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Article History

Received: 21 September 2024

Accepted: 20 November 2024

First Online: 15 January 2025

Declarations

:

: Mainstay Medical (“Mainstay”) funded this trial and compensated all investigators and committee members either directly (consultant fees) or indirectly (payments to institution). Travel expenses related to investigator meetings and training were reimbursed only with prior authorization. Dr. Schwab was the principal investigator for the RESTORE Trial and reports consultant fees and royalties/licenses from Zimmer Biomet, Stryker, and Medtronic, consultant fees from Mainstay Medical and Medicrea, is an executive board member with International Spine Study Group, is a shareholder and has other interests with SeaSpine and VFT Solutions. Dr. K. Patel reports consultant fees from Abbott, Boston Scientific, Biotronik, Mainstay Medical, Vertos, Saluda, SPR Therapeutics, and fiduciary roles as Vice President for the North American Neuromodulation Society and Women Innovators in Pain Medicine, and Director-at-Large for the International Neuromodulation Society. Dr. Langhorst reports consultant fees, honoraria, and meeting support from Mainstay, consultant fees from Vivex, is an advisory/data safety monitoring board member for Vivex, and is a shareholder/holds stock/stock options in Boston Scientific and ATEC Spine. Dr. Heros reports grants, meeting support, and consultant fees from Saluda Medical, grants from Abbott and Ethos Laboratories, meeting support and consultant fees from Mainstay Medical, and consultant fees from Boston Scientific. Dr. Costandi reports grants from Vertos, Medtronic, Vivex, and Saluda. Dr. Moore reports honoraria from Mainstay Medical. Dr. Gilmore reports consultant fees from Mainstay, SPR Therapeutics, Nevro, Nalu, Biotronik, and Saluda, and other interests with SPR Therapeutics. Dr. Chakravarthy reports consultant fees and shareholder/stock options/stock from Mainstay. Dr. Tate reports consultant fees from Nevro, Saluda, Curonix, Vivex, Abbott, Medtronic, and Vertos, honoraria from the Virginia Pain Society and Georgia Society of Interventional Pain Practitioners, board memberships in Women Innovators in Pain Medicine and American Society for Pain and Neuroscience, and secretary of Georgia Society of Interventional Pain Practitioners. Dr. Sanders reports consultant fees and educational event support from Mainstay Medical and Vertos. Dr. Goree reports consultant fees from Saluda, Abbott, and Stratus Medical. Dr. V. Patel reports consultant fees from Mainstay, grants from Orthofix, Pfizer, Premia Spine, Medicrea, Globus, 3-Spine, and Spinal Kinetics, contracts and grants from Aesculap and Medtronic, contracts from Zimmer Biomet Spine, Inc., Johnson & Johnson Medical Device Business Services, NCS America, Simplify Medical, SI Bone, Orthobond Corp., Cerapedics, consultant fees from Spine Welding, SI Bone, expert testimony for Ogborn Mihm, LLP Expert Witness Deposition, and educational event support from Ecential Robotics and Johnson & Johnson Medical. Dr. Lehmen reports consultant fees, honoraria, and meeting support from Mainstay and Globus Medical-NuVasive. Dr. Desai reports royalties/licenses from Nevro, consultant fees from Medtronic, Nalu, and SPR Therapeutics, data safety monitoring/advisory board membership with FUSMobile, shareholder/stock/stock options in HypreVention, SPR Therapeutics, SynerFuse, and Virdio Health. Dr. Pope reports consulting fees, honoraria, research grants, educational support, and shareholder/stock options/stock from Abbott and Saluda, research grants, honoraria, royalties/license, consulting fees and shareholder/stock options/stock from Aurora, research grant from AIS, research grants, consulting fees, and honoraria from Boston Scientific, Flowonix, Ethos, Mainstay Medical, Muse, grants, consulting fees, honoraria, and shareholder/stock options/stock from Painteq, SPR Therapeutics, Theraquil, Vertos, consulting fees and honoraria from Medtronic, Tersera, Vertiflex, and WISE, consulting fees, honoraria, and shareholder/stock options/stock from Spark and SpineThera, shareholder/stock options/stock from Anesthetic Gas Reclamation, Axonics, Celeri Health, Pacific Research Institute, and Stimgenics, royalties/licenses and shareholder/stock options/stock from Neural Integrative Solutions, royalties/licenses from Elsevier and Springer, a patent for Neuronmonitoring, and fiduciary roles as Chairman for Pacific Spine and Pain Society and immediate past president of the American Society for Pain and Neuroscience. Dr. Giuffrida reports consultant fees, medical writing support and a medical advisory board membership from Mainstay, and executive board membership for the American Society of Pain and Neuroscience. Dr. Hayek reports payment for expert witness defense testimony, data safety/monitoring board membership on three non-industry funded studies, and was 2022–2023 past president of North American Neuromodulation Society. Dr. Virk reports research/educational event support from Mainstay, and consultant fees and research support from LifeSpine. Dr. Paicius reports consulting fees from Abbott and Biotronik; Dr. Mekhail functioned as independent medical monitor of the RESTORE trial has a consultancy agreement with Mainstay Medical. Dr. Levy reports unpaid consultancies with Abbott, Biotronik, Nalu, and Saluda, and stock options with Nalu and Saluda. Dr. Gilligan reports consultant fees from Mainstay Medical, Saluda, Persica, Iliad Lifesciences, and Biotronik, expert witness testimony payment, and fiduciary roles as Editor in Chief of Pain Practice, finance committee member for North American Neuromodulation Society, and on the board of directors for International Neuromodulation Society. Drs. Gentile, Bundy, Manion, and Klemme report consultant fees from Mainstay Medical. Drs. Meyer, Vaid, and Szentirmai have no other disclosures.

: The RESTORE trial followed the principles of the Declaration of Helsinki of 1964 and its later amendments and Good Clinical Practice (GCP). The WCG IRB acted as the Central IRB (RN#20,211,219) for most sites while other sites had local IRB approval prior to enrollment of patients. All patients provided written informed consent to participate in the trial.