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.
|Ages Eligible for Study:
||21 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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:
- 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)
- Acute fracture
- Crystal arthropathy
- History of recent (<1 year) major trauma to pelvis
- Previously diagnosed osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture). Patients meeting the osteoporosis screening criteria identified by the National Osteoporosis Foundation should be screened for osteoporosis with DEXA.**** See Section 3.6.4.
- Osteomalacia or other metabolic bone disease
- Chronic rheumatologic condition (e.g., rheumatoid arthritis)
- Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
- Known allergy to titanium or titanium alloys
- Use of medications known to have detrimental effects on bone quality and soft-tissue healing
- Prominent neurologic condition that would interfere with physical therapy
- Current local or systemic infection that raises the risk of surgery
- Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation.
- Currently pregnant or planning pregnancy in the next 2 years
- Patient is a prisoner or a ward of the state.
- Known or suspected drug or alcohol abuse***
- Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
- Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation