iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction

Running, not enrolling · Phase 4

Conditions studied: Sacroiliac Joint Dysfunction, Sacroiliac; Fusion, Sacroiliac Disorder, Sacroiliac Joint Pain

In brief

iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction (STACI) is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system.

Key facts

Study ID

NCT05870488

Run by

SI-BONE, Inc.

People needed

110

Starts

2023-05-23

Expected to finish

2027-11-01

Last updated by the study team

2026-08-06

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 21 at time of screening
• Patient has lower back / buttock pain for at least 6 months inadequately responsive to non-surgical care
• Diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or sacroiliac disruption)
• Baseline Oswestry Disability Index (ODI) score of at least 30%
• Baseline SIJ pain score of at least 5 on 0-10 numerical rating scale
• BMI < 35
• Patient has signed study-specific informed consent form

You may not qualify if…

• 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
• Cluneal neuralgia
• Previous SIJ implant placement, including allograft
• 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
• Currently participating in another interventional clinical trial

Where it is running

• Napa Valley Orthopaedics — Napa, California, United States
• Source Healthcare — Santa Monica, California, United States
• Comprehensive Pain and Spine Specialists — Shelbyville, Indiana, United States
• Ascentist Healthcare — Leawood, Kansas, United States
• Crimson Pain Management — Overland Park, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• Clearway Pain — Annapolis, Maryland, United States
• St Louis Pain Consultants — Chesterfield, Missouri, United States
• Nevada Advanced Pain — Reno, Nevada, United States
• Clinical Investigations — Edmond, Oklahoma, United States
• Neurological Associates of Lancaster — Lancaster, Pennsylvania, United States
• Advanced Pain Institute of Texas — Lewisville, Texas, United States
• Anesis Spine & Pain Care — Renton, Washington, United States
• Pro Spine and Pain — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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