Back to resultsGeniculate Artery Embolization for Treatment of Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcatheter arterial embolization
Embozene™ Microspheres
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- 30-80 years of age of any gender;
- Kellgren-Lawrence Grade 2, 3, or 4 (in select subjects who have no bony deformity) knee OA on most recent knee radiograph obtained within 6 months of screening visit;
- Knee pain resistant to conservative treatment for at least 3 months (anti- inflammatory drugs, acetaminophen, physical therapy, muscle strengthening, or intra- articular injection of hyaluronic acid and/or steroids);
- Moderate to severe knee pain: pain VAS ≥ 40 mm with 0 representing 'no pain' and 100 'the worst pain imaginable. If both knees meet inclusion criteria, the one with a higher VAS score will be chosen for the study (i.e., target knee).
- Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaire is validated in English.
Exclusion Criteria:
- Active systemic or local knee infection;
- Active malignancy;
- Life expectancy less than 12 months;
- Prior ipsilateral knee surgery (within 3 years of baseline visit), arthroscopic surgery (within 6 months of baseline), total or partial knee replacement regardless of timing;
- Ipsilateral knee intra-articular injection in the last 3 months;
- Rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus;
- Pregnant during the study period;
- Renal dysfunction as defined by serum creatinine >1.6 dl/mg or eGFR <60 on blood tests obtained within 30 days of procedure;
- Body weight greater than 200 Kg;
- Uncorrectable coagulopathy (platelet count < 50,000, international normalized ratio >1.5 within 30 days of procedure;
- Known history of contrast allergy resulting in anaphylaxis;
- Known significant arterial atherosclerosis that would limit selective angiography and/or lower extremity symptoms thought to be secondary to arterial vascular disease (eg claudication, ischemic rest pain);
- Post-traumatic knee (if trauma occurred within 12 months of baseline or was associated with fractures);
- Known avascular necrosis in the target knee;
- Contraindications to MRI such as such as claustrophobia, metallic fragment/implants, pacemaker.
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Embolization Group
Arm Description
23 participants who are aged between 30 to 75 years old, with grade 2 or 3 knee OA on the most recent knee radiographs obtained within 6 months of intervention. Each individual participant will be enrolled for approximately 13 months to complete all study visits from the initial screening visit to last follow up at 12-months post intervention.
Outcomes
Primary Outcome Measures
Change in Knee pain using Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) score
Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) questionnaire has 24 questions on daily activities. WOMAC pain score includes five questions regarding pain (pain during walking, stair climbing, nocturnal, rest, weight bearing); each question will be scored suing the following points: 0 for no pain, 1 for mild, 2 for moderate, 3 for severe, and 4 for extreme pain. possible score ranges for pain are 0-20. WOMAC Score will be calculated from the Knee injury and Osteoarthritis Outcome Score (KOOS) score which was developed as an extension of the WOMAC score with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis.
Secondary Outcome Measures
Change in Knee pain using the Visual Analogue Scale (VAS) scale
The change in knee pain will be assessed by the Visual Analogue Scale (VAS) scale which is a validated, subjective measure for acute and chronic pain. The electronic VAS is a horizontal line with no markings on the scale except "No pain" on the left (score: 0 mm) and "worst possible pain" on the right end of the scale (score: 100 mm). Subjects mark the VAS to indicate their current pain level, with 0 mm representing "No pain" and 100 mm representing "worst possible pain".
Change in Knee Stiffness
Knee stiffness will be measured through the KOOS questionnaire to obtain the WOMAC score. The Knee injury and Osteoarthritis Outcome Score (KOOS) was developed as an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).
Change in Physical Functioning
Physical functioning will be measured through the KOOS questionnaire to obtain the WOMAC score. The Knee injury and Osteoarthritis Outcome Score (KOOS) was developed as an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).
Change in Quality of life
The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04379700
Brief Title
Geniculate Artery Embolization for Treatment of Osteoarthritis
Official Title
Feasibility and Safety of Geniculate Artery Embolization for Treatment of Mild to Moderate Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
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
Single-arm, single-center, no sham or placebo, prospective pilot trial designed to evaluate the feasibility and safety of transcatheter arterial embolization in patients with mild to moderate radiographic knee OA. Eligible participants will receive geniculate artery embolization using Embozene™ Color-Advanced Microspheres. Patients will be followed up for a total of 12 months.
Detailed Description
The current study seeks to determine whether transcatheter arterial embolization of abnormal neovasculature arising from the genicular arterial branches is safe and effective in the treatment of mild-to-moderate knee OA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Embolization Group
Arm Type
Experimental
Arm Description
23 participants who are aged between 30 to 75 years old, with grade 2 or 3 knee OA on the most recent knee radiographs obtained within 6 months of intervention. Each individual participant will be enrolled for approximately 13 months to complete all study visits from the initial screening visit to last follow up at 12-months post intervention.
Intervention Type
Procedure
Intervention Name(s)
Transcatheter arterial embolization
Intervention Description
Transcatheter arterial embolization of one or more genicular artery(ies) using Embozene™ Color-Advanced Microspheres. Embozene™ Color-Advanced Microspheres are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer used for embolization.
Intervention Type
Device
Intervention Name(s)
Embozene™ Microspheres
Intervention Description
Embozene™ Microspheres are spherical, tightly calibrated, biocompatible, nonresorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer (Polyzene™-F). The microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue. They are available in prefilled syringes in a range of sizes suitable for embolic therapy. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter and color-coded by size to allow for easy identification. 250 μm microsphere will be used and are supplied in prefilled yellow syringes.
Primary Outcome Measure Information:
Title
Change in Knee pain using Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) score
Description
Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) questionnaire has 24 questions on daily activities. WOMAC pain score includes five questions regarding pain (pain during walking, stair climbing, nocturnal, rest, weight bearing); each question will be scored suing the following points: 0 for no pain, 1 for mild, 2 for moderate, 3 for severe, and 4 for extreme pain. possible score ranges for pain are 0-20. WOMAC Score will be calculated from the Knee injury and Osteoarthritis Outcome Score (KOOS) score which was developed as an extension of the WOMAC score with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis.
Time Frame
Baseline, 1 month, 3 month and 12 month follow up visits
Secondary Outcome Measure Information:
Title
Change in Knee pain using the Visual Analogue Scale (VAS) scale
Description
The change in knee pain will be assessed by the Visual Analogue Scale (VAS) scale which is a validated, subjective measure for acute and chronic pain. The electronic VAS is a horizontal line with no markings on the scale except "No pain" on the left (score: 0 mm) and "worst possible pain" on the right end of the scale (score: 100 mm). Subjects mark the VAS to indicate their current pain level, with 0 mm representing "No pain" and 100 mm representing "worst possible pain".
Time Frame
Baseline, 1 month, 3 month and 12 month follow up visits
Title
Change in Knee Stiffness
Description
Knee stiffness will be measured through the KOOS questionnaire to obtain the WOMAC score. The Knee injury and Osteoarthritis Outcome Score (KOOS) was developed as an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).
Time Frame
Baseline, 1 month, 3 month and 12 month follow up visits
Title
Change in Physical Functioning
Description
Physical functioning will be measured through the KOOS questionnaire to obtain the WOMAC score. The Knee injury and Osteoarