Zyga Technology presented publication on the first 50 patients in its EVoluSIon clinical study. The 250 patient at 40 site study is evaluating long-term fusion and pain reduction in patients that undergo procedures using the SImmentry Sacroiliac Joint Fusion System.
Here are five insights:
1. Six months post surgery, the mean low back pain was recorded at 35.1, a 54 percent reduction in pain from the pre-operative mean of 76.2. These number show significant reductions in pain; however, they remain consistent with similar SI joint fusion studies.
2. Patients also showed a reduction in opioid use, 55 percent. The decrease in opiod dependency following SI joint fusions was greater than similar studies.
3. Patients will continue to undergo follow-ups at 12 and 24 months to assess the presence of bony fusion across the joint through CT imaging and determine pain reductions.
4. Zyga released results from a 19-patient, multi-center study on minimally invasive SI joint fusion surgery with decortication recently. After 24 months, 94 percent of patients showed bridging bone across the SI joint.
5. The EVoluSI clinical study is designed to build upon the findings of the previous study. The company’s SImmetry Sacroiliac Joint Fusion System is a minimally invasive procedure designed for SI joint disruptions and degenerative sacroiliitis.