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For the past five decades, there has been little progress in the development of oral anticoagulants, with the choices being limited to the vitamin K antagonists (VKAs). The situation is changing with the development of orally active small molecules that directly target thrombin or activated factor X (FXa). The two agents in the most advanced stages of development are dabigatran etexilate and rivaroxaban, which inhibit thrombin and FXa, respectively. Both are approved in the EU and Canada for venous thromboprophylaxis in patients undergoing elective hip- or knee-replacement surgery. Other agents in the early stages of development include several FXa inhibitors (apixaban, DU 176b, LY 517717, YM 150, betrixaban, eribaxaban [PD 0348292] and TAK 442) and one thrombin inhibitor (AZD 0837). With a predictable anticoagulant response and low potential for drug-drug interactions, these new agents can be given in fixed doses without coagulation monitoring. This renders them more convenient than VKAs. While the anticoagulant effect of the new thrombin and FXa inhibitors is similar, differences in the pharmacokinetic and pharmacodynamic parameters may influence their use in clinical practice. Here, we compare the pharmacokinetic and pharmacodynamic features of these new oral agents.

Rivaroxaban is an orally administered direct inhibitor of factor Xa. As compared with enoxaparin, rivaroxaban was more effective in preventing venous thromboembolism after hip replacement, without a significant increase in major bleeding. Rivaroxaban is an orally administered direct inhibitor of factor Xa. As compared with enoxaparin, rivaroxaban was more effective in preventing venous thromboembolism after hip replacement, without a significant increase in major bleeding. Prophylactic anticoagulant therapy is standard practice after total hip or knee arthroplasty, with a minimum recommended duration of 10 days. 1 After total hip arthroplasty, extended prophylaxis for 5 weeks after surgery reduces the incidence of symptomatic and asymptomatic venous thromboembolism more effectively than does short-term prophylaxis. 2 New deep-vein thromboses have been shown to form after the discontinuation of short-term prophylaxis. 3 Several meta-analyses suggest that extended thromboprophylaxis after total hip arthroplasty leads to a reduction in symptomatic venous thromboembolic events, without increasing the risk of major bleeding. 4 – 6 These findings led to a grade 1A recommendation for extended thromboprophylaxis after total . . .

The risk of venous thromboembolism is high after total hip arthroplasty and could persist after hospital discharge. Our aim was to compare the use of rivaroxaban for extended thromboprophylaxis with short-term thromboprophylaxis with enoxaparin. 2509 patients scheduled to undergo elective total hip arthroplasty were randomly assigned, stratified according to centre, with a computer-generated randomisation code, to receive oral rivaroxaban 10 mg once daily for 31–39 days (with placebo injection for 10–14 days; n=1252), or enoxaparin 40 mg once daily subcutaneously for 10–14 days (with placebo tablet for 31–39 days; n=1257). The primary efficacy outcome was the composite of deep-vein thrombosis (symptomatic or asymptomatic detected by mandatory, bilateral venography), non-fatal pulmonary embolism, and all-cause mortality up to day 30–42. Analyses were done in the modified intention-to-treat population, which consisted of all patients who had received at least one dose of study medication, had undergone planned surgery, and had adequate assessment of thromboembolism. This study is registered at ClinicalTrials.gov, number NCT00332020. The modified intention-to-treat population for the analysis of the primary efficacy outcome consisted of 864 patients in the rivaroxaban group and 869 in the enoxaparin group. The primary outcome occurred in 17 (2·0%) patients in the rivaroxaban group, compared with 81 (9·3%) in the enoxaparin group (absolute risk reduction 7·3%, 95% CI 5·2–9·4; p<0·0001). The incidence of any on-treatment bleeding was much the same in both groups (81 [6·6%] events in 1228 patients in the rivaroxaban safety population vs 68 [5·5%] of 1229 patients in the enoxaparin safety population; p=0·25). Extended thromboprophylaxis with rivaroxaban was significantly more effective than short-term enoxaparin plus placebo for the prevention of venous thromboembolism, including symptomatic events, in patients undergoing total hip arthroplasty. Bayer HealthCare AG, Johnson & Johnson Pharmaceutical Research and Development LLC.

