It’s good news for those suffering from degenerative sacroiliitis and/or sacroiliac (SI) joint disruptions. SI-BONE, Inc. is reporting 5-year results indicating that patients treated with its iFuse procedure experienced low back pain relief and patient satisfaction. In this single center study, the minimally invasive SI joint fusion involved a series of triangular TPS coated implants. These findings, reported in The Open Orthoapedics Journal, are consistent with multiple clinical case series previously published and a recently published multi-center prospective study.
The company reported that of the initial 21 consecutive patients, 17 provided clinical information and 15 patients underwent X-ray and CT imaging at 5 years. Clinical improvements observed at 12 months postoperatively were maintained or improved at the 5-year time point, including patient satisfaction (82% at both). Level of pain was assessed via the visual analog scale (VAS); pain improved from 8.3 at baseline to 3.4 at 12 months and further improved to 2.4 at 5 years. Functional improvement was assessed via survey, and evaluated the ability to perform light, moderate and vigorous activities as well as sleep disturbance, overall happiness and effect of pain on social life. The ability to perform light, moderate and vigorous activities showed continual improvement. Mean Oswestry Disability Index score was 21.5, indicating minimal to moderate disability.
There were no complications reported and no evidence of device migration. Qualitative review of X-ray and CT imaging, obtained at both 1 and 5 years following surgery, showed increased bone density immediately adjacent to all implants, which the company says is suggestive of biological fixation.
Dr. Gunnar Andersson, president of the International Society for the Advancement of Spine Surgery (ISASS) commented in the October 27, 2014 news release, “There are well over a dozen peer-reviewed publications now that demonstrate safety and effectiveness of the iFuse Implant System. This most recent publication reporting 5-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 SI joint disorders.”
SI-BONE recently submitted for publication six month results for all patients enrolled in their SIFI study. By the end of 2014 the company plans to submit their INSITE study for publication; INSITE is a prospective, multi center, randomized trial of iFuse vs non-operative care.
The graph below summarizes results for nine of the current publications that measured VAS pain scores and illustrates consistent rapid and sustained reduction in VAS pain scores among patients treated with iFuse.
Jeff Dunn, CEO of SI-BONE, told OTW, “The most important thing in medical devices is high quality clinical evidence and lots of it. There have now been over 15 studies published and they pretty much all show the same thing…a reduction in patient pain from the 7-9 range to the 2-3 range. As well this 5-year study shows that the iFuse solution is a good long term solution for these SIJ patients and I congratulate Dr. Leonard Rudolf for his work. That said, as a company we are excited that additional high quality clinical and safety evidence including a large USA randomized control study will be submitted for publication in the next 45 days.”
Does this require a hospital stay. And does any insurance cover this?