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 our technique is broadly reproducible and results in intra-articular fusion.”
Added Dr. Kucharzyk, “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.”
“We are excited about the publication of the EVoluSIon study, as it demonstrates improved patient outcomes due to our unique approach to SIJ fusion,” said Doug Bireley, executive vice president of marketing and business development at Surgalign. “We believe the SIJ fusion market provides a large opportunity for Surgalign to provide excellent care and long-term relief for patients with SIJ dysfunction.”
About SImmetry
The SImmetry system was designed from the outset to not just fixate, but to also fuse the SI joint. The SImmetry system is a minimally invasive SI joint fusion system that uses proven orthopedic principles, including joint decortication, bone grafting and fixation, to achieve true arthrodesis. The ultimate goal of SI joint fusion is to stabilize the sacroiliac joint to relieve pain due to joint disruption and degeneration.
About SIJ Dysfunction
The SIJ has been reported to be the source of pain in approximately 18-30% of patients presenting with chronic low back pain8,9,10, and increases to more than 40% in patients with prior lumbar fusion11,12. SIJ dysfunction often occurs in combination with other pathologies and must be carefully diagnosed. Both NASS (North American Spine Society) and ISASS (International Society for the Advancement of Spine Surgery) have published diagnostic algorithms to aid in accurate SIJ diagnosis.
About Surgalign Holdings, Inc.
Surgalign Holdings, Inc. is a global medical technology company committed to the promise of digital health to drive transformation across the surgical landscape. Uniquely aligned and resourced to advance the standard of care, the company is building technologies physicians and other health providers will look to for what is truly possible for their patients. Surgalign is focused on developing solutions that predictably deliver superior clinical and economic outcomes. Surgalign markets products throughout the United States and in more than 50 countries worldwide through an expanding network of top independent distributors. Surgalign is headquartered in Deerfield, IL, with commercial, innovation and design centers in San Diego, CA, Warsaw and Poznan, Poland, and Wurmlingen, Germany. Learn more at www.surgalign.com and connect on LinkedIn and Twitter.
- Kucharzyk D, Colle K, Boone C, Araghi A. Clinical Outcomes Following Minimally Invasive Sacroiliac Joint Fusion With Decortication: The EVoluSIon Study. Int J Spine Sur 2022, 16 (1) 168-175. doi: https://doi.org/10.14444/8185.
- Duhon BS, et al. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-Up from a Prospective Multicenter Trial. Int J Spine Surg. 2016;10:Article 13.
- Polly DW, et al. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016;10: Article 28.
- Dengler J, et al. Randomized Trial of Sacroiliac Joint Arthrodesis Compared with Conservative Management for Chronic Low Back Pain Attributed to the Sacroiliac Joint. J Bone Joint Surg Am. 2019;101(5):400-411.
- Patel v, et al. Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants: 24-Month Follow-Up. Med Devices (Auckl). 2020;14:211-216.
- Cross WW, et al. Minimally Invasive Sacroiliac Joint Fusion: 2-Year Radiographic and Clinical Outcomes with a Principles-Based SIJ Fusion System. Open Orthop J. 2018; 12: 7–16.
- Abbasi H, Hipp JA. The Assessment of Fusion Following Sacroiliac Joint Fusion Surgery. Cureus 9(10): e1787.
- DePalma MJ, et al. What is the source of chronic low back pain and does age play a role? Pain Med. 2011;12(2):224‐233.
- Schwarzer AC, et al. The sacroiliac joint in chronic low back pain. Spine (Phila Pa 1976). 1995; 20(1):31‐37.
- Bernard TN Jr, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;(217):266‐280.
- DePalma MJ, et al. Etiology of chronic low back pain in patients having undergone lumbar fusion. Pain Med. 2011;12(5):732‐739.
- Maigne JY, Planchon CA. Sacroiliac joint pain after lumbar fusion. A study with anesthetic blocks. Eur Spine J. 2005;14(7):654‐658.
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