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Authors
Rosenstock, Tizian https://orcid.org/0000-0002-0620-9118
Picht, Thomas https://orcid.org/0000-0002-8630-1466
Engelhardt, Melina https://orcid.org/0000-0002-2921-6329
Grittner, Ulrike https://orcid.org/0000-0003-2595-0224
Mönch, Maximilian https://orcid.org/0009-0006-6267-5400
Vajkoczy, Peter https://orcid.org/0000-0003-4350-392X
Lavrador, José Pedro https://orcid.org/0000-0002-9518-111X
Mirallave-Pescador, Ana
Vergani, Francesco https://orcid.org/0000-0002-8820-9268
Schwendner, Maximilian https://orcid.org/0000-0001-7380-9992
Schroeder, Axel https://orcid.org/0000-0001-7014-7751
Kram, Leonie
Zhang, Haosu
Prabhu, Sujit https://orcid.org/0000-0002-8155-0623
Prinsloo, Sarah https://orcid.org/0000-0003-3078-4558
Meyer, Bernhard https://orcid.org/0000-0001-6486-7955
Ille, Sebastian https://orcid.org/0000-0003-2065-6464
Krieg, Sandro M. https://orcid.org/0000-0003-4050-1531
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Funding
Funding for this research was provided by:
Medizinische Fakultät Heidelberg der Universität Heidelberg
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Article History
Received: 21 November 2024
Accepted: 26 December 2024
First Online: 23 January 2025
Declarations
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: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organization for the submitted work.BM received honoraria, consulting fees, and research grants from Medtronic (Meerbusch, Germany), Icotec AG (Altstätten, Switzerland), and Relievant Medsystems Inc. (Sunnyvale, CA, USA); honoraria, and research grants from Ulrich Medical (Ulm, Germany); honoraria and consulting fees from Spineart Deutschland GmbH (Frankfurt, Germany) and DePuy Synthes (West Chester, PA, USA); and royalties from Spineart Deutschland GmbH (Frankfurt, Germany). SK is a consultant for Ulrich Medical (Ulm, Germany) and Need Inc. (Santa Monica, CA, USA). TP, SK, SI and BM are consultants for Brainlab AG (Munich, Germany).SI, TP, and SK received honoraria from Nexstim Plc (Helsinki, Finland) for a webinar. TP received research grants from Carl Zeiss Meditec (Oberkochen, Germany) and Olympus Corporation (Center Valley, PA, USA).However, all authors declare that they have no conflict of interest regarding the materials used or the results presented in this study. All authors declare no other relationships or activities that could appear to have influenced the submitted work.
: We performed the study in accordance with the Declaration of Helsinki. There were 4 centers involved in this study: Charité – Universitätsmedizin Berlin (I), Technical University of Munich (II), King’s College Hospital, London (III), MD Anderson Cancer Center (IV). The study was conducted as an RCT at 2 sites (I; II), with the study transitioning to a single-arm study at one site after recruitment completion (II). All included patients provided written informed consent at each center. Local ethics boards reviewed and approved the study protocol (registration numbers: Munich NCT03982329 and 12/15, Berlin EA4/132/15, London: 20230701NCR; Houston: NCT03606161).
: Munich: NCT03982329, Local institutional registration: 12/15; Berlin: Deutsches Register für klinische Studien (DRKS00010043), Ethics Committee of the Charité (EA4/132/15); London: Local institutional registration 20230701NCR; Houston: NCT03606161.
