Ethics approval and consent to participate
All investigative sites obtained approval from their corresponding ethics committees prior to data collection. All sites required patients to sign the approved informed consent document prior to participating in the study.
Consent for publication
Not applicable.
Availability of data and materials
All data generated or analyses during this study are included in this published article. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Competing interests
Prof Edward T. Davis, MB, ChB, MSc, PGCME, FRCS(T&O) reports research funding and payment as speaker for Smith & Nephew, Inc. All other authors declare no potential competing interests. All other authors declare they have no potential competing interests.
Funding
The study was funded by Smith & Nephew, Inc.
Author’s Contributions
Prof Edward T. Davis, MB, ChB, MSc, PGCME, FRCS(T&O): Acquisition of data, revising the manuscript critically for important intellectual content, approval of the final submitted version of the manuscript to be published, agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Ville Remes, MD, PhD: Conception and design of study, acquisition of data, revising the manuscript critically for important intellectual content, approval of the final submitted version of the manuscript to be published, agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Petri Virolainen, MD, PhD: Conception and design of study, acquisition of data, analysis or interpretation of data, revising the manuscript critically for important intellectual content, approval of the final submitted version of the manuscript to be published, agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Peter Gebuhr, MD: Acquisition of data, revising the manuscript critically for important intellectual content, approval of the final submitted version of the manuscript to be published, agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Bart Van Backlé MD: Acquisition of data, revising the manuscript critically for important intellectual content, approval of the final submitted version of the manuscript to be published, agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Matthew P. Revell, MBA,FRCS: Acquisition of data, revising the manuscript critically for important intellectual content, approval of the final submitted version of the manuscript to be published, agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Branko Kopjar, M.D., M.S., Ph.D., FACE, FAcadTM: Revising the manuscript critically for important intellectual content, approval of the final submitted version of the manuscript to be published, agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Trial registration
ClinicalTrials.Gov, NCT03566082, Registered 10 January 2018 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03566082
Acknowledgements
The authors wish to thank the following surgeons for their contribution to this study:
Lucien CM Keijser, MD, PhD
Northwest Clinics Alkmaar
Noordwest Ziekenhuisgroep
Department of Orthopaedic Surgery
Wilhelminalaan 12
1815 JD Alkmaar, The Netherlands
Tel: +31 725482518
[email protected]
Pablo Diaz-Freire, MD
Orthopaedic Surgeon, Hip Unit
Department of Orthopaedic Surgery and Traumatology
Hospital Universitario La Paz
Madrid, Spain
[email protected]
Enrique Gil-Garay, MD, PhD
Professor of Orthopaedic Surgery, Facultad de Medicina
Universidad Autónoma de Madrid
Department of Orthopaedic Surgery and Traumatology
Hospital Universitario La Paz
Madrid, Spain
[email protected]
As well as Karen K. Anderson, Nor Consult, LLC for providing medical writing and editing services.