Not Yet RecruitingNot Applicable

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

110 participantsStarted 2026-09

Plain-language summary

The purpose of this study is to evaluate outcomes in patients treated with iFuse INTRA Ti for chronic SI joint pain.

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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).

Composite endpoint of safety and performance

Timeframe: 6 months.

NCT IDNCT07565545

SponsorSI-BONE, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-03

Director of Clinical Affairs

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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).