SI-BONE, Inc. Announces Publication of Two-Year Results From a Prospective Multicenter Clinical Trial Showing Long-Term Clinical Benefits from SI Joint Fusion with the iFuse Implant System
SAN JOSE, Calif., April 20, 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 the publication of two-year results from SIFI (Sacroiliac Joint Fusion with iFuse Implant System) a prospective multicenter clinical trial of SI joint fusion. The trial included 172 subjects at 26 US centers and was published in The International Journal of Spine Surgery which is the official journal of the International Society for the Advancement of Spine Surgery (ISASS). The publication is titled Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-up from a Prospective Multicenter Trial and the lead author was Bradley Duhon, MD of the University of Colorado.i
Two-year results show marked improvements in SI joint pain, disability and quality of life achieved at 6 and 12 months were maintained to two years. Outcome assessments included an intent-to-treat primary success/failure composite endpoint at 6 months that consisted of a reduction from baseline VAS SI joint pain of at least 20 points, absence of device-related serious adverse events, absence of neurological worsening related to the sacral spine, and absence of surgical reintervention for SI joint pain. Secondary endpoints included success rates at other time points, improvement from baseline in VAS SI joint pain, ODI, SF-36 and EQ-5D scores. Success rates were 80.2% at 6 months and remained high at 79.9% at both the 12- and 24-month follow-up. Mean SI joint pain improved from 79.8 at baseline to 28.1 at 12 months and remained low at 26.0 at 24 months (see Figure 1). ODI decreased from 55.2 at baseline to 31.5 at 12 months and remained low at 30.9 at 24 months (see Figure 2). Quality of life improvements seen at 12 months were maintained at 24 months.
Figure 1 - VAS SI Joint Pain
Figure 2 - Oswestry Disability Index (ODI)
Furthermore, although the trial did not have the specific goal of opioid use reduction and patients were not required to participate in a structured drug reduction program, results showed a decrease in opioid use of 28% by month 24. Thirty-seven patients who were taking opioids at baseline had stopped taking them at month 24.
The surgical revision rate was low with 8 subjects having revision surgery (4.7%) and there were 7 device-related adverse events. Radiographic analysis was performed via CT scans at one year and showed a high rate of bony apposition to at least two implants on both the iliac and sacra sides with greater than 30% implant surface area coverage on each side of the SI joint.
"The target patient population and study eligibility criteria for SIFI were identical to INSITE, a prospective multicenter randomized controlled trial of iFuse vs. non-surgical management," said Dr. Danny Cher, Vice President of Clinical Affairs at SI-BONE. "INSITE showed superiority of iFuse compared to non-surgical management at nearly every endpoint at one year and SIFI at two years is an excellent proxy for INSITE two-year results which are expected to be published this summer."
Bradley Duhon, MD at the University of Colorado and lead author of the paper, commented, "Two-year results from the SIFI study further validate the long-term durability of the iFuse procedure and provide compelling, high quality evidence that early improvements in pain and disability are sustained to two years."
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
One or more of the individuals named herein may be past or present SI-BONE employees, consultants, investors, clinical trial investigators, or grant recipients. Research described herein may have been supported in whole or in part by SI-BONE.
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2016 SI-BONE, Inc. All Rights Reserved. 9572.042016
i Duhon BS, Bitan F, Lockstadt H, Kovalsky DA, Cher DJ, Hillen T, on behalf of the SIFI Study Group. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-year Follow-up from a Prospective Multicenter Trial. Int J Spine Surg. 2016;10:Article 13.