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Article History

Received: 29 May 2024

Accepted: 10 December 2024

First Online: 20 December 2024

Declarations

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: The present study will be conducted according to the Helsinki II declaration, the Danish Health Act, and The Act on Processing of Personal Data. Approval of the study will be sought using CTIS seeing that it is a clinical trial involving medical drugs. This definition is written and updated by The Danish Medicine Agency and can be found on their website. The Danish Medicine Agency and the National Committee on Health Research Ethics are applied for approval simultaneously in CTIS. Furthermore, the study needs to be approved by The Danish Data Protection Agency. The principal investigator will inform the National Committee on Health Research Ethics and The Danish Medicine Agency if any significant changes are made to the protocol. The project is also registered on ClinicalTrials.gov. The study will only be initiated when all relevant approvals have been granted and the initiation visit by the GCP unit has been completed.Any participating patient must provide informed both oral and written consent before inclusion. The principal investigator or sub-investigator is obligated to inform patients of any aspects regarding participation in the study. All data will be treated confidentially. Any involved personnel is subject to professional secrecy. Reporting of study data will be anonymized using patient study numbers which will be assigned upon inclusion. The sponsor and principal investigator assure direct access to data or documents and allow monitoring, auditing, and inspections from The Danish Medicine Agency and GCP unit. The principal investigator ensures that the study meets GCP criteria. The authors declare no conflict of interest and regardless of the study outcome, the results will be published in an internationally recognized peer-reviewed medical journal.The inclusion of patients meets the criteria regarding the rights of a subject as written by the National Committee on Health Research Ethics. Patients must provide both oral and written informed consent before inclusion and are informed of their right to have an assessor. They are informed of any aspects of the study which also include risks and side effects. They will be given 2 h of consideration before consent is obtained. Patients receive information from and are recruited by orthopedic doctors. Furthermore, consent to participation can be withdrawn at any time without affecting the patient or the quality of treatment. Patients can obtain insight to study results after completion if they tick off the field regarding study results in the statement of consent. Any patient who has ticked off the field will receive a link to the final publication through a message in e-Boks.

: By submitting this protocol for publication, the authors hereby consent to the dissemination and publication of the protocol, including all its contents, in the chosen journal or other publication medium. The authors acknowledge that the protocol contains details of a randomized controlled trial (RCT) and understand that publication of this protocol may lead to the dissemination of sensitive or confidential information related to the trial, including study design, intervention methods, outcome measures, and data analysis plans.The authors grant permission to the journal or publication medium to reproduce, distribute, and publicly display the protocol, in whole or in part, in print or electronic format, including but not limited to publication in online repositories, databases, and indexing services. Furthermore, the authors affirm that they have obtained all necessary permissions, approvals, and clearances required for the publication of this protocol, including any ethical approvals from relevant ethics committees, and have complied with all applicable regulations and guidelines governing the conduct of clinical trials and publication of trial protocols.The authors understand that publication of the protocol does not imply acceptance or endorsement of the study findings and that subsequent publication of trial results will be subject to separate review and editorial processes. We can provide a model consent form on request.

: All authors declare no competing interests. Study personnel and site had no economic interests in completing the study.