Document is current
Any future updates will be listed below
-
Authors
Elazaly, Hisham
Dimitriou, Ioanna Maria
Maleitzke, Tazio
Dahne, Michael
Jaecker, Vera
Maerdian, Sven
Tafelski, Sascha
Diekhoff, Torsten
Lindner, Tobias
Akgün, Doruk
Mielke, Anna-Maria
Paksoy, Alp
Amini, Dominik Adl
Planatscher, Elisa Marie
Leopold, Vincent
González-Khatib, Susana
Köhli, Paul Christoph
Niemann, Marcel
Hildebrandt, Alexander
Oehme, Stephan
Palmowski, Yannick
Paraskevaidis, Melissa
Schönnagel, Lukas
Braun, Sebastian Benedict
Pumberger, Matthias
Hardt, Sebastian
Stricker, Sigmar
Akyüz, Levent
Grütz, Gerald
Schaller, Stefan
Lauterbach, Luis
Volcksdorff, Maximilian
Mödl, Lukas
Textor, Martin
Ort, Melanie
Reinke, Simon
Stöckle, Ulrich
Perka, Carsten
Duda, Georg N.
Schmidt-Bleek, Katharina
Geissler, Sven
Winkler, Tobias
-
Funding
Funding for this research was provided by:
Charité - Universitätsmedizin Berlin
- License Information
-
More Information
Article History
Received: 18 February 2025
Accepted: 27 April 2025
First Online: 22 May 2025
Declarations
:
: This study is being conducted in Germany. The recruiting center is located in Berlin at the Center for Musculoskeletal Surgery of the Charité– Universitaetsmedizin Berlin. The trial is conducted according to the ethical principles of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the General Assembly of the World Medical Association (1996), and is consistent with the ICH-GCP and applicable regulatory requirements. The trial sponsor is Charité– Universitaetsmedizin Berlin. Ethical approval was obtained from the ethics committee of Landesamt für Gesundheit und Soziales (LAGeSo) Berlin (Reference number 19/0132 - EK Mi) and was further approved by the Federal Institute for Drugs and Medical Devices (submission number: 4043778) (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)), which are the relevant competent authorities. Study amendments will be referred to the concerned Ethics Committee and/or competent authority (BfArM) for approval or notification, depending on the exact nature of the amendment. According to the new regulations, all amendments will be submitted through the Clinical Trials Information System (CTIS).
: Not applicable. No identifying images or other personal or clinical details of the participants are presented here or will be presented in reports of the trial results.
: The authors declare no competing interests.
