Back to resultsGenicular Artery Embolization for the Treatment of Knee Osteoarthritis (GAE-OA)
Primary Purpose
Knee Osteoarthritis, Degenerative Joint Disease of Knee
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Embozene MicroSpheres
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Microspheres, Artery Embolization, Knee Osteoarthritis, Chronic Pain, Embozene
Eligibility Criteria
Inclusion Criteria:
- Provided informed consent
- Age ≥ 40 years and less than 80 years
- Life expectancy greater than 12 months
- Ineligibility for or refusal of surgical management
- Moderate-severe knee pain as determined by visual analog scale > 4
- Osteoarthritis based on xray
- Local knee tenderness
- Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection)
Exclusion Criteria:• Mild knee pain as determined by visual analog scale < 4
- Chronic renal insufficiency (serum creatinine >2 mg/dL)
- Uncorrectable bleeding diathesis: INR >1.6, Platelets <50,000
- Significant arterial atherosclerosis that would limit selective angiography
- Allergy to iodinated contrast agents that is not responsive to steroid management
- Active Infection or malignancy
- Appropriate candidate for knee replacement surgery determined by clinical and physical examination
- Recent (within 3 months) or active cigarette use
Sites / Locations
- Siddharth Padia, M.D.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GAE OA
Arm Description
Subjects will be treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the subject's pain.
Outcomes
Primary Outcome Measures
Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety
Treatment-related AEs from gennicular artery embolization during the study period
Secondary Outcome Measures
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Efficacy
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into 3 subscales. Each item is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). With a total possible range of 0-96, higher scores indicate worse pain, stiffness, and functional limitations.
Pain (5 items, possible range 0-20): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items, possible range 0-8): after first waking and later in the day Physical Function (17 items, possible range 0-68): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale as a Measure of Efficacy
The WOMAC Pain Subscale is a self-administered questionnaire of 5 items to assess Pain: during walking, using stairs, in bed, sitting or lying, and standing upright.
Each item is scored on a scale of 0-4: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4), with a possible total score range of 0-20.
Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy
The patient-reported severity of knee pain was quantified using a visual analog scale (VAS) score ranging from 0 (indicating no pain) through 10 (indicating the worst pain imaginable).
Full Information
NCT ID
NCT03491397
First Posted
March 23, 2018
Last Updated
November 7, 2022
Sponsor
Siddharth Padia, MD
Collaborators
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03491397
Brief Title
Genicular Artery Embolization for the Treatment of Knee Osteoarthritis
Acronym
GAE-OA
Official Title
Safety and Efficacy of Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 10, 2019 (Actual)
Primary Completion Date
October 29, 2021 (Actual)
Study Completion Date
October 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Siddharth Padia, MD
Collaborators
Boston Scientific Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this clinical research study is to examine whether Embozene treatment of the genicular artery is a safe and effective way to treat arthritic knee pain. Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.
Detailed Description
This is a phase 2, single-center, prospective, single arm investigational study to evaluate the safety and efficacy of genicular artery embolization (GAE) for treatment of symptomatic knee osteoarthritis (OA). Subjects will be treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the subject's pain. The primary objective of this investigation is to assess safety of genicular artery embolization (GAE) for knee osteoarthritis (OA) using Embozene particles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Degenerative Joint Disease of Knee
Keywords
Microspheres, Artery Embolization, Knee Osteoarthritis, Chronic Pain, Embozene
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The stratification will not be randomized, but each category will be limited to 20 patients.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GAE OA
Arm Type
Experimental
Arm Description
Subjects will be treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the subject's pain.
Intervention Type
Device
Intervention Name(s)
Embozene MicroSpheres
Other Intervention Name(s)
Color-Advanced Microspheres, Microspheres for Embolization
Intervention Description
Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety
Description
Treatment-related AEs from gennicular artery embolization during the study period
Time Frame
Up to 12 Months after GAE
Secondary Outcome Measure Information:
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Efficacy
Description
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into 3 subscales. Each item is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). With a total possible range of 0-96, higher scores indicate worse pain, stiffness, and functional limitations.
Pain (5 items, possible range 0-20): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items, possible range 0-8): after first waking and later in the day Physical Function (17 items, possible range 0-68): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties
Time Frame
Baseline, Month 1, Month 3, Month 6, Month 12
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale as a Measure of Efficacy
Description
The WOMAC Pain Subscale is a self-administered questionnaire of 5 items to assess Pain: during walking, using stairs, in bed, sitting or lying, and standing upright.
Each item is scored on a scale of 0-4: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4), with a possible total score range of 0-20.
Time Frame
Baseline, Month 1, Month 3, Month 6, Month 12
Title
Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy
Description
The patient-reported severity of knee pain was quantified using a visual analog scale (VAS) score ranging from 0 (indicating no pain) through 10 (indicating the worst pain imaginable).
Time Frame
Baseline, Month 1, Month 3, Month 6, Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provided informed consent
Age ≥ 40 years and ≤ 80 years
Life expectancy greater than 12 months
Ineligibility for or refusal of surgical management
Moderate-severe knee pain as determined by visual analog scale > 4
Osteoarthritis based on xray
Local knee tenderness
Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection)
Exclusion Criteria:• Mild knee pain as determined by visual analog scale < 4
Chronic renal insufficiency (serum creatinine >2 mg/dL)
Uncorrectable bleeding diathesis: international normalized ratio (INR) >1.6, Platelets <50,000
Significant arterial atherosclerosis that would limit selective angiography
Allergy to iodinated contrast agents that is not responsive to steroid management
Active Infection or malignancy
Appropriate candidate for knee replacement surgery determined by clinical and physical examination
Recent (within 3 months) or active cigarette use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siddharth Padia, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siddharth Padia, M.D.
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Genicular Artery Embolization for the Treatment of Knee Osteoarthritis
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