Ethics
The present study received Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) on 13/05/2019 (no. 16956), received Institutional Review Board (IRB) approval from WIRB Copernicus Group, Inc. (Olympia, WA, USA) on 23/07/2019 for study site Sanford USD Medical Center, Sioux Falls, SD, USA (IRB Tracking Number: 20191931; Study Number: 1263181) and on 29/09/2019 for study site Sanford Orthopedic Sports Medicine Clinic, Fargo, ND, USA (IRB Tracking Number: 20191931; Study Number: 1266705), and was registered at Clinicaltrials.gov on 04/09/2019 (NCT04077190). The first subject was enrolled in the present study on 21/11/2019, and the last subject on 20/03/2020. The present study was closed on 05/05/2022 at study site Sanford Orthopedic Sports Medicine Clinic, Fargo, ND, USA, and on 09/05/2022 at study site Sanford USD Medical Center, Sioux Falls, SD, USA.Written, informed consent to participate was obtained from all subjects.The former study