About this trial
The purpose of this study is to evaluate outcomes in patients treated with iFuse INTRA Ti for chronic SI joint pain.
Eligibility criteria
Qualifiers
Age > 21 years.
Patient has chronic lower back pain (≥6 months) refractory to non-surgical care.
Diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or SIJ disruption) and scheduled to be treated with INTRA Ti.
Patient has SIJ pain of at least 5 on a 0-10 numeric rating scale (NRS) prior to procedure.
Disqualifiers
ASA score 4 or 5.
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: inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy), tumor, infection, acute fracture.
Current diagnosis of cluneal neuralgia.
Trial design
Treatments tested in this trial
- iFuse INTRA Ti Implant System