Skin Antisepsis before Surgical Fixation of Extremity Fractures.

BACKGROUND: Studies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture). METHODS: In a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications. RESULTS: A total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P = 0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P = 0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups. CONCLUSIONS: Among patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.).

Early Treatment with Pegylated Interferon Lambda for Covid-19.

BACKGROUND: The efficacy of a single dose of pegylated interferon lambda in preventing clinical events among outpatients with acute symptomatic coronavirus disease 2019 (Covid-19) is unclear. METHODS: We conducted a randomized, controlled, adaptive platform trial involving predominantly vaccinated adults with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in Brazil and Canada. Outpatients who presented with an acute clinical condition consistent with Covid-19 within 7 days after the onset of symptoms received either pegylated interferon lambda (single subcutaneous injection, 180 µg) or placebo (single injection or oral). The primary composite outcome was hospitalization (or transfer to a tertiary hospital) or an emergency department visit (observation for >6 hours) due to Covid-19 within 28 days after randomization. RESULTS: A total of 933 patients were assigned to receive pegylated interferon lambda (2 were subsequently excluded owing to protocol deviations) and 1018 were assigned to receive placebo. Overall, 83% of the patients had been vaccinated, and during the trial, multiple SARS-CoV-2 variants had emerged. A total of 25 of 931 patients (2.7%) in the interferon group had a primary-outcome event, as compared with 57 of 1018 (5.6%) in the placebo group, a difference of 51% (relative risk, 0.49; 95% Bayesian credible interval, 0.30 to 0.76; posterior probability of superiority to placebo, >99.9%). Results were generally consistent in analyses of secondary outcomes, including time to hospitalization for Covid-19 (hazard ratio, 0.57; 95% Bayesian credible interval, 0.33 to 0.95) and Covid-19-related hospitalization or death (hazard ratio, 0.59; 95% Bayesian credible interval, 0.35 to 0.97). The effects were consistent across dominant variants and independent of vaccination status. Among patients with a high viral load at baseline, those who received pegylated interferon lambda had lower viral loads by day 7 than those who received placebo. The incidence of adverse events was similar in the two groups. CONCLUSIONS: Among predominantly vaccinated outpatients with Covid-19, the incidence of hospitalization or an emergency department visit (observation for >6 hours) was significantly lower among those who received a single dose of pegylated interferon lambda than among those who received placebo. (Funded by FastGrants and others; TOGETHER ClinicalTrials.gov number, NCT04727424.).

Effect of Early Treatment with Ivermectin among Patients with Covid-19.

BACKGROUND: The efficacy of ivermectin in preventing hospitalization or extended observation in an emergency setting among outpatients with acutely symptomatic coronavirus disease 2019 (Covid-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is unclear. METHODS: We conducted a double-blind, randomized, placebo-controlled, adaptive platform trial involving symptomatic SARS-CoV-2-positive adults recruited from 12 public health clinics in Brazil. Patients who had had symptoms of Covid-19 for up to 7 days and had at least one risk factor for disease progression were randomly assigned to receive ivermectin (400 µg per kilogram of body weight) once daily for 3 days or placebo. (The trial also involved other interventions that are not reported here.) The primary composite outcome was hospitalization due to Covid-19 within 28 days after randomization or an emergency department visit due to clinical worsening of Covid-19 (defined as the participant remaining under observation for >6 hours) within 28 days after randomization. RESULTS: A total of 3515 patients were randomly assigned to receive ivermectin (679 patients), placebo (679), or another intervention (2157). Overall, 100 patients (14.7%) in the ivermectin group had a primary-outcome event, as compared with 111 (16.3%) in the placebo group (relative risk, 0.90; 95% Bayesian credible interval, 0.70 to 1.16). Of the 211 primary-outcome events, 171 (81.0%) were hospital admissions. Findings were similar to the primary analysis in a modified intention-to-treat analysis that included only patients who received at least one dose of ivermectin or placebo (relative risk, 0.89; 95% Bayesian credible interval, 0.69 to 1.15) and in a per-protocol analysis that included only patients who reported 100% adherence to the assigned regimen (relative risk, 0.94; 95% Bayesian credible interval, 0.67 to 1.35). There were no significant effects of ivermectin use on secondary outcomes or adverse events. CONCLUSIONS: Treatment with ivermectin did not result in a lower incidence of medical admission to a hospital due to progression of Covid-19 or of prolonged emergency department observation among outpatients with an early diagnosis of Covid-19. (Funded by FastGrants and the Rainwater Charitable Foundation; TOGETHER ClinicalTrials.gov number, NCT04727424.).

Intravenous Vitamin C in Adults with Sepsis in the Intensive Care Unit.

