Outcomes

Clinical Results of iFuse SI Joint Fusion

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 2-level 1 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 dozens of published papers, clinical studies, and procedures. Here are the highlights:

  • Clinically Proven: 60+ peer-reviewed published papers, including results from 4 major clinical trials18,19,20,22
  • Patented triangle design is like no other
  • 34,000+ iFuse procedures have been completed by more than 1,700 trained providers and the number is climbing

See additional clinical data for healthcare providers.

60+ 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.

  • More than 60 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 randomized controlled trials.18,19
  • The iFuse implant, available since 2009, is also the only implant for SI joint fusion with multiple clinical studies demonstrating that treatment improved pain, patient function, and quality of life.18,19,20,21,22

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 published articles on iFuse, MIS joint fusion, and SI joint dysfunction.

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 engaged in sponsoring two RCTs [INSITE, iMIA] and two multi-center prospective trials [SIFI, LOIS]. More information on these trials can be found on ClinicalTrials.gov.

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