SI-Bone reported one-year results from the iMIA clinical trial.
Here are five things to know:
1. The iMIA clinical trial examines the iFuse implant system for minimally invasive arthrodesis. The randomized, controlled trial was conducted at nine hospitals across four European countries.
2. The iFuse system is designed for minimally invasive SI joint fusion and the study compared surgery to conservative management in patients with chronic SI joint dysfunction.
3. Study authors found surgery with the iFuse system is safe and effective for patients with chronic low back pain due to SI joint dysfunction. The procedure improved function and quality of life by one year after surgery.
4. Of the 109 patients enrolled in the trial, most had previously undergone steroid injections and 16.5 percent had prior radiofrequency ablation. One year after surgery, VAS scores improved by 41.6 points in the surgical group, compared to 14 points in the conservative management group. Oswestry Disability Index scores were also more improved in the surgical group.
5. The study allowed patients to cross over after six months of conservative treatment. The patients who did cross over reported no improvement in pain and ODI scores during conservative treatment, but reported improvement in most measures after surgery.