BACKGROUND: Studies that have evaluated the use of intravenous vitamin C in adults with sepsis who were receiving vasopressor therapy in the intensive care unit (ICU) have shown mixed results with respect to the risk of death and organ dysfunction. METHODS: In this randomized, placebo-controlled trial, we assigned adults who had been in the ICU for no longer than 24 hours, who had proven or suspected infection as the main diagnosis, and who were receiving a vasopressor to receive an infusion of either vitamin C (at a dose of 50 mg per kilogram of body weight) or matched placebo administered every 6 hours for up to 96 hours. The primary outcome was a composite of death or persistent organ dysfunction (defined by the use of vasopressors, invasive mechanical ventilation, or new renal-replacement therapy) on day 28. RESULTS: A total of 872 patients underwent randomization (435 to the vitamin C group and 437 to the control group). The primary outcome occurred in 191 of 429 patients (44.5%) in the vitamin C group and in 167 of 434 patients (38.5%) in the control group (risk ratio, 1.21; 95% confidence interval [CI], 1.04 to 1.40; P = 0.01). At 28 days, death had occurred in 152 of 429 patients (35.4%) in the vitamin C group and in 137 of 434 patients (31.6%) in the placebo group (risk ratio, 1.17; 95% CI, 0.98 to 1.40) and persistent organ dysfunction in 39 of 429 patients (9.1%) and 30 of 434 patients (6.9%), respectively (risk ratio, 1.30; 95% CI, 0.83 to 2.05). Findings were similar in the two groups regarding organ-dysfunction scores, biomarkers, 6-month survival, health-related quality of life, stage 3 acute kidney injury, and hypoglycemic episodes. In the vitamin C group, one patient had a severe hypoglycemic episode and another had a serious anaphylaxis event. CONCLUSIONS: In adults with sepsis receiving vasopressor therapy in the ICU, those who received intravenous vitamin C had a higher risk of death or persistent organ dysfunction at 28 days than those who received placebo. (Funded by the Lotte and John Hecht Memorial Foundation; LOVIT ClinicalTrials.gov number, NCT03680274.).

The response of Canada's clinical health research ecosystem to the COVID-19 pandemic.

BACKGROUND: The response of Canada's research community to the COVID-19 pandemic provides a unique opportunity to examine the country's clinical health research ecosystem. We sought to describe patterns of enrolment across Canadian Institutes of Health Research (CIHR)-funded studies on COVID-19. METHODS: We identified COVID-19 studies funded by the CIHR and that enrolled participants from Canadian acute care hospitals between January 2020 and April 2023. We collected information on study-and site-level variables from study leads, site investigators, and public domain sources. We described and evaluated factors associated with cumulative enrolment. RESULTS: We obtained information for 23 out of 26 (88%) eligible CIHR-funded studies (16 randomized controlled trials [RCTs] and 7 cohort studies). The 23 studies were managed by 12 Canadian and 3 international coordinating centres. Of 419 Canadian hospitals, 97 (23%) enrolled a total of 28 973 participants - 3876 in RCTs across 78 hospitals (median cumulative enrolment per hospital 30, interquartile range [IQR] 10-61), and 25 097 in cohort studies across 62 hospitals (median cumulative enrolment per hospital 158, IQR 6-348). Of 78 hospitals recruiting participants in RCTs, 13 (17%) enrolled 50% of all RCT participants, whereas 6 of 62 hospitals (9.7%) recruited 54% of participants in cohort studies. INTERPRETATION: A minority of Canadian hospitals enrolled the majority of participants in CIHR-funded studies on COVID-19. This analysis sheds light on the Canadian health research ecosystem and provides information for multiple key partners to consider ways to realize the full research potential of Canada's health systems.

Oral Fluvoxamine With Inhaled Budesonide for Treatment of Early-Onset COVID-19 : A Randomized Platform Trial.

BACKGROUND: Previous trials have demonstrated the effects of fluvoxamine alone and inhaled budesonide alone for prevention of disease progression among outpatients with COVID-19. OBJECTIVE: To determine whether the combination of fluvoxamine and inhaled budesonide would increase treatment effects in a highly vaccinated population. DESIGN: Randomized, placebo-controlled, adaptive platform trial. (ClinicalTrials.gov: NCT04727424). SETTING: 12 clinical sites in Brazil. PARTICIPANTS: Symptomatic adults with confirmed SARS-CoV-2 infection and a known risk factor for progression to severe disease. INTERVENTION: Patients were randomly assigned to either fluvoxamine (100 mg twice daily for 10 days) plus inhaled budesonide (800 mcg twice daily for 10 days) or matching placebos. MEASUREMENTS: The primary outcome was a composite of emergency setting retention for COVID-19 for more than 6 hours, hospitalization, and/or suspected complications due to clinical progression of COVID-19 within 28 days of randomization. Secondary outcomes included health care attendance (defined as hospitalization for any cause or emergency department visit lasting >6 hours), time to hospitalization, mortality, patient-reported outcomes, and adverse drug reactions. RESULTS: Randomization occurred from 15 January to 6 July 2022. A total of 738 participants were allocated to oral fluvoxamine plus inhaled budesonide, and 738 received placebo. The proportion of patients observed in an emergency setting for COVID-19 for more than 6 hours or hospitalized due to COVID-19 was lower in the treatment group than the placebo group (1.8% [95% credible interval {CrI}, 1.1% to 3.0%] vs. 3.7% [95% CrI, 2.5% to 5.3%]; relative risk, 0.50 [95% CrI, 0.25 to 0.92]), with a probability of superiority of 98.7%. No relative effects were found between groups for any of the secondary outcomes. More adverse events occurred in the intervention group than the placebo group, but no important differences between the groups were detected. LIMITATION: Low event rate overall, consistent with contemporary trials in vaccinated populations. CONCLUSION: Treatment with oral fluvoxamine plus inhaled budesonide among high-risk outpatients with early COVID-19 reduced the incidence of severe disease requiring advanced care. PRIMARY FUNDING SOURCE: Latona Foundation, FastGrants, and Rainwater Charitable Foundation.

What Is the Prevalence of Intimate Partner Violence and Traumatic Brain Injury in Fracture Clinic Patients?

