The iFuse Implant, cleared by the FDA in 2009, 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.
Clinically Proven Effective for SI Joint Pain
Patients with sacroiliac joint dysfunction may experience pain that can be debilitating. iFuse Technology® is backed by a unique design, published papers, clinical studies, and thousands of procedures.
- Design: Patented triangular shape is like no other
- Clinically Proven: Numerous peer-reviewed published articles, including results from 5 prospective clinical trials18, 20, 76, 79, 105
- Utilization: Tens of thousands iFuse procedures have been completed by thousands of trained surgeons and the number is climbing
Published Medical Papers
Clinical data that demonstrates positive patient outcomes over a sustained period of time are essential for all medical treatments. iFuse is no exception.
- Peer-reviewed articles have been published reporting the safety, effectiveness, biomechanics, and economic benefits of the iFuse Implant. [Full List]
- iFuse Implant is the only SI joint fusion device with published results from randomized controlled trials (RCTs).18, 76
- iFuse Technology® is also the only SI joint fusion system with multiple clinical studies demonstrating that treatment improved pain, patient function, and quality of life.18, 20, 21, 76, 79, 105
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
- Economics of SI joint treatment
- Burden of disease
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 Level I evidence randomized controlled trials [INSITE, iMIA] and several multi-center prospective trials [SIFI, LOIS, SALLY, SILVIA]. More information on these trials can be found on the clinical trials page and each is registered on ClinicalTrials.gov.
Top Clinical Publications
- Randomized Controlled Trial - INSITE 2-year Results (Polly - IJSS 2016)
- 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)