A new study published in the International Journal of Spine Surgery examines the results of the Investigation of Sacroiliac Fusion Treatment.
The prospective multicenter randomized controlled trial includes six month results on 148 patients. There were 19 centers across the United States involved in the study, which compared outcomes for patients with SI joint dysfunction due to degenerative sacroiliitis. The patients either received immediate surgery with the iFuse Implant System from SI-BONE or non-surgical management.
Here are five key notes from the study:
1. The patients who underwent fusion improved SI joint pain from 82.3 at baseline to 29.8 at six months on a zero to 100 scale. The patients who underwent non-surgical management reported a 12-point pain drop from 82.2 before surgery to 70.4 six months later.
2. The Oswestry Disability Index scores improved by 30 points for the patients who underwent surgery, compared with 4.9 points for the patients who underwent non-surgical treatment.
3. The quality of life outcomes were measured by EQ-5D and SF-36, showing significant differences between the two groups. In the fusion group, 81.4 percent of the patients achieved overall treatment success with no device-related complications, no neurological worsening and no re-intervention; 23.9 percent of the non-surgical treatment group reported the same.
4. This is the first Level 1 study showing positive outcomes for minimally invasive SI joint fusions; there are 19 studies in peer-review publications examine outcomes ranging from Level 4 to Level 2b in addition to this Level 1 study.
5. Estimates show SI joint could be the pain generator in 15 percent to 30 percent of low back pain patients and in around 43 percent of the post-lumbar fusion SI joint pain patients.