BACKGROUND: Individuals in violent intimate relationships are at a high risk of sustaining both orthopaedic fractures and traumatic brain injury (TBI), and the fracture clinic may be the first place that concurrent intimate partner violence (IPV) and TBI are recognized. Both IPV and TBI can affect all aspects of fracture management, but prevalence of TBI and comorbid TBI and IPV is unknown. QUESTIONS/PURPOSES: (1) What are the previous-year and lifetime prevalence of IPV and TBI in women presenting to an outpatient orthopaedic fracture clinic? (2) What are the conditional probabilities of TBI in the presence of IPV and the reverse, to explore whether screening for one condition could effectively identify patients with the other? (3) Do patients with TBI, IPV, or both have worse neurobehavioral symptoms than patients without TBI and IPV? METHODS: The study was completed in the fracture clinic at a community Level 1 trauma center in Southern Ontario from July 2018 to March 2019 and included patients seen by three orthopaedic surgeons. Inclusion criteria were self-identification as a woman, age 18 years or older, and the ability to complete forms in English without assistance from the person who brought them to the clinic (for participant safety and privacy). We invited 263 women to participate: 22 were ineligible (for example, they were patients of a surgeon who was not on the study protocol), 87 declined before hearing the topic of the study, and data from eight were excluded because the data were incomplete or lost. Complete data were obtained from 146 participants. Participants' mean age was 52 ± 16 years, and the most common diagnosis was upper or lower limb fracture. Prevalence of IPV was calculated as the number of women who answered "sometimes" or "often" to direct questions from the Woman Abuse Screening Tool, which asks about physical, emotional, and sexual abuse in the past year or person's lifetime. The prevalence of TBI was calculated as the number of women who reported at least one head or neck injury that resulted in feeling dazed or confused or in loss of consciousness lasting 30 minutes or less on the Ohio State University Traumatic Brain Injury Identification Method, a standardized procedure for eliciting lifetime history of TBI through a 3- to 5-minute structured interview. Conditional probabilities were calculated using a Bayesian analysis. Neurobehavioral symptoms were characterized using the Neurobehavioral Symptom Inventory, a standard self-report measure of everyday emotional, somatic, and cognitive complaints after TBI, with total scores compared across groups using a one-way ANOVA. RESULTS: Previous-year prevalence of physical IPV was 7% (10 of 146), and lifetime prevalence was 28% (41 of 146). Previous-year prevalence of TBI was 8% (12 of 146), and lifetime prevalence was 49% (72 of 146). The probability of TBI in the presence of IPV was 0.77, and probability of IPV in the presence of TBI was 0.36. Thus, screening for IPV identified proportionately more patients with TBI than screening for TBI, but the reverse was not true. Neurobehavioral Symptom Inventory scores were higher (more symptoms) in patients with TBI only (23 ± 16) than those with fractures only (12 ± 11, mean difference 11 [95% CI 8 to 18]; p < 0.001), in those with IPV only (17 ± 11) versus fractures only (mean difference 5 [95% CI -1 to -11]; p < 0.05), and in those with both TBI and IPV (25 ± 14) than with fractures only (mean difference 13 [95% CI 8 to 18]; p < 0.001) or those with IPV alone (17 ± 11, mean difference 8 [95% CI -1 to 16]; p < 0.05). CONCLUSION: Using a brief screening interview, we identified a high self-reported prevalence of TBI and IPV alone, consistent with previous studies, and a novel finding of high comorbidity of IPV and TBI. Given that the fracture clinic may be the first healthcare contact for women with IPV and TBI, especially mild TBI associated with IPV, we recommend educating frontline staff on how to identify IPV and TBI as well as implementing brief screening and referral and universal design modifications that support effective, efficient, and accurate communication patients with TBI-related cognitive and communication challenges. LEVEL OF EVIDENCE: Level II, prognostic study.

Intravenous Vitamin C for Patients Hospitalized With COVID-19: Two Harmonized Randomized Clinical Trials.

