Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive devices to treat underserved conditions of the lumbar spine, today announced the publication of 12-month clinical and radiographic results in The Open Orthopaedics Journal. The study evaluated long-term fusion and pain reduction in patients receiving SImmetry® Sacroiliac Joint Fusion.
“Minimally Invasive SI joint fusion procedures have demonstrated significant reduction in pain and disability, but it is important that these procedures create a bony fusion to give patients the best opportunity for long-term relief,” said Richard A Kube MD, study author and orthopedic spine surgeon at Prairie Spine and Pain Institute in Peoria, Ill. “This technique minimizes the invasiveness of the procedure without compromising any of the orthopedic principles that provide the foundation for a successful fusion.”
This single-center study enrolled 18 patients who underwent a total of 20 minimally invasive SI joint fusion procedures with decortication and bone grafting. Pain and disability scores were collected pre-surgery and at 6 weeks, 3 months, 6 months, 9 months and 12 months post-surgery. A CT scan was also performed at 12-month follow-up. At 12 months, fusion was reported in 88% of patients, and back pain decreased from 81.7 to 44.1 (p<0.001) on average. Freedom from device- or procedure-related adverse events through 12 months was 100%.
“Zyga is proud to support Dr. Kube, a leader in SI joint fusion, and other ongoing clinical research to demonstrate the importance and efficacy of sacroiliac joint fusion,” said Jim Bullock, president and CEO of Zyga Technology. “This study will be closely succeeded by several other publications, including early results of a prospective, multi-center study evaluating pain reduction and long-term, radiographic fusion.”
The Centers for Disease Control and Prevention lists back problems as the second most common cause of disability in U.S. adultsi. It has been reported that approximately 20 percent of all chronic low back pain derives from the sacroiliac jointii.