254. Minimally invasive sacroiliac joint fusion with decortication and bone grafting: 2-year clinical outcomes

Abstract

BACKGROUND CONTEXT Minimally invasive (MI) sacroiliac (SI) joint fusion has become a preferred treatment alternative for pain originating in the SI joint that is refractory to conservative treatment. PURPOSE The EVoluSIon (EVSI) study of the SImmetry Sacroiliac Joint Fusion System (NCT02074761) is a prospective, multicenter single-arm study to evaluate the impact of MI SI joint fusion with decortication on patient pain, function, quality of life and pain medication usage, and to also assess the effectiveness of inducing joint fusion. STUDY DESIGN/SETTING All 250 participants have been enrolled and are in follow-up. Here, interim results of 100 subjects at 24 months are described. Results may be updated should new information become available. PATIENT SAMPLE The key inclusion criteria for participation were 18 years of age or greater; at least 6 months of nonoperative management of SI joint pain; three positive provocative tests (FABER, Gaenslen, Compression, Thigh Thrust, Distraction); at least one positive diagnostic SI joint injection that resulted in at least a 50% reduction in pain; visual analog scale (VAS) SI joint pain score of 60 or greater; and Oswestry Disability Index (ODI) score of at least 40. OUTCOME MEASURES Primary endpoints for the study were fusion and a decrease in back pain from baseline to 6 months as evaluated by the VAS. Fusion was defined as presence of a continuous segment of solid bridging bone that extended from the sacrum to the ilium. Fusion was evaluated at 12 and 24 months (if fusion was not noted in the 12-mo CT) by independent radiologists. Additional endpoints included change in VAS, change in ODI, and changes in quality of life measures assessed at 3, 6, 12 and 24-month visits. METHODS NA RESULTS Mean VAS pain demonstrated a significant reduction (p CONCLUSIONS We conclude minimally invasive SI joint fusion with decortication can be performed safely and has a positive impact on patient pain, function and quality of life with evidence of a high degree of fusion. FDA DEVICE/DRUG STATUS SImmetry Sacroiliac Joint Fusion System (Approved for this indication)