Clement, Nick D. https://orcid.org/0000-0001-8792-0659
Bardgett, Michelle
Galloway, Steven
Baron, Y. Jenny
Smith, Karen
Weir, David J.
Deehan, David J.
Funding for this research was provided by:
Stryker
Article History
Received: 2 May 2021
Accepted: 11 December 2021
First Online: 22 January 2022
Declarations
:
: Ethical approval was obtained by the Tyne & Wear South Research Ethics Committee, UK (reference /NE/0027). The study is sponsored by the Newcastle Hospitals NHS Foundation Trust (NUTH R&D: 8822). The CI will ensure that this study is conducted in accordance with the principles of the Declaration of Helsinki. The Investigator will ensure that this study is conducted in full conformity with relevant regulations and with the ICH Guidelines for Good Clinical Practice (CPMP/ICH/135/95) July 1996. Informed written consent will be obtained from participants wishing to enrol to the study on site and prior to data collection. Consent to use the data collected for scientific reporting and publication will also be obtained at the same time as the consent to participate
: The findings of this research will be published in peer-review journals. All study patients will provide informed consent for publication of anonymised patient data and study findings. Authorship will reflect the amount of time spent designing the study, collating the data, analysing the results, and writing the manuscript.
: The authors declare that they have no competing interests.