Published, peer-reviewed clinical results

More than thirty published articles have reported on the safety and effectiveness of the iFuse Implant. The iFuse Implant, available since 2009, is the only SI joint fusion device with published results from randomized controlled trials and the only one with multiple clinical studies demonstrating that treatment improved pain, patient function, and quality of life

  • Highest level of clinical evidence (results from two Level I, Randomized Controlled Trials)
  • Superior results compared to non-surgical management (pain medication, physical therapy, SI joint injections, radiofrequency ablation)
  • Studies of iFuse Implant show rapid and sustained improvements in SIJ pain, disability (as measured by Oswestry Disability Index) and quality of life (as measured by SF-36 and EQ-5D).
  • Long-term positive outcomes out to 5 years
  • Consistent clinical outcomes across studies
  • Low surgical revision and complication rates
  • Cost-effective – on par with surgical replacement of hips and knees
  • More than 50 peer-reviewed publications covering clinical results, biomechanics, and economics

Click here for a complete list of iFuse articles

The following summary tables include patients who underwent minimally invasive surgery with the iFuse Implant for SI joint disruption or degenerative sacroiliitis. 

 
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Clinical Trials

SI-BONE is conducting several clinical trials of the iFuse Implant System in the United States and Europe. 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. Click here to learn more.
SIFI - a single-arm multicenter prospective trial of iFuse Implant for degenerative sacroiliitis and sacroiliac joint disruption. 
ClinicalTrials.gov Identifier: NCT01640353. Click here to learn more.
iMIA – a European multicenter randomized trial of iFuse Implant vs. non-surgical management for degenerative sacroiliitis and sacroiliac joint disruption. ClinicalTrials.gov Identifier: NCT01640353. Click here to learn more.
LOIS - extended follow-up study of cases performed in two multicenter prospective US clinical trials (SIFI, INSITE). ClinicalTrials.gov Identifier: NCT02270203. Click here to learn more.

 

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. 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, visit: www.si-bone.com/risks

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