Clinical Outcomes Following Minimally Invasive Sacroiliac Joint Fusion With Decortication: The EVoluSIon Clinical Study

Background: This report documents 1-year results of 250 patients enrolled in a prospective, multicenter study of a minimally invasive (MI) sacroiliac joint fusion (SIJF) system that uses decortication, graft placement, and joint fixation. Methods: The cohort includes all patients enrolled in the EVoluSIon (EVSI) clinical study who had MI SIJF surgery and completed 1-year follow-up. Average age at baseline was 60.5 years, and 70.8% were female. Sacroiliac (SI) joint-related pain duration was >= 2 years in 56% of patients. Visual analog scale (VAS) SI joint pain, Oswestry Disability Index (ODI), quality of life, and opioid use were assessed preoperatively and at 1 year. Results: At 1 year, the mean VAS pain demonstrated a significant reduction of more than 43 points, from 76.4 at baseline to 33.0 (P < 0.0001), with 72.2% of patients attaining the minimal clinically important difference (MCID, >= 20-point improvement). Mean ODI scores also significantly improved from 54.4 at baseline to 30.5 at 1 year (P < 0.0001), with 62.5% of patients achieving the MCID (>= 15-point improvement). Prior to surgery. 62.7% (126/201) of patients were taking opioids or other narcotics, but by 1 year postsurgery. only 26.9% (54/201) of patients reported using these medications. representing a significant 57.1% decrease in narcotic/opioid use (P < 0.0001). Fusion of the SI joint was seen in 68.7% of patients. Few procedural complications were reported. In all, there were 8 (8/250) serious procedure-related events, including 1 device malposition observed on the day of surgery that required replacing the superior screw with a shorter screw. Conclusions: Analysis of patients treated with MI SIJF in the EVSI study demonstrated that the procedure can be performed safely and results in significant improvements in pain, quality of life. and opioid use at 1 year as well as causing fusion in the majority of patients.