CompletedNot Applicable

Investigation of Sacroiliac Fusion Treatment (INSITE)

United States159 participantsStarted 2012-09

Plain-language summary

The purpose of this study is to compare outcomes when patients with degenerative sacroiliitis (arthritis of the SI joint) and or sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint)undergo either SI joint fusion with the iFuse Implant System or undergo specific, targeted non-surgical treatment of the SI joint.

Who can participate

Age range21 Years – 70 Years

SexALL

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Inclusion criteria

✓. Age 21-70 at time of screening
✓. Patient has lower back pain for \>6 months inadequately responsive to conservative care
✓. Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following:
✓. 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:
✓. Baseline Oswestry Disability Index (ODI) score of at least 30%

Exclusion criteria

✕. 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)

What they're measuring

Subject Success

Timeframe: 6 months

Trial details

NCT IDNCT01681004

SponsorSI-BONE, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-02

Results submitted2017-06-22

View on ClinicalTrials.gov More Degenerative Sacroiliitis trials