Yilmaz, Müjgan https://orcid.org/0000-0002-1822-0453
Thorn, Andrea
Sørensen, Michala Skovlund
Jensen, Claus Lindkær
Petersen, Michael Mørk
Funding for this research was provided by:
Rigshospitalet
Article History
Received: 9 August 2021
Accepted: 9 June 2022
First Online: 18 June 2022
Declarations
:
: Approval from the Scientific Ethical Committee of the Capital Region of Denmark (H-21013549) and the Danish Data Protection Agency (P-2021-150) has been obtained, and the study is registered at (NCT04960332) before the inclusion of patients. All patients will receive both oral and written information before written informed consent to participate is obtained.This trial will follow the ethics outlined in the Helsinki declaration [].Knowledge from our study will benefit society in general and optimize utilization of resources, in terms of the best treatment for future patients.In case of serious adverse preliminary results, data will be analyzed, and if one of the treatments is found to cause significant critical problems compared to the other (<i>p</i> < 0.05), the study will be ended. The study is thus designed to minimize unnecessary risks to the patients.If any modification in the protocol is necessary, supplement approval from the Scientific Ethical Committee and Danish Data Protection Agency is needed to be obtained, and registration on as well as patients included is needed to be updated.All results, whether positive, negative, and inconclusive from the trial, will be published in leading international peer-reviewed scientific orthopedic journals and also be presented at scientific meetings. Furthermore, all results will also be presented at local meetings.
: All authors give consent for the publication, and the ICMJE Form for Disclosure of Potential Conflicts of Interest [] will be completed by each author.
: The authors declare that they have no competing interests.