Six Month Interim Outcomes from SECURE: A Single arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device. (4th May 2022)

• Record Type: Journal Article
• Authors: Calodney, Aaron K.; Azeem, Nomen; Buchanan, Patrick; Skaribas, Ioannis; Antony, Ajay; Kim, Christopher; Girardi, George; Vu, Chau; Bovinet, Christopher; Vogel, Rainer S.; Li, Sean; Jassal, Naveep; Josephson, Youssef; Lubenow, Timothy R.; Girardi, Nicholas; Pope, Jason E.
• Is Part Of: Expert review of medical devices. Volume 19:Number 5(2022)
• Page Start: 451
• Page End: 461
• Publication Date: 2022-05-04
• Subjects: Sacroiliac joint disease -- the novel posterior fusion -- multicenter -- prospective -- single arm study -- clinical outcomes -- evidence; Medical instruments and apparatus -- Periodicals; 610.28
• DOI: 10.1080/17434440.2022.2090244
• Languages: English
• ISSNs: 1743-4440

Abstract

ABSTRACT: Introduction: Sacroiliac joint disease is a prominent diagnosis across the world. A novel fixation technique employing a posterior approach, single point, bone allograft transfixation has proven to be helpful anecdotally. The purpose of this is study is to investigate prospectively the safety and efficacy of this approach. Methods: A multicenter, prospective, single arm study was performed after patient identification and treatment with the novel posterior fusion, single-point transfixation system and followed for 24 months. Target enrollment is 100 patients. Interim results on the first 69 consecutive patients at 6 months is presented. Primary endpoint at 6-month analysis was Pain Intensity reduction by visual analogue scale and functional improvement by Oswestry Disability Index. Adverse events were assessed for safety analysis. Results: In total, 69 patients were identified for this analysis. At 6 months, a mean improvement of 34.9 was identified by a reduction in VAS and functional improvement was demonstrated by a mean reduction in ODI of 17.7. There were three adverse events, all unrelated to the device. Conclusion: The posterior single point transfixation is safe and efficacious for the treatment of sacroiliac joint dysfunction with statistical improvements in pain and function.