Included in the new data are 1-year results from 2 clinical trials and a systemic review of 18 different studies of the MIS SI joint fusion system.
“Collectively, these 3 recent publications significantly strengthen the more than 20 clinical papers already published on iFuse and further solidify our clinical evidence foundation supporting MIS SI joint surgery using Si-Bone’s unique triangular implants,” CEO Jeffrey Dunn said in a press release.
The 1st clinical trial data comes from the randomized controlled study 148-patient Insite study, published in the journal Neurosurgery. One-year results reported a 52 point reduction in SI joint pain as rated by the visual analog scale at 6 months in patients treated with the iFuse. The pain relief scores were maintained at 12 months, the company reported.
The trial allowed for patients in the non-surgical control group to opt for the surgery after 6 months and Si-Bone reported that 79.5% of patients opted for the surgery. Patients who chose to be treated later showed similar pain relief effects, Si-Bone said.
Patients in the trial also reported reduced scores on the Oswestry Disability Index, which measures the level of disability due to back pain. Patients treated with the iFuse reported a nearly 50% reduction in their scores, versus a less-than-10% decrease in the control group.
“Surgery vs. non-surgery studies are difficult to execute. Insite’s design and execution in preventing early crossover has provided significant, high quality, Level 1 evidence to the existing body of literature demonstrating that, for patients with certain SI joint disorders, SI joint fusion with triangular porous coated titanium implants can meaningfully improve pain, function and quality of life compared to non-surgical management. This study shows that significant improvements in pain, disability and quality of life achieved at 6 months were sustained at 12 months and that subjects who crossed over to iFuse treatment did nearly as well as those originally assigned to iFuse,” lead author Dr. David Polly said in prepared remarks.
The 2nd trial, titled the Sifi study and published in the Global Spine Journal, examined 172 patients with similar enrollment criteria to the Insite study, Si-Bone reported.
At both 6 and 12 months, the study reported that roughly 80% of the patients met the study’s defined criteria for treatment success. Pain improvements were nearly 50% in patients, and mean ODI reductions were slightly under 40%. At the 6 and 12 month mark, 94% and 87% of subjects, respectively, reported being satisfied, and over 90% stated they would have the procedure again.
The study did not report adverse events, but stated that 2 subjects underwent revision for immediate postoperative radiculopathy due to implant malposition and 2 subjects underwent late revision surgery, according to Si-Bone.
“The 1-year results from the SIFI study have shown durable improvements in pain, disability, and quality of life with the iFuse procedure. This paper adds important, high quality clinical evidence to the more than two-dozen existing publications that support the safety and effectiveness of the iFuse procedure,” lead author Dr. Brad Duhon said in a prepared statement.
A 3rd study, published in the International Journal of Spine Surgery, reviewed 18 articles and 432 subjects, including 368 patients treated with the iFuse. The mean operation time for iFuse procedures was 59 minutes, the study reported, and hospital stays were 1.7 days on average.
The registry found the mean pain score dropped 5.2 points at 6 months and 5.3 points at 12 months, with a mean score of 2 points at 24 months in patients treated with the iFuse. ODI scores decreased 31 points, Si-Bone said.
In May, Si-Bone reported it raised $21 million in a funding round, and hired Laura Francis as its new CFO.
Si-Bone’s iFuse bone fixation system received FDA 510(k) clearance in 2008, and CE Mark approval in the European Union in 2010. In 2014, a Medicare contractor reversed non-compensation for treatment with the system in select markets.