Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes

Exclusion Criteria

• •1. ASA score 4 or 5.
• •2. 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.
• •3. Other known sacroiliac pathology such as: inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy), tumor, infection, acute fracture.
• •4. Current diagnosis of cluneal neuralgia.
• •5. Previous SIJ implant placement, including allograft, on the treated (index) side.
• •6. Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable 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, disability remuneration, 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, personality disorders) that could interfere with study participation.