2-Year Results from SI-BONE iFuse INSITE Trial
Two-year results from a randomized, controlled trial in the management of sacroiliac joint dysfunction revealed that SI-BONE's iFuse yielded more rapid improvements in pain, disability and quality of life vs. non-surgical management (NSM). Results were durable to two years.
Further, revision surgery rates were low (3.4%) and ~1/3 of rates for lumbar fusion.
The multicenter INSITE trial (Investigation of Sacroiliac Fusion Treatment) enrolled 148 subjects, randomized at 2:1 and treated at 19 U.S. centers, including private practice and academic institutions.
Results have been published in the International Journal of Spine Surgery, "Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction."
In 4Q15, iFuse received FDA clearance reflecting one-year clinical data derived from retrospective and prospective studies, including INSITE, SIFI (Sacroiliac Joint Fusion with iFuse Implant System; 172 patients) and additional studies reviewed by FDA.
Sources: SI-BONE, Inc., ORTHOWORLD Inc.