Researchers published the two-year results from San Jose, Calif.-based SI-BONE's INSITE study comparing the iFuse Implant System to non-surgical management for sacroiliac joint dysfunction.
The trial included 148 patients treated at 19 centers across the Untied States.
International Journal of Spine Surgery published the results.
Here are six observations:
1. The multicenter, Level 1 randomized controlled trial compared MIS SI joint fusion with iFuse to non-surgical management.
2. The iFuse group patients experienced a mean SI joint pain score improvement from 82.3 at baseline to:
- 30.1 — six months
- 28.6 — 12 months
- 26.7 — two years
3. The iFuse group patients experienced Oswestry Disability Index score decreases from a mean 57.2 at baseline to:
- 29.9 — six months
- 28.3 — 12 months
- 28.7 — two years
4. The iFuse group saw a 3.4 percent revision surgery rate.
5. The study also revealed a 29.7 percent decrease from baseline in the number of iFuse patients taking opioids at two years.
6. These positive two-year results join the more than 40 peer-reviewed publications on iFuse.
"These two-year results from the INSITE study illustrate the durability of SI joint fusion with iFuse and further validate previously reported six- and 12-month results that showed rapid improvement in pain, function and quality of life in this highly debilitated patient population," said Frank Phillips, MD, Chicago-based Rush University Medial Center.