Sacroiliac Joint Dysfunction Clinical Trial
Official title:
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction
NCT number | NCT05870488 |
Other study ID # | 301140 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 23, 2023 |
Est. completion date | May 2026 |
STACI is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | May 2026 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: 1. 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: 1. 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 |
Country | Name | City | State |
---|---|---|---|
United States | Clearway Pain | Annapolis | Maryland |
United States | Total Spine Institute | Calabasas | California |
United States | St Louis Pain Consultants | Chesterfield | Missouri |
United States | Clinical Investigations | Edmond | Oklahoma |
United States | Neurological Associates of Lancaster | Lancaster | Pennsylvania |
United States | Ascentist Healthcare | Leawood | Kansas |
United States | Advanced Pain Institute of Texas | Lewisville | Texas |
United States | University of Kentucky | Lexington | Kentucky |
United States | iSpine | Maple Grove | Minnesota |
United States | Pro Spine and Pain | Milwaukee | Wisconsin |
United States | Napa Valley Orthopaedics | Napa | California |
United States | Crimson Pain Management | Overland Park | Kansas |
United States | Nevada Advanced Pain | Reno | Nevada |
United States | Anesis Spine & Pain Care | Renton | Washington |
United States | Source Healthcare | Santa Monica | California |
United States | Comprehensive Pain and Spine Specialists | Shelbyville | Indiana |
United States | Northwest Pain Care | Spokane | Washington |
Lead Sponsor | Collaborator |
---|---|
SI-BONE, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in SI joint pain measured by numerical rating scale (NRS) | Change in SI joint pain measured by NRS (0- no pain to 10- worst pain imaginable) | At baseline and 6 months | |
Secondary | Improvement from baseline in SI joint (SIJ) pain | Improvement from baseline in SIJ pain as measured by numeric rating scale (0- no pain to 10- worst pain imaginable). | At baseline, 1-, 3-, 6-, 12-, and 24-months | |
Secondary | Improvement from baseline in disability | Improvement from baseline in disability as measured by Oswestry Disability Index | At baseline, 1-, 3-, 6-, 12-, and 24-months | |
Secondary | Improvement from baseline in quality of life | Improvement from baseline in aggregate quality of life and individual domains as measured by PROMIS-29. | At baseline, 1-, 3-, 6-, 12-, and 24-months | |
Secondary | Proportion of subjects with a complication rated as probably or definitely related to the procedure or device. | At baseline, 1-, 3-, 6-, 12-, and 24-months | ||
Secondary | Evidence of bone binding | Evidence of bone binding to at least 50% of the porous surface area of each implanted device | At baseline and 24 months | |
Secondary | Proportion of treated sides showing signs of loosening of iFuse TORQ or other instrumentation | Proportion of treated sides showing signs of loosening of iFuse TORQ or other instrumentation, as evidenced by both radiopaque areas around implant plus bony reaction ("rind") near implant | At baseline and 24 months | |
Secondary | Proportion of iFuse TORQ implants that show evidence of device migration | At baseline and 24 months | ||
Secondary | Proportion of iFuse TORQ implants that show breakage | At baseline and 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
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