RTI Surgical will showcase its body of clinical data on the SImmetry sacroiliac joint fusion system at the 2020 International Society for the Advancement of Spine Surgery annual meeting (ISASS20; February 26–28, Puerto Rico, USA).
Interim results on 50 patients at 24 months in the EVoluSIon study indicate 98% of treated joints show evidence of fusion and 78% of patients are opioid-free, reinforcing the importance of decortication as part of the SImmetry System procedure to drive fusion and pain relief for patients with SI joint dysfunction, RTI said in a press release.
“In my experience using the SImmetry System, I have observed it follows true orthopaedic principles for fusion with decortication, bone grafting and fixation,” said Donald Kucharzyk of DK Orthopedics (Indiana, USA), who will present the results through a podium presentation. “It is reproducible and consistent in its technique case after case, even with anatomic variations. Patients feel the difference immediately. These interim EVoluSIon study results reveal a significant reduction in opioid use from baseline, significant improvements in activity levels, and compared to the previous literature published, compelling evidence of fusion.”
RTI noted that the interim results of the 50 patients at 24 months also show Mean Visual Analogue Scale (VAS) SI joint pain decreasing from 75.2 at baseline to 30.1, a statistically significant reduction in pain of 60%.
Mean Oswestry Disability Index (ODI) scores improved from 55.2 at baseline to 26.9, a statistically significant reduction of 51% and clinically meaningful improvement in disability related to SI joint pain.
“Interim EVoluSIon study data continue to show that joint decortication as part of the SImmetry System helps to achieve real fusion, which supports reduced opioid use and significant pain relief,” said Camille Farhat, president and CEO of RTI Surgical. “As we progress toward our future as a more focused spine company, RTI is committed to offering surgeons a growing portfolio of differentiated clinical solutions and therapies backed by data to deliver better outcomes for patients.”
The EVoluSIon study will continue to evaluate pain and disability at 12- and 24-month follow-up visits, as well as joint fusion rates, which is expected to define similarities or further distinctions between different types of implants for the SI joint.
The SImmetry sacroiliac joint fusion system was initially developed by Zyga, which was acquired by RTI Surgical in January 2018.