Received: 16 July 2020
Accepted: 15 September 2021
First Online: 27 October 2021
: Ethical approval was obtained on the 9th of September 2018 and approval of amendments was obtained the 9th of November 2018 from the Ethical Review Board of the Capital Region of Denmark, identifier H-18013145.The study is carried out in accordance with the principles of the Helsinki Declaration. Patients are covered by the patient insurance of Copenhagen University Hospital Hvidovre and Zealand University hospital.All patients will receive verbal and written information concerning the study. The inclusion will take place after a declaration of consent has been obtained. It is the responsibility of the investigator to provide patients with comprehensive verbal and written information of the study, purpose, and potential risks and benefits. Upon inclusion of the patient, he/she will be informed of the scientific aspects of the study. The verbal information follows the content of the written information, which will be reviewed together with the patient where specific content will be elaborated if needed. The verbal information will be tailored according to age, socio-economic status and education of the patient. The investigator in question will ensure that the patient is thoroughly informed. The verbal information is given in undisturbed conditions at a scheduled time in the outpatient orthopaedic clinic. The project manager must ensure that the investigator or other authorized person who is presenting a patient with information is thoroughly informed of the project and professionally qualified to provide information.
: Model consent form and other related documentation given to the participants and authorized surrogates.
: Lipogems® has contributed significantly to the study. The equipment from Lipogems® is delivered free of charge by the company. The company also contributed to the training of the surgeons prior to the start. Lipogems® was not contacted until after the study had been designed and the first approval was granted by the National Ethics Committee. The company has had no influence on the study design or writing of the protocol. The research team has the rights to all data, analysis of the data and final publication. Lipogems® have no rights and/ or decisions in regard to the publication of the results.None of the investigators have financial or other interests in relation to the study.