iFuse Clinical Trials
Do you have a patient who might be a candidate for an iFuse clinical trial? Use the following Clinical Trials identifiers to locate the right trial.
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
- 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:
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: si-bone.com/risks