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

PAULA - Pelvic Fixation and Fusion During Multilevel Spinal Surgery (PAULA). A multicenter, open label, single-arm observational clinical study consisting of prospective and retrospective study cohorts. ClinicalTrials.gov Indentifier: NCT05640908

Clinical Trials That Have Completed Enrollment

INSITE - Investigation of Sacroiliac Fusion Treatment (INSITE). A multicenter randomized trial of iFuse Implant vs. non-surgical management for degenerative sacroiliitis and sacroiliac joint disruption. ClinicalTrials.gov Identifier: NCT01681004.

• 2-year peer-reviewed publication (Polly - Int J Spine Surg 2016) [HERE]

iMIA – iFuse Implant System® Minimally Invasive Arthrodesis (iMIA). A European multicenter randomized trial of iFuse Implant vs. non-surgical management for degenerative sacroiliitis and sacroiliac joint disruption. ClinicalTrials.gov Identifier: NCT01741025

• 2-year peer-reviewed publication (Dengler - J Bone Joint Surgery Am 2019) [HERE]

SIFI - Sacroiliac Joint Fusion with iFuse Implant System (SIFI). A single-arm multicenter prospective trial of iFuse Implant for degenerative sacroiliitis and sacroiliac joint disruption. ClinicalTrial.gov Identifier: NCT01640353

• 2-year peer-review publication (Duhon - Int J Spine Surg 2016) [HERE]

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

• 5-year peer-review publication (Whang - Med Device Evid Res 2019) [HERE]

SALLY - Study of Bone Growth in the Sacroiliac Joint After Minimally Invasive Surgery with Titanium Implants (SALLY). A multicenter study of bone growth in the sacroiliac joint after minimally invasive surgery with titanium implants (iFuse 3D). ClinicalTrials.gov Identifier: NCT03122899

• 5-year peer-review publication (Patel - Spine 2024) [HERE]

SILVIA - SI Joint Stabilization in Long Fusion to the Pelvis: Prospective Cohort Analysis (SILVIA). A multicenter study of bone growth in the sacroiliac joint after minimally invasive surgery with titanium implants (iFuse 3D). ClinicalTrials.gov Identifier: NCT04062630

SAFFRON - Sacral Fracture Fusion/​Fixation for Rapid Rehabilitation (SAFFRON). A prospective, multicenter, randomized, controlled trial of surgical fixation of sacral insufficiency or fragility fractures (SFIF) with concomitant fusion of the sacroiliac (SI) joint vs. nonsurgical management (NSM). ClinicalTrials.gov Identifier: NCT05426356

STACI - iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction (STACI). A prospective, multicenter, study of SI joint fusion using the iFuse TORQ Implant System. ClinicalTrials.gove Identifier NCT05870488
 

Healthcare professionals should refer to the Instructions For Use for indications, contraindications, warnings, and precautions at https://si-bone.com/label. 

There are potential risks associated with iFuse procedures. They may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit https://si-bone.com/risks.