SI-BONE Submits Data to Yale Open Data Program

SI-BONE, Inc., makers of the iFuse Implant System, is announcing the submission of the INSITE (Investigation of Sacroiliac Fusion Treatment) two-year randomized controlled trial (RCT) data to Yale University’s Open Data Access (YODA) program. INSITE compares MIS (minimally invasive surgery) SI joint fusion with iFuse to non-surgical management.

According to the October 5, 2016 news release, “The trial enrolled 148 subjects at 19 centers in the U.S. Earlier this year, SI-BONE initiated a partnership with YODA and released 2 [two] year results from a sister study, SIFI (Sacroiliac Joint Fusion With iFuse Implant System), a prospective multicenter clinical trial of SI joint fusion that included 172 subjects treated at 26 U.S. centers. The goal of the partnership between SI-BONE and YODA is to make data from key clinical trials of sacroiliac joint fusion available to approved researchers to allow secondary analyses of clinical trial data and set a new standard for transparency of clinical evidence in medical devices.”

Joe Powers, vice president of marketing for SI-BONE, told OTW, “In today’s medical device industry, it is critical that any new technology has high level clinical studies, society support, abundant peer-reviewed publications documenting safety and effectiveness as well as economic evidence showing cost savings to the healthcare system. SI-BONE and organizations like Blue Cross Blue Shield Association believe that transparency will soon become a requirement in establishing payor support and coverage. The bar is high and getting higher. That said, we believe that there is an abundance of positive clinical evidence on minimally invasive SI joint fusion with the iFuse implant.

“We believe that data transparency will diminish criticism that industry-sponsored studies are biased. In a review of spine surgery device studies registered on clinicaltrials.gov, >90% of randomized trials with at least one U.S. site were industry-sponsored. Industry-sponsored trials had higher numbers of study centers and larger sample sizes, indicators of study quality. Industry-sponsored studies are highly monitored and subject to FDA oversight whereas non-industry studies are not. Our experience is that industry-sponsored studies are valid and represent the best efforts to measure device safety and effectiveness. Through Yale’s YODA program, any interested scientist can request data for re-analysis or further scientific inquiry, i.e., analyze the data for themselves. What they will find are crisp consistent studies that show safety, effectiveness, durability and cost effectiveness.

“SI-BONE is excited to share data through such a prestigious academic platform as YODA and encourages independent secondary analysis of its clinical trial data. Orthopedic surgeons can have confidence in SI-BONE’s published studies given its willingness to share patient-level data with qualified interested scientists and clinicians. SI-BONE is proud to be a leader in data-sharing and encourages other companies and our academic partners to also share their clinical data.”