Pain and Opioid use Outcomes Following Minimally Invasive Sacroiliac Joint Fusion with Decortication and Bone Grafting: The Evolusion Clinical Trial
Ali Araghi1, Robert Woodruff2, Kyle Colle3, Christopher Boone4, Lisa Ingham5, Antoine Tomeh6, Louis C Fielding7, *
1 The CORE Institute, Phoenix, Arizona, United States
2 Black Hills Orthopedic and Spine Center, Rapid City, South Dakota, United States
3 Regional Brain and Spine, Cape Girardeau, Missouri, United States
4 Bellevue Bone and Joint Physicians, Bellevue, Washington, United States
5 Zyga Technology, Inc. Minnetonka, Minnesota, United States
6 Northwest Orthopaedic Specialists, Spokane, Washington, United States
7 Tahoe Labs, LLC, 1057 Montgomery St., San Carlos, 94070 California, United States
This report documents six-month results of the first 50 patients treated in a prospective, multi-center study of a minimally invasive (MI) sacroiliac (SI) joint fusion system.
Patients and Methods:
This cohort includes 50 patients who had MI SI joint fusion surgery and completed 6 month follow-up. Average age at baseline was 61.5, 58% were female, and SI joint-related pain duration was ≥2yrs in 54.0% of patients. Visual Analog Scale (VAS) SI joint pain, Oswestry Disability Index (ODI), quality of life and opioid use were assessed preoperatively and at 6 months.
At 6 months, mean VAS pain demonstrated a significant reduction from 76.2 at baseline to 35.1 (54% reduction, p<0.0001), with 72% of patients attaining the minimal clinically important difference (MCID, ≥20 point improvement). Mean ODI improved from 55.5 to 35.3 at 6 months (p < 0.001), with 56% of patients achieving the MCID (≥15 point improvement). Prior to surgery 33/50 (66%) of patients were taking opioids, but by 6 months the number of patients taking opioids had decreased by 55% to 15/50 (30%). Few procedural complications were reported. Two procedure-related events required hospitalization: a revision procedure (2%) for nerve impingement and one case of ongoing low back pain.
Analysis of patients treated with MI SI joint fusion using the SImmetry System demonstrated that the procedure can be performed safely and results in significant improvements in pain, disability, and opioid use at 6 months. Longer term follow-up in this study will determine whether these improvements are durable, as well as the associated radiographic fusion rates.
open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
* Address correspondence to this author at the Tahoe Labs, LLC, 1057 Montgomery St., San Carlos, California 94070, United States; Tel: 206-953-9839; Fax: 650-585-6307; E-mail: firstname.lastname@example.org