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  • 1
    In: Journal of Bone and Joint Surgery, Ovid Technologies (Wolters Kluwer Health), Vol. 101, No. 14 ( 2019-7-17), p. e69-
    Type of Medium: Online Resource
    ISSN: 0021-9355 , 1535-1386
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
    Location Call Number Limitation Availability
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  • 2
    In: Journal of Bone and Joint Surgery, Ovid Technologies (Wolters Kluwer Health), Vol. 102, No. 21 ( 2020-11-4), p. 1883-1890
    Abstract: The purpose of this multicenter, randomized trial was to determine the optimal dosing regimen of tranexamic acid (TXA) to minimize perioperative blood loss in revision total hip arthroplasty. Methods: Six centers prospectively randomized 175 patients to 1 of 4 regimens: (1) 1-g intravenous (IV) TXA prior to incision (the single-dose IV group), (2) 1-g IV TXA prior to incision followed by 1-g IV TXA after arthrotomy wound closure (the double-dose IV group), (3) a combination of 1-g IV TXA prior to incision and 1-g intraoperative topical TXA (the combined IV and topical group), or (4) 3 doses totaling 1,950-mg oral TXA (the multidose oral group). Randomization was based on revision subgroups to ensure equivalent group distribution. An a priori power analysis (α = 0.05; β = 0.80) determined that 40 patients per group were required to identify a 〉 1-g/dL difference in postoperative hemoglobin reduction between groups. Per-protocol analysis involved an analysis of variance, Fisher exact tests, and two 1-sided t tests for equivalence. Demographic and surgical variables were equivalent between groups. Results: No significant differences were found between TXA regimens when evaluating reduction in hemoglobin (3.4 g/dL for the single-dose IV group, 3.6 g/dL for the double-dose IV group, 3.5 g/dL for the combined IV and topical group, and 3.4 g/dL for the multidose oral group; p = 0.95), calculated blood loss (p = 0.90), or transfusion rates (14% for the single-dose IV group, 18% for the double-dose IV group, 17% for the combined group, and 17% for the multidose oral group; p = 0.96). Equivalence testing revealed that all possible pairings were statistically equivalent, assuming a 〉 1-g/dL difference in hemoglobin reduction as clinically relevant. There was 1 venous thromboembolism, with no differences found between groups (p = 1.00). Conclusions: All 4 TXA groups tested had equivalent blood-sparing properties in the setting of revision total hip arthroplasty, with a single venous thromboembolism reported in this high-risk population. Based on the equivalence between groups, surgeons should utilize whichever of the 4 investigated regimens is best suited for their practice and hospital setting. Given the transfusion rate in revision total hip arthroplasty despite TXA utilization, further work is required in this area. Level of Evidence: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.
    Type of Medium: Online Resource
    ISSN: 0021-9355 , 1535-1386
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    Location Call Number Limitation Availability
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  • 3
    In: Journal of Bone and Joint Surgery, Ovid Technologies (Wolters Kluwer Health), Vol. 99, No. 5 ( 2017-3-1), p. 373-378
    Abstract: Tranexamic acid is an antifibrinolytic that has been shown to reduce blood loss and the need for transfusions when administered intravenously in total hip arthroplasty. Oral formulations of the drug are available at a fraction of the cost of the intravenous preparation. The purpose of this randomized controlled trial was to determine if oral and intravenous formulations of tranexamic acid have equivalent blood-sparing properties. Methods: In this double-blinded trial, 89 patients undergoing primary total hip arthroplasty were randomized to receive 1.95 g of tranexamic acid orally 2 hours preoperatively or a 1-g tranexamic acid intravenous bolus in the operating room prior to incision; 6 patients were eventually excluded for protocol deviations, leaving 83 patients available for study. The primary outcome was the reduction of hemoglobin concentration. Power analysis determined that 28 patients were required in each group with a ±1.0 g/dL hemoglobin equivalence margin between groups with an alpha of 5% and a power of 80%. Equivalence analysis was performed with a two one-sided test (TOST) in which a p value of 〈 0.05 indicated equivalence between treatments. Results: Forty-three patients received intravenous tranexamic acid, and 40 patients received oral tranexamic acid. Patient demographic characteristics were similar between groups, suggesting successful randomization. The mean reduction of hemoglobin was similar between oral and intravenous groups (3.67 g/dL compared with 3.53 g/dL; p = 0.0008, equivalence). Similarly, the mean total blood loss was equivalent between oral and intravenous administration (1,339 mL compared with 1,301 mL; p = 0.034, equivalence). Three patients (7.5%) in the oral group and one patient (2.3%) in the intravenous group were transfused, but the difference was not significant (p = 0.35). None of the patients in either group experienced a thromboembolic event. Conclusions: Oral tranexamic acid provides equivalent reductions in blood loss in the setting of primary total hip arthroplasty, at a greatly reduced cost, compared with the intravenous formulation. Level of Evidence: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.
