Si-Bone touts maintained results at 2 years in iFuse study

Si-Bone this week released 2-year results from the SIFI trial of iFuse implant system designed for sacroiliac joint fusion procedures, touting improvements in quality of life and a 28% reduction in opioid use.

Results from the trial were published in The International Journal of Spine Surgery, the San Jose, Calif.-based company said.

The 172-patient multi center trial reported improvements in SI joint pain, disability and quality of life maintain it found at 6 and 12 months were maintained up to 2 years.

“The target patient population and study eligibility criteria for SIFI were identical to Insite, a prospective multicenter randomized controlled trial of iFuse vs. non-surgical management. Insite showed superiority of iFuse compared to non-surgical management at nearly every endpoint at one year and SIFI at 2 years is an excellent proxy for Insite 2-year results which are expected to be published this summer,” clinical affairs veep Dr. Danny Cher said in a prepared statement.

Primary endpoints for the trial included a reduction in baseline VAS SI joint pain of at least 20 points, absence of device-related serious adverse events and neurological worsening related to the sacral spine and absence of surgical reintervention. Secondary endpoints included success rates at other time points, improvements from baseline VAS SI joint pain, ODI, SF-36 and EQ-5D scores, the company said.

At 6 months, success rates were 80.2% and remained at 79.9% at 12 and 24 months, the company said. Mean SI joint pain improved from 79.8 at baseline to 28.1 at 12 months, and remained at 26 at 2 years. ODI fell from 55.2 at baseline to 31.5 at 12 months and remained at 30.9 at 24 months.

SI-Bone said that quality of life improvements at 12 months were maintained at 24 months. The company said that while the trial did not have a goal of opioid use reduction, results showed a 28% reduction in use at 24 months, with 37 patients stopping opioid treatments completely.

“Two-year results from the SIFI study further validate the long-term durability of the iFuse procedure and provide compelling, high quality evidence that early improvements in pain and disability are sustained to 2 years,” lead author Dr. Bradley Duhon of the University of Colorado said in prepared remarks.

Surgical revision rate was 4.7% for the trial with 7 device-related adverse events, the company said.

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