Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System

Exclusion Criteria

• •Planned bi-lateral SI joint fixation
• •Severe lower 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 (this is done by physical exam, medical history, and MRI/CT/X-ray as required)
• •Other known sacroiliac pathology such as: sacral dysplasia, inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA- associated spondyloarthropathy), tumor, acute fracture, crystal arthropathy
• •History of recent (\<1 year) fracture of the pelvis with documented malunion, non-union of sacrum or ilium or any type of internal fixation of the pelvic ring
• •Severe osteoporosis
• •Paget's disease, osteomalacia, osteomalacia or other metabolic bone disease
• •Any condition or anatomy that makes treatment with the CATAMARAN SI Joint Fusion System infeasible including deformity
• •Known allergy to titanium or titanium alloys
• •Morbid obesity
• •Active malignancy: a history of any invasive malignancy (except non-melanoma skin cancer), unless the subject has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least five years
• •Patient has systemic infection or active infection at the treatment site
• •Chronic rheumatologic condition (e.g., rheumatoid arthritis)
• •Patient has uncontrolled diabetes
• •Patient is currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation
• •Prominent neurologic condition that would interfere with physical therapy
• •Patient is pregnant or wishes to become pregnant in the next two years
• •Patient is not likely to comply with the follow-up evaluation schedule
• •Patient is participating in a clinical trial of another investigational drug or device in which the primary endpoint has not occurred
• •Patient has a psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
• •Known or suspected drug or alcohol abuse
• •Patient is a prisoner or a ward of the state