Goldberg, Andrew J.
Bordea, Ekaterina http://orcid.org/0000-0002-3772-7049
Chowdhury, Kashfia
Hauptmannova, Iva
Blackstone, James
Brooking, Deirdre
Deane, Elizabeth L.
Bendall, Stephen
Bing, Andrew
Blundell, Chris
Dhar, Sunil
Molloy, Andrew
Milner, Steve
Karski, Mike
Hepple, Steve
Siddique, Malik
Loveday, David T.
Mishra, Viren
Cooke, Paul
Halliwell, Paul
Townshend, David
Skene, Simon S.
Doré, Caroline J.
Brown, Rick
Butler, Michael
Chadwick, Carolyn
Clough, Tim
Cullen, Nick
Davies, Mark
Davies, Howard
Doré, Caroline
Goldberg, Andrew
Harries, Bill
Hill, Simon
Khoo, Michael
Loveday, David T.
Makwana, Nilesh
Marquis, Chris
Murty, An
Najefi, Ali
O’Donnell, Paul
Raglan, Martin
Ramaskandhan, Jayasree
Rogers, Mark
Sakellariou, Anthony
Skene, Simon
Smith, George
Smith, Robert
Solan, Matt
Thomas, Rhys
Torres, Paulo
Welck, Matthew
Winson, Ian
Zaidi, Razi
,
Clinical trials referenced in this document:
Documents that mention this clinical trial
Cost-Utility Analysis of Total Ankle Replacement Compared with Ankle Arthrodesis for Patients Aged 50–85 Years with End-Stage Ankle Osteoarthritis: The TARVA Study
https://doi.org/10.1007/s41669-023-00449-4
Funding for this research was provided by:
Health Technology Assessment Programme (12/35/27)
Article History
Accepted: 15 October 2023
First Online: 8 January 2024
Declarations
:
: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme (12/35/27). The trial was sponsored by University College London.
: AJG received a grant from NIHR HTA (12/35/27); has been a paid presenter for Stryker Inc. and Paragon 28; has patents issued, but not relevant to this manuscript; is an American Orthopaedic Foot and Ankle Society, British Orthopaedic Foot and Ankle Society, and National Joint Registry for England board or committee member; is a minor shareholder for Standing CT Company and Elstree Waterfront Outpatients; and holds stock options in X Bolt Orthopaedics. DL is a member of the British Foot and Ankle Society scientific committee. MK has received funding from the NIHR TARVA trial to set-up the trial locally and for the Research Department to collect data. SH is a paid consultant for Stryker Medical and a principal investigator in a long-term follow-up study of Infinity TARs, and has received payments for attending meetings relevant to this study. JB was paid by a UK NIHR HTA grant via UCL as Trial Manager for this project, 2015–2018. ED was paid by a UK NIHR HTA grant via UCL. AB was paid by a UK NIHR HTA grant via his institution, and received consulting fees from Wright Medical and MatOrtho. CB is a Director of the British Orthopaedic Foot and Ankle Society. SD received consulting fees from Wright Medical, Stryker, DePuy and MatOrtho, and was a President of the British Orthopaedic Foot and Ankle Society. SM received an institutional per-patient payment from a UK NIHR HTA grant; received personal fees from EIDO Healthcare for authoring patient information documents; and received travel support from DePuy and Arthrex to attend an educational workshop. PC received royalty assignment fees from Orthosolutions for an unrelated implant, and owns a company providing expert testimonials to lawyers on the management of foot and ankle disorders for use in court cases. PH received payment from Stryker and DJO UK for teaching and training, and was President of the British Orthopaedic Foot and Ankle Society from 2022 to 2023. DT received an institutional payment from a UK NIHR HTA grant; received personal consulting fees, payment for guest lectures and payment for travel support from Stryker; is a National Joint Registry Scientific committee member and British Orthopaedic Foot and Ankle Society member; and holds stock in Standing CT company. CD received an institutional payment from a UK NIHR HTA grant. POD, EB, KC, IH, DB, SB, AM, SS, VM, and MS declare that they have no conflicts of interest.
: Not applicable.
: The code is not publicly available.
: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the London Bloomsbury Research Ethics Committee (14/LO/0807). The committee reviewed and approved the trial protocol and all materials given to prospective participants, including informed consent forms.
: Informed consent was obtained from all individual participants included in the study.
: All data requests should be submitted to the Comprehensive Clinical Trials Unit at UCL at cctu-enquiries@ucl.ac.uk for consideration. Data that underlie the results presented here will be shared on reasonable request, while preserving patient anonymity. (The complete de-identified patient dataset will be made available, upon publication, to researchers whose proposed use of the data has been approved. Requests should be sent to CTU Enquiries at cctu-enquiries@ucl.ac.uk.)
: Conception and design: PC, ED, SD, CD, AJG, IH, MK, VM, AM, POD. Obtaining funding: PC, ED, CD, AJG, IH. Collection and assembly of data: IH, SB, SD, AB, JB, CB, DB, PC, ED, SD, AJG, PH, SH, MK, DL, SM, VM, AM, MS, DT. Analysis and interpretation of the data: EB, AJG, KC, CD. Drafting of the article: EB, AJG, KC, CD. Statistical expertise: EB, KC, SS, CD, AJG. All authors read, critically revised, and approved the final manuscript.