Genesys Spine has announced positive results from a Prospective multicentre clinical study evaluating the safety and effectiveness of the SIros Lateral Sacroiliac Joint Fusion System for patients with Sacroiliac Joint (SIJ) dysfunction.

The study demonstrated statistically significant improvements in pain and function at six months, along with strong radiographic evidence of fusion and a favourable safety profile.

According to the findings, patients experienced a 38 percent reduction in pain scores, with the mean Numerical Rating Scale (NRS) decreasing from 6.8 at baseline to 4.2 at six months (p<0.01). Functional outcomes also improved significantly, as measured by the Oswestry Disability Index (ODI), which declined from 50.3 percent at baseline to 34.9 percent (p<0.01), reflecting a shift from severe to moderate disability.

Radiographic analysis showed that 96 percent of patients exhibited bone apposition to both the iliac and sacral sides across at least two of the three implants. Additionally, 72 percent of patients demonstrated bridging across the sacroiliac joint at six months, indicating successful fusion progression.

Importantly, the study reported no cases of implant failure, device migration or procedure-related serious adverse events. Opioid use among participants also declined by nearly 50 percent over the study period.

Dr. Douglas P. Beall, Principal Investigator of the study, said the findings confirm that the SIros system delivers pain relief and functional outcomes comparable to other titanium-based implants, while achieving excellent safety outcomes, optimal operative parameters and low fluoroscopic exposure.

Meredith Gavlick, Chief Strategy Officer at SI Fusion, added that the results further validate SIros as a key minimally invasive solution for SI joint fusion, highlighting its ability to provide stabilization with minimal radiation exposure and improved recovery prospects for patients.