SI-BONE, Inc. Announces SI Joint Burden of Disease and Economic Burden Publications

SAN JOSE, Calif., April 14, 2014 /PRNewswire/ -- SI-BONE, Inc. (San Jose, California), a medical device company that has pioneered the use of the iFuse Implant System^®, a minimally invasive surgical (MIS) device used to fuse the sacroiliac (SI) joint for sacroiliac joint disruptions and degenerative sacroiliitis, announced today the publication of three new clinical articles that highlight the economic and health impact of lower back pain caused by a variety of SIJ disorders, including SI joint disruptions or degenerative sacroiliitis.

The first article entitled "Sacroiliac joint pain: burden of disease" is a comparative cohort analysis of 198 patients diagnosed with chronic SI joint pain who were about to undergo SI joint fusion versus a normal cohort of 3,844 patients participating in a nationally representative cross-sectional survey (U.S. National Health Measurement Study [NHMS]).  EQ-5D and SF-36 standardized questionnaires were used to measure health outcomes to assess the relative disability of patients in the SI joint cohort.  Results demonstrate that this cohort of patients with SI joint pain report significant compromise of their health status when compared with normal controls and when compared with other common medical and surgical conditions.  Compared to nationally representative age and sex-matched peers, these patients with SI joint pain had a health-related quality-of-life in the 20^th percentile or less.  The burden of SI joint pain in this cohort appears to be higher than 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 in this cohort appears to be similar to that of similar cohorts with other prominent orthopedic surgical conditions including hip and knee osteoarthritis, degenerative spondylolisthesis and spinal stenosis – all of which are recognized as significantly debilitating conditions.¹

The second article, published in the Journal of Neurosurgery: Spine, is entitled "Nonoperative care to manage sacroiliac joint disruption and degenerative sacroiliitis: high costs and medical resource utilization in the United States Medicare population."  This is a retrospective claim-level data analysis from the Medicare 5% Standard Analytic Files (SAF) that included 14,552 Medicare beneficiaries who met the inclusion criteria of having a primary ICD-9-CM diagnosis code for a variety of SI joint disorders including degenerative sacroiliitis and/or SI joint disruptions and who were continuously enrolled in Medicare for at least one year prior to and five years after diagnosis.  The estimated national medical expenditure (Medicare payments) over the five-year period across practice settings attributable to SI joint disorders is approximately $270 million among these 14,552 Medicare beneficiaries.  When extrapolated over Medicare patients' lifetimes, the estimated national medical expenditure is approximately $10.7 billion.  As a point of reference, the annual economic burden per patient of SI joint disorders is about half that of heart failure and several times that of hypertension.²

The third article is entitled: "Management of sacroiliac joint disruption and degenerative sacroiliitis with nonoperative care is medical resource-intensive and costly in a United States commercial payer population."  This analysis evaluates the health care resource utilization and direct medical costs of non-operative care of SI joint disorders including SI joint disruptions and/or degenerative sacroiliitis to private payers and assesses the economic burden of disease.  Similar to the Medicare analysis above, this study is also a retrospective claims data analysis but based on commercially insured patients in the MarketScan^® Commercial Claims and Encounters and Medicare Supplemental Databases.  A total of 78,533 patients were identified who met the inclusion criteria of having an ICD-9-CM diagnosis of an SI joint disorder including SI joint disruptions and/or degenerative sacroiliitis in the primary diagnosis field and continuous enrollment for at least one year prior to and three years after diagnosis.  The cumulative 3-year costs (insurance payments) associated with non-operative care are estimated to be $1.6 billion per 100,000 commercial payer beneficiaries.  Within this analysis, a subgroup of patients who underwent lumbar spinal fusion showed a 5-fold higher economic burden compared to patients who did not undergo lumbar spinal fusion.  In addition, 17% of those patients who received a lumbar fusion were subsequently diagnosed with SI joint pain within a year or less following their lumbar fusion, suggesting that these patients may have been misdiagnosed, had concomitant disease or developed new SI joint disease.³

"These three studies provide additional evidence that SI joint pain can have a high clinical impact and is costly to our society.  The cost burden accumulates annually across a broad age range consuming significant healthcare resources when managed and treated non-operatively.  Given these high costs, it is imperative that we investigate alternative treatment options such as minimally invasive SI joint fusion, which may have the potential to reduce the overall cost of care because they address the pathophysiology of the source of the pain," said David Polly, MD.

Sigurd Berven, MD stated: "It's well known that chronic lower back pain is prevalent in our society and causes significant disability.  These studies shed compelling light on the role that the SI joint may play in contributing to this significant healthcare burden."

SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System (then called the "SI Joint Fusion System") for fracture fixation of long bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and an additional clearance in April 2011 for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The CE mark for European commercialization was obtained in November 2010.

Clinical publications have identified the SI joint as a pain generator for up to 22% of low back pain patients.⁴  In addition, DePalma et al, Pain Medicine 2011, identified the SI joint as a low back pain generator in 43% to 61% of post-lumbar fusion, so-called "failed back surgery," patients.⁵  Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical treatment of the SI joint fails, surgical treatments such as the iFuse may provide an option.

The iFuse Implant System is a commercially available device in the U.S. and Europe.   The iFuse procedure uses a small incision for delivery and implantation of titanium implants.  The implants are coated with a porous, titanium plasma spray 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. These implants have substantial thickness and sophisticated metallurgy and are able to produce a much stronger construct than that of conventional screws used to surgically fix bony structures.  The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.  As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse Implant.

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is the leading sacroiliac joint 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.  The company has developed, and is manufacturing and marketing, less invasive approaches using implants for the treatment of certain SI joint pathology.  SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices.  SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2014 SI-BONE, Inc. All Rights Reserved.  8573.112113

¹Cher D,^a Polly D,^b Berven S. Sacroiliac joint pain: burden of disease.  Medical Devices: Evidence and Research 2014:7 1-9.

²Ackerman S,^c Polly D,^b Knight M,^c Holt T,^d Cummings J.^d  Nonoperative care to manage sacroiliac joint disruption and degenerative sacroiliitis: high costs and medical resource utilization in the United States Medicare population.  Journal of Neurosurgery: Spine  February 14, 2014.

³Ackerman S,^c Polly D,^b Knight M,^c Holt T,^d Cummings J.^d  Management of sacroiliac joint disruption and degenerative sacroiliitis with nonoperative care is medical resource-intensive and costly in a United States commercial payer population.  ClinicoEconomics and Outcomes Research 2014:6 63-74.

⁴ Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clinical Orthopedics and Related Research. 1987;217:266–80.

⁵DePalma M, Ketchum JM, Saullo TR. Etiology of chronic LBP patients having undergone lumbar fusion. Pain Medicine. 2011;12:732-9.

Disclosures
^a Employee of SI-BONE Inc.
^b Investigator on a clinical research study sponsored by SI-BONE.  No financial interest in SI-BONE.
^c Consultants to SI-BONE through their employment at Covance.
^d Paid consultant of, and conducts clinical research for, SI-BONE, Inc.

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