12-Month Interim Outcomes SECURE a Single Arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device

Introduction: Sacroiliac joint disease is a common diagnosis facing patients with chronic pain back pain. Historically, this was treated with radiofrequency ablation or a more invasive lateral approach. A novel fixation technique employing a posterior approach, single point, bone allograft transfixation has proven to be helpful in an interim analysis of the first 69 consecutive patients at 6 months, demonstrating 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. We are happy to first report on the interim analysis of 12-month outcomes in the first 61 consecutive patients.

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 61 consecutive patients at 12 months is presented. The primary endpoint at the 6 month analysis was Pain Intensity reduction by the visual analogue scale and functional improvement by Oswestry Disability Index. Adverse events were assessed for safety analysis.IRB approval was provided by WCG IRB (Study Number 1275013)

Results: 61 patients were identified for this analysis. Data reported include Visual analogue scale (VAS), Oswestry Disability Index (ODI), and PROMIS 29, along with adverse events (AE). For measures including the VAS, ODI, PROMIS 29, and quantitative outcomes, paired test was performed. ANOVA regression analysis was utilized to identify and verify the correlations reported. The data analysis was performed utilizing IBM SPSS statistics.
VAS Baseline mean(SD) 76.4(14) Average Improvement ,mean 47(28.9) (p-value < .001) Improvement >20 mm,n(%) 47(77%)
ODI Baseline mean (SD) 52(14) Baseline, mean(SD)25.6(21.6) Average improvement,mean(SD) (p-value < .001) Improvement>15, n(%) 41(67%)

Conclusion : The posterior single-point transfixation is safe and efficacious for the treatment of sacroiliac joint dysfunction with statistical improvements in pain and function.