Study published in the IJSS shows Surgalign product to be a reliable solution for SIJ dysfunction
By Admin | April 13, 2022
DEERFIELD, Ill., March 24, 2022 (GLOBE NEWSWIRE) -- Surgalign Holdings, Inc. (NASDAQ: SRGA), a global medical technology company focused on elevating the standard of care by driving the evolution of digital health, today announced the publication of results from EVoluSIon (EVSI), a large, prospective, multi-center study of clinical outcomes following minimally invasive sacroiliac joint (SIJ) fusion with decortication.
Published in the February 2022 issue of the International Journal of Spine Surgery, Clinical Outcomes Following Minimally Invasive Sacroiliac Joint Fusion with Decortication: The EVoluSIon Clinical Study1, reports 12-month clinical outcomes following minimally invasive SIJ fusion using the SImmetry Sacroiliac Joint Fusion system to treat SIJ dysfunction. With 250 patients and 23 sites participating, EVSI is one of the largest SIJ fusion studies conducted to date.
The 12-month results from EVSI demonstrated statistically significant improvements in both pain and disability, along with a statistically significant reduction in the number of patients using opioids.
More specifically, 72.2% of patients achieved the minimal clinically important difference (MCID) criteria of reduction in VAS, a measure of pain; 62.5% of patients achieved the MCID criteria of reduction in ODI, a measure of disability; 57.1% of patients reported (N=201) cessation of opioid use; and 68.7% achieved radiographic fusion. These results compare favorably to published competitive data2,3,4,5 and are consistent with prior SImmetry publications6,7. Surgalign is only the second company to report data on a study of this scale to offer a procedural solution with statistically significant data for SIJ fusion.
“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,” stated lead investigator Donald Kucharzyk, DO. “Not only did EVSI demonstrate pain relief, improved functionality, and reduction in opioid usage, it showed us that...(More)
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