The five-year clinical and radiographic outcomes for minimally invasive sacroiliac joint fusion with SI-BONE's iFuse system were recently published in The Open Orthopaedics Journal.
There were 21 consecutive patients who participated in the single-center study, with 17 patients who provided clinical information and 15 who underwent x-ray and CT imaging at five years after surgery.
Here are 10 key findings from the study:
1. The clinical improvements reported one year after surgery were maintained or improved at five years after surgery.
2. Patient satisfaction was 82 percent at both one and five years after surgery.
3. Visual analogue scale scores improved from 8.3 at baseline to 3.4 at one year and then 2.4 at five years.
4. Functional improvement was also assessed and improved through one year and five years after surgery. The average Oswestry Disability Index score was 21.5 at five years, indicating minimal to moderate disability.
5. There were no intraoperative or long-term complications.
6. None of the patients showed evidence of device migration.
7. Patients experienced increased bone density immediately adjacent to all implants, suggestive of bone fixation, and there was no evidence of loosening or migration.
8. The osseous bridged across the SI joint clearly in 87 percent of the patients.
9. The majority of patients experienced substantial clinical benefit — a 2.5 point decrease in VAS pain scores or a follow-up score of less than 3.5:
• 12 months: 77 percent
• 24 months: 82 percent
• 60 months: 88 percent
10. These findings are consistent with other clinical case studies previously published and a recently published multi-center prospective study.
"There are well over a dozen peer-reviewed publications now that demonstrate safety and efficacy of the iFuse Implant System," said Gunnar Andersson, MD, president of the International Society for the Advancement of Spine Surgery. "The most recent publication reporting five year results provides further clinical evidence that this minimally invasive surgical technique is safe and effective and provides lasting relief for patients who suffer from certain joint disorders."