Zyga: 12-Month Results on SI Joint Fusion

Zyga Technology, Inc. has some positive results to announce…their 12-month clinical and radiographic results have been published 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 M.D., study author and orthopedic spine surgeon at Prairie Spine and Pain Institute in Peoria, Illinois, in the December 14, 2016. “This technique minimizes the invasiveness of the procedure without compromising any of the orthopedic principles that provide the foundation for a successful fusion.”

As indicated in the news release, “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 company President and CEO Jim Bullock. “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.”

Dr. Kube told OTW, “I was fascinated to watch our diagnostic protocols be validated by the clinical success we saw in the patients, as well as radiological evidence that the procedure achieved what it was meant to do: decorticate and fuse the joint. It is always rewarding to see the clinical results match the benchtop hypothesis.”

“All patients outside of major multi-trauma patients who were candidates were included in the study. If I had selected for patients with truly isolated SIJ disease or excluded workers comp and personal injury patients, the clinical results would have been even better. None of us practice in a vacuum. I think this study accurately depicts real life practice results outside the vacuum and provides surgeons a realistic narrative to provide their patients when discussing this procedure as an option. It was also reassuring that the vast majority of patients fused, including a lot of smokers.”