Nine Hospitals in 4 Countries Enrolled 100+ Patients Showing Consistent Improvement in Pain, Disability, Function and Quality of Life that Further Validate Previously Published US RCT
SAN JOSE, California, May 17, 2016 /PRNewswire/ -- SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System(®) ("iFuse"), a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that the European Spine Journal, one of Europe's most well-respected spine journals, has published 6-month results from iMIA (iFuse Implant System Minimally Invasive Arthrodesis; ClinicalTrials.gov ID NCT01741025 [https://clinicaltrials.gov/ct2/show/NCT01741025]). iMIA is a randomized controlled trial (RCT) conducted in Europe that measured the safety and effectiveness of minimally invasive sacroiliac joint fusion using iFuse patented triangular titanium implants compared to conservative management (CM) in patients with chronic SI joint dysfunction. iMIA is the second RCT comparing iFuse to conservative therapy and results from iMIA mirror those of INSITE, an earlier multicenter RCT performed in the US. Both trials were performed in the post market setting and utilized very similar inclusion and exclusion criteria. Moreover, study entry criteria were designed to reflect real-world clinical practice, promoting generalizability.
The publication, entitled Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs. conservative management(1), reports results on 103 patients with chronic SI joint pain enrolled at 9 centers in 4 European countries. Study subjects were randomly assigned to either SI joint fusion with iFuse (n = 52) or CM (n=51). CM was performed according to the European guidelines for the diagnosis and management of pelvic girdle pain and consisted of optimization of medical therapy, individualized physical therapy (PT), and adequate information and reassurance as part of a multifactorial treatment. The primary outcome was the difference in change in self-rated low back pain (LBP) at 6 months. Additional endpoints included quality of life using EQ-5D-3L, disability using Oswestry Disability Index (ODI), SI joint function using active straight leg raise (ASLR) test, and adverse events.
In the study , iFuse provided superior improvement in pain, disability, function and quality of life compared to conservative management. Mean LBP improved by 43.9 points in the iFuse group compared to 5.7 points in the CM group (difference of 38.2 points, p