Si-Bone today released data from a 6-year study of its iFuse Implant, touting significant reduction in opioid use for pain control in patients treated with the device.
Data from the study, which compared the iFuse implant to both conservative management and radiofrequency denervation for treating SI joint pain, was published in the journal Neurosurgery.
The iFuse implant system is a triangular shaped minimally invasive surgical device designed for spinal fusion procedures to treat certain disorders of the sacroiliac joint, the San Jose, Calif.-based company said.
Data from a 137-patient trial indicated that patients treated with radiofrequency denervation or conservative management showed no long-term improvement in pain or function or got worse, while patients in the iFuse implant group reported superior improvements in pain and function.
At the last follow up, 80% of both the conservative management and radiofrequency denervation groups were using opioids for pain control, compared to only 7% of patients in the iFuse implant group, the company said.
A reported 70% of patients in the iFuse arm had returned to work on their last follow-up visit, Si-Bone said, compared to only 34% in the radiofrequency denervation group and 19% of those treated with conservative management.
“An interesting observation from our study was that over one-third of patients seen in our clinic and initially treated with conservative management failed to achieve adequate pain relief and required additional treatments. Of the treatments available, only SI joint fusion with the iFuse implant provided sustained, long term pain relief. Furthermore, the fact that the treatment option provided was often decided by external factors enhanced the comparability of groups. This study offers solid evidence that the iFuse implant is an effective long-term treatment for those patients with chronic pain resulting from certain types of SI joint pathologies who fail to respond to initial conservative management,” study primary author Dr. Vicente Vanaclocha-Vanaclocha said in a prepared statement.
“This study is remarkable in that it highlights the profound positive impact on patients with SI joint pain who have access to SI joint fusion. The opioid epidemic is a challenging public health problem in the U.S. and coverage policies that provide access to technologies like the iFuse implant can have a meaningful impact on reducing dependence on opioids,” CEO Jeffrey Dunn said in a press release.