Zyga Technology has announced the first patient enrolment in Sacroiliac fusion study (SAIF), a prospective, single-arm post market study designed to evaluate fusion and pain reduction following use of the Simmetry sacroiliac joint fusion system.
The study will be performed at a single centre and will include up to 15 patients. “Clinical studies such as SAIF are critical to demonstrate the empirical value of sacroiliac joint fusion,” states Noel D Goldthwaite, who performed the surgery. “This kind of objective data may show payers, other physicians, and of course those suffering from sacroiliac joint dysfunction the clinical and economic benefits of true sacroiliac joint arthrodesis including decortication and bone grafting.”
The Centers for Disease Control and Prevention lists low back pain as the second most common cause of disability in American adults. It has been reported that up to 30% of all chronic low back pain derives from the sacroiliac joint, but the condition has not been widely acknowledged due to challenges in diagnosis and a lack of treatment options.
“The introduction of the Simmetry system, a minimally invasive sacroiliac joint fusion procedure that utilises proven orthopaedic principles of decortication, grafting and fixation, is the first step in providing a viable treatment option for sacroiliac joint dysfunction,” says Jim Bullock, president and chief executive officer of Zyga. “Now, through SAIF and additional planned clinical studies, we will demonstrate the clinical and economic value of the true sacroiliac joint arthrodesis allowing for consistent insurance coverage and availability to patients in need.”