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Article History

Received: 27 November 2024

Accepted: 24 April 2025

First Online: 1 May 2025

Declarations

:

: All patients provided informed consent. The study was reviewed and approved by an independent institutional review board (IRB), Sterling IRB (Atlanta, GA, USA). The trial was conducted in accordance with the Declaration of Helsinki and prospectively registered at ClinicalTrials.gov on December 30, 2021 (NCT05201287).

: Not applicable.

: DPB is a scientific advisor to Vivex Biologics; received grants or contracts from Medtronic, Medical Metrics, Avanos, Relievant, Boston Scientific, Stryker, Sollis Pharmaceuticals, Simplify Medical, Lenoss Medical, Spine BioPharma, Eliem Therapeutics, Smart Soft, Tissue Tech, Vivex, Stratus Medical, Restorative Therapies, Kolon, TissueGene, Companion Spine, DiscGenics; royalties from VIVEX and IZI; consulting fees from Medtronic, Spineology, Merit Medical, Johnson & Johnson, IZI, Techlamed, Peterson Enterprises, Medical Metrics, Avanos, Boston Scientific, Sollis Pharmaceuticals, Simplify Medical, Stryker, Lenoss Medical, Spine BioPharma, Piramal, ReGelTec, Nanofuse, Spinal Simplicity, Pain Theory, Spark Biomedical, Micron Medical Corp, Bronx Medical, Smart Soft, Tissue Tech, RayShield, Stayble, Thermaquil, Vivex, Stratus Medical, Genesys, Abbott, Eliquence, SetBone Medical, Amber Implants, Cerapedics, Neurovasis, Varian Medical Systems, Companion Spine, DiscGenics, Discure, SpinaFX, PainTEQ; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Artio, Sophiris, Eleven Biotherapeutics, Flow Forward, Lenoss Medical, ReGelTech, Spark Biomedical; and support for attending meetings and/or travel from Medtronic, ReGelTec, Nanofuse, Talosix, Spinal Simplicity, Pain Theory, Spark Biomedical, Smart Soft, Tissue Tech, Bronx Medical, Thermaquil, Vivex, Genesys, SetBone Medical, Amber Implants, Cerapedics, SpinaFX. TTD received consulting fees from Abbott, Boston Scientific, Biotronik; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Abbott, Boston Scientific, Biotronik. RKN received consulting fees from Vivex, Boston Scientific, Ferring Pharmaceuticals. MJD is a scientific advisor to Vivex Biologics; received grants or contracts from Spine BioPharma, Restorative, Novartis, SPR, Saol, Paradigm; royalties from Springer; patents from iSpine Ingenuity. SC received grants or contracts from the Cleveland Clinic. ESY received consulting fees from Neurovasis. JWF received support for attending meetings and/or travel from Medtronic, Stryker, Nevro, Seattle Science Foundation, HMP Global, American Society of Neuroradiology, American Society of Spine Radiology; received stock or stock options from BackTable LLC. JEB received support for medical writing from Vivex Biologics; consulting fees from Vivex. NM received consulting fees from Vivex Biologics. The other author, KA, reports no additional conflicts of interest.