Mantel, Jack
Ruppenkamp, Jill W.
Cantu, Maricruz
Holy, Chantal E.
Funding for this research was provided by:
Johnson and Johnson
Article History
Received: 1 February 2023
Accepted: 24 March 2023
First Online: 4 April 2023
Declarations
:
: All data in the Premier Healthcare Database being deidentified, the use of these data for this study is exempt from Institutional Review Board oversight as dictated by Title 45 Code of Federal Regulations, Part 46 of the United States, specifically 45 CFR 46.101(b)(4). In addition, in accordance with the HIPAA Privacy Rule, disclosed data from the PHD are considered deidentified per 45 CFR 164.506(d)(2)(ii)(B) through the “Expert Determination” method. All methods were conducted in accordance with relevant guidelines and regulations. Experimental protocols were drafted and approved by all co-authors and the MedTech Epidemiology research team within Johnson & Johnson, prior to the conduct of the study.
: Not applicable – no identifiable patient-level data are included in this publication.
: JM and MC are employees of DePuy Synthes. JWR and CEH are employees of Johnson & Johnson (JNJ). The Attune Knee System described in this paper is a DePuy Synthes device. DePuy Synthes is a JNJ company.