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Article History

Received: 16 November 2019

Accepted: 23 June 2020

First Online: 2 July 2020

Ethics approval and consent to participate

: 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-454/2017).This trial was registered in the German Clinical Trials Register (DRKS) in Freiburg, a primary registry within the WHO Registry Network, Germany, on 07 December 2017 with the trial registration number DRKS00013562.The trial will be conducted at our Center for Orthopedics and Trauma Surgery in the context of Good Clinical Practice and in accordance with the Declaration of Helsinki.The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist for the implementation of study protocols was followed (Fig.  and Additional file ) [, ].Written informed consent will be obtained from each patient. In the event that a patient’s physical or mental health becomes jeopardized because of participation in the present study, the patient will be dismissed immediately and excluded from the study. All protocol modifications will be registered with the DRKS, published in the final paper and communicated to the participants. Before inclusion into the trial, participants will be 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 will be 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.