Sacroiliac Joint Fusion With iFuse Implant System (SIFI)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the use of the iFuse Implant System to treat degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint). The iFuse Implant System (iFuse device) is a medical device that is surgically implanted into the sacroiliac (SI) joint during a minimally invasive surgical procedure (one that uses a smaller incision and less damage to the skin and other tissues than standard surgery). The purpose of implanting the device is to stabilize and fuse the SI joint.

Official Title
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Sacroiliac Joint Fusion With iFuse Implant System (SIFI)

Conditions
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Degenerative Sacroiliitis, Sacroiliac Joint Disruption

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Age 21-70 at time of screening 2. Patient has lower back pain for >6 months inadequately responsive to conservative care 3. Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following: Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test), and Patient has at least 3 of 5 physical examination maneuvers specific for the SI joint (see Table 3), and Patient has improvement in lower back pain numeric rating scale (NRS) of at least 50% after injection of local anesthetic into affected SI joint(s) (see Section 3.6.4), and One or more of the following: i. SI joint disruption: Asymmetric SI joint widening on X-ray or CT scan Leakage of contrast on diagnostic arthrography ii. Degenerative sacroiliitis: Radiographic evidence of SI joint degeneration, including sclerosis,osteophytes, subchondral cysts, or vacuum phenomenon on CT or plain film, or Due to prior lumbosacral spine fusion 4. Baseline Oswestry Disability Index (ODI) score of at least 30% 5. Baseline SI joint pain score of at least 50 on 0-100 mm visual analog scale 6. Patient has signed study-specific informed consent form 7. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements Exclusion Criteria: 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: Sacral dysplasia Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy) Tumor Infection Acute fracture Crystal arthropathy History of recent (< 1 year) major trauma to pelvis Previously diagnosed osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture). Osteomalacia or other metabolic bone disease Chronic rheumatologic condition (e.g., rheumatoid arthritis) Any condition or anatomy that makes treatment with the iFuse Implant System infeasible Chondropathy Known allergy to titanium or titanium alloys Use of medications known to have detrimental effects on bone quality and soft-tissue healing Prominent neurologic condition that would interfere with physical therapy 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 Patient is a prisoner or a ward of the state. Known or suspected drug or alcohol abuse Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Success | Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention. | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm) | The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. | 24 months | 
| Change in Back Dysfunction | Oswestry Disability Index is a validated patient questionnaire aiming to assess low back pain. The computed scores can be 0% to 100%. Lower scores indicate low disability while high scores indicate high disability. There are 10 questions on the questionnaire. Each has 6 possible answers (0 points - 5 points). If the question is skipped, it's points are subtracted from the denominator. If the raw score is 30 and all 10 questions were answered, the calculation would be 30 / 50 = 60%. If one question was skipped, it would be 30 / 45 = 67%. | 24 months | 
| Change in Quality of Life | Change in QOL as measured by Short Form-36 PCS and EQ-5D at post-operative visits | Baseline and 24 months | 
| Ambulatory Status | Percentage of population fully ambulatory at 24 months post operatively. | 24 months | 
| Work Status | Proportion of non-working subjects who return to work | Basline, 24 months | 
| Serious Adverse Events | Occurrence of adverse events meeting the ISO14155:2011 definition of serious occurring during the procedure, at the time of hospital discharge (typically day of or next day after procedure), and at various times in late follow-up. | Procedure, discharge, 1,3,6,12,18 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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si joint, si joint pain, si joint injury, si joint treatment, si joint injections, si joint inflammation, si joint problems, si joint symptoms, hypermobile si joint, si joint arthritis, si joint pain treatment, inflamed si joint, si joint sclerosis, locked si joint, si joint injuries, si joint disease, si joint infection, sacroiliac joint pelvic pain, sacroiliac joint arthritis treatment