The purpose of this study is to evaluate outcomes in patients treated with iFuse INTRA Ti for chronic SI joint pain.
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.
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.
Patients with sacroiliac joint (SIJ) dysfunction due to degenerative sacroiliitis or sacroiliac joint disruption for at least 6 months refractory to non-surgical care
Case-only
Prospective
iFuse INTRA Ti Implant System
DeviceFDA-cleared implant used for fusion of the sacroiliac joint (SIJ) for SIJ dysfunction, that is a direct result of SIJ disruption and degenerative sacroiliitis.
Composite endpoint of safety and performance
The participant is considered a success if all the following criteria are met: * A ≥ 2 point improvement from baseline in SIJ pain on the target side. * Absence of device-related SAE. * Absence of SSI at index procedure.
Proportion of Participants with a Serious Adverse Event (SAE)
Proportion of participants with a serious adverse event classified as probably or definitely related to the study device or procedure
Proportion of Participants with ≥1 Subsequent Surgical Intervention(s) (SSI)
Proportion of participants undergoing one or more SSI related to the index procedure.
Proportion of Treated Sides with Radiographic Evidence of Loosening
Proportion of treated sides showing signs of loosening of INTRA Ti, as evidenced by both radiolucent areas around implant plus bony reaction ("rind") near implant.
Proportion of Implants with Radiographic Evidence of Device Migration.
Proportion of INTRA Ti implants that show evidence of device migration.
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