#USA #Austin #Genesys Spine #SI Joint #SIros Fusion

Promising Results for SIros® Lateral SI Joint Fusion System

Genesys Spine has made headlines with the announcement of positive outcomes from a prospective multicenter clinical study examining the SIros® Lateral Sacroiliac Joint Fusion System. This innovative system showcases an effective treatment option for individuals suffering from sacroiliac joint (SIJ) dysfunction, underscoring its significance in minimally invasive surgical options.

In a thorough evaluation, the study demonstrated remarkable advancements in pain management and functional capabilities among patients. Dr. Douglas P. Beall, the Principal Investigator, expressed confidence in the results, stating, "The study confirms that the SIros system offers pain relief and functional outcomes on par with other titanium-based implants, while upholding exceptional safety measures, optimal operative specifications, and minimal fluoroscopic exposure."

Key Findings of the Study

The findings from the study highlighted a staggering 38% reduction in pain scores within six months, with the average score on the Numerical Rating Scale (NRS) dropping from 6.8 at baseline to 4.2. This level of improvement was statistically significant (p<0.01), showcasing the effectiveness of the SIros® system in alleviating discomfort for patients.

Moreover, functional outcomes, as measured by the Oswestry Disability Index (ODI), improved significantly—from an average of 50.3% at baseline to 34.9% after treatment (p<0.01). This change reflects a shift from severe to moderate disability among participants, marking a substantial step forward in enhancing daily activities and quality of life.

Radiographic evaluations were equally promising, revealing that 96% of study participants demonstrated bone apposition to both iliac and sacral sides across at least two of the three implants utilized in the procedure. Furthermore, 72% of patients exhibited bridging across the SI joint at the six-month mark, indicating successful integration of the device into the patient's anatomy.

Importantly, the study reported no incidents of implant failure, device migration, or significant adverse events related to the procedure, further solidifying the SIros system's reputation for safety and efficacy. Notably, during the course of the study, patient reliance on opioids was noticeably reduced by nearly 50%, suggesting a shift towards non-pharmacological management of pain, which could be crucial for patient recovery.

Implications for Patient Care

Meredith Gavlick, Chief Strategy Officer at SI Fusion, emphasizes the importance of these findings, stating, "The prospective study further validates SIros as a key solution for SI joint fusion. Demonstrating stabilization with minimal radiation exposure and a minimally invasive approach represents a major advancement for patient outcomes and recovery." These results illuminate the path toward improved treatment options for those grappling with SI joint dysfunction, offering hope for a new standard of care in this aspect of orthopedic medicine.

As part of Genesys Spine's extensive SI fusion portfolio—which also includes the SIrten® Intra-Articular and SIros-O™ Posterior Oblique Systems—the SIros® system is poised to continue making strides in addressing the needs of patients dealing with degenerative sacroiliitis and SI joint disruption.

In summary, the promising findings from the clinical study not only showcase the effectiveness of the SIros® Lateral Sacroiliac Joint Fusion System but also highlight the potential transformation in patient treatment options moving forward.

For further details, the full study can be accessed here.