Injury
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The aim of the study was to propose a classification system of posterior malleolar fractures by fracture lines with the use of CT scans, including 3D CT reconstruction, which can better understand morphological characteristics, analyze the mechanism and guide the surgeon to choose the optimal approach and fixation. ⋯ The morphology of posterior malleolar fractures, involvement of the fibular notch, or the medial malleolus can be obviously assessed by our classification system. We found the relation of the injury mechanism between type 1 and type 2 by comparing the area of the fragment. We have indicated that each type of fracture corresponds to its associated injury mechanism and which surgical approach and fixation can be chosen.
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Ankle fracture surgery comes with a risk of fracture-related infection (FRI). Identifying risk factors are important in preoperative planning, in management of patients, and for information to the individual patient about their risk of complications. In addition, modifiable factors can be addressed prior to surgery. The aim of the current paper was to identify risk factors for FRI in patients operated for ankle fractures. ⋯ Level III retrospective case-control study.
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Prehospital trauma systems are designed to ensure optimal survival from critical injuries by triaging and transporting such patients to the most appropriate hospital in a timely manner. ⋯ In the context of an inclusive trauma system and an established prehospital major trauma protocol, increasing prehospital transport times and scene location were not associated with increased mortality.
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Pediatric proximal tibial fractures (PTF) are rare but potentially debilitating. So far, no system for guiding surgical treatment based on injury-force mechanism has been documented, while adult tibial plateau fractures have benefited greatly from such an approach. This study reviews the diagnosis and treatment experience at a tertiary trauma center and introduces the reduction-traction method. ⋯ Pediatric PTF has a bimodal distribution with high risk before three years and after 15 years. The injury-force classification can supplement the Salter-Harris classification in guiding surgical treatment. The "reduction-traction" approach in children differs from adults, and results in good outcomes.
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In May 2021, the new Medical Device Regulation in the EU came into force. While the US has a centralized governmental authority, the Food and Drug Administration (FDA), the EU implemented a system of different Notified Bodies responsible for the approval process of medical devices. Both regions have a similar system to classify medical devices based on their overall risks but specific devices, like joint prostheses, are classified differently in the US and the EU. ⋯ In both regions, it is possible to place a new device on the market based on the demonstration of equivalence to an already marketed device, but the MDR significantly increased the regulatory requirements for the equivalence pathway. While an approved medical device in the US in most cases only requires general post-market surveillance activities, manufacturers in the EU must continuously collect clinical data and submit specific reports to the Notified Bodies. In this article, we will compare the regulatory requirements between the US and Europe and provide an overview of similarities and differences.