After hip replacement surgery, prophylaxis following discharge from hospital is recommended to reduce the risk of venous thromboembolism. Our aim was to assess the oral, direct thrombin inhibitor dabigatran etexilate for such prophylaxis. In this double-blind study, we randomised 3494 patients undergoing total hip replacement to treatment for 28–35 days with dabigatran etexilate 220 mg (n=1157) or 150 mg (1174) once daily, starting with a half-dose 1–4 h after surgery, or subcutaneous enoxaparin 40 mg once daily (1162), starting the evening before surgery. The primary efficacy outcome was the composite of total venous thromboembolism (venographic or symptomatic) and death from all causes during treatment. On the basis of the absolute difference in rates of venous thromboembolism with enoxaparin versus placebo, the non-inferiority margin for the difference in rates of thromboembolism was defined as 7·7%. Efficacy analyses were done by modified intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00168818. Median treatment duration was 33 days. 880 patients in the dabigatran etexilate 220 mg group, 874 in the dabigatran etexilate 150 mg group, and 897 in the enoxaparin group were available for the primary efficacy outcome analysis; the main reasons for exclusion in all three groups were the lack of adequate venographic data. The primary efficacy outcome occurred in 60 (6·7%) of 897 individuals in the enoxaparin group versus 53 (6·0%) of 880 patients in the dabigatran etexilate 220 mg group (absolute difference −0·7%, 95% CI −2·9 to 1·6%) and 75 (8·6%) of 874 people in the 150 mg group (1·9%, −0·6 to 4·4%). Both doses were thus non-inferior to enoxaparin. There was no significant difference in major bleeding rates with either dose of dabigatran etexilate compared with enoxaparin (p=0·44 for 220 mg, p=0·60 for 150 mg). The frequency of increases in liver enzyme concentrations and of acute coronary events during the study did not differ significantly between the groups. Oral dabigatran etexilate was as effective as enoxaparin in reducing the risk of venous thromboembolism after total hip replacement surgery, with a similar safety profile.

Purpose The purpose of this prospective randomized controlled study was to evaluate the long-term results after an acute Achilles tendon rupture in patients treated surgically or non-surgically. The focus was to evaluate whether any improvements occurred between the one and 2-year evaluation. Method Eighty-one patients (67 men, 14 women) with a mean (SD) age of 42 (9.1) were included in this study. Forty-two patients were treated surgically, and 39 treated non-surgically otherwise the treatment was identical for the two groups. All patients were evaluated using the Achilles tendon Total Rupture Score (ATRS), the Physical Activity Scale (PAS) and validated functional tests one and 2 years after injury. Results There were significant functional deficits on the injured side compared with the contralateral side 2 years after Achilles tendon rupture, regardless of treatment. Only minor improvements, even though statistically significant, occurred between the 1- and 2-year evaluations. The physical activity level remained significantly reduced as compared with prior to injury, but the ATRS mean was relatively high in both groups (89 and 90). Conclusion This long-term follow-up indicates that the majority of patients with an Achilles tendon rupture have not fully recovered (in regards to symptoms, physical activity level and function) 2 years after injury regardless of surgical or non-surgical treatment. Furthermore, only minor improvements occur between the 1- and 2-year evaluations. This indicates that to enhance the final outcome the focus should be on improvements in treatment within the first year. The patients appear to have adjusted to their impairments since the patient-reported outcome is relatively high in spite of functional deficits and lower activity level compared with pre-injury. Level of evidence Prospective randomized study, Level I.

Background: Tendon healing differs between the sexes. Comparisons in outcome between the sexes after an Achilles tendon rupture are often not possible because of the small cohort (<20%) of women. Purpose: To evaluate whether there are any differences in outcome between the sexes by combining the data from 2 large randomized controlled trials that used identical outcome measures. Study Design: Cohort study; Level of evidence, 3. Methods: Included in the evaluation were patients from 2 consecutive randomized controlled trials comparing surgical and nonsurgical treatment performed at our research laboratory. Patients who had a rerupture were excluded from analysis. A total of 182 patients (152 males, 30 females), with mean ± SD age of 40 ± 11 years, were included; 94 (76 males, 18 females) were treated with surgery and 88 (76 males, 12 females) nonsurgically. Patient-reported outcome was evaluated using the Achilles tendon Total Rupture Score (ATRS), and the functional outcome was measured with a heel-rise test (measurement of muscular endurance and heel-rise height) at 6 and 12 months after injury. Results: Male patients had a greater improvement in heel-rise height at 12 months (P = .004). When each treatment group was analyzed separately, it was found that female patients had significantly (P < .03) more symptoms after surgical treatment (mean ± SD ATRS, 59 ± 24) compared with males at 6 (73 ± 19) and 12 months (74 ± 27 vs 86.5 ± 17). This sex difference was not found in the nonsurgical treatment group. For the entire group, there were no significant differences between treatments on ATRS at 6 and 12 months. The surgical group had significantly better results compared with the nonsurgical group in heel-rise endurance at 6 and 12 months and in heel-rise height recovery at 6 months (P < .03 for both). Conclusion: Sex differences were demonstrated, and female patients had a greater degree of deficit in heel-rise height as compared with males, irrespective of treatment. Females had more symptoms after surgery both at 6 and 12 months, but this difference was not found when treated nonsurgically. Clinical Relevance: Further research is needed to determine whether women will benefit more from nonsurgical compared with surgical treatment after an Achilles tendon rupture.

