Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain

Study Overview
=================
Brief Summary
-----------------
The objective of this investigation is to evaluate the safety of the geniculate artery embolization (GAE) procedure with HydroPearl® Microspheres in 30 patients with knee pain caused by osteoarthritis with 24 months follow-up. The GAE procedure is an arterial embolization procedure that blocks abnormal blood vessels caused be knee arthritis in order to evaluate the effect on knee pain.

Official Title
-----------------
Genicular Artery Embolization for the Treatment of Moderate to Severe Osteoarthritic Knee Pain

Conditions
-----------------
Knee Osteoarthritis, Knee Pain Chronic, Knee Pain Swelling, Knee Arthritis, Arterial Occlusion

Intervention / Treatment
-----------------
* Device: Genicular artery embolization (GAE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide informed consent Age ≥ 40 years Moderate to severe knee pain (VAS >40 mm) Pain refractory to 3 months of conservative treatments, including at least one of the following: a. Anti-inflammatory medications b. Physical therapy c. Intra-articular injections Kellgren-Lawrence radiographic grade 1, 2, or 3 disease MRI features of active synovitis (synovial thickening and/or enhancement on MRI). Ineligibility or refusal of surgical management. Local knee tenderness Exclusion Criteria: Rheumatoid or infectious arthritis Advanced lower extremity atherosclerosis that would limit selective angiography Local knee infection Prior knee surgery (excluding arthroscopic/meniscal interventions) Uncorrectable coagulopathy (INR>1.8, platelets<50,000/µL) Iodine allergy resulting in anaphylaxis Chronic renal insufficiency (serum creatinine >2 mg/dL) Life expectancy less than 6 months

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genicular artery embolization<br>Participants will undergo the genicular artery embolization (GAE) procedure for the treatment of moderate to severe knee osteoarthritis. A total of 30 patients will be enrolled in the single treatment arm of the study. The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, patients will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ). Following treatment, patients will undergo follow-up at 1, 6, 12, and 24 months post GAE. | Device: Genicular artery embolization (GAE)<br>* Participants will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with treatment related adverse events | Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | 1 month post GAE | 
| Number of patients with treatment related adverse events | Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | 6 months post GAE | 
| Number of patients with treatment related adverse events | Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | 12 months post GAE | 
| Number of patients with treatment related adverse events | Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | 24 months post GAE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline pain scores | Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents no pain and 100 mm represents worse possible pain. | Baseline to 1 month post GAE | 
| Mean change from baseline pain scores | Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents no pain and 100 mm represents worse possible pain. | Baseline to 6 months post GAE | 
| Mean change from baseline pain scores | Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents no pain and 100 mm represents worse possible pain. | Baseline to 12 months post GAE | 
| Mean change from baseline pain scores | Pain score measured using visual analogue scale (VAS). The VAS is a numerical scale used to report pain intensity from 0 to 100. Subjects mark the scale with a vertical line to indicate their current pain level. 0 mm represents no pain and 100 mm represents worse possible pain. | Baseline 24 months post GAE | 
| Mean change from baseline knee function scores | Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of 0 indicates no symptoms and 4 indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms. | Baseline to 1 month post GAE | 
| Mean change from baseline knee function scores | Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of 0 indicates no symptoms and 4 indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms. | Baseline to 6 months post GAE | 
| Mean change from baseline knee function scores | Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of 0 indicates no symptoms and 4 indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms. | Baseline to 12 months post GAE | 
| Mean change from baseline knee function scores | Knee function measured using the Western Ontario and McMaster University Osteoarthritis index (WOMAC) scale. The WOMAC is a 24-question tool that is completed by the patient to evaluate osteoarthritis of the knee, including pain, stiffness, and physical function of the joints. There are 5 items regarding pain, 2 items for stiffness, and 17 items for physical function. Questions are ranked on a 5 point Likert scale. A score of 0 indicates no symptoms and 4 indicates severe symptoms. The individual scores are added and an overall higher score indicates worse symptoms. | Baseline to 24 months post GAE | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Geniculate artery embolization, Knee osteoarthritis, Genicular artery embolization