For Patients
Clinical Results of iFuse SI Joint Fusion
The iFuse Implant, CE marked since 2010, is the only device for treatment of SI joint dysfunction that is supported by significant published clinical evidence, including two Level I Randomized Controlled Trials (RCTs). The clinical evidence shows safety, durable effectiveness, and lasting relief from SI joint pain.
Outcomes
Clinically Proven Effective for SI Joint Pain
Patients with sacroiliac joint dysfunction may experience pain that can be debilitating. The iFuse Implant is backed by significant clinical evidence. Here are the highlights:
- 100+ published, peer-reviewed articles have demonstrated the safety, effectiveness, durability and economic benefits of the iFuse implant, including results from 5 prospective clinical trials18,20,76,78,79,105
- Patented triangle design is like no other
- Tens of thousands of patients have subsequently been treated with iFuse by thousands of trained surgeons around the world.
Peer-reviewed Articles
Clinical data that demonstrates positive patient outcomes over a sustained period of time are essential for all medical treatments. iFuse is no exception.
- More than 100 articles have been published reporting the safety, effectiveness, biomechanics, and economic benefits of the iFuse Implant. [Full List]
- The iFuse Implant is the only SI joint fusion device with published results from two randomized controlled trials.18,76
- The iFuse implant, available since 2009, is also the only implant for SI joint fusion with multiple prospective clinical studies demonstrating that treatment improved pain, patient function, and quality of life.18,20,21,76,79
SI-BONE also has supported numerous publications investigating a range of topics regarding the SI joint:
- Clinical outcomes and operative process measures
- Comparison of open surgery vs. MIS (minimally invasive surgery)
- Utilization of MIS SI joint fusion
- Complaints/safety
- Economics of SI joint treatment
- Burden of disease
- Biomechanics
View the full list of iFuse published articles.
Outcomes
Randomized Controlled Trials (RCTs)
SI-BONE, Inc. believes clinical research is imperative and recognizes that product safety, effectiveness and reliability are critical factors for providing excellent patient care, so we continue to invest in clinical research for SI joint fusion and pain relief.
SI-BONE has sponsored two RCTs [INSITE, iMIA] and several multi-center prospective trials [SIFI, LOIS, SALLY]. More information on these trials can be found on ClinicalTrials.gov.
Publications
Top Clinical Publications
- Randomized Controlled Trial - INSITE 2-year Results (Polly - IJSS 2016)
- Randomized Controlled Trial - iMIA 2-year Results (Dengler - JBJS Am 2019)
- Consistent Prospective Results - Pooled Analysis of 3 Prospective Trials - INSITE, iMIA, SIFI (Dengler - Spine 2017)
- Long-Term Prospective Results - LOIS 5-year (Whang - Med Devices Evid Res 2019)
- Comparison, Long-Term Results (Vanaclocha - Neurosurgery 2017)
- Safety: 4-year Revision Rate (Cher - Med Devices Evid Res 2015)