Sacroiliac Disorder, Sacroiliac; Fusion, Sacroiliac Joint Dysfunction, Sacroiliac Joint Pain
Conditions
Brief summary
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction (STACI) is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system.
Detailed description
This trial is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system. The goal of the trial is to demonstrate the effectiveness of the device for its intended use.
Interventions
DEVICEUse of iFuse TORQ
Use of iFuse TORQ for the treatment of SI Joint dysfunction
Sponsors
SI-BONE, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SI joint pain measured by numerical rating scale (NRS) | At baseline and 6 months | Change in SI joint pain measured by NRS (0- no pain to 10- worst pain imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement from baseline in SI joint (SIJ) pain | At baseline, 1-, 3-, 6-, 12-, and 24-months | Improvement from baseline in SIJ pain as measured by numeric rating scale (0- no pain to 10- worst pain imaginable). |
| Improvement from baseline in disability | At baseline, 1-, 3-, 6-, 12-, and 24-months | Improvement from baseline in disability as measured by Oswestry Disability Index |
| Improvement from baseline in quality of life | At baseline, 1-, 3-, 6-, 12-, and 24-months | Improvement from baseline in aggregate quality of life and individual domains as measured by PROMIS-29. |
| 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 | — |
| Evidence of bone binding | At baseline and 24 months | Evidence of bone binding to at least 50% of the porous surface area of each implanted device |
| Proportion of treated sides showing signs of loosening of iFuse TORQ or other instrumentation | At baseline and 24 months | 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 |
| Proportion of iFuse TORQ implants that show evidence of device migration | At baseline and 24 months | — |
| Proportion of iFuse TORQ implants that show breakage | At baseline and 24 months | — |
Countries
United States
Contacts
STUDY_DIRECTORStacie Tran, MPH
SI-BONE
Outcome results
None listed