SI-BONE, Inc. Announces Publication of Second Multicenter Randomized Controlled Trial of the iFuse Implant System vs. Conservative Care in European Spine Journal
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, Calif., 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). 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 management1, 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.
Figure 1 and Figure 2
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<.0001) (see Figure 1). Mean ODI improved by 26 points in the iFuse group and 6 points in the CM group (p<.0001) (see Figure 2). ASLR, EQ-5D-3L, walking distance and satisfaction were statistically superior in the subjects treated by iFuse. The frequency of adverse events did not differ between groups.
The iMIA trial extends the findings from prior studies in two key aspects. First, iMIA included two functional assessments (walking distance and SI joint function via ASLR), neither of which had been previously reported; both showed improvement in the iFuse group but not in the CM group. Second, CM was provided per European treatment guidelines, meaning that the control group intervention may have been more standardized than in prior trials. The iMIA findings therefore not only replicate but also extend prior trials, such as INSITE, and serve to validate the iFuse procedure overall.
"Results from iMIA provide additional, independent confirmation that the improvements after iFuse surgery are clinically important and statistically superior to those seen with continued conservative care," said Bengt Sturesson, MD, from Ängelholm Hospital, Ängelholm, Sweden, lead author of the paper. "Furthermore, results from iMIA, combined with the INSITE RCT, as well as 4- and 5-year outcomes from other published cohorts, suggest that MIS SI joint fusion with iFuse can be added to the portfolio of typical spine surgeries that European surgeons can now offer their patients."
"It is a significant milestone to now have two RCTs comparing iFuse to conservative therapies from two distinct geographies. These landmark surgery vs. no surgery studies are challenging to execute but provide the key information that supports improved patient outcomes associated with surgery. Most importantly, the results from both studies consistently show that surgery with iFuse is superior to conservative care for those patients who meet the diagnostic criteria," said Jeffrey Dunn, President and CEO of SI-BONE.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading sacroiliac joint medical device company dedicated to the development of tools and products for patients with low back issues related to certain SI joint disorders. The company develops, manufactures and markets minimally invasive products for the SI joint. SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for European commercialization was obtained in November 2010.
The iFuse Implant System is a minimally invasive surgical option that uses titanium implants coated with a porous, titanium plasma spray (TPS) that acts as an interference surface, designed to help decrease implant motion, and allow for biological fixation to support long term fusion. The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2016 SI-BONE, Inc. All Rights Reserved. 9475.051716
1 Sturesson B, Kools D, Pflugmacher R, Gasbarrini A, Prestamburgo D, Dengler J. Six-Month Outcomes from a Randomized Controlled Trial of Minimally Invasive SI Joint Fusion with Triangular Titanium Implants vs. Conservative Management. Eur Spine J. 2016 May 14. DOI 10.1007/s00586-016-4599-9
One or more of the individuals named herein may be a past or present SI-BONE employee, paid consultant, investor, clinical trial investigator, or grant recipient. Research described herein was supported by SI-BONE.