Zyga has announced the enrollment of its 100th patient in the Evolusion (EVSI) Clinical Study. This prospective, 40-site, 250-patient trial will evaluate long-term fusion and pain reduction in patients receiving SImmetry sacroiliac joint fusion.
“There is clear evidence demonstrating the value of minimally Invasive sacroiliac joint fixation for appropriately selected patients,” says Antoine G Tohmeh, the orthopaedic surgeon who performed the procedure at Deaconess Hospital in Spokane, Wash. “But spine surgeons know that any metal implant will weaken over time. To ensure that a patient’s clinical benefit lasts, a true fusion, including decortication, bone grafting and fixation, is critical. Studies such as Evolusion are important to demonstrate that efficacy.”
Zyga recently released results of a 19-patient, prospective, multicentre study of minimally anvasive sacroiliac joint fusion surgery with decortication. At 24 months postoperation, 94% of patients had evidence of bridging bone across the sacroiliac joint, with 83% categorised as solid fusion. Of patients with solid fusion, 88% of the joints were fused within the area of decortication, demonstrating the importance of this step in achieving fusion. In addition to fusion, the study demonstrated a 73% reduction in average pain. The EVSI study is designed to build on the findings of this study.