Importance: The efficacy of vitamin C for hospitalized patients with COVID-19 is uncertain. Objective: To determine whether vitamin C improves outcomes for patients with COVID-19. Design, Setting, and Participants: Two prospectively harmonized randomized clinical trials enrolled critically ill patients receiving organ support in intensive care units (90 sites) and patients who were not critically ill (40 sites) between July 23, 2020, and July 15, 2022, on 4 continents. Interventions: Patients were randomized to receive vitamin C administered intravenously or control (placebo or no vitamin C) every 6 hours for 96 hours (maximum of 16 doses). Main Outcomes and Measures: The primary outcome was a composite of organ support-free days defined as days alive and free of respiratory and cardiovascular organ support in the intensive care unit up to day 21 and survival to hospital discharge. Values ranged from -1 organ support-free days for patients experiencing in-hospital death to 22 organ support-free days for those who survived without needing organ support. The primary analysis used a bayesian cumulative logistic model. An odds ratio (OR) greater than 1 represented efficacy (improved survival, more organ support-free days, or both), an OR less than 1 represented harm, and an OR less than 1.2 represented futility. Results: Enrollment was terminated after statistical triggers for harm and futility were met. The trials had primary outcome data for 1568 critically ill patients (1037 in the vitamin C group and 531 in the control group; median age, 60 years [IQR, 50-70 years]; 35.9% were female) and 1022 patients who were not critically ill (456 in the vitamin C group and 566 in the control group; median age, 62 years [IQR, 51-72 years]; 39.6% were female). Among critically ill patients, the median number of organ support-free days was 7 (IQR, -1 to 17 days) for the vitamin C group vs 10 (IQR, -1 to 17 days) for the control group (adjusted proportional OR, 0.88 [95% credible interval {CrI}, 0.73 to 1.06]) and the posterior probabilities were 8.6% (efficacy), 91.4% (harm), and 99.9% (futility). Among patients who were not critically ill, the median number of organ support-free days was 22 (IQR, 18 to 22 days) for the vitamin C group vs 22 (IQR, 21 to 22 days) for the control group (adjusted proportional OR, 0.80 [95% CrI, 0.60 to 1.01]) and the posterior probabilities were 2.9% (efficacy), 97.1% (harm), and greater than 99.9% (futility). Among critically ill patients, survival to hospital discharge was 61.9% (642/1037) for the vitamin C group vs 64.6% (343/531) for the control group (adjusted OR, 0.92 [95% CrI, 0.73 to 1.17]) and the posterior probability was 24.0% for efficacy. Among patients who were not critically ill, survival to hospital discharge was 85.1% (388/456) for the vitamin C group vs 86.6% (490/566) for the control group (adjusted OR, 0.86 [95% CrI, 0.61 to 1.17]) and the posterior probability was 17.8% for efficacy. Conclusions and Relevance: In hospitalized patients with COVID-19, vitamin C had low probability of improving the primary composite outcome of organ support-free days and hospital survival. Trial Registration: ClinicalTrials.gov Identifiers: NCT04401150 (LOVIT-COVID) and NCT02735707 (REMAP-CAP).

Reamed compared with unreamed nailing of tibial shaft fractures: Does the initial method of nail insertion influence outcome in patients requiring reoperations?

BACKGROUND: Patients with a tibial shaft fracture experiencing their first postoperative complication following treatment with intramedullary nails may be at greater risk of subsequent complications than the whole population. We aimed to determine whether the initial method of nail insertion influences outcome in patients with a tibial shaft fracture requiring multiple reoperations. METHODS: Using the Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures trial data, we categorized patients as those not requiring reoperation, those requiring a single reoperation and those requiring multiple reoperations, and we compared them by nail insertion technique (reamed v. unreamed) and fracture type (open v. closed). We then determined the number of patients whose first reoperation was in response to infection, and we compared other clinical outcomes between the reamed and unreamed groups. RESULTS: Among 1226 patients included in this analysis, 175 (14.27%) experienced a single reoperation and 44 patients (3.59%) underwent multiple reoperations. Nail insertion techniques (reamed v. unreamed) did not play a role in the need to perform multiple reoperations. Seventy-five percent of patients requiring multiple reoperations had open tibial shaft fractures. An equal number of these were reamed and unreamed insertions. The majority of patients had their course complicated by infection and almost 50% of patients whose first reoperation was for infection required more than 2 reoperations for management. The rest required multiple procedures for nonunion or bone loss. CONCLUSION: Our findings corroborate those of other studies, in which open fracture type rather than nail insertion technique was found to be the cause of morbidity following intramedullary nailing of tibial fractures. CLINICAL TRIAL REGISTRATION: www. CLINICALTRIALS: gov, no. NCT00038129.

A Pilot Feasibility Randomized Controlled Trial of Intravenous Vitamin C in Adults with Sepsis in the Intensive Care Unit: The Lessening Organ Dysfunction with Vitamin C-India (LOVIT-India) Trial.

Background: The burden of sepsis is high in India and is associated with substantial morbidity and mortality. Vitamin C, an endogenous antioxidant, may improve patient outcomes. Methods: This was a parallel-group pilot feasibility randomized controlled trial conducted at 2 intensive care units in India. Adult patients (≥18 years) with proven or suspected infection as the main diagnosis and needing a continuous intravenous vasopressor infusion were randomized to intravenous vitamin C (50 mg/kg every 6 hours for a maximum of 16 doses) or matching placebo. Primary outcomes were related to protocol adherence and feasibility (enrollment per month). The key secondary outcome was the composite of mortality or persistent organ dysfunction (POD) at day 28 after randomization. Results: 60 patients were screened, 51 were eligible, 32 were randomized, and 30 were included in the analysis (randomized/eligible ratio: 0.63). The overall rate of enrollment was 1.5 patients per month. The median (IQR) age was 63.5 (51.0, 70.0) and 70.0% of the patients were male. In both arms, all patients received ≥90% of scheduled doses of the study drug. No patient received open-label vitamin C and there were no deviations from the glucose monitoring protocol. The composite outcome of mortality or POD at day 28 occurred in 56.3% (9/16) in the vitamin C arm as compared to 42.9% (6/14) in the placebo arm [RR: 1.31 (95% CI: 0.62, 2.76), p = 0.47]. Conclusion: In this pilot feasibility randomized controlled trial of vitamin C for adult patients with sepsis, protocol adherence was excellent and feasibility endpoints were met. Trial registration: CTRI/2020/03/024371. How to cite this article: Vijayaraghavan BKT, Venkataraman R, Ramanathan Y, Margabandhu S, Jayakumar D, Ramachandran P, et al. A Pilot Feasibility Randomized Controlled Trial of Intravenous Vitamin C in Adults with Sepsis in the Intensive Care Unit: The Lessening Organ Dysfunction with Vitamin C-India (LOVIT-India) Trial. Indian J Crit Care Med 2023;27(12):910-916.

