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The goal of this study is to perform a feasibility study to show the effectiveness of the genicular artery embolization procedure in reducing bilateral or unilateral osteoarthritic knee pain at 12 months as measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score, Knee Injury and Osteoarthritis Outcome (KOOS) score, and Oswestry Disability Index.
This is a single-center, pilot study to assess the feasibility of a study show the effectiveness of the genicular artery embolization (GAE) in reducing arthritic pain and dysfunction associated with mild to moderate Bilateral or unilateral osteoarthritis of the knee. Patients with bilateral or unilateral Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale, will be offered enrollment to the study. Following a screening questionnaire, these patients will then be enrolled in this study. Baseline MRI will be obtained prior to the GAE procedure. Follow up intervals will include 3, 6, 9, and 12 months with the primary objective measured by a clinician as the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score, Knee Injury and Osteoarthritis Outcome (KOOS) score, and Oswestry Disability Index at the 12-month follow up visit. Patients will also undergo 1 year follow up MRI to be interpreted by a diagnostic radiologist with subspecialty training in musculoskeletal radiology. This radiologist will compare the treated knee to the baseline screening according to the WORMS classification (Whole Organ Magnetic Resonance Scoring) to assess for radiologic changes of osteoarthritis and any adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GAE Arm | Experimental | Patients who meet study eligibility will be scheduled to undergo the Genicular Artery Embolization procedure and will subsequent be followed for 12 months after their procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the Terumo Hydropearl® microspheres device | Device | Genicular artery embolization (GAE) is a new, minimally invasive investigational not yet approved therapy. In previous studies, this procedure has provided pain relief in patients with mild to moderate OA in the short to midterm. We will be utilizing the Terumo Hydropearl® microspheres particle beads during the GAE procedures. The procedure will take place utilizing fluoroscopic and ultrasound guidance. Following catheterization of the femoral artery, angiography of the affected limb will be performed to define the genicular arterial anatomy. Genicular arteries demonstrating abnormal vascularity and corresponding to the site of the patient's pain will be catheterized and embolized using microspheres. Prior to and after embolization, parametric imaging will be performed utilizing proprietary software to quantify changes in blood flow to the target area The intended use of the Terumo Hydropearl® microspheres device is to embolize the geniculate artery branch. |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC Scale | The reduction of Bilateral or unilateral knee pain and dysfunction associated with mild to moderate osteoarthritis at 12 months as measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score | 12 Months |
| KOOS Scale | The reduction of Bilateral or unilateral knee pain and dysfunction associated with mild to moderate osteoarthritis at 12 months as measured by the Knee Injury and Osteoarthritis Outcome (KOOS) score | 12 Months |
| Oswestry Disability Index | The reduction of Bilateral or unilateral knee pain and dysfunction associated with mild to moderate osteoarthritis at 12 months as measured by the Oswestry Disability Index | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC for Knee Pain and Dysfunction | To assess reduction in knee pain and dysfunction at 3, 6, and 9-months for subjects undergoing the GAE procedure using the WOMAC scale | 12 Months |
| KOOS for Knee Pain and Dysfunction |
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Inclusion Criteria:
We intend to include patients who meet the following criteria in the study:
Exclusion Criteria:
We plan to exclude patients who meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Osmanuddin Ahmed, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Hospital | Chicago | Illinois | 60637 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Patients who meet study eligibility will undergo the novel Genicular artery embolization procedure by a licensed Interventional Radiologist at the University of Chicago Medical Center.
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|
To assess reduction in knee pain and dysfunction at 3, 6, and 9-months for subjects undergoing the GAE procedure using the KOOS scale
| 12 Months |
| Oswestry Disability Index for Knee Pain and Dysfunction | To assess reduction in knee pain and dysfunction at 3, 6, and 9-months for subjects undergoing the GAE procedure using the Oswestry Disability Index | 12 Months |
| VAS for Pain | To report the outcomes of Visual Analog Score (VAS) for pain at 0, 3, 6, 9, and 12 months post. | 12 Months |
| Six-Minute Walk Test for Functional Improvement | To determine and report six-minute walk test performance and to assess functional improvement at baseline, 3, 6, 9, and 12 months | 12 months |
| Thirty-Second Chair Test for Performance | To determine and report thirty-second chair stand test performances and to assess functional improvement at baseline, 3, 6, 9, and 12 months. | 12 Months |
| Opiate Usage | Change in usage of opiate or opiate-equivalent medications calculated by using the internal opioid change log, kept and updated by the study team from baseline to 12 months | 12 Months |
| D012216 |
| Rheumatic Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |