Si-Bone has announced the publication of a six-year study comparing the company’s Ifuse implant to both conservative management and radiofrequency denervation. The long-term study was published in the journal Neurosurgery.
The study evaluated 137 patients seen in an outpatient neurosurgery clinic who received either conservative management (63 patients), sacroiliac joint denervation (47) or sacroiliac joint fusion with the Ifuse implant (27) for sacroiliac joint pain due to either osteoarthritic degenerative sacroiliitis or joint disruption. Outcomes were based on SI joint pain ratings using a 0-10 visual analog scale (VAS), functional status using Oswestry Disability Index (ODI), pain medication use and work status. Patients treated with conservative management as well as those treated with radiofrequency denervation had no long-term improvement in pain or function, and in fact got worse, whereas the implant group had markedly superior improvements in pain (see Figure 1) and function.
At last follow-up, 80% of the patients in both the conservative management and radiofrequency denervation groups were using opioids, compared to only 7% of the patients in the Ifuse group. At last follow-up, 70% of patients treated with the implant had returned to work, compared to 34% of those treated with radiofrequency denervation 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 sacroiliac joint fusion with the Ifuse implant provided sustained, long term pain relief,” says Vicente Vanaclocha-Vanaclocha, primary author of the study. “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.”