iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction

Study Overview
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Brief Summary
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STACI is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system.

Detailed Description
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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.

Official Title
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iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction

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

Intervention / Treatment
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* Device: Use of iFuse TORQ


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Use of iFuse TORQ for SI Joint Fusion<br>Participants with SI joint dysfunction are treated with iFuse TORQ. | Device: Use of iFuse TORQ<br>* Use of iFuse TORQ for the treatment of SI Joint dysfunction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | Evidence of bone binding to at least 50% of the porous surface area of each implanted device | At baseline and 24 months | 
| 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 | 
| 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 |