A Prospective, Observational, Open-Label, Non-Randomized, Multicenter Study Measuring Functional Outcomes in a Novel Interspinous Fusion Device in Subjects with Low Back Pain: REFINE Study.

"Disclosures Dr. Steven M. Falowski serves as a consultant for Abbott, Medtronic, Saluda, VertiFlex, Vertos, Surgentec, CornerLoc, Mainstay and Relievant, has received grant for research funding from Mainstay, Relievant, Medtronic, Abbott, VertiFlex, Saluda, Nalu, CornerLoc, Aurora, Biotronik, and Stimgenics, and has an equity position in SynerFuse, Aurora Spine, Thermaquil. SPR Therapeutics, Saluda, CornerLoc, PainTEQ, Stimgenics, Anesthetic Gas Reclamation, Neural Integrative Solutions, SpineThera, and Celeri Health. Dr. Louis J. Raso serves on the speakers Bureau for Boston Scientific, Aurora Spine, SurGen Tec, Vertiflex, and FloSpine. He is a Stockholder for Aurora Spine and receives Royalties from Flospine and SurGen Tec. Dr.Vipul Mangal serves as a consultant for Medtronic, Aurora and has received educational support from Medtronic, Abbott, Boston Scientific, Nevro, Vertos, Stimwave, Nalu, Aurora, Spinal Simplicity, SI Fix. Dr. Ali Narizi serves as a Consultant for Nevro, Flowonix, Boston Scientific, Surgentec, Aurora Pain and Spine; has received research support from Nevro, Corner Loc, Cardio Surgical Partners, Flowonix. Dr. Denis G. Patterson serves as a consultant for Abbott, AIS, Allergan, Amgen, Aurora Spine, CornerLoc, Flowonix, Lundbeck, Pajunk Medical, Saluda, Spark Biomedical, Vertos, has received grant and research support from Abbott, Flowonix, Nevro, Saluda and Vertiflex, serve on the Speaker Bureau or Honoraria for Abbott, Allergan, Amgen, CornerLoc, Lundbeck, Saluda, Vertos, and has equity in CornerLoc. Dr. Michael D. Danko is a consultant for Medtronic, Abbott, and Aurora spine and has Stock Options at Aurora Spine. Dr. Rafael Justiz serves as a consultant for Abbott, Medtronic, and has research or grant support from Medtronic and Stimgenics. Dr. Rainer S. Vogel serves as a consultant for Medtronic, Nevro, BSCI and Aurora Spine; teaching agreements with Medtronic, Nevro, BSCI, and Aurora Spine; research associated funding with Medtronic, Nevro, BSCI, PainTEQ, Aurora Spine, Vertos, and Vertiflex; Investments with Medtronic, Nevro and Aurora Spine. Dr. Sebastian Koga is a consultant for Aurora Spine Corp., Synpative Medical Inc., and Osseus Spine; and a shareholder in Aurora Spine Corp. and Synpative Medical Inc. Dr. Youssef Josephson serves as a consultant for Medtronic, Aurora, Abbott, NALU, Sprint, and PainTEQ; research associated funding with Aurora, Abbott, Sprint, and PainTEQ. Dr. Jason E. Pope serves as a consultant for Abbott, Medtronic, Saluda, Flowonix, SpineThera, Painteq, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, Mainstay, WISE, Boston Scientific, Thermaquil; has received grant and research support from: Abbott, Flowonix, Saluda, Aurora, Painteq, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, Thermaquil; and is a shareholder of: PainTEQ, Vertos, SPR Therapeutics, Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil and Anesthetic Gas Reclamation."

"Funding This study was sponsored by Aurora Spine. Aurora Spine also funded the Rapid Service Fee. No other funding source was present. Aurora Spine had no access to the data or for the writing of this manuscript."

"Trial Registration ClinicalTrials.gov identifier, NCT05504499."