-- One-year results from two prospective clinical trials demonstrate early and marked improvements in pain, disability and quality of life achieved at six months are sustained at one year.
-- Systematic review of 18 MIS SI joint fusion studies shows clinically important reductions in pain and disability that were consistent and maintained out to five years.
SAN JOSE, California, Aug. 24, 2015 /PRNewswire/ -- SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System, a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the publication of one-year results from two separate prospective multicenter clinical trials as well as the publication of a systematic review of 18 MIS SI joint fusion studies.
Photo - http://photos.prnewswire.com/prnh/20150821/260337-INFO [http://photos.prnewswire.com/prnh/20150821/260337-INFO]Photo - http://photos.prnewswire.com/prnh/20150821/260338-INFO [http://photos.prnewswire.com/prnh/20150821/260338-INFO]
"Collectively, these three recent publications significantly strengthen the more than 20 clinical papers already published on iFuse and further solidify our clinical evidence foundation supporting MIS SI joint surgery using SI-BONE's unique triangular implants," said Jeffrey Dunn, President and CEO of SI-BONE.
The first clinical trial publication is of INSITE (Investigation of Sacroiliac Fusion Treatment), a prospective multicenter randomized controlled trial (RCT) that included 148 subjects treated at 19 centers. One-year results from INSITE were published in the journal Neurosurgery and titled Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants Vs Non-Surgical Management for Sacroiliac Joint Dysfunction: 12-Month Outcomes.(1) Subjects were randomized in a 2:1 ratio to either immediate SI joint fusion with iFuse (102 subjects) or non-surgical management (NSM, 46 subjects).
Subjects surgically treated with iFuse had a mean 52.0-point reduction in SI joint pain at six months on the 0-100 Visual Analog Scale (VAS) versus only a mean 12.2-point decrease in the NSM group. Pain relief was sustained at twelve months in the surgical group with a mean 54.2-point reduction from the baseline VAS measurement. The study design allowed subjects in the NSM group to cross over and have surgery after six months and 79.5% of the NSM group elected to have the iFuse procedure as of June 30, 2015. NSM group subjects who elected to cross over to iFuse surgery after six months had pain reduction similar to that seen in subjects originally assigned to iFuse surgery (see Figure 1).
The study also included Oswestry Disability Index (ODI), a measure of disability due to back pain, where a score of 0 indicates no disability and scores > 60 indicate severe disability. At baseline, all subjects showed a high degree of disability (mean 56.8). Subjects assigned to iFuse had a mean 27.4-point reduction in ODI at six months while subjects assigned to NSM had only a mean 4.6-point decrease (p 60 indicate severe disability. At baseline, all subjects showed a high degree of disability (mean 56.8). Subjects assigned to iFuse had a mean 27.4-point reduction in ODI at six months while subjects assigned to NSM had only a mean 4.6-point decrease (p