Outcomes of arthroscopic-assisted lateral tibial plateau fixation: a systematic review.

PURPOSE: The purpose of this study is to evaluate and summarize the current literature on outcomes of arthroscopic-assisted tibial plateau fixation (AATPF) when applied for only lateral tibial plateau fractures. METHODS: A comprehensive search of nine databases was conducted: ClinicalTrials.gov, Cochrane Library via Wiley, Embase and MEDLINE via Ovid, Global Index Medicus, PubMed, Scopus, SPORTDiscus via EBSCO, and Web of Science Core Collection. The study was performed in concordance with PRISMA guidelines. Studies eligible for inclusions included Schatzker I-III lateral tibial plateau fractures with a minimum of 6-month follow-up. Data extraction was performed by two authors independently using a predesigned form. RESULTS: A total of 17 studies, 7 prospective and 10 retrospective, including 565 patients (age 15-82 years old) treated with AATPF were included in this review with follow-up ranging from 6 to 138 months. All 10 studies that used categorical functional outcomes demonstrated excellent/very good or good outcomes in > 90% of patients. When compared to patients managed with the traditional open reduction internal fixation (ORIF), patients treated with AATPF had statistically significantly better range of motion mean difference [5.21° (95% CI - 2.50 to 12.92, p < 0.0001)], lower blood loss [66.19 mL (95% confidence interval (CI) 32.54-99.84 mL, p < 0.0001)], shorter hospital stay [- 1.41 days (95% CI - 3.39 to 0.58 days, p < 0.0001)], better Hospital Special Surgery score [11.31 (95% CI 6.49-16.12, p < 0.0001)], and higher Rasmussen radiographic score [1.26 (95% CI - 0.72 to 3.23, p < 0.0001)]. CONCLUSION: AATPF is a promising treatment of lateral tibial plateau fractures with some advantages over the traditional ORIF. LEVEL OF EVIDENCE: Therapeutic Level III.

Total Hip Arthroplasty or Hemiarthroplasty for Hip Fracture.

BACKGROUND: Globally, hip fractures are among the top 10 causes of disability in adults. For displaced femoral neck fractures, there remains uncertainty regarding the effect of a total hip arthroplasty as compared with hemiarthroplasty. METHODS: We randomly assigned 1495 patients who were 50 years of age or older and had a displaced femoral neck fracture to undergo either total hip arthroplasty or hemiarthroplasty. All enrolled patients had been able to ambulate without the assistance of another person before the fracture occurred. The trial was conducted in 80 centers in 10 countries. The primary end point was a secondary hip procedure within 24 months of follow-up. Secondary end points included death, serious adverse events, hip-related complications, health-related quality of life, function, and overall health end points. RESULTS: The primary end point occurred in 57 of 718 patients (7.9%) who were randomly assigned to total hip arthroplasty and 60 of 723 patients (8.3%) who were randomly assigned to hemiarthroplasty (hazard ratio, 0.95; 95% confidence interval [CI], 0.64 to 1.40; P = 0.79). Hip instability or dislocation occurred in 34 patients (4.7%) assigned to total hip arthroplasty and 17 patients (2.4%) assigned to hemiarthroplasty (hazard ratio, 2.00; 99% CI, 0.97 to 4.09). Function, as measured with the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score, pain score, stiffness score, and function score, modestly favored total hip arthroplasty over hemiarthroplasty. Mortality was similar in the two treatment groups (14.3% among the patients assigned to total hip arthroplasty and 13.1% among those assigned to hemiarthroplasty, P = 0.48). Serious adverse events occurred in 300 patients (41.8%) assigned to total hip arthroplasty and in 265 patients (36.7%) assigned to hemiarthroplasty. CONCLUSIONS: Among independently ambulating patients with displaced femoral neck fractures, the incidence of secondary procedures did not differ significantly between patients who were randomly assigned to undergo total hip arthroplasty and those who were assigned to undergo hemiarthroplasty, and total hip arthroplasty provided a clinically unimportant improvement over hemiarthroplasty in function and quality of life over 24 months. (Funded by the Canadian Institutes of Health Research and others; ClinicalTrials.gov number, NCT00556842.).

Prevalence and Perception of Intimate Partner Violence-Related Traumatic Brain Injury.

BACKGROUND: Traumatic brain injury (TBI) is a serious and often undiagnosed consequence of intimate partner violence (IPV). Data on prevalence of TBI among IPV survivors are emerging, but prevalence of IPV among patients presenting to TBI clinics is unknown. Identification of IPV is important to ensure patients with TBI receive appropriate intervention and referrals. OBJECTIVE: To determine the proportion of women 18 years and older presenting to an acquired brain injury (ABI) clinic with confirmed or suspected concussion who reported experiencing IPV in the last 12 months or their lifetime. METHODS: Single-center cross-sectional cohort study. Proportion of IPV-related TBI or head, neck, or facial) injuries were determined using a modified HELPS Brain Injury Screening Tool and the Neurobehavioral Symptom Inventory. RESULTS: Of the 97 women approached, 50 were enrolled in the study. The average age was 46.1 years and 32 women (64.0%) reported a relationship history with a violent partner; 12-month prevalence of IPV was 26.5% and lifetime prevalence was 44.0%. Within their lifetime, all (44.0%) who reported an IPV history reported emotional abuse, 24.0% reported physical abuse, and 18.0% sexual abuse. HELPS responses indicated a high potential of lifetime IPV-related TBI for 29.2%, most commonly from being hit in the face or head (20.8%). CONCLUSION: Implementation of IPV screening in community-based ABI clinics is a pivotal step toward understanding the potential scope of TBI and addressing the wide range of somatic, cognitive, and affective symptoms experienced by IPV survivors. IPV screening also will lead to timely referral and follow-up and increase patient safety after discharge from rehabilitation.

