SI-Bone has submitted INSITE (Investigation of Sacroiliac Fusion Treatment) two-year randomised controlled trial data to Yale University’s Open Data Access (YODA) programme.
INSITE is a randomised controlled trial of minimally invasive sacroiliac joint fusion using the company’s iFuse devices, in comparison to non-surgical management. The trial enrolled 148 subjects at 19 centres in the US.
Earlier this year, SI-Bone initiated a partnership with YODA and released two-year results from a sister study, SIFI (Sacroiliac Joint Fusion With iFuse Implant System), a prospective multicentre clinical trial of sacroiliac joint fusion that included 172 subjects treated at 26 US centres.
According to a press release, 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.
“Interest in clinical trial data-sharing has increased markedly, with several recent editorials in the New England Journal of Medicine on the topic. SI-Bone welcomes independent analysis of its clinical trial data, as it may shed new light on aspects of the treatment procedure. SI-Bone encourages its colleagues in both industry and academia to share their clinical trial data,” says Daniel Cher, vice president of clinical affairs, SI-Bone.