iFuse Implant System® Minimally Invasive Arthrodesis

Study Overview
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Brief Summary
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The purpose of this study is to compare outcomes when patients with chronic sacroiliac joint pain undergo either SI joint fusion with the iFuse Implant System or undergo conservative management of the SI joint

Detailed Description
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This study is a multicenter randomized controlled, post-market clinical follow-up clinical trial of the iFuse Implant System for SI joint fusion vs. conservative management. Subjects assigned to conservative management may cross over to iFuse after a minimum of 6 months of conservative treatment. Conservative management does not include interventional procedures such as prolotherapy, steroid injections and/or RF ablation.

Official Title
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A Multicenter Randomized Controlled Post-market Clinical Follow-up Trial Comparing the Effectiveness and Safety of the iFuse Implant System® Versus Conservative Management for Patients With Chronic, Disabling SI Joint Pain.

Conditions
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Sacroiliac Joint Pain

Intervention / Treatment
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* Device: iFuse Implant System
* Other: Conservative Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21-70 at time of screening Patient has lower back pain for >6 months or >18 months for pregnancy induced lower back pain Diagnosis of the SI joint as the primary lower back pain generator based on ALL of the following: a. 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 b. Patient has at least 3 of 5 physical examination maneuvers specific for SI joint pain, and c. Patient has improvement in lower back pain NRS of at least 50% of the pre injection NRS score after fluoroscopic controlled injection of local anesthetic into affected SI joint(s) (including previous documented test <6 months ago) Baseline Oswestry Disability Index (ODI) score of at least 30% Baseline lower back pain score of at least 50 on 0-100 point VAS Patient has signed study-specific informed consent form Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements Exclusion Criteria: Severe lower 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 Sacroiliac pathology caused by auto-immune disease (e.g. ankylosing spondylitis) and/or neoplasia (e.g. benign or malignant tumor) and/or crystal arthropathy History of recent (<1 year) fracture of the pelvis with documented malunion, non-union of sacrum or ilium or any type of internal fixation of the pelvic ring. Spine surgery during the past 12 months. Previously diagnosed or suspected osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture) Documented osteomalacia or other metabolic bone disease Any condition or anatomy that makes treatment with the iFuse Implant System infeasible 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 systemic infection or local infection at the SI joint Currently pregnant or planning pregnancy in the next year 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 of surgery

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iFuse Implant System<br>Surgical placement of iFuse implants in the affected SI joint | Device: iFuse Implant System<br>* Placement of iFuse implant system via surgery<br>|
| Active Comparator: conservative management<br>Medications, physical therapy, information | Other: Conservative Management<br>* Medications for pain, physical therapy, cognitive behavour therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in lower back pain as rated by the study subject using a 0-100 visual analog scale (VAS) at 6 months after initiation of treatment |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in lower back pain (VAS) |  | 1, 3, 12 and 24 months | 
| Change from baseline in leg pain (VAS |  | 1, 3, 6, 12 and 24 months | 
| Change in disability due to back pain (ODI |  | 3, 6, 12 and 24 months | 
| Change in quality of life (EQ-5D |  | 3, 6, 12 and 24 months | 
| Change in ambulatory and work status |  | 1, 3, 6, 12 and 24 months | 
| Change in depression score (Zung Depression Scale |  | 3, 6, 12 and 24 months | 
| Change in objective functional test (ASLR |  | 3, 6, 12 and 24 months | 
| Change in walking distance |  | 3, 6, 12 and 24 months | 
| Patient satisfaction and self-rating of disease state |  | 3, 6, 12 and 24 months | 
| Serious adverse events |  | during 24 months | 
| Device breakage, loosening and migration |  | 12 months |