Castellanos Dolk, Daniel
Sarakatsianos, Vasileios
Wörner, Tobias
Östin, Mikael
Cristiani, Riccardo
Kvist, Joanna
Stålman, Anders
Funding for this research was provided by:
Karolinska Institute
Article History
Received: 25 March 2025
Accepted: 3 September 2025
First Online: 13 October 2025
Declarations
:
: Ethical approval for this study has been obtained by the Swedish Ethical Review Authority (reference 2019–03359). The study will be conducted in accordance with the ethical guidelines formulated in the Declaration of Helsinki. Patients will receive complete and adequate oral and written information about the purpose and content of the study, as well as about the possible risks and benefits for the patient. The patient must also be clearly informed of his or her right to discontinue his/her participation in the study at any time. The patient shall receive a copy of the patient information and the signed informed consent form. The data is managed in Capio Artro Clinic's medical record data system and stored on an internal server at Capio Artro Clinic/Sophiahemmet. The processing of data complies with the Health Care Act and applicable rules for confidentiality and data protection. Study records and medical records are available only to those responsible for studies. The patient's right to access their medical records is not affected.The trial involves two well-known surgical procedures with well-established safety profiles; hence no Data Monitoring Committee (DMC) is deemed needed. Both surgical procedures are routinely performed in clinical care at Capio Artro Clinic by experienced surgeons, and no experimental intervention, techniques or devices are being introduced. We do not plan to do any interim analyses that could influence decisions about the modification of the trial, hence reducing the need of a DMC. Safety monitoring will be conducted routinely by the study investigators.The study results will be submitted for various publications in international peer-reviewed journals over the upcoming years. The results will also be disseminated to participants as well as healthcare professional in the field of ACL surgery via newsletters, social media and press release.
: Not applicable. The manuscript does not contain patient information or details.
: The authors declare no competing interests.