The results are published in The International Journal of Spine Surgery. The trial included 172 subjects at 26 U.S. centers.
Here are five insights:
1. The results show marked improvements in SI joint pain, disability and quality of life achieved at six and 12 months were maintained to two years.
2. Mean SI joint pain improved from 79.8 at baseline to 28.1 at 12 months and remained low at 26 at 24 months.
3. The Oswestry Disability Index decreased from 55.2 at baseline to 31.5 at 12 months and remained low at 30.9 at 24 months.
4. The surgical revision rate was low with eight subjects having to undergo revision surgery. Additionally, there were seven device-related adverse events.
5. SI-BONE received FDA 510(k) clearance in November 2008 to market its iFuse Implant System. The system is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction.
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