    Type of Medium: Online Resource
    ISSN: 0021-9355 , 1535-1386
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2017
    Location Call Number Limitation Availability
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  • 4
    Online Resource
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    Ovid Technologies (Wolters Kluwer Health) ; 2017
    In:  Journal of Bone and Joint Surgery Vol. 99, No. 24 ( 2017-12-20), p. 2110-2118
    In: Journal of Bone and Joint Surgery, Ovid Technologies (Wolters Kluwer Health), Vol. 99, No. 24 ( 2017-12-20), p. 2110-2118
    Abstract: This article was updated on February 8, 2018, because of a previous error. On page 2111, in the Statistical Analysis section, the sentence that had read “Unfortunately, for rare outcomes (classically defined as those occurring at a rate of 〈 10%), odds ratios become exaggeratedly large compared with relative risks.” now reads “Odds ratios and relative risk approximate each other when the outcome is rare (classically defined as an outcome occurring at a rate of 〈 10%), but become increasingly divergent as the outcome becomes more common.” An erratum has been published: J Bone Joint Surg Am. 2018 Mar 21;100(6):e41. Background: Serum albumin level is the most well-established serum marker of malnutrition, with a serum albumin concentration 〈 3.5 g/dL considered to be suggestive of malnutrition. The purpose of this study was to test if serum albumin level is associated with death, specific postoperative complications (e.g., pneumonia), length of hospital stay, and readmission following a surgical procedure for geriatric hip fracture. Methods: A retrospective cohort study of geriatric patients (≥65 years of age) undergoing a hip fracture surgical procedure as part of the American College of Surgeons National Surgical Quality Improvement Program was conducted. Outcomes were compared between patients with and without hypoalbuminemia. All comparisons were adjusted for baseline and procedural differences between populations, and patients with missing serum albumin concentration were included in analyses using a missing data indicator. Results: There were 29,377 geriatric patients undergoing a hip fracture surgical procedure who met inclusion criteria; of these patients, 17,651 (60.1%) had serum albumin available for analysis. The prevalence of hypoalbuminemia was 45.9%. Following adjustment for baseline and procedural characteristics, the risk of death was inversely associated with serum albumin concentration as a continuous variable (adjusted relative risk, 0.59 [95% confidence interval (CI), 0.53 to 0.65]; p 〈 0.001). In comparison with patients with normal albumin concentration, patients with hypoalbuminemia had higher rates of death (9.94% compared with 5.53% [adjusted relative risk, 1.52 (95% CI, 1.37 to 1.70); p 〈 0.001]), sepsis (1.19% compared with 0.53% [adjusted relative risk, 1.92 (95% CI, 1.36 to 2.72); p 〈 0.001]), and unplanned intubation (2.64% compared with 1.47% [adjusted relative risk, 1.51 (95% CI, 1.21 to 1.88); p 〈 0.001]). The mean length of stay (and standard deviation) was longer among patients with hypoalbuminemia at 5.67 ± 4.68 days compared with those without hypoalbuminemia at 4.99 ± 3.95 days; the adjusted difference was 0.50 day (95% CI, 0.38 to 0.63 day; p 〈 0.001). However, the rate of readmission did not differ (p = 0.054) between patients with hypoalbuminemia (10.91%) and those without hypoalbuminemia (9.03%); the adjusted relative risk was 1.10 (95% CI, 1.00 to 1.21). Conclusions: Hypoalbuminemia is a powerful independent risk factor for mortality following a surgical procedure for geriatric hip fracture. These data suggest that further investigation into postoperative nutritional supplementation is warranted to decrease the risk of complications. Level of Evidence: Prognostic Level IV . See Instructions for Authors for a complete description of levels of evidence.
    Type of Medium: Online Resource
    ISSN: 0021-9355 , 1535-1386
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2017
    Location Call Number Limitation Availability
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