INSITE trial receives Leon L Wiltse Award for best paper at ISASS 2015


SI-Bone has announced that results from the INSITE study, presented at this year’s Annual International Society for the Advancement of Spine Surgery meeting (ISASS; 15–17 April, San Diego, USA) was awarded the Leon L Wiltse Award for best overall paper by the ISASS meeting programme committee. The award, sponsored by Hansen Yuan and his wife, is voted on by the committee chairs each year and is based on a combination of quality of submitted abstract and podium presentation.

This years’ paper was chosen from over 450 submitted abstracts. The paper was presented by Peter Whang, principal investigator of the INSITE trial. Six-month results on the 148 patients enrolled in INSITE were published in the International Journal of Spine Surgery earlier this year. Results showed that the iFuse implant provided superior outcomes for SI joint pain, disability and quality of life vs. non-surgical management in patients with SI joint dysfunction due to degenerative sacroiliitis or sacroiliac joint disruptions. 

Included in the presentation were initial results from ongoing 12-month follow-up. Of the 102 subjects randomised to iFuse, 12-month follow-up showed continued improvement in pain and disability scores. Of the 44 subjects randomised to non-surgical management and still participating in the study, 34 crossed over to receive iFuse and 10 did not. All 34 crossover subjects underwent SI joint fusion with the iFuse Implant System. Initial results of twelve-month follow-up in this group showed marked improvements in pain and disability similar to those initially randomised to iFuse. Of the 10 subjects who did not crossover after six months, 12-month follow-up showed no further improvement in pain or disability.

“It is truly a great honour to receive the Leon L Wiltse award for best overall paper at this year’s ISASS meeting and I would just like to congratulate and thank the other 18 clinical site investigators who participated in the trial as well the dozens of clinical support staff who have contributed to the quality and success of this study,” said Peter Whang. Whang further commented: “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 sacroiliac joint fusion. 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.”

Clinical publications have identified the sacroiliac joint as a pain generator in 15–30% of low back pain patients. In addition, the prevalence of sacroiliac joint pain in post-lumbar fusion, so called failed back surgery, has been shown to be up to 43%. Of these patients, some may have degenerative sacroiliitis or sacroiliac joint disruptions. Initial treatment options for patients with sacroiliac joint disorders typically involve non-surgical management and, when non-surgical management of the joint fails, surgical options such as the iFuse procedure may be considered.