Aurora Spine announced publication of a new clinical study evaluating performance of its SiLO TFX sacroiliac (SI) joint fixation system compared to traditional posterolateral transosseous techniques.

The study is entitled “Fixation of the Sacroiliac Joint: A Cadaver-Based Concurrent-Controlled Biomechanical Comparison of Posterior Interposition and Posterolateral Transosseous Techniques” and was published in Neurospine.

SiLO TFX is a minimally invasive solution for SI joint fusion. It addresses conditions like SI joint disruptions and degenerative sacroiliitis.

The system includes a transfixing cone, an ilium screw, a sacrum screw, and related instrumentation engineered to transfix the sacrum and ilium to provide stability conducive to bony fusion. It was designed according to the AO Principles of Fusion: providing mechanical stability, preserving vascular supply, minimizing soft tissue disruption, and promoting an optimal environment for bone healing by proper decortication and use of bone graft.

Study Findings

SiLO TFX was found to remove less bone volume and provide a larger surface area for bony fusion compared to the posterolateral transosseous technique.

Upon fatigue loading, the posterior interposition implant maintained the bone-implant interface in all specimens. The posterolateral transosseous implant showed migration or subsidence in 20–50% of specimens.

“The study demonstrated the superior performance of the SiLO TFX system in sacroiliac joint fusion,” said Trent Northcutt, president and CEO of Aurora Spine. “These findings align with Aurora Spine’s commitment to developing innovative, minimally invasive solutions that optimize patient outcomes and establish new standards in sacroiliac joint care.”

“The posterior interposition technique demonstrated significant advantages in reducing joint motion and preserving bone integrity,” added Dr. Michael Stoffman, University at Buffalo Neurosurgery, Buffalo, N.Y., one of the study’s authors. “This approach offers a promising alternative to traditional methods, potentially leading to improved patient recovery and long-term success.”

Last week, the company granted U.S. Food and Drug Administration (FDA) 510(k) clearance for its Aero facet fusion system, a minimally invasive surgical system for patients suffering from facet joint-related pain or instability.