.7, 20.1; Home-PT: 70.9, 24.4; P = .868, .454, respectively). Postoperative complications were rare and equivalent between groups. Conclusions: Comparison of outcomes between patients with operatively treated displaced ankle fractures/dislocations with Formal-PT vs Home-PT showed no difference in SMFA and FAAM scores. These findings suggest patients receiving supervised PT produced a similar outcome to those under routine physician-directed rehabilitation at 6 months. The cost for therapy averaged $2012.96 per patient receiving Formal-PT.

Electronically augmented gait abnormality assessment following lower extremity trauma.

BACKGROUND: Objective evaluation of patient outcomes has become an essential component of patient management. Along with patient-reported outcomes, performance-based measures (PBMs) such as gait analysis are an important part of this evaluation. The purpose of this study was to evaluate the validity of utilizing a wearable inertial measurement unit (IMU) in an outpatient clinic setting to assess its ability to provide clinically relevant data in patients with altered gait resulting from lower extremity trauma. METHODS: Five orthopaedic trauma patients with varying degrees of gait pathologies were compared to 5 healthy control subjects. Kinematic data were simultaneously recorded by the IMU and a gold standard Vicon video motion analysis system (Vicon Motion Systems Ltd, Oxford, UK) during a modified 10-m walk test. Raw data captured by the IMU were directly compared to Vicon data. Additionally, 5 objective gait parameters were compared for controls and the 5 trauma patients. RESULTS: The IMU data streams strongly correlated with Vicon data for measured variables used in the subsequent gait analysis: vertical acceleration, vertical displacement, pitch angular velocity, and roll angular velocity (Pearson r-value > 0.9 for all correlations). Quantitative kinematic data in post-trauma patients significantly differed from control data and correlated with observed gait pathology. CONCLUSIONS: When compared to the gold standard motion capture reference system (Vicon), an IMU can reliably and accurately measure clinically relevant gait parameters and differentiate between normal and pathologic gait patterns. This technology is easily integrated into clinical settings, requires minimal time, and represents a performance-based method for quantifiably assessing gait outcomes. LEVEL OF EVIDENCE: Diagnostic Level 1.

Association Between 6-Week Postdischarge Risk Classification and 12-Month Outcomes After Orthopedic Trauma.

Importance: Numerous studies have demonstrated that long-term outcomes after orthopedic trauma are associated with psychosocial and behavioral health factors evident early in the patient's recovery. Little is known about how to identify clinically actionable subgroups within this population. Objectives: To examine whether risk and protective factors measured at 6 weeks after injury could classify individuals into risk clusters and evaluate whether these clusters explain variations in 12-month outcomes. Design, Setting, and Participants: A prospective observational study was conducted between July 16, 2013, and January 15, 2016, among 352 patients with severe orthopedic injuries at 6 US level I trauma centers. Statistical analysis was conducted from October 9, 2017, to July 13, 2018. Main Outcomes and Measures: At 6 weeks after discharge, patients completed standardized measures for 5 risk factors (pain intensity, depression, posttraumatic stress disorder, alcohol abuse, and tobacco use) and 4 protective factors (resilience, social support, self-efficacy for return to usual activity, and self-efficacy for managing the financial demands of recovery). Latent class analysis was used to classify participants into clusters, which were evaluated against measures of function, depression, posttraumatic stress disorder, and self-rated health collected at 12 months. Results: Among the 352 patients (121 women and 231 men; mean [SD] age, 37.6 [12.5] years), latent class analysis identified 6 distinct patient clusters as the optimal solution. For clinical use, these clusters can be collapsed into 4 groups, sorted from low risk and high protection (best) to high risk and low protection (worst). All outcomes worsened across the 4 clinical groupings. Bayesian analysis shows that the mean Short Musculoskeletal Function Assessment dysfunction scores at 12 months differed by 7.8 points (95% CI, 3.0-12.6) between the best and second groups, by 10.3 points (95% CI, 1.6-20.2) between the second and third groups, and by 18.4 points (95% CI, 7.7-28.0) between the third and worst groups. Conclusions and Relevance: This study demonstrates that during early recovery, patients with orthopedic trauma can be classified into risk and protective clusters that account for a substantial amount of the variance in 12-month functional and health outcomes. Early screening and classification may allow a personalized approach to postsurgical care that conserves resources and targets appropriate levels of care to more patients.