Patients With Femoral Neck Fractures Are at Risk for Conversion to Arthroplasty After Internal Fixation: A Machine-learning Algorithm.

BACKGROUND: Femoral neck fractures are common and are frequently treated with internal fixation. A major disadvantage of internal fixation is the substantially high number of conversions to arthroplasty because of nonunion, malunion, avascular necrosis, or implant failure. A clinical prediction model identifying patients at high risk of conversion to arthroplasty may help clinicians in selecting patients who could have benefited from arthroplasty initially. QUESTION/PURPOSE: What is the predictive performance of a machine-learning (ML) algorithm to predict conversion to arthroplasty within 24 months after internal fixation in patients with femoral neck fractures? METHODS: We included 875 patients from the Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trial. The FAITH trial consisted of patients with low-energy femoral neck fractures who were randomly assigned to receive a sliding hip screw or cancellous screws for internal fixation. Of these patients, 18% (155 of 875) underwent conversion to THA or hemiarthroplasty within the first 24 months. All patients were randomly divided into a training set (80%) and test set (20%). First, we identified 27 potential patient and fracture characteristics that may have been associated with our primary outcome, based on biomechanical rationale and previous studies. Then, random forest algorithms (an ML learning, decision tree-based algorithm that selects variables) identified 10 predictors of conversion: BMI, cardiac disease, Garden classification, use of cardiac medication, use of pulmonary medication, age, lung disease, osteoarthritis, sex, and the level of the fracture line. Based on these variables, five different ML algorithms were trained to identify patterns related to conversion. The predictive performance of these trained ML algorithms was assessed on the training and test sets based on the following performance measures: (1) discrimination (the model's ability to distinguish patients who had conversion from those who did not; expressed with the area under the receiver operating characteristic curve [AUC]), (2) calibration (the plotted estimated versus the observed probabilities; expressed with the calibration curve intercept and slope), and (3) the overall model performance (Brier score: a composite of discrimination and calibration). RESULTS: None of the five ML algorithms performed well in predicting conversion to arthroplasty in the training set and the test set; AUCs of the algorithms in the training set ranged from 0.57 to 0.64, slopes of calibration plots ranged from 0.53 to 0.82, calibration intercepts ranged from -0.04 to 0.05, and Brier scores ranged from 0.14 to 0.15. The algorithms were further evaluated in the test set; AUCs ranged from 0.49 to 0.73, calibration slopes ranged from 0.17 to 1.29, calibration intercepts ranged from -1.28 to 0.34, and Brier scores ranged from 0.13 to 0.15. CONCLUSION: The predictive performance of the trained algorithms was poor, despite the use of one of the best datasets available worldwide on this subject. If the current dataset consisted of different variables or more patients, the performance may have been better. Also, various reasons for conversion to arthroplasty were pooled in this study, but the separate prediction of underlying pathology (such as, avascular necrosis or nonunion) may be more precise. Finally, it may be possible that it is inherently difficult to predict conversion to arthroplasty based on preoperative variables alone. Therefore, future studies should aim to include more variables and to differentiate between the various reasons for arthroplasty. LEVEL OF EVIDENCE: Level III, prognostic study.

Impact of centre volume, surgeon volume, surgeon experience and geographic location on reoperation after intramedullary nailing of tibial shaft fractures

Background: Tibial shaft fractures are the most common long-bone injury, with a reported annual incidence of more than 75 000 in the United States. This study aimed to determine whether patients with tibial fractures managed with intramedullary nails experience a lower rate of reoperation if treated at higher-volume hospitals, or by higher-volume or more experienced surgeons. Methods: The Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) was a multicentre randomized clinical trial comparing reamed and nonreamed intramedullary nailing on rates of reoperation to promote fracture union, treat infection or preserve the limb in patients with open and closed fractures of the tibial shaft. Using data from SPRINT, we quantified centre and surgeon volumes into quintiles. We performed analyses adjusted for type of fracture (open v. closed), type of injury (isolated v. multitrauma), gender and age for the primary outcome of reoperation using multivariable logistic regression. Results: There were no significant differences in the odds of reoperation between high- and low-volume centres (p = 0.9). Overall, surgeon volume significantly affected the odds of reoperation (p = 0.03). The odds of reoperation among patients treated by moderate-volume surgeons were 50% less than those among patients treated by verylow-volume surgeons (odds ratio [OR] 0.50, 95% confidence interval [CI] 0.28­0.88), and the odds of reoperation among patients treated by high-volume surgeons were 47% less than those among patients treated by very-low-volume surgeons (OR 0.53, 95% CI 0.30­0.93). Conclusion: There appears to be no significant additional patient benefit in treatment by a higher-volume centre for intramedullary fixation of tibial shaft fractures. Additional research on the effects of surgical and clinical site volume in tibial shaft fracture management is needed to confirm this finding. The odds of reoperation were higher in patients treated by very-low-volume surgeons; this finding may be used to optimize the results of tibial shaft fracture management. Clinical trial registration: ClinicalTrials.gov, NCT00038129

