Sacroiliac Joint Fusion With iFuse Implant System (SIFI)



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:21 - 70
Updated:11/30/2013
Start Date:July 2012
End Date:September 2014
Contact:Kathryn Wine, MPH
Email:kwine@si-bone.com
Phone:408-207-0700

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The purpose of this study is to evaluate the use of the iFuse Implant System to treat
degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal
separation or tearing of the sacroiliac joint). The iFuse Implant System (iFuse device) is
a medical device that is surgically implanted into the sacroiliac (SI) joint during a
minimally invasive surgical procedure (one that uses a smaller incision and less damage to
the skin and other tissues than standard surgery). The purpose of implanting the device is
to stabilize and fuse the SI joint.


Inclusion Criteria:

1. Age 21-70 at time of screening

2. Patient has lower back pain for >6 months inadequately responsive to conservative care

3. Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL
of the following:

1. Patient has pain at or close to the posterior superior iliac spine (PSIS) with
possible radiation into buttocks, posterior thigh or groin and can point with a
single finger to the location of pain (Fortin Finger Test), and

2. Patient has at least 3 of 5 physical examination maneuvers specific for the SI joint
(see Table 3), and

3. Patient has improvement in lower back pain numeric rating scale (NRS) of at least 50%
after injection of local anesthetic into affected SI joint(s) (see Section 3.6.4),
and

4. One or more of the following:

i. SI joint disruption:

1. Asymmetric SI joint widening on X-ray or CT scan

2. Leakage of contrast on diagnostic arthrography

ii. Degenerative sacroiliitis:

1. Radiographic evidence of SI joint degeneration, including sclerosis,osteophytes,
subchondral cysts, or vacuum phenomenon on CT or plain film, or

2. Due to prior lumbosacral spine fusion

4. Baseline Oswestry Disability Index (ODI) score of at least 30% 5. Baseline SI joint
pain score of at least 50 on 0-100 mm visual analog scale 6. Patient has signed
study-specific informed consent form 7. Patient has the necessary mental capacity to
participate and is physically able to comply with study protocol requirements

Exclusion Criteria:

1. Severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc
herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet
degeneration, and lumbar vertebral body fracture

2. Other known sacroiliac pathology such as:

1. Sacral dysplasia

2. Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated
spondyloarthropathy)

3. Tumor

4. Infection

5. Acute fracture

6. Crystal arthropathy

3. History of recent (< 1 year) major trauma to pelvis

4. Previously diagnosed osteoporosis (defined as prior T-score <-2.5 or history of
osteoporotic fracture).

5. Osteomalacia or other metabolic bone disease

6. Chronic rheumatologic condition (e.g., rheumatoid arthritis)

7. Any condition or anatomy that makes treatment with the iFuse Implant System
infeasible

8. Chondropathy

9. Known allergy to titanium or titanium alloys

10. Use of medications known to have detrimental effects on bone quality and soft-tissue
healing

11. Prominent neurologic condition that would interfere with physical therapy

12. Current local or systemic infection that raises the risk of surgery

13. Patient currently receiving or seeking worker's compensation, disability
remuneration, and/or involved in injury litigation.

14. Currently pregnant or planning pregnancy in the next 2 years

15. Patient is a prisoner or a ward of the state.

16. Known or suspected drug or alcohol abuse

17. Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality
disorders) that could interfere with study participation

18. Patient is participating in an investigational study or has been involved in an
investigational study within 3 months prior to evaluation for participation
We found this trial at
28
sites
1044 SW 44th Street
Oklahoma City, Oklahoma 73109
405-616-4888
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Bellevue, Washington 98004
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Campbell, California 95008
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Campbell, CA
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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College Station, Texas 77845
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Columbia, Missouri 65201
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Daytona Beach, Florida 32117
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Gainsville, Florida 32607
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Huntsville, Alabama 35801
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Indianapolis, Indiana 46219
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Indianapolis, IN
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Johnson City, Tennessee 37064
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Kansas City, MO
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Lakeland, Florida 33806
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Lebanon, New Hampshire 03766
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Lebanon, NH
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Lexington, KY
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Macon, Georgia 31210
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Mt. Vernon, Illinois 62864
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New York, New York 10075
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Orange, California 92869
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Parker, Colorado 80138
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Plano, Texas 75093
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Pomona, CA
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Reston, Virginia 20190
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Richmond, Virginia 23226
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San Francisco, California 94117
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Springfield, Missouri 65807
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Tyler, Texas 75701
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Tyler, TX
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