iFuse Clinical Trials

For more information about these studies, please refer to the U.S. National Institutes of Health clinicaltrials.gov website at the following links:

Clinical Trials Currently Enrolling

SILVIA - a multicenter randomized controlled, postmarket clinical study of titanium implants (iFuse-3D) for use during multilevel fusion surgery (4 or more levels). ClinicalTrials.gov Identifier: NCT04062630

Clinical Trials That Have Completed Enrollment

SI-BONE has conducted several clinical trials of the iFuse Implant System that's been available since 2009 in the United States. For more information about these studies, please refer to the U.S. National Institutes of Health clinicaltrials.gov website at the following links:

INSITE - a multicenter randomized trial of iFuse Implant vs. non-surgical management for degenerative sacroiliitis and sacroiliac joint disruption. ClinicalTrials.gov Identifier: NCT01681004

iMIA – a European multicenter randomized trial of iFuse Implant vs. non-surgical management for degenerative sacroiliitis and sacroiliac joint disruption. ClinicalTrials.gov Identifier: NCT01741025

SIFI - a single-arm multicenter prospective trial of iFuse Implant for degenerative sacroiliitis and sacroiliac joint disruption. ClinicalTrial.gov Identifier: NCT01640353

LOIS - extended follow-up study of cases performed in two multicenter prospective US clinical trials (SIFI, INSITE). ClinicalTrials.gov Identifier: NCT02270203

SALLY - a multicenter study of bone growth in the sacroiliac joint after minimally invasive surgery with titanium implants (iFuse-3D). ClinicalTrials.gov Identifier: NCT03122899

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. The iFuse Implant System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as a part of a lumbar or thoracolumbar fusion.

There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and not all patients may benefit. Rx Only. For information about the risks, visit this link.