Medical device company, SI-BONE, Inc. announced five-year clinical and radiographic outcomes favorable to the iFuse procedure. The clinical improvement observed at 12 months were maintained or improved in five years, including relief from back pain, function and patient satisfaction in patients treated with iFuse.

This report entitled "Five-year clinical and radiographic outcomes following the merger with minimally invasive sacroiliac joint use of facilities triangular "was published in The Open Orthopaedics Journal. This is the first publication reporting the results of long-term MIS SI joint fusion using the 'iFuse Implant System.

The results support the favorable long-term clinical outcomes in patients treated for degenerative sacroiliitis and/or sacroiliac joint dislocation with the merger MIS SI joint using a series of triangular systems covered TPS. These results are in line with a series of multiple case studies previously published and with a prospective multicenter study recently published.

Twenty-one consecutive patients who participated in this single-center study. Of these, 17 have provided clinical information and 15 were subjected to X-rays and CT scans for 5 years. The clinical improvement observed in the 12 months after surgery were maintained or further improved to the point in time of five years, including patient satisfaction (82% in both times). The level of pain, assessed using a visual analogue scale (VAS) from 0 to 10 (0 = no pain, 10 = worst pain imaginable), was down from a 8.3 at baseline to 3.4 at 12 months and declined further to 2.4 5 years. The functional improvement was measured based on a survey instrument SI joint which assessed the ability to perform light activity, moderate or vigorous, as well as sleep disturbance, the general sense of happiness and effect of pain on society. The ability to perform tasks light, moderate and vigorous showed continued improvement from 12 months to the time frame of five years. Average dell'Oswestry Disability Index (ODI), a measure of disability due to back pain only detected at 5 years was 21.5, indicating minimal disability in the media.

There were no intraoperative complications or long-term reported and there was no evidence of device migration. A qualitative examination of the X-ray and CT images obtained at both 1 and 5 years after the operation, showed increased bone density immediately adjacent to all facilities, indicating a biological fixation, and no evidence of loosening or migration system. "Evidence of bone bridges through the articulation YES has been clearly observed in 13 of 15 (87%) patients." The percentage of patients achieving substantial clinical benefit (SCB), defined as a reduction of 2.5 points in VAS pain score or follow-up less than 3.5, remained high at each time point (77% at 12 months, 82 % at 24 months and 88% at 60 months).

Dr. Gunnar Andersson, president of the International Society for the Advancement of Spine Surgery (ISASS), said: "There are now well over a dozen publications in peer confirmed that demonstrate the safety and efficacy of 'iFuse Implant System. This most recent publication reporting the results provide further five-year clinical trial that this minimally invasive surgical technique is safe and effective and gives lasting relief to patients suffering from certain pathologies of the SI. "

SI-BONE, Inc. has received approval from the original 510 (k) in November 2008 by the Food and Drug Administration (FDA) to market its iFuse Implant System. The CE mark for marketing in Europe was achieved in November 2010.

The clinical publications have identified the SI joint as a source of pain in 30% of patients with low back pain.  In addition, the prevalence of SI joint pain in post-lumbar fusion, the so-called patients to "failure of spine surgery", was found to be 43%.    The initial options for the treatment of patients with disorders of the SI normally involve a non-surgical management, and only when the non-surgical treatment of the joint YES fails, surgical techniques such as iFuse may provide an alternative.

L 'iFuse Implant System is a solution of minimally invasive surgery that uses titanium implants coated with a porous titanium plasma spray (TPS) that acts as interference surface, designed to help reduce the movement of the system, provide an immediate fixation and allow the biological fixation of supporting a fusion of long duration. The 'iFuse System is designed for the fusion of the sacroiliac joint in conditions that include the SI joint dysfunction as a direct result of broken SI joint and degenerative sacroiliitis. As with all surgical procedures and permanent installations, there are considerations and risks associated with surgery and the use of iFuse Implant. Physicians should refer to the product label for a discussion of these risks and patients will have to talk about these risks with their doctors before deciding whether the 'iFuse implant is right for them.

SI-BONE, Inc.  is a leader in the equipment medical sacroiliac joint, committed to the development of tools and products for diagnosing and treating patients with problems lumbar linked to disorders of the SI.