Böpple, Jessica C.
Tanner, Michael
Campos, Sarah
Fischer, Christian
Müller, Sebastian
Wolf, Sebastian I.
Doll, Julian http://orcid.org/0000-0002-8563-3493
Funding for this research was provided by:
Ruprecht-Karls-Universität Heidelberg
Article History
Received: 13 September 2021
Accepted: 12 December 2021
First Online: 8 January 2022
Declarations
:
: Ethical approval was obtained by the Ethics Committee of the University of Heidelberg Medical Faculty prior to the beginning of the study (Ethikkommission I der Medizinischen Fakultät Heidelberg, S-402/2009).This trial was registered in the German Clinical Trials Register (DRKS) in Freiburg, a primary registry within the WHO Registry Network, Germany, on 21 January 2021 with the trial registration number DRKS00023379.The trial was conducted at our Center for Orthopedics and Trauma Surgery in the context of Good Clinical Practice and in accordance with the Declaration of Helsinki.Written informed consent were obtained from each patient. In the event that a patient’s physical or mental health was jeopardized because of participation in the present study, the patient was dismissed immediately and excluded from the study. Before inclusion into the trial, participants were informed both orally and in writing about all relevant aspects of the trial (e.g. aims, methods, anticipated benefits, potential risks of the study and possibly entailed discomfort). Participants must be at least 18 years of age and provide written informed consent. They have to be able to understand the character and individual consequences of the clinical trial. The participants’ free decision to participate was documented by signature on the informed consent form.All patient-related information is subject to medical confidentiality and to medical secrecy, the European General Data Protection Regulation (DSGVO — Datenschutz-.Grundverordnung), the Federal Data Protection Act (Bundesdatenschutzgesetz) and the State Data Protection Act (Landesdatenschutzgesetz). Third parties will not have any insight into original data.
: Not applicable. This manuscript does not contain data from any individual person.
: The authors declare that they have no competing interests in this section.