To determine the effect of anti-factor Xa assay dosing of low-molecular-weight heparin (LMWH) on rates of venous thromboembolism (VTE), deep vein thrombosis (DVT), pulmonary embolism (PE), bleeding, and mortality among orthopaedic trauma patients.PubMed/MEDLINE, Embase, Ovid, Cochrane Central Register of Controlled Trials (CENTRAL), clinicaltrials.gov , and Scopus were systematically searched from inception of the database to 2021.Prospective, retrospective, and randomized controlled trial studies were included if they compared rates of VTE, DVT, PE, bleeding, and/or mortality between orthopaedic trauma patients receiving anti-factor Xa-based LMWH dosing and those receiving standard dosing.Two independent reviewers screened titles and abstracts for eligibility. Study characteristics including study design, inclusion criteria, and intervention were extracted.Meta-analysis was performed using pooled proportion of events (effect size) with 95% confidence intervals. A random-effects model was used. Heterogeneity was quantified by Higgins I 2 . Heterogeneity and variability between subgroups indicated differences in the pooled estimate represented by a P -value.Six hundred eighty-five studies were identified, and 10 studies including 2870 patients were included. In total, 30.3% and 69.7% received an adjusted and nonadjusted dose of LMWH, respectively. The rate of VTE and DVT were significantly lower in the anti-factor Xa-adjusted cohort, whereas there was no statistically significant difference in rates of PE, bleeding, or mortality between the cohorts.This systematic review and meta-analysis demonstrates that anti-factor Xa activity assay dosing of LMWH among orthopaedic trauma patients leads to a reduction in overall DVT rates, although not PE rates, without an increased risk of bleeding events.Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients.7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p < 0.001).Implementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.
Background and purpose: Clavicle fractures are common shoulder injuries, but treatment strategies are debated. While a non-surgical approach has been preferred historically, recent studies suggest surgical intervention may reduce non-union rates and improve outcomes for displaced fractures. Despite ongoing research there is still no consensus on the optimal treatment choice. We aimed to report national incidences and trends in treatment of clavicle fractures in Denmark across 2 decades.Methods: The Danish National Patient Register was used to extract data on clavicle fracture diagnosis and treatment in patients aged 18 and above from 1996 to 2018. Primary treatment was categorized as surgical if a relevant surgical procedure code was registered within 3 weeks of the fracture code, otherwise treatment was defined as non-surgical.Results: There were 81,597 clavicle fractures recorded; 67% were in men and the mean age was 50.3 years (standard deviation [SD] 19.5). The overall fracture incidence was 82/100,000/person-years, increasing by 11% from 76 in 1996 to 84 in 2018. The incidence was more than 50% higher in males (113) than females (53). 6,096 cases (7.5%) were treated surgically, mainly with plate osteosynthesis (94%). The surgical rate increased from 1% in 1996 to 14% in 2011, whereafter it decreased again. In 2018, 7% of clavicle fractures were treated surgically, with inter-hospital variations ranging from 0 to 15%.Conclusion: The incidence of clavicle fractures increased over the period. Non-surgical treatment remained prevalent, though surgical rates fluctuated with plate osteosynthesis being the preferred method.
Relative value units (RVUs) are assigned to Current Procedural Technology (CPT) codes and give relative economic values to the services physicians provide. This study compared the RVU reimbursements for the surgical options of proximal humerus fractures in the elderly, which include arthroplasty (reverse [RSA] and total [TSA]), hemiarthroplasty (HA), and open reduction and internal fixation (ORIF).Using the National Surgical Quality Improvement Program, a total of 1,437 patients of at least 65 years of age with proximal humerus fractures between 2008 and 2016 were identified. Of those, 259 underwent RSA/TSA (CPT code 23472), 418 underwent HA (CPT codes 23470 and 23616), and 760 underwent ORIF (CPT code 23615). Univariate analysis compared RVU per minute, reimbursement rate, and the average annual revenue across cohorts based on respective operative times.RSA/TSA generated a mean RVU per minute of 0.197 (SD 0.078; 95%CI [0.188, 0.207]), which was significantly greater than the mean RVU per minute for 23470 HA (0.156; SD 0.057; 95%CI [0.148, 0.163]), 23616 HA (0.166; SD 0.065; 95%CI [0.005, 0.156]), and ORIF (0.135; SD 0.048; 95%CI [0.132, 0.138]; P<0.001). This converted to respective reimbursement rates of $6.97/min (SD 2.78; 95%CI [6.63, 7.31]), $5.48/min (SD 2.05; 95%CI [5.22, 5.74]), $5.83/min (SD 2.28; 95%CI [5.49, 6.16]) and $4.74/min (SD 1.69; 95%CI [4.62, 4.87]). After extrapolation, respective average annual revenues were $580,386, $456,633, $475,077, and $395,608.RSA/TSA provides significantly greater reimbursement rates compared to HA and ORIF. Orthopaedic surgeons can use this information to optimize daily procedural cost-effectiveness in their practices.