Early Functional Outcomes in Low Back Pain Subjects with a Novel Interspinous Fusion Device: REFINE Study 6-Month Results.
Steven Michael FalowskiLouis J RasoVipul MangalAli NairiziDenis G PattersonMichael D DankoRafael JustizRainer S VogelSebastian F KogaYousseff JosephsonJason E PopeOluwatodimu Richard RajiPublished in: Journal of pain research (2023)
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.