SI-BONE, Inc. is the leading medical device company dedicated to the development of tools and products for diagnosing and treating patients with low back issues related to SI joint disorders.
Clinical publications have identified the SI joint as a pain generator in up to 22% of low back pain patients.1 In addition, DePalma et al. Pain Medicine 2011, identified the SI joint as a low back pain generator in 43% to 61% of symptomatic post-lumbar fusion, so-called “failed back surgery” patients.2
A recent publication highlights the impact of lower back pain caused by a variety of SI joint disorders, including SI joint disruptions or degenerative sacroiliitis. This study demonstrated that the burden of SI joint pain appears to be higher than in many common medical conditions that are considered to be very disabling, including COPD, coronary heart disease, angina, asthma and mild heart failure. Furthermore, the impact of SI joint pain appears to be similar to that of other prominent orthopaedic surgical conditions including hip and knee osteoarthritis, degenerative spondylolisthesis and spinal stenosis – all of which are well recognised as significantly debilitating conditions.3
Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical treatment of the SI joint fails, minimally invasive surgical treatments such as the iFuse Implant System may provide an option.
The iFuse Implant System is a commercially available device in the US and Europe. The iFuse procedure requires a small incision for delivery and implantation of triangular-shaped titanium implants. These triangular-shaped implants are coated with a porous, titanium plasma spray (TPS) that acts as an interference surface, designed to help decrease implant motion and provide immediate fixation, and allow for biological fixation to support long-term fusion. To date, more than 13,000 procedures have been performed worldwide by more than 800 surgeons.
Over a dozen peer-reviewed published articles have reported positive clinical results for the iFuse Implant System. Outcome measures include back pain visual analog scale (VAS), Oswestry Disability Index (ODI), quality of life (SF-36 and EQ-5D), and patient satisfaction with the surgery. An independent review of the company complaints database with information on over 5,000 procedures documents a low complaint rate and a low revision rate4.
The iFuse System is indicated for sacroiliac joint fusion. As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse Implant.
1. Bernard TN, et al. Recognizing specific characteristics of nonspecific low back pain. Clinical Orthopedics and Related Research. 1987;217:266–80.
2. DePalma M*, et al. Etiology of chronic LBP patients having undergone lumbar fusion. Pain Medicine. 2011;12:732–9.
3. Cher D**, et al. Sacroiliac joint pain: burden of disease. Medical Devices: Evidence and Research 2014:7 1–9.
4. Miller LE, et al. Analysis of the postmarket complaints database for the iFuse SI Joint Fusion System: a minimally invasive treatment for degenerative sacroiliitis and sacroiliac joint disruption. Medical Devices: Evidence and Research. 2013;6:77–84.
*Conducts clinical research for SI-BONE Inc.
** Employee of SI-BONE, Inc.