European Spine Journal published six-month results from the iFuse Implant System Minimally Invasive Arthrodesis clinical trial.
A randomized controlled trial, iMIA is comparing the safety and effectiveness of minimally invasive joint fusion using iFuse patented triangular titanium implants to conservative therapy. The results include analysis of 103 patients with chronic SI joint pain, who were split into either SI joint fusion with iFuse or conservative management centers. SI-BONE developed the iFuse Implant System.
Here are six insights:
1. The study found iFuse offers enhanced improvements in pain, disability, function and quality of life compared to conservative therapy.
2. Mean self-rated low back pain increased 43.9 points for the iFuse group compared to 5.7 points in the conservative management group.
3. Mean Oswestry Disability Index scores improved 26 points in the iFuse group compared to 6 points in the conservative management group.
4. Active straight leg raise, EQ-5D-3L quality of life, walking distance and satisfaction ratings also fared better in the iFuse group.
5. Adverse event frequency did not change between groups.
6. This study follows the United States' INSITE randomized clinical trial, which produced similar results favoring iFuse.
"Results from iMIA provide additional, independent confirmation that the improvements after iFuse surgery are clinically important and statistically superior to those seen with continued conservative care," said Bengt Sturesson, MD, of Ängelholm Hospital in Sweden.
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