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

PIERCE is a prospective, multicenter, post-market observational study evaluating the safety, performance, and efficacy of iFuse INTRA Ti.

Inclusion criteria

• 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.
• Participant has signed study-specific informed consent form.

Exclusion criteria

• 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.
• Previous SIJ implant placement, including allograft, on the treated (index) side.
• Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable device placement.
• History of recent (<1 year) major trauma to pelvis.
• Previously diagnosed or suspected severe osteoporosis (defined as prior T-score < -2.5 or history of osteoporotic fracture).
• Chronic rheumatologic condition (e.g., rheumatoid arthritis).
• Current diagnosis of fibromyalgia.
• Known allergy to titanium or titanium alloys.
• Current local or systemic infection that raises the risk of surgery.
• Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation.
• Currently pregnant or planning pregnancy in the next 2 years (self-reported).
• Patient is a prisoner or a ward of the state.
• Known or suspected active drug or alcohol abuse, including opioids
• Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.