Delgrande, Damien
Lonjon, Guillaume
Hardy, Philippe
Schoch, Bradley
Werthel, Jean-David https://orcid.org/0000-0002-1123-1758
Article History
Received: 21 July 2020
Accepted: 17 March 2021
First Online: 26 March 2021
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. Each author certifies that his or her institution approved the human protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research.
: Not applicable
: Neither the article nor portions of it have been previously published elsewhere; the manuscript is not under consideration for publication in another journal and will not be submitted elsewhere; all authors consent to the publication of the manuscript in <i>International Orthopaedics</i>.
: Jean-David Werthel receives royalties for shoulder prosthesis design from FH Orthopedics. Bradley Schoch receives royalties for shoulder prosthesis design from Exactech. The other authors, their immediate families, and any research foundations 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<i>.</i>