Journal of Pain Research (Dec 2023)

Early Functional Outcomes in Low Back Pain Subjects with a Novel Interspinous Fusion Device: REFINE Study 6-Month Results

  • Falowski SM,
  • Raso LJ,
  • Mangal V,
  • Nairizi A,
  • Patterson DG,
  • Danko MD,
  • Justiz R,
  • Vogel RS,
  • Koga S,
  • Josephson Y,
  • Pope JE,
  • Raji OR

Journal volume & issue
Vol. Volume 16
pp. 4113 – 4126

Abstract

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Steven M Falowski,1,* Louis J Raso,2 Vipul Mangal,3 Ali Nairizi,4 Denis G Patterson,5 Michael D Danko,6 Rafael Justiz,7 Rainer S Vogel,8 Sebastian Koga,9 Yousseff Josephson,10 Jason E Pope,11,* Oluwatodimu Richard Raji12 1Argires-Marotti Neurosurgical Associates of Lancaster, Lancaster, PA, USA; 2Jupiter Medical Center, Jupiter, FL, USA; 3National Spine and Pain Centers, Oxon Hill, MD, USA; 4Reno Tahoe Pain Associates, Reno, NV, USA; 5Nevada Pain Specialists, Reno, NV, USA; 6Premier Pain Treatment Institute, Loveland, OH, USA; 7Oklahoma Pain Physicians, Oklahoma City, OK, USA; 8Comprehensive and Interventional Pain Management, Henderson, NV, USA; 9Koga Neurosurgery, Covington, LA, USA; 10National Spine and Pain Centers, Voorhees, NJ, USA; 11Evolve Restorative Center, Santa Rosa, CA, USA; 12Medical Device Development, San Francisco, CA, USA*These authors contributed equally to this workCorrespondence: Oluwatodimu Richard Raji, Medical Device Development, 2390 Mission Street, Suite 8, San Francisco, CA, 94110, USA, Tel +15105707741, Email [email protected]: Lumbar interlaminar decompression with interspinous fixation is an established safe and effective treatment for spinal stenosis. Early maintenance of improvements in pain intensity and function are critical for durability of symptom relief. The purpose of this study was to investigate the efficacy of minimally invasive treatments for low back pain during the early period after treatment and their utility in setting the course for longer term success.Patients and Methods: This study utilized patient evaluations at 3- and 6-months following treatment and is part of an actively enrolling, institutional review board (IRB) approved, single-arm, multicenter, prospective, open-label 12-month study. Clinical efficacy was assessed primarily using the change from baseline in Oswestry Disability Index (ODI), Visual Analog Scale (VAS) of the back and leg pain during walking and standing, and Zurich Claudication Questionnaire (ZCQ), and secondarily using the Patient Global Impression of Change (PGIC) and Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1. The safety endpoints were the adverse events and reoperations or revisions at the index level(s).Results: At 6-month post-op, 76%, 62%– 64%, and 64% of patients demonstrated clinical meaningful, and statistically significant improvement in their pain as defined by ZCQ, VAS (back and leg), and ODI, respectively. In addition, 78% of patients noted improvement in PGIC. Two procedure-related adverse events were noted which fully resolved without surgical intervention.Conclusion: This 6-month interim analysis at 42% enrollment of patients was conducted to determine prolonged safety and efficacy of the interspinous fusion device. Our analysis showed a sustained improvement in clinical efficacy, and safety endpoints, when compared to the 3-months evaluations, across both interventional pain and neurosurgery specialties.Keywords: interspinous fixation, degenerative disc disease, neurogenic claudication, spinal stenosis

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