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

Autor:	Calodney AK; Precision Spine Care, Tyler, TX, USA., Azeem N; Florida Spine and Pain Specialists, Tampa, FL, USA., Buchanan P; Spanish Hills Interventional Pain Specialists, Camarillo, CA, USA., Skaribas I; Expert Pain P.A, Houston, TX, USA., Antony A; The Orthopaedic Institute, Gainesville, FL, USA., Kim C; The Spine and Nerve Center, Charleston, WV, USA., Girardi G; Medical Center of the Rockies, Fort Collins, CO, USA., Vu C; Evolve Restoration Center, Santa Rosa, CA, USA., Bovinet C; The Spine Center of Southeast Georgia, Brunswick, GA, USA., Vogel RS; Comprehensive and Interventional Pain Management, Henderson, NV, USA., Li S; National Spine and Pain Centers, Shrewsbury, NJ, USA., Jassal N; Spine and Pain Institute of Florida, Lakeland, FL, USA., Josephson Y; National Spine & Pain Centers, Voorhees Township, NJ, USA., Lubenow TR; University of Colorado School of Medicine, Aurora, CO, USA., Girardi N; Rush University Medical Center, Chicago, IL, USA., Pope JE; Evolve Restorative Center, Santa Rosa, CA, USA.
Jazyk:	angličtina
Zdroj:	Expert review of medical devices [Expert Rev Med Devices] 2022 May; Vol. 19 (5), pp. 451-461. Date of Electronic Publication: 2022 Jul 18.
DOI:	10.1080/17434440.2022.2090244
Abstrakt:	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.
Databáze:	MEDLINE
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