Contexte: La fracture de la diaphyse tibiale est la plus commune des fractures des os longs, avec une incidence annuelle déclarée de plus 75 000 cas aux États-Unis. Cette étude visait à déterminer si les patients traités par enclouage intramédullaire pour une fracture du tibia sont moins souvent réopérés quand l'intervention est effectuée dans des établissements qui traitent de plus forts volumes de cas ou par des chirurgiens opérant un plus fort volume de cas ou plus expérimentés. Méthodes: L'étude SPRINT (Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures) est un essai clinique multicentrique randomisé qui a comparé l'effet de l'enclouage alésé c. non alésé sur le taux des réinterventions visant à promouvoir la consolidation osseuse de la fracture, à traiter une infection ou à préserver le membre chez des patients victimes de fractures fermées ou ouvertes de la diaphyse tibiale. À partir des données de l'étude SPRINT, nous avons classé les établissements et les chirurgiens en quintiles selon les volumes de cas traités. Nous avons effectué des analyses ajustées en fonction du type de fracture (ouverte c. fermée), du type de blessure (isolée c. polytraumatisme), du sexe et de l'âge, pour établir le taux de réintervention (paramètre principal), en utilisant la régression logistique multivariée. Résultats: On n'a noté aucune différence significative quant au risque de réintervention entre les centres qui traitaient des volumes élevés c. bas (p = 0,9). Dans l'ensemble le volume d'opérations des chirurgiens a significativement influé sur le risque de réintervention (p = 0,03). Le risque de réintervention chez les patients traités par des chirurgiens dont le volume d'interventions était moyen était de 50 % de moins que chez les patients traités par des chirurgiens dont le volume était très bas (risque relatif [RR] 0,50, intervalle de confiance [IC] à 95 % 0,28­0,88) et le risque de réintervention chez les patients traités par des chirurgiens dont le volume était très élevé était de 47 % de moins que chez les patients traités par des chirurgiens dont le volume était très bas (RR 0,53, IC à 95 % 0,30­0,93). Conclusion: Il ne semble y avoir aucun bienfait additionnel significatif au fait d'être opéré dans un centre où le volume d'interventions pour enclouage intramédullaire des fractures de la diaphyse tibiale est élevé. Il faudra approfondir la recherche sur les effets du volume chirurgical et de l'expérience clinique des établissements pour confirmer cette observation. Le risque de réintervention a été plus élevé chez les patients traités par des chirurgiens dont le volume d'interventions était très bas; cette observation pourrait être utilisée pour optimiser l'issue du traitement des fractures de la diaphyse tibiale. Enregistrement de l'essai clinique : ClinicalTrials. gov, NCT00038129.

Top 10 Things Every Radiologist Needs to Know About Intimate Partner Violence [Formula: see text].

INTRODUCTION: Intimate partner violence (IPV) is considered to be the leading cause of nonfatal injury to women worldwide. Moreover, the need for effective training for health care professionals (HCPs) and protocol for addressing IPV in health care contexts are well-documented. This article addresses key questions that radiologists may have related to supporting patients who have experienced IPV. METHODS: Peer-reviewed journal articles and other formal reports were located using Google Scholar and PubMed in order to assemble this review. CONCLUSIONS: Radiologists are well-equipped to help identify possible instances of IPV if they are aware of the injury patterns commonly associated with IPV. Along with other HCPs, radiologists can also advocate for the implementation of protocols that will guide their responses to victims of IPV within their own health care institution.

How Successful Is Antibiotic Treatment for Superficial Surgical Site Infections After Open Fracture? A Fluid Lavage of Open Wounds (FLOW) Cohort Secondary Analysis.

BACKGROUND: Although many studies report the incidence and prevalence of surgical site infections (SSIs) after open fractures, there is limited information on the treatment and subsequent outcomes of superficial SSIs in patients with open fractures. Additionally, clinical studies describing the factors that are associated with persistent infection after nonoperative treatment with antibiotics for patients with superficial SSIs are lacking. QUESTIONS/PURPOSES: Therefore, we asked: (1) What proportion of patients with superficial SSIs after open fracture treatment developed persistent infection after nonoperative treatment (that is, treatment with antibiotics alone)? (2) What risk factors are associated with SSIs that do not resolve with nonoperative (antibiotic) treatment? As a secondary objective, we planned to analyze the microbiological information about participants wound cultures, when these were available, and the proportion of positive cultures for patients whose SSIs were not resolved by antibiotics alone. METHODS: This is a secondary analysis of the Fluid Lavage of Open Wounds (FLOW) trial dataset. The FLOW trial included 2445 patients with operatively managed open fractures. FLOW participants who had a nonoperatively managed superficial SSI diagnosed in the 12 months post-fracture were included in this analysis. Superficial SSIs were diagnosed in 168 participants within 12 months of their fracture. Of these, 83% (139) had their superficial SSI treated with antibiotics alone. Participants were grouped into two categories: (1) 97 participants whose treatment with antibiotics alone resolved the superficial SSI and (2) 42 participants whose treatment with antibiotics alone did not resolve the SSI (defined as undergoing surgical management or the SSI being unresolved at latest follow-up [12-months post-fracture for the FLOW trial]). Of the participants whose treatment with antibiotics alone resolved the SSI, 92% (89 of 97) had complete follow-up, 6% (6 of 97) were lost to follow-up before 12 months, 1% (1 of 97) withdrew consent from the study before 12 months, and 1% (1 of 97) experienced mortality before 12 months. Of the participants whose treatment with antibiotics alone did not resolve the SSI, 90% (38 of 42) had complete follow-up, 7% (3 of 42) were lost to follow-up before 12 months, and 2% (1 of 42) withdrew consent from the study before 12 months. A logistic binary regression analysis was conducted to identify factors associated with persistent infection despite superficial SSI antibiotic treatment. Based on biologic rationale and previous evidence, we identified a priori 13 potential factors (corresponding to 14 levels) to be included in the regression model. RESULTS: The antibiotic treatment resolved the superficial SSI in 70% (97 of 139) of patients and did not resolve the SSI in 30% (42 of 139). After controlling for potential confounding variables, such as age, fracture severity, and time from injury to initial surgical irrigation and débridement, superficial SSIs diagnosed later in follow-up were associated with antibiotics not resolving the SSI (odds ratio 1.05 [95% CI 1.004 to 1.009] for every week of follow-up; p = 0.03). Sex, fracture pattern, and wound size were not associated with antibiotics not resolving the SSI. CONCLUSIONS: Our secondary analysis of prospectively collected FLOW data suggests that antibiotics alone can be an appropriate treatment option when treating superficial SSIs after an open fracture wound, especially when promptly diagnosed. Further research with longer follow-up time is needed to better identify the natural history of superficial SSIs and possibly some dormant or subclinical infections to help clinicians in the treatment decision-making process. LEVEL OF EVIDENCE: Level III, therapeutic study.

