Sacroiliac Joint Fusion With iFuse Implant System (SIFI) (NCT01640353) | Clinical Trial Compass
CompletedNot Applicable
Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
United States194 participantsStarted 2012-07
Plain-language summary
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.
Who can participate
Age range21 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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
✓. Patient has at least 3 of 5 physical examination maneuvers specific for the SI joint (see Table 3), and
✓. 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
✓. One or more of the following:
✓. Asymmetric SI joint widening on X-ray or CT scan
✓. Leakage of contrast on diagnostic arthrography
✓. Radiographic evidence of SI joint degeneration, including sclerosis,osteophytes, subchondral cysts, or vacuum phenomenon on CT or plain film, or
. 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
✕. Other known sacroiliac pathology such as:
✕. Sacral dysplasia
✕. Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy)