SAN JOSE, Calif., Dec. 16, 2013 /PRNewswire/ -- SI-BONE, Inc. (San Jose, California), a medical device company that pioneered the use of the iFuse Implant System®, a minimally invasive surgical (MIS) device used to fuse the sacroiliac (SI) joint, announced today the publication of results from two clinical trials studying the iFuse Implant System. The first publication, entitled "Open vs. minimally invasive sacroiliac joint fusion: a multi-center comparison of perioperative measures and clinical outcomes," is a retrospective comparative cohort study of patients who underwent SI joint fusion using either an open surgical technique or the minimally invasive iFuse Implant System. The study involved surgeons at 7 sites and assessed both perioperative and 12- and 24-month outcomes measures on 263 patients. Patients treated with iFuse had significantly greater pain relief (6.2 and 5.6 point improvement from baseline in VAS pain scores at 12 and 24 months, respectively) compared to those treated with open surgery (2.7 and 2.0 point improvement at 12 and 24 months, respectively). The degree of pain relief was approximately 3 points greater after minimally invasive fusion compared to open SI joint fusion (p<0.0001) after controlling for age, gender and history of prior lumbar fusion. In addition, the iFuse group showed significantly better perioperative measures, including less blood loss (33 ml vs. 288 ml), reduced operative time (70 minutes vs. 163 minutes) and shorter length of hospital stay (1.3 days vs. 5.1 days).1 The complication rate was lower in the minimally invasive group and fewer patients underwent revision of the implanted hardware (3.5% vs. 44%).
A second publication entitled "Safety and 6-month effectiveness of minimally invasive sacroiliac join fusion: a prospective study" reports early results from the SIFI (Sacroiliac Joint Fusion with iFuse Implant System) study, a multicenter, single-arm, prospective clinical trial. This is the first prospective multicenter study designed to evaluate the safety and effectiveness of a minimally invasive SI joint fusion technique in patients with degenerative sacroiliitis or SI joint disruption. The paper reports baseline patient and procedure characteristics on the first 94 subjects treated at 23 sites, as well as midterm effectiveness results on the first 32 subjects who reached 6 months of follow-up. In the effectiveness cohort, subjects showed a mean 49 point improvement from baseline in VAS (0-100 scale) at 6 months after SI joint fusion and a mean 15.8 point decrease in Oswestry Disability Index (ODI), a measure of impairment due to back pain. Subjects reported improvement in quality of life (23 point increase in EQ-5D, and 6.7 and 5.8 increase in SF-36 PCS and MCS, respectively) and high rates of satisfaction. All changes were statistically significant. Of 94 subjects in the safety cohort, there were no device revisions or removals.2
Dr. Arnold Graham Smith, lead author of the retrospective comparative cohort study, stated: "As healthcare and medical coverage policies evolve, the need for well designed scientific evidence is essential. These studies, individually and also together, are the largest, most rigorous studies ever done on the SI joint. They provide strong evidence that a minimally invasive approach to SI joint fusion is more effective and less morbid than open surgery and that the patients do very well. After over 20 years of studying, diagnosing and treating sacroiliac joint patients, I am excited that there is now a technology available like iFuse that is clinically effective."
Jeffrey Dunn, President and CEO of SI-BONE said: "Almost 10,000 surgeries have been performed to date with the iFuse Implant System and the company estimates that over 90% of all minimally invasive SI joint surgeries are performed with the SI-BONE implants, making it far and away the first choice among surgeons worldwide today. The results of these two clinical trials speak for themselves in an incredibly positive way. We believe that the growing, substantial body of evidence warrants coverage by commercial insurance companies and the Medicare Administrative Contractors (MACs). We hope that positive coverage policies will be issued as soon as possible to ensure that all appropriate patients have continued access to this treatment."
Dr. Brad Duhon, lead investigator for the SIFI study and experienced iFuse surgeon, stated, "This study is both well designed and rigorously executed. Because of this study, I believe that surgeons will become even better at the diagnosis of lower back pain as we include the SI joint in our overall work-up. This will ultimately benefit all patients with lower back pain. As physicians we need to speak up and push for positive reimbursement for our patients now that we have these two excellent publications as well as 9 other clinical papers demonstrating the safety and effectiveness of this procedure."
SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System for fracture fixation of long bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and an additional clearance in April 2011 for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The CE mark for European commercialization was obtained in November 2010.
The iFuse Implant System is a commercially available device in the U.S. and Europe. The procedure requires a small incision for delivery and placement of triangular shaped titanium implants. The implants are coated with a porous, titanium plasma spray that creates an interference surface designed to help decrease implant motion, allow immediate fixation and provide for biological fixation to support long-term fusion. These implants have substantial thickness and sophisticated metallurgy and are able to produce a much stronger construct than that of conventional screws used to surgically fix bony structures. Clinical publications regarding the safety and effectiveness of the iFuse system can be found at www.si-bone.com under Clinical Publications. The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse Implant. The product labeling provides additional details in this regard.
1 Smith AG, Capobianco R, Cher D, Rudolf L, Sachs D, Gundanna M, Kleiner J, Milan M, Shamie AN. Open versus Minimally Invasive Sacroiliac Joint Fusion: a Multi-Center Comparison of Perioperative Measures and Clinical Outcomes. Annals of Surgical Innovation and Research. 2013, 7:14
2 Duhon BS, Cher DJ, Wine KD, Lockstadt H, Kovalsky D, Soo CL. Safety and Six-Month Effectiveness of Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study. Medical Devices: Evidence and Research. 2013;6:219-29
Dr. Daniel Cher, Robyn Capobianco and Kathryn Wine are SI-BONE employees
Dr. Leonard Rudolf and Dr. Nick Shamie are paid teaching and clinical research consultants for, and are investors in, SI-BONE.
Dr. Donald Sachs, Dr. Mukund Gundanna and Dr. Brad Duhon are paid teaching and clinical research consultants for SI-BONE.
Dr. Arnold Graham Smith is a paid clinical research consultant for SI-BONE.
Dr. Jeffrey Kleiner and Dr. M Milan have not received any financial support from SI-BONE.
Dr. Harry Lockstadt, Dr. Donald Kovalsky and Dr. Kim Soo are paid clinical research consultants for SI-BONE.