Zyga Technology, Inc. is announcing the enrollment of its first four patients in the expanded EVoluSIon (EVSI) Clinical Study, a prospective, 40-site, 250-patient trial that will evaluate long-term fusion and pain reduction in patients receiving SImmetry Sacroiliac Joint Fusion.
Zyga Technology Enrolls First Patients in EVoluSIon Clinical Study
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According to Antoine G. Tohmeh, M.D., the orthopedic surgeon who performed the procedures at Deaconess Hospital in Spokane, Washington in the April 4, 2016 news release: “Minimally Invasive SI [sacroiliac] joint fusion procedures are rapidly gaining acceptance within the medical community, but it is important that the technology gives patients the best opportunity for long-term relief. I believe that a true fusion, including decortication, bone grafting and fixation, is critical to achieving that goal. Studies such as EVoluSIon are important to reinforce our knowledge and the growing base of clinical evidence for SI joint fusion.”
Asked about his vision for this study, Dr. Tohmeh told OTW, “It should provide us with reliable long-term clinical and radiographic outcomes of an MIS Sacroiliac Fusion technique. Strict inclusions criteria, interval outcome measures and long-term follow-up are key.”
Asked if surgeons are missing something as far as “true fusion, ” Dr. Tohmeh added, “They are. Most systems rely on ‘trauma-type screws’ that achieve short-term fixation without bone integration. Unthreaded dowels achieve long-term fixation via bone ingrowth, which may not occur in some patients. SImmetry includes a reproducible decortication and bone grafting system that optimizes the fusion bed environment.”
“I always include SI pain in the differential diagnosis of low back/buttock pain. Surgeons consider diagnoses of ‘piriformis syndrome, ’ Ischial tuberosity pain, hamstring spasm, gluteus medius tear, hip bursitis and labral tears, but usually do not consider SI-mediated pain. You will be surprised how many you will diagnose if you start looking for it. You could be depriving patients who satisfy a provocative and diagnostic test from a relatively small procedure that can provide lasting relief.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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