A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds.

BACKGROUND: The management of open fractures requires wound irrigation and débridement to remove contaminants, but the effectiveness of various pressures and solutions for irrigation remains controversial. We investigated the effects of castile soap versus normal saline irrigation delivered by means of high, low, or very low irrigation pressure. METHODS: In this study with a 2-by-3 factorial design, conducted at 41 clinical centers, we randomly assigned patients who had an open fracture of an extremity to undergo irrigation with one of three irrigation pressures (high pressure [>20 psi], low pressure [5 to 10 psi], or very low pressure [1 to 2 psi]) and one of two irrigation solutions (castile soap or normal saline). The primary end point was reoperation within 12 months after the index surgery for promotion of wound or bone healing or treatment of a wound infection. RESULTS: A total of 2551 patients underwent randomization, of whom 2447 were deemed eligible and included in the final analyses. Reoperation occurred in 109 of 826 patients (13.2%) in the high-pressure group, 103 of 809 (12.7%) in the low-pressure group, and 111 of 812 (13.7%) in the very-low-pressure group. Hazard ratios for the three pairwise comparisons were as follows: for low versus high pressure, 0.92 (95% confidence interval [CI], 0.70 to 1.20; P=0.53), for high versus very low pressure, 1.02 (95% CI, 0.78 to 1.33; P=0.89), and for low versus very low pressure, 0.93 (95% CI, 0.71 to 1.23; P=0.62). Reoperation occurred in 182 of 1229 patients (14.8%) in the soap group and in 141 of 1218 (11.6%) in the saline group (hazard ratio, 1.32, 95% CI, 1.06 to 1.66; P=0.01). CONCLUSIONS: The rates of reoperation were similar regardless of irrigation pressure, a finding that indicates that very low pressure is an acceptable, low-cost alternative for the irrigation of open fractures. The reoperation rate was higher in the soap group than in the saline group. (Funded by the Canadian Institutes of Health Research and others; FLOW ClinicalTrials.gov number, NCT00788398.).

Pilot randomized controlled trials in the orthopaedic surgery literature: a systematic review.

BACKGROUND: The primary objective of this systematic review is to examine the characteristics of pilot randomized controlled trials (RCTs) in the orthopaedic surgery literature, including the proportion framed as feasibility trials and those that lead to definitive RCTs. This review aim to answer the question of whether pilot RCTs lead to definitive RCTs, whilst investigating the quality, feasibility and overall publication trends of orthopaedic pilot trials. METHODS: Pilot RCTs in the orthopaedic literature were identified from three electronic databases (EMBASE, MEDLINE, and Pubmed) searched from database inception to January 2018. Search criteria included the evaluation of at least one orthopaedic surgical intervention, research on humans, and publication in English. Two reviewers independently screened the pool of pilot trials, and conducted a search for corresponding definitive trials. Screened pilot RCTs were assessed for feasibility outcomes related to efficiency, cost, and/or timeliness of a large-scale clinical trial involving a surgical intervention. The quality of the pilot and definitive trials were assessed using the Checklist to Evaluate a Report of a Non-Pharmacological Trial (CLEAR NPT). RESULTS: The initial search for pilot RCTs yielded 3857 titles, of which 49 articles were relevant for this review. 73.5% (36/49) of the orthopaedic pilot RCTs were framed as feasibility trials. Of these, 5 corresponding definitive trials (10.2%) were found, of which four were published and one ongoing. Based on author responses, the lack of a definitive RCT following the pilot trial was attributed to a lack of funding, inadequacies in recruitment, and belief that the pilot RCT sufficiently answered the research question. CONCLUSIONS: Based on this systematic review, most pilot RCTs were characterized as feasibility trials. However, the majority of published pilot RCTs did not lead to definitive trials. This discrepancy was mainly attributed to poor feasibility (e.g. poor recruitment) and lack of funding for an orthopaedic surgical definitive trial. In recent years this discrepancy may be due to researchers saving on time and cost by rolling their pilot patients into the definitive RCT rather than publish a separate pilot trial.