Проект капитального ремонта автомобильной дороги М-53 Байкал с км 955+00 по км 967+00

Background and purpose — The number of patients who are suitable for outpatient total hip and knee arthroplasty (THA and TKA) in an unselected patient population remains unknown. The purpose of this prospective 2-center study was to identify the number of patients suitable for outpatient THA and TKA in an unselected patient population, to investigate the proportion of patients who were discharged on the day of surgery (DOS), and to identify reasons for not being discharged on the DOS. Patients and methods — All consecutive, unselected patients who were referred to 2 participating centers and who were scheduled for primary THA and TKA were screened for eligibility for outpatient surgery with discharge to home on DOS. If patients did not fulfill the discharge criteria, the reasons preventing discharge were noted. Odds factors with relative risk intervals for not being discharged on DOS were identified while adjusting for age, sex, ASA score, BMI and distance to home. Results — Of the 557 patients who were referred to the participating surgeons during the study period, 54% were potentially eligible for outpatient surgery. Actual DOS discharge occurred in 13–15% of the 557 patients. Female sex and surgery late in the day increased the odds of not being discharged on the DOS. Interpretation — This study shows that even in unselected THA and TKA patients, same-day discharge is feasible in about 15% of patients. Future studies should evaluate safety aspects and economic benefits

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices).

In the European Union (EU), the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, while authorising the placing on the market of medical devices is decentralised to independent 'conformity assessment' organisations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the Medical Device Directive, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details - which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE-MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024. Here, we describe how it may contribute to the development of regulatory science in Europe. Cite this article: EFORT Open Rev 2021;6:839-849. DOI: 10.1302/2058-5241.6.210081

Thromboprophylaxis only during hospitalisation in fast-track hip and knee arthroplasty, a prospective cohort study

OBJECTIVES: International guidelines recommend thrombosis prophylaxis after total hip arthroplasty (THA) and total knee arthroplasty (TKA) for up to 35 days. However, previous studies often have hospital stays (length of stay; LOS) of 8–12 days and not considering early mobilisation, which may reduce incidence of venous thromboembolic events (VTE). We investigated the incidence of any symptomatic thromboembolic events (TEEs) with only in-hospital prophylaxis if LOS ≤5 days after fast-track THA and TKA. DESIGN: A prospective descriptive multicentre cohort study in fast-track THA and TKA from February 2010 to December 2011, with complete 90-day follow-up through the Danish National Patient Registry and patient files. SETTING: 6 Danish high-volume centres with a similar standardised fast-track setup, including spinal anaesthesia, opioid-sparing analgesia, early mobilisation, functional discharge criteria and discharge to own home. PARTICIPANTS: 4924 consecutive unselected unilateral primary THA and TKAs in patients ≥18 years with no preoperative use of continuous ‘potent’ anticoagulative therapy (vitamin K antagonists). EXPOSURE: Prophylaxis with low-molecular-weight heparin or factor Xa-inhibitors only during hospitalisation when LOS ≤5 days. OUTCOMES: Incidence of symptomatic TEE-related, VTE-related and VTE-related mortality ≤90 days postoperatively. RESULTS: LOS ≤5 days and thromboprophylaxis only during hospitalisation occurred in 4659 procedures (94.6% of total). Median LOS and prophylaxis duration was 2 days (IQR 2–3) with 0.84% (95% CI 0.62% to 1.15%) TEE and 0.41% (0.26% to 0.64%) VTE during 90-day follow-up. VTE consisted of five pulmonary embolisms (0.11% (0.05% to 0.25%)) and 14 deep venous thrombosis (0.30% (0.18% to 0.50%)). There were four (0.09% (0.04% to 0.23%)) surgery-related deaths, of which 1 (0.02% (0.00% to 0.12%)) was due to pulmonary embolism, and 6 (0.13% (0.06% to 0.28%)) deaths of unknown causes after discharge. CONCLUSIONS: The low incidence of TEE and VTE suggests that in-hospital prophylaxis only, is safe in fast-track THA and TKA patients with LOS of ≤5 days. Guidelines on thromboprophylaxis may need reconsideration in fast-track elective surgery. TRIAL REGISTRATION: ClinicalTrials.gov: NCT0155772