SI-BONE, Inc. Announces Two-Year Results from a Randomized Controlled Trial of the iFuse Implant System® vs. Non-Surgical Management for Some Causes of Sacroiliac Joint Dysfunction

Two-Year RCT Demonstrates Long-Term Durability of iFuse, Further Validation of Previous 3, 4 and 5 Year Published Results

SAN JOSE, California, Aug. 24, 2016 /PRNewswire/ -- SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System(®) ("iFuse"), a patented triangular-shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the publication of two-year results from INSITE (Investigation of Sacroiliac Fusion Treatment - NCT01681004) a landmark prospective, multicenter, randomized controlled trial (RCT) of MIS SI joint fusion with iFuse compared to non-surgical management (NSM). Results of this Level 1, high quality study were published in the International Journal of Spine Surgery titled: Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction(1). The study showed that rapid improvements in pain, disability and quality of life for the iFuse group were larger than those seen for the NSM group and were durable to two years. This large, Level 1 RCT adds to the more than 40 peer-reviewed publications on iFuse and further reinforces positive outcomes and product durability demonstrated in previously reported 3 year, 4.5 year and 5 year publications.(2-4)

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148 subjects were enrolled, randomized 2:1 (102 iFuse/46 NSM), and treated at 19 centers in the United States including both private practice and academic institutions. In the iFuse group, the mean SI joint pain score improved from 82.3 at baseline to 30.1 at 6 months, 28.6 at 12 months and 26.7 at two years, corresponding to improvements from baseline of 52.3, 53.7 and 55.4 points, respectively (all p

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