The outcomes showed reductions in pain and disability, as well as a decrease in the number of patients who used opioids
Surgalign's SImmetry SIJ fusion system shows positive results in study. (Credit: Darko Stojanovic from Pixabay)
Surgalign announced that its SImmetry sacroiliac joint fusion system has shown positive results in treating sacroiliac joint (SIJ) dysfunction in a study.
The results of EVoluSIon (EVSI), a large, prospective, multi-center study, were published in the International Journal of Spine Surgery (IJSS).
EVSI reported results of 12-month clinical outcomes following minimally invasive SIJ fusion using the SImmetry system to treat SIJ dysfunction.
The firm claims that EVSI is the largest SIJ fusion study conducted to date with a participation from 250 patients across 23 sites.
The outcomes showed reductions in pain and disability, as well as a decrease in the number of patients who used opioids.
According to the study, 72.2% of patients showed a reduction in pain; 62.5% of patients showed reduction in disability; 57.1% of patients reported quitting opiate use, and 68.7% achieved radiographic fusion.
EVSI lead investigator Donald Kucharzyk said: “The EVSI study results provide significant empirical support for both minimally-invasive SIJ fusion as well as the SImmetry SIJ Fusion System with its unique decortication and bone grafting instrumentation.
“Not only did EVSI demonstrate pain relief, improved functionality, and reduction in opioid usage, it showed us that our technique is broadly reproducible and results in intra-articular fusion.
“The most gratifying aspect of this procedure is the patients’ satisfaction and how happy and pleased they are with the results.
“SImmetry truly gives us a solution to a complex problem that for a long time has been overlooked.”
The SImmetry system is a minimally invasive SI joint fusion system that uses joint decortication, bone grafting and fixation principles.
In January this year, Surgalign secured the US Food and Drug Administration (FDA) 510(k) clearance for its HOLO Portal surgical guidance system for use within lumbar spine procedures.
The HOLO Portal system is an artificial intelligence (AI)-driven augmented reality (AR) guidance system for spine.