More than thirty published articles listed below have reported on the safety and effectiveness of the iFuse Implant System.1 iFuse is the only SI joint fusion device with published results from a randomized controlled trial and the only one with clinical studies demonstrating that treatment improved pain, patient function, and quality of life.2 Outcome measures include the visual analog scale (VAS), Oswestry Disability Index (ODI), quality of life (SF-36), and patient satisfaction with the surgery. An independent review of the company complaints database with information on over 5,000 procedures documents a low complaint rate and a low revision rate.3 The following summary tables include patients who underwent the iFuse procedure for SI joint disruptions or degenerative sacroiliitis.
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 may have been supported in whole or in part by SI-BONE.
1 Polly, D.W. et al., Neurosurgery. 2015.— Dr. Polly is an investigator on a clinical research study sponsored by SI-BONE. He has no financial interest in SI-BONE. Research was funded by SI-BONE, Inc. A list of additional published studies is available at www.si-bone.com/results.
2 Duhon, B* et al., 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. * Paid consultant of and conducts clinical research for SI-BONE Inc.
3 Miller, Larry, W. Carlton Reckling*, and Jon E Block. 2013. “Analysis of Postmarket Complaints Database for the iFuse SI Joint Fusion System: A Minimally Invasive Treatment for Degenerative Sacroiliitis and Sacroiliac Joint Disruption.” Medical Devices: Evidence and Research 6 (May): 77–84.
*Employee of SI-BONE, Inc.
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. 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, click here.