iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction
Purpose
STACI is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system.
Conditions
- Sacroiliac Joint Dysfunction
- Sacroiliac; Fusion
- Sacroiliac Disorder
- Sacroiliac Joint Pain
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age > 21 at time of screening 2. Patient has lower back / buttock pain for at least 6 months inadequately responsive to non-surgical care 3. Diagnosis of sacroiliac joint dysfunction (degenerative sacroiliitis or sacroiliac disruption) 4. Baseline Oswestry Disability Index (ODI) score of at least 30% 5. Baseline SIJ pain score of at least 5 on 0-10 numerical rating scale 6. BMI < 35 7. Patient has signed study-specific informed consent form
Exclusion Criteria
- ASA score 4 or 5 2. 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 3. Other known sacroiliac pathology such as: inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy), tumor, infection, acute fracture 4. Cluneal neuralgia 5. Previous SIJ implant placement, including allograft 6. Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable device placement 7. History of recent (<1 year) major trauma to pelvis 8. Previously diagnosed or suspected severe osteoporosis (defined as prior T-score < -2.5 or history of osteoporotic fracture). 9. Chronic rheumatologic condition (e.g., rheumatoid arthritis) 10. Current diagnosis of fibromyalgia 11. Known allergy to titanium or titanium alloys 12. Current local or systemic infection that raises the risk of surgery 13. Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation 14. Currently pregnant or planning pregnancy in the next 2 years (self-reported) 15. Patient is a prisoner or a ward of the state. 16. Known or suspected active drug or alcohol abuse, including opioids 17. Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation 18. Currently participating in another interventional clinical trial
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Use of iFuse TORQ for SI Joint Fusion |
Participants with SI joint dysfunction are treated with iFuse TORQ. |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
University of Kentucky
Lexington, Kentucky 40504
Lexington, Kentucky 40504
Contact:
Amy Banfield
Amy Banfield
More Details
- NCT ID
- NCT05870488
- Status
- Recruiting
- Sponsor
- SI-BONE, Inc.
Detailed Description
STACI is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system. The goal of the study is to demonstrate the effectiveness of the device for its intended use.