iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction

Inclusion Criteria:

1. Age > 21 at time of screening

2. Patient has lower back / buttock pain for at least 6 months inadequately responsiveto non-surgical care

3. Diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or sacroiliacdisruption)

4. Baseline Oswestry Disability Index (ODI) score of at least 30%

5. Baseline SIJ pain score of at least 5 on 0-10 numerical rating scale

6. BMI < 35

7. Patient has signed study-specific informed consent form

Exclusion Criteria:

1. ASA score 4 or 5

2. Severe back pain due to other causes, such as lumbar disc degeneration, lumbar discherniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facetdegeneration, and lumbar vertebral body fracture

3. Other known sacroiliac pathology such as: inflammatory sacroiliitis (e.g.,ankylosing spondylitis or other HLA-associated spondyloarthropathy), tumor,infection, acute fracture

4. Cluneal neuralgia

5. Previous SIJ implant placement, including allograft

6. Anatomic anomalies/defects that would preclude safe and/or biomechanicallyacceptable device placement

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

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

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

10. Current diagnosis of fibromyalgia

11. Known allergy to titanium or titanium alloys

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

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

14. Currently pregnant or planning pregnancy in the next 2 years (self-reported)

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

16. Known or suspected active drug or alcohol abuse, including opioids

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

18. Currently participating in another interventional clinical trial