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Background: Minimally invasive approaches to the hip joint for total hip arthroplasty such as the DAA ("Direct Anterior Approach with bikini incision") are increasingly utilized. According to the literature, this approach is more muscle-sparing, results in less postoperative pain, and achieves higher patient satisfaction. The existence of postoperative lymphedema after hip arthroplasty is hardly considered. The aim of this paper is to contribute to the evaluation of the different access methods related to postoperative lymphedema and their functional outcomes. Methods: This is a prospective non-randomized study at an orthopedic specialist clinic in Northern Europe. The surgeons that performed the arthroplasties are high-volume surgeons in private practice affiliated to the clinic. The study included 188 patients with primary hip arthroplasty in a 1:1 ratio (DAA: standard accesses (posterior, transgluteal, and anterolateral access)). Epidemiologic data, Harris Hip Score, Oxford Hip Score, European Quality of Life 5, and Visual Analog Scale were collected preoperatively on admission day, 3rd and 5th postoperative day, and follow-up after 1 year. Furthermore, the range of motion, gait, and ability to climb stairs, as well as the presence of hypesthesia were assessed. To evaluate the edema situation, both legs were measured on the 3rd and 5th postoperative day. The prescription of manual lymphatic drainage and remaining swelling conditions 1 year postoperatively were recorded. Results: For each group, 94 patients with a mean age of 61.7 years (DAA 60.7 and standard access 62.6) were included. All but one patient in the DAA group showed postoperative lymphedema (n: 93/94; 98.9%). In the standard surgery group, only n: 37/94 (39.4%) showed swelling symptoms requiring treatment. After 1 year, lymphedema persisted in 20 patients in the DAA group and 0 patients in the standard-OR group. Hypesthesia at the ventral thigh persisted in 16/94 (= 17%) patients of the DAA group versus 0/94 patients of the standard group after 12 months. Of these 16 cases, 10 had concomitant edema (62.5%). The DAA showed better results than the standard accesses in terms of Oxford Hip Score (p < 0.05) and ability to climb stairs (p < 0.05). In contrast, the Visual Analog Scale and patient quality of life results showed no significant difference (p > 0.05). Conclusion: The present study demonstrated the increased incidence of postoperative lymphedema in patients operated on via DAA access using a Bikini-type skin incision. In the follow-up, significantly more hypesthesia of the ventral thigh occurred in the DAA group. Otherwise, the DAA proved to be superior to the standard approaches from a functional point of view at short-term follow-up. Future research is needed to compare the horizontally oblique to the longitudinal oblique skin incision technique in direct anterior hip surgery regarding the above-mentioned adverse effects found in this study. [ABSTRACT FROM AUTHOR]

Background: The new European Medicines Agency (EMA) Clinical Trials Information System (CTIS), based on the Clinical Trials Regulation (CTR EU 536/2014), came into full effect on 31 January 2022 and was intended to provide an easier, more streamlined approach to the registration of clinical trials taking place in Europe. Using the experience gained on the new regulatory framework from three multi-national European clinical research studies of outbreak-prone infectious diseases, this article describes the advantages and shortcomings of the new clinical trial submission procedure. Methods: We report the time to approval, size of the application dossier, and number of requests for information (RFIs) for each study. We also explore the experience of each study within the regulatory framework and its use of CTIS to document the real-world, practical consequences of the system on individual studies. The study assesses the experience of three multi-country studies conducted in Europe working within the EU and non-EU regulatory environments. Results: While the time to regulatory and ethical approval has improved since the implementation of the new regulation, the timelines for approvals are still unacceptably slow, particularly for studies being conducted in the context of an evolving outbreak. Within the new regulatory approval procedure, there is evidence of conflicting application requirements, increased document burden, barriers to submitting important modifications, and debilitating technical hurdles. Conclusions: CTIS promised to lower the administrative bar, but unfortunately this has not been achieved. There are challenges that need to be urgently confronted and addressed for international research collaborators to effectively manage health crises in the future. While the value of multi-national outbreak research is clear, the limitations and delays imposed by the system, which raise challenging ethical questions about the regulation, are prejudicial to all clinical research, especially publicly funded academic studies. This report is relevant to both regulators and clinical researchers. It is hoped that these findings can help improve pan-European clinical trials, especially for the purpose of epidemic preparedness and response. Trial registration: This paper references experiences gained during management of three pan-European trials: EU-SolidAct's Bari-SolidAct (CT No. 2022-500385-99-00 - 15 March 2022) and AXL-SolidAct (CT No. 2022-500363-12-00 - 19 April 2022), and MOSAIC (CT No. 2022-501132-42-00 - 22 June 2022). [ABSTRACT FROM AUTHOR]