Kuklinski, David
Oschmann, Laura
Pross, Christoph
Busse, Reinhard
Geissler, Alexander
Funding for this research was provided by:
Innovationsfond des Gemeinsamen Bundesausschusses (01NVF18016)
Article History
Received: 4 February 2020
Accepted: 13 March 2020
First Online: 9 April 2020
Ethics approval and consent to participate
: The study was approved by the lead Charité Ethics Committee, Berlin (EA4/169/19). Assent was given by the other responsible ethical review committees (Medical Association Hamburg, Medical Association Schleswig-Holstein, Hannover Medical School, Friedrich-Schiller University Jena, and the Medical Association Brandenburg). The study is registered at the German Clinical Trials Register (DRKS) under DRKS00019916. All potentially eligible participants will be approached to offer their informed consent to participate in the study. Additionally, they can accept to release their hospital administrative data in an optional consent form. For patients insured by participating sickness funds, a third consent form is handed out to ask for permission to process their insurance claims data at the end of the study period. Patients will be free to withdraw from either of the three consents without stating a reason. If the patients withdraw from the consent for participation, all their data will be deleted.
: Material in this article is not subject to publication restrictions.
: CP is contracted full-time with Stryker Corporation, a medical technology company that also produces knee and hip implants. The other authors declare that they have no competing interests.