SI-BONE, Inc. Announces Journal of Bone and Joint Surgery (JBJS) Publishes 2-Year Results from iMIA, a European Multicenter R...
March 06 2019 - 3:05PM
SI-BONE, Inc. (Nasdaq: SIBN), a medical device company that
pioneered minimally invasive surgery of the sacroiliac (SI) joint
with the iFuse Implant System® (iFuse), announced publication of
2-year results from iMIA (iFuse Implant System Minimally Invasive
Arthrodesis; ClinicalTrials.gov ID NCT01741025), a multicenter
European RCT in the Journal of Bone and Joint Surgery (JBJS).
iMIA is a Level 1 RCT, conducted at nine hospitals in four
countries in Europe, that assessed the safety and effectiveness of
SI joint fusion (SIJF), also referred to as SI joint arthrodesis in
the manuscript, with the triangular iFuse Implants compared to
conservative management (CM) in patients with chronic SI joint
dysfunction. The JBJS publication, titled Randomized Trial of
Sacroiliac Joint Arthrodesis Compared with Conservative Management
for Chronic Low Back Pain Attributed to the Sacroiliac Joint,1
showed that minimally invasive SIJF with iFuse Implants was safe
and more effective than CM in relieving pain, reducing disability,
and improving patient function and quality of life at two
years.
“What I find remarkable is the consistency of the results
between the 2-year iMIA and 2-year INSITE RCTs,” said David Polly,
Jr., MD, Professor, Department of Orthopedic Surgery at the
University of Minnesota. “The studies, which were well
designed and well executed, were conducted at a combined 28
different centers on two different continents, yet the results are
almost identical, which only further validates the effectiveness of
the use of the iFuse triangular titanium implants for the treatment
of patients with chronic SI joint dysfunction who no longer respond
to conservative treatment.”
The iMIA 2-year results were published in JBJS, which has an
impact factor of 4.84, the highest among orthopedic journals, and
is a highly valued source of information for orthopedic surgeons
and researchers. As such, this publication, which is the 67th
peer-reviewed iFuse publication, is a significant indication
of the broad acceptance of SI joint surgery as an important topic
of study in orthopedics.
“The publication of this Level 1 study in a prestigious
orthopedic journal such as JBJS is an important milestone signaling
recognition of the sacroiliac joint, like all other joints in the
human body, as a pain generator and acknowledgement of the high
quality of evidence that supports iFuse as an effective minimally
invasive procedure for patients with SI joint pain”, said Daniel
Cher, MD, Vice President of Clinical Affairs at SI-BONE, Inc.
As shown in Figures 1 and 2 below, 2-year results from iMIA were
remarkably consistent with 2-year results from INSITE
(Investigation of Sacroiliac Fusion Treatment – NCT01681004), the
RCT conducted at 19 institutions in the U.S. and published in
August, 2016 in the International Journal of Spine
Surgery.2
In the iMIA study, 103 subjects were randomly assigned to CM
(n=51) or SIJF (n=52) between June 6, 2013 and May 15, 2015.
At 2 years, mean low back pain (as measured on the Visual
Analog Scale, or VAS) improved by 45 points in the SIJF group and
11 points in the CM group (mean difference between groups 34
points, p<0.0001). Mean ODI improved by 26 points in the
SIJF group and 8 points in the CM group (mean difference 18 points,
p<0.0001). Parallel improvements were seen in leg pain and
several quality of life measures. Moreover, objective
improvements were observed in SI joint function, including active
straight leg raise test and a number of positive physical
examination signs for SI joint pain. In the SIJF group, the
prevalence of opioid use decreased from 56% at baseline to 33% at 2
years (p<0.01), while no significant change was observed in the
CM group (47.1% and 45.7%). Subjects in the CM group who derived
minimal benefit after 6 months of CM showed improvements in all
measures similar to those originally assigned to SIJF after
crossing over to surgery. One case of postoperative nerve
impingement occurred in the SIJF group. The full article can
be found at the following
link: https://journals.lww.com/jbjsjournal/Fulltext/2019/03060/Randomized_Trial_of_Sacroiliac_Joint_Arthrodesis.4.aspx
About SI-BONE
SI-BONE is a medical device company that pioneered the iFuse
Implant System, a minimally invasive surgical system for fusion of
the sacroiliac joint to treat sacroiliac joint dysfunction.
The SI joint is the last major joint with a clinically proven
surgical treatment. The iFuse Implant, commercially available
since 2009, is the only SI joint fusion device supported by
multiple prospective clinical studies showing improved pain,
patient function and quality of life resulting from
treatment. There are more than 65 peer-reviewed publications
supporting the safety, durable effectiveness, and biomechanical and
economic benefits unique to the iFuse Implant
(www.si-bone.com/results). This body of evidence has enabled
multiple government and private insurance payors to establish
coverage of the SI joint fusion procedure exclusively when
performed with the iFuse Implant System.
The iFuse Implant System is intended for sacroiliac fusion for
conditions including sacroiliac joint dysfunction that is a direct
result of sacroiliac joint disruption and degenerative
sacroiliitis. This includes conditions whose symptoms began
during pregnancy or in the peripartum period and have persisted
postpartum for more than 6 months. There are potential risks
associated with the iFuse Implant System. It may not be
appropriate for all patients and all patients may not
benefit.
SI-BONE and iFuse Implant System are registered trademarks of
SI-BONE, Inc. ©2019 SI-BONE, Inc. All Rights Reserved.
10309.030719
- Dengler J, Kools D, Pflugmacher R, Gasbarrini A, Prestamburgo
D, Gaetani P, Cher D, Van Eeckhoven E, Annertz M, Sturesson
B. Randomized Trial of Sacroiliac Joint Arthrodesis Compared with
Conservative Management for Chronic Low Back Pain Attributed to the
Sacroiliac Joint. J Bone Joint Surg. 2019;101(5):400-411. doi:
10.2106/JBJS.18.00022
- Polly DW, Swofford J, Whang PG, Frank CJ, Glaser JA, Limoni RP,
Cher DJ, Wine KD, Sembrano JN, and the INSITE Study Group. Two-Year
Outcomes from a Randomized Controlled Trial of Minimally Invasive
Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac
Joint Dysfunction. Int J Spine Surg. 2016;10:Article 28. doi:
10.14444/3028
Contact:For SI-BONE, Inc.:Joe
PowersVice President of Marketing669-206-2521
jpowers@si-bone.com
Photos accompanying this announcement are available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/6d116c9c-0bf2-452c-a154-672ac3b2df8f
http://www.globenewswire.com/NewsRoom/AttachmentNg/742f9332-30ef-4f2a-a04f-7eae432dbe0b
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