Background There is a high prevalence of blood product transfusions in orthopedic surgery. The reported prevalence of red blood cell transfusions in unselected patients undergoing hip or knee replacement varies between 21% and 70%. We determined current blood loss and transfusion prevalence in total hip and knee arthroplasty when tranexamic acid was used as a routine prophylaxis, and further investigated potential predictors for excessive blood loss and transfusion requirement. Methods/materials In total, 193 consecutive patients undergoing unilateral hip ( n  = 114) or knee arthroplasty ( n  = 79) were included in a prospective observational study. Estimated perioperative blood loss was calculated and transfusions of allogeneic blood products registered and related to patient characteristics and perioperative variables. Results Overall transfusion rate was 16% (18% in hip patients and 11% in knee patients, p  = 0.19). Median estimated blood loss was significantly higher in hip patients (984 vs 789 mL, p  < 0.001). Preoperative hemoglobin concentration was the only independent predictor of red blood cell transfusion in hip patients while low hemoglobin concentration, body mass index, and operation time were independent predictors for red blood cell transfusion in knee patients. Conclusions The prevalence of red blood cell transfusion was lower than previously reported in unselected total hip or knee arthroplasty patients. Routine use of tranexamic acid may have contributed. Low preoperative hemoglobin levels, low body mass index, and long operation increase the risk for red blood cell transfusion.

Purpose The aim of this study was to compare the Ilizarov circular fixator (IL) and locked intramedullary nailing (IM). Patients and methods Patients with isolated tibia shaft fractures were randomly allocated to either the IL ( n  = 31) or IM ( n  = 27) method. Conventional radiographs, postoperative pain assessment, self-appraisal scores and complications were evaluated. At the clinical 1-year follow-up, the patients were also evaluated by an independent observer. Results The minority of patients had open fractures, two and nine patients in the IM and IL groups, respectively. Eight patients in the IM group and four in the IL group sustained major complications ( p  = 0.107). In the IM group, two patients developed compartment syndrome, one deep infection, one hardware failure, one delayed union, one pseudarthrosis and two had a malunion. In the IL group, two patients developed pseudarthrosis and two had a malunion. Superficial pin-site infections were observed in 16 patients in the IL group. The fractures had healed radiographically at 12 weeks in both groups. At the 1-year follow-up, there were differences in pain (VAS) and satisfaction (VAS) scores in favor of IL treatment (VAS, p  = 0.03 and p  = 0.02, respectively). There were no differences between the groups with regard to range of motion (ROM) in the knee and ankle joints. The registration of local tenderness and pain revealed that there were 19 patients with anterior knee pain in the IM group and one in the IL group at the 1-year follow-up ( p  < 0.001). Conclusion The IL is a safe and reliable alternative to IM for the treatment of tibial shaft fractures, with a low complication rate and good clinical outcome. Both treatments were well tolerated, but at the 1-year follow-up the patients in the IM group had more pain and were less satisfied. Finally, there was a high frequency of anterior knee pain in the IM group.

Team members in ORs have frequent hand contact with many surfaces and sites during high workload, thus increasing the risk for microorganism cross-transmission. This study aimed at identifying risks for hand contamination and microorganism cross-transmission during invasive procedures in ORs. We carried out observations during 22 daytime sessions and analyzed data using qualitative content analysis. The results revealed that clinicians’ hands may be contaminated by self-contamination, via objects, or by touching the patient. Contamination may occur before, during, or directly after performing an invasive procedure requiring the use of aseptic technique, which risks cross-transmitting microorganisms. The results of the study contribute detailed knowledge about risk-associated activities and behaviors in relation to performing invasive procedures in the OR. This knowledge provides clinicians, managers, and educators with specific information that can be used in nursing and medical education and in quality improvement projects aimed at improving hand hygiene routines and enhancing aseptic technique.

Background Current knowledge suggests that, by applying evidence-based measures relating to the correct use of prophylactic antibiotics, perioperative normothermia, urinary tract catheterization and hand hygiene, important contributions can be made to reducing the risk of postoperative infections and device-related infections. The aim of this study was to explore and describe the application of intraoperative evidence-based measures, designed to reduce the risk of infection. In addition, we aimed to investigate whether the type of surgery, i.e. total joint arthroplasty compared with tibia and femur/hip fracture surgery, affected the use of protective measures. Method Data on the clinical application of evidence-based measures were collected structurally on site during 69 consecutively included operations involving fracture surgery (n = 35) and total joint arthroplasties (n = 34) using a pre-tested observation form. For observations in relation to hand disinfection, a modified version of the World Health Organization hand hygiene observation method was used. Results In all, only 29 patients (49%) of 59 received prophylaxis within the recommended time span. The differences in the timing of prophylactic antibiotics between total joint arthroplasty and fracture surgery were significant, i.e. a more accurate timing was implemented in patients undergoing total joint arthroplasty ( p  = 0.02). Eighteen (53%) of the patients undergoing total joint arthroplasty were actively treated with a forced-air warming system. The corresponding number for fracture surgery was 12 (34%) ( p  = 0.04). Observations of 254 opportunities for hand hygiene revealed an overall adherence rate of 10.3% to hand disinfection guidelines. Conclusions The results showed that the utilization of evidence-based measures to reduce infections in clinical practice is not sufficient and there are unjustifiable differences in care depending on the type of surgery. The poor adherence to hand hygiene precautions in the operating room is a serious problem for patient safety and further studies should focus on resolving this problem. The WHO Safe Surgery checklist “time out” worked as an important reminder, but is not per se a guarantee of safety; it is the way we act in response to mistakes or lapses that finally matters.