Funding for this research was provided by:
Toyota (KJ/BG-9303 H)
Sundhed, Region Midtjylland
Received: 28 February 2020
Accepted: 19 April 2020
First Online: 12 May 2020
Ethics approval and consent to participate
: The participating centers of the study are all familiar with both operative and non-operative treatment of acute Achilles tendon rupture. The participants enrolled will not be subject to any extraordinary inconvenience because both operative and non-operative treatment of acute Achilles tendon rupture is currently standard treatment. We just do not know who will benefit the most from each of the treatments.We believe that the potential benefits for the participants enrolled in the study (improved health-related well-being due to closer follow-up) exceed the potential inconveniences (time-consuming additional follow-up audits and possible risks/side effects).It is a disadvantage for the participant to attend extended follow-up examinations after 6 months and 12 months. On the other hand, this will ensure that the participant receives a thorough follow-up and examination during the healing process.The study is carried out in accordance with the principles of the Helsinki Declaration.The protocol (second version), as well as the patient information and declaration of consent, was approved by the National Committee on Health Research Ethics (journal number 1–10–72-428-17), ExternalRef removed NCT03525964.The project manager is responsible for informing the National Committee on Health Research Ethics of any critical adverse event and/or major changes of the protocol. The project manager will file all correspondence.All participants receive verbal and written information concerning the study. Inclusion takes place after a declaration of consent is obtained. It is the responsibility of the investigators to provide patients with comprehensive verbal and written information concerning the course of the study, purpose, potential risks, and benefits.Upon including a participant, he/she will be informed of the scientific aspects of the study, that he/she has the right to bring a lay representative to the first information meeting, and that he/she has the right to 24 h of reflection after receiving verbal and written information about the study.The verbal information follows the content of the written information, which will be reviewed together with the participant where specific content will be elaborated on if needed. The verbal information is tailored according to age, social conditions, and educational level of the patient. It will be ensured by the investigator in question that the patient is thoroughly informed of the contents of the study.The verbal information is given under undisturbed conditions at a scheduled time in the outpatient clinic by a doctor or physiotherapist.
: All patients are giving written consent for publication.
: DJO Global has made a significant contribution to the trial. The company has not at any time shown a special interest in the trial design or any other vital part of the project. The authors do not recognize that one outcome would be more beneficial than the other for DJO. Based on this, DJO’s incentives to influence the study is believed to be non-existent. None of the authors have other competing interests in relation to the study.