SI-BONE presented the results from the INSITE study at the Annual International Society for the Advancement of Spine Surgery meeting earlier this year.
The paper was titled "Minimally Invasive SI Joint Fusion Using Triangular Implants vs. Non-surgical Management of Chronic SI Joint Dysfunction: Results of a Prospective Multicenter Randomized Trial" and included 148 patients from 18 clinical site investigators.
Here are five things to know about the paper:
1. Peter Whang, MD, was the principle investigator of the study with the results published in the International Journal of Spine Surgery.
2. The results showed the iFuse Implant for minimally invasive sacroiliac joint fusion provided superior outcomes for pain, disability and quality of life when compared with non-surgical management in patients with SI joint dysfunction.
3. The paper earned the Leon L. Wiltse award for best overall paper at the meeting.
4. The 102 patients who were randomized to the iFuse group reported continued improvement in pain and disability scores one year after surgery. There were 34 patients who crossed from the non-surgery group to the iFuse group.
5. Ten patients did not crossover from the non-surgical group and at the one year follow-up, the patients showed no improvement in pain or disability.
"I am impressed with the study's preliminary 12-month results and, although follow-up is continuing, there is now very strong evidence that patients in the non-surgical group who crossed over to surgery after six months of continued non-surgical treatment had postoperative improvements in pain and disability almost as large as those initially assigned to SI-joint fusion," said Dr. Whang. "Those who did not cross over had no further improvements in pain or disability. These results add to the validity of the study's findings."