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New EVoluSIon Study Data Demonstrates Strong Support for the SImmetry® Sacroiliac Joint Fusion System

admin by admin
April 2, 2022
in Spine
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New EVoluSIon Study Data Demonstrates Strong Support for the SImmetry® Sacroiliac Joint Fusion System

Research printed within the IJSS exhibits Surgalign product to be a dependable resolution for SIJ dysfunction

DEERFIELD, Ailing., March 24, 2022 (GLOBE NEWSWIRE) — Surgalign Holdings, Inc. (NASDAQ: SRGA), a worldwide medical expertise firm targeted on elevating the usual of care by driving the evolution of digital well being, immediately introduced the publication of outcomes from EVoluSIon (EVSI), a big, potential, multi-center examine of scientific outcomes following minimally invasive sacroiliac joint (SIJ) fusion with decortication.

Printed within the February 2022 concern of the Worldwide Journal of Backbone Surgical procedure, Scientific Outcomes Following Minimally Invasive Sacroiliac Joint Fusion with Decortication: The EVoluSIon Scientific Research1, reviews 12-month scientific outcomes following minimally invasive SIJ fusion utilizing the SImmetry Sacroiliac Joint Fusion system to deal with SIJ dysfunction. With 250 sufferers and 23 websites collaborating, EVSI is likely one of the largest SIJ fusion research performed so far.

The 12-month outcomes from EVSI demonstrated statistically vital enhancements in each ache and incapacity, together with a statistically vital discount within the variety of sufferers utilizing opioids.

Extra particularly, 72.2% of sufferers achieved the minimal clinically necessary distinction (MCID) standards of discount in VAS, a measure of ache; 62.5% of sufferers achieved the MCID standards of discount in ODI, a measure of incapacity; 57.1% of sufferers reported (N=201) cessation of opioid use; and 68.7% achieved radiographic fusion. These outcomes evaluate favorably to printed aggressive knowledge2,3,4,5 and are per prior SImmetry publications6,7. Surgalign is just the second firm to report knowledge on a examine of this scale to supply a procedural resolution with statistically vital knowledge for SIJ fusion.

“The EVSI examine outcomes present vital empirical assist for each minimally-invasive SIJ fusion in addition to the SImmetry SIJ Fusion System with its distinctive decortication and bone grafting instrumentation,” acknowledged lead investigator Donald Kucharzyk, DO. “Not solely did EVSI show ache aid, improved performance, and discount in opioid utilization, it confirmed us that our method is broadly reproducible and leads to intra-articular fusion.”

Added Dr. Kucharzyk, “Probably the most gratifying side of this process is the sufferers’ satisfaction and the way joyful and happy they’re with the outcomes. SImmetry really provides us an answer to a fancy drawback that for a very long time has been missed.”

“We’re excited in regards to the publication of the EVoluSIon examine, because it demonstrates improved affected person outcomes on account of our distinctive strategy to SIJ fusion,” mentioned Doug Bireley, government vice chairman of promoting and enterprise improvement at Surgalign. “We imagine the SIJ fusion market gives a big alternative for Surgalign to offer wonderful care and long-term aid for sufferers with SIJ dysfunction.”

About SImmetry

The SImmetry system was designed from the outset to not simply fixate, however to additionally fuse the SI joint. The SImmetry system is a minimally invasive SI joint fusion system that makes use of confirmed orthopedic ideas, together with joint decortication, bone grafting and fixation, to realize true arthrodesis. The final word purpose of SI joint fusion is to stabilize the sacroiliac joint to alleviate ache on account of joint disruption and degeneration.

About SIJ Dysfunction

The SIJ has been reported to be the supply of ache in roughly 18-30% of sufferers presenting with continual low again ache8,9,10, and will increase to greater than 40% in sufferers with prior lumbar fusion11,12. SIJ dysfunction typically happens together with different pathologies and should be fastidiously identified. Each NASS (North American Backbone Society) and ISASS (Worldwide Society for the Development of Backbone Surgical procedure) have printed diagnostic algorithms to assist in correct SIJ analysis.

About Surgalign Holdings, Inc.

Surgalign Holdings, Inc. is a worldwide medical expertise firm dedicated to the promise of digital well being to drive transformation throughout the surgical panorama. Uniquely aligned and resourced to advance the usual of care, the corporate is constructing applied sciences physicians and different well being suppliers will look to for what is really potential for his or her sufferers. Surgalign is concentrated on creating options that predictably ship superior scientific and financial outcomes. Surgalign markets merchandise all through america and in additional than 50 nations worldwide by an increasing community of prime impartial distributors. Surgalign is headquartered in Deerfield, IL, with business, innovation and design facilities in San Diego, CA, Warsaw and Poznan, Poland, and Wurmlingen, Germany. Study extra at www.surgalign.com and join on LinkedIn and Twitter.

  1. Kucharzyk D, Colle Okay, Boone C, Araghi A.  Scientific Outcomes Following Minimally Invasive Sacroiliac Joint Fusion With Decortication: The EVoluSIon Research. Int J Backbone Sur 2022, 16 (1) 168-175. doi: https://doi.org/10.14444/8185.
  2. Duhon BS, et al. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Yr Comply with-Up from a Potential Multicenter Trial. Int J Backbone Surg. 2016;10:Article 13.
  3. Polly DW, et al. Two-Yr Outcomes from a Randomized Managed Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Administration for Sacroiliac Joint Dysfunction. Int J Backbone Surg. 2016;10: Article 28.
  4. Dengler J, et al. Randomized Trial of Sacroiliac Joint Arthrodesis In contrast with Conservative Administration for Continual Low Again Ache Attributed to the Sacroiliac Joint. J Bone Joint Surg Am. 2019;101(5):400-411.
  5. Patel v, et al. Potential Trial of Sacroiliac Joint Fusion Utilizing 3D-Printed Triangular Titanium Implants: 24-Month Comply with-Up. Med Units (Auckl). 2020;14:211-216.
  6. Cross WW, et al. Minimally Invasive Sacroiliac Joint Fusion: 2-Yr Radiographic and Scientific Outcomes with a Rules-Primarily based SIJ Fusion System. Open Orthop J. 2018; 12: 7–16.
  7. Abbasi H, Hipp JA. The Evaluation of Fusion Following Sacroiliac Joint Fusion Surgical procedure. Cureus 9(10): e1787.
  8. DePalma MJ, et al. What’s the supply of continual low again ache and does age play a job? Ache Med. 2011;12(2):224‐233.
  9. Schwarzer AC, et al. The sacroiliac joint in continual low again ache. Backbone (Phila Pa 1976). 1995; 20(1):31‐37.
  10. Bernard TN Jr, Kirkaldy-Willis WH. Recognizing particular traits of nonspecific low again ache. Clin Orthop Relat Res. 1987;(217):266‐280.
  11. DePalma MJ, et al. Etiology of continual low again ache in sufferers having undergone lumbar fusion. Ache Med. 2011;12(5):732‐739.
  12. Maigne JY, Planchon CA. Sacroiliac joint ache after lumbar fusion. A examine with anesthetic blocks. Eur Backbone J. 2005;14(7):654‐658.

Picture: Worldwide Journal of Backbone Surgical procedure

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