Three new studies on the iFuse Implant System from SI-BONE have significant outcomes and findings for minimally invasive sacroiliac joint fusion.
“Collectively, these three recent publications significantly strengthen the more than 20 clinical papers already published on iFuse and further solidify our clinical evidence foundation supporting MIS SI joint surgery using SI-BONE’s unique triangular implants,” said President and CEO Jeffrey Dunn.
Here are five key notes on the first clinical trial, INSITE:
1. It was a prospective, multicenter randomized controlled trial with 148 subjects treated at 19 centers in one year. The patients were either randomized into the iFuse group or non-surgical management.
2. Researchers found iFuse met the 52-point reduction in SI joint pain at six months on the Visual Analog Scale compared with 12.2-point decrease in the non-surgical management group.
3. At 12 months, the surgical group reported a 54.2-point from the baseline VAS measurement.
4. Nearly 80 percent of the non-surgical group elected to have the iFuse procedure after six months of non-surgical care.
5. When patients from the non-surgical group crossed over to have the iFuse procedure, they reported pain reduction six months after surgery, similar to the patients who were initially randomized into the iFuse group.
Here are five things to know about the second study:
6. The second study included one-year results from a multicenter clinical trial of minimally invasive SI joint fusion that included 172 subjects at 26 centers in the United States.There were 157 patients available for follow-up.
7. Six months after surgery, 81 percent of the patients reported a “successful” treatment; at 12 months, the procedure had an 80 percent success rate.8. The average SI joint pain improved from 79.8 at baseline to 30 and 30.4 at six and 12 months.
8. The average Oswestry Disability Index score improved from 55.2 at baseline to 32.5 and 31.4 at six and 12 months.
9. The quality of life improvement measurements, SF-36, was 31.7 at baseline and improved to 40.2 and 40.3 at six and 12 months.
10. Around 94 percent of the patients reported somewhat or very satisfied with the procedure at six months; that number dropped to 87 percent by the end of the year. There were around 92 percent of the patients reporting they would have the procedure again at six months after surgery; 91 percent said the same one year after surgery.
The third study was as literature review examining 18 articles measuring patients’ pain, disability and quality of life for patients at 12 months after surgery. The researchers found the procedure was 59 minutes on average, bloodloss was 36.9 cc and hospital length of stay was 1.7 days. Pain scores and ODI scores improved for patients after surgery.