Kazum, Efi
Martinez-Catalan, Natalia
Caruso, Giovanni
Schofield, Brian A.
Nidtahar, Imen
Zampeli, Frantzeska
Valenti, Philippe
Article History
Received: 18 April 2022
Accepted: 21 July 2022
First Online: 3 August 2022
Declarations
:
: This study was classified as observational (non-interventional) by our local ethics committee Statutory and ethical obligations of observational (non-interventional) studies in France: According to the past Huriet law on biomedical research, and to the current regulation that went into effect in August 2006 (law n°2004–806), such studies do not require prior submission or approval to/from an IRB, and they do not require written consent. There is a current discrepancy on observational studies between the French legal requirements and the editors’ requirements. This observational research on data fulfils current French regulatory and ethical obligations.
: Philippe Valenti and Brian A. Schofield receive royalties for shoulder prosthesis design from FH Orthopedics. All other authors, their immediate family, and any research foundation with which they are affiliated did not receive any financial payments or other benefits from any commercial entity related to the subject of this article.