Klotz, Rémi
Emile, Guilhem
Daviet, Jean-Christophe
De Sèze, Mathieu
Godet, Julien
Urbinelli, Renaud http://orcid.org/0000-0001-9661-6755
Krasny-Pacini, Agata
Funding for this research was provided by:
Össur
Article History
Received: 31 August 2022
Accepted: 25 June 2023
First Online: 14 July 2023
Declarations
:
: This protocol of the study (version 2) was approved by the French Committee for the Protection of Research Participants “CPP SUD MÉDITERRANÉE 1”, (i.e. official French Institutional Review Board) on July 20, 2020 (2020-A01309-30), and by the French Health Products Safety Agency (ANSM) on June 26, 2020 (2020-A01309-30)Each patient will sign an informed consent, the consent will be collected by each main investigator of the center.
: Not applicable.
: In accordance with BMC Sports Science, Medicine and Rehabilitationpolicy and ethical obligation as a researcher, Dr. Krasny-Pacini is reporting that she is a consultant to Ossür for designing the study and for presenting the N-of-1 trial methodology to the French High Authority of Health but is not linked to a results obligation. M. Urbinelli is reporting that he is a consultant to Ossür for managing the clinical trial. No potential competing interest was reported by the others authors.