Objective: To quantify work impairment and economic losses due to lost employment, lost work time (absenteeism), and lost productivity while working (presenteeism) after a lateral compression pelvic ring fracture. Secondarily, productivity loss of patients treated with surgical fixation versus nonoperative management was compared.
Design: Secondary analysis of a prospective, multicenter trial.
Contemp Clin Trials Commun
October 2022
Background: At the initiation of the COVID-19 pandemic, restrictions forced researchers to decide whether to continue their ongoing clinical trials. The PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities) trial is a pragmatic cluster-randomized crossover trial in patients with open and closed fractures. PREPARE was enrolling over 200 participants per month at the initiation of the pandemic.
View Article and Find Full Text PDFObjective: To compare unreamed intramedullary nailing versus external fixation for the treatment of Gustilo-Anderson type II and IIIA open tibial fractures admitted to a hospital in rural Uganda.
Design: Randomized clinical trial.
Setting: Regional referral hospital in Uganda.
Contemp Clin Trials Commun
June 2021
Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent.
View Article and Find Full Text PDFJ Am Coll Cardiol
June 2021
Background: Pathological cardiac hypertrophy is a result of afterload-increasing pathologies including untreated hypertension and aortic stenosis. It features progressive adverse cardiac remodeling, myocardial dysfunction, capillary rarefaction, and interstitial fibrosis often leading to heart failure.
Objectives: This study aimed to establish a novel porcine model of pressure-overload-induced heart failure and to determine the effect of inhibition of microribonucleic acid 132 (miR-132) on heart failure development in this model.
Objective: To compare the early pain and functional outcomes of operative fixation versus nonoperative management for minimally displaced complete lateral compression (LC; OTA/AO 61-B1/B2) pelvic fractures.
Design: Prospective clinical trial.
Setting: Two academic trauma centers.
Objectives: To conduct a pilot trial for the Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) protocol to assess feasibility of a definitive trial.
Design: Pilot trial.
Setting: Twenty-five clinical sites across North America and Australia were initiated, but enrolment occurred in only 15 North American sites.
Background: Preoperative antiseptic skin solutions are used prior to most surgical procedures; however, there is no definitive research comparing infection-related outcomes following use of the various solutions available to orthopedic trauma surgeons. The objective of this pilot study was to test the feasibility of a cluster randomized crossover trial that assesses the comparative effectiveness of a 10% povidone-iodine solution versus a 4% chlorhexidine gluconate solution for the management of open fractures.
Methods: Two orthopedic trauma centers participated in this pilot study.
Purpose: Femoral neck fractures in young patients are typically managed with internal fixation using either cancellous screws or a sliding hip screw (SHS). Although fixation preserves the hip joint, patients are still at risk of complications and poor clinical outcomes which lead to diminished function and health related quality of life (HRQL). The Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) pilot randomized controlled factorial trial evaluated the effect of surgical fixation (cancellous screws vs.
View Article and Find Full Text PDFObjective: To assess whether the fixation method and vitamin D supplementation affect the risk of patient-important outcomes within 12 months of injury in nongeriatric femoral neck fracture patients.
Design: A pilot factorial randomized controlled trial.
Setting: Fifteen North American clinical sites.
J Am Coll Cardiol
April 2020
Background: miR-21 is a central regulator of cardiac fibrosis, and its inhibition in small-animal models has been shown to be an effective antifibrotic strategy in various organs, including the heart. Effective delivery of therapeutic antisense micro-ribonucleic acid (antimiR) molecules to the myocardium in larger organisms is challenging, though, and remains to be established for models of chronic heart failure.
Objectives: The aims of this study were to test the applicability and therapeutic efficacy of local, catheter-based delivery of antimiR-21 in a pig model of heart failure and determine its effect on the cardiac transcriptomic signature and cellular composition.
Importance: The risk of developing a surgical site infection after extremity fracture repair is nearly 5 times greater than in most elective orthopedic surgical procedures. For all surgical procedures, it is standard practice to prepare the operative site with an antiseptic solution; however, there is limited evidence to guide the choice of solution used for orthopedic fracture repair.
Objective: To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair.
BMC Med Res Methodol
December 2019
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.
Background: The inclusion of low and middle-income country (LMIC) hospitals in multicenter orthopaedic trials expands the pool of eligible patients and improves the external validity of the evidence. Furthermore, promoting studies in LMIC hospitals defines the optimal treatments for low-resource settings, the conditions under which the majority of musculoskeletal injuries are treated. The objective of this study was to determine the feasibility of a randomized controlled trial comparing external fixation with intramedullary (IM) nailing in patients with an isolated open tibial fracture who presented to a regional hospital in Uganda.
View Article and Find Full Text PDFImportance: 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.
Antimicrob Resist Infect Control
September 2019
Background: Surgically-managed fractures, particularly open fractures, are associated with high rates of surgical site infections (SSIs). To reduce the risk of an SSI, orthopaedic surgeons routinely clean open fracture wounds in the emergency department (ED) and then apply a bandage to the open wound. Prior to the surgical incision, it is standard practice to prepare the fracture region with an antiseptic skin solution as an additional SSI prevention strategy.
View Article and Find Full Text PDFJ Orthop Trauma
September 2018
Objective: To determine the risk factors for knee stiffness surgery after tibial plateau fixation.
Design: Retrospective observational cohort study.
Setting: Academic Level I trauma center.
Translations of new therapeutic options for cardiovascular disease from animal studies into a clinical setting have been hampered, in part by an improper reflection of a relevant patient population in animal models. In this study, we investigated the impact of thymosin β4 (Tβ4), which promotes collateralization and capillarization, during hypercholesterolemia, a known risk factor of coronary artery disease. Initial in vitro results highlighted an improved endothelial cell function upon Tβ4 treatment under control conditions and during hypercholesterolemic stress (scratch area [pixels]: oxidized low-density lipoprotein [oxLDL], 191,924 ± 7,717; and oxLDL + Tβ4, 105,621 ± 11,245).
View Article and Find Full Text PDFJ Am Coll Cardiol
January 2017
Background: Diabetes mellitus causes microcirculatory rarefaction and may impair the responsiveness of ischemic myocardium to proangiogenic factors.
Objectives: This study sought to determine whether microvascular destabilization affects organ function and therapeutic neovascularization in diabetes mellitus.
Methods: The authors obtained myocardial samples from patients with end-stage heart failure at time of transplant, with or without diabetes mellitus.
The benefits of high-pressure pulsatile lavage for open fracture irrigation have been controversial based on conflicting experimental animal research. Recently published data definitively demonstrated that irrigation pressure does not affect the incidence of reoperation for the treatment of open fractures. However, proponents of pulsatile lavage argue a faster irrigation time is an important benefit of the high-pressure treatment.
View Article and Find Full Text PDFEcotoxicol Environ Saf
February 2009
Paired liver and kidney samples from 100 free-range cattle in different parts of Jamaica were analyzed for essential and non-essential trace elements. We found significant enrichment of elements in the kidney (K) compared to the liver (L) with the K/L concentration ratios being 5.2 for Cd, 4.
View Article and Find Full Text PDFEnviron Geochem Health
February 2005
The concentrations of 27 elements in Jamaican food categories consisting of fruit, legumes, leafy and root vegetables and other root crops are reported. The main analytical techniques used were neutron activation analysis and flame and graphite furnace atomic absorption spectrophotometry. The results are compared, where possible, with values from Denmark, the United Kingdom, the United States and Nigeria, and with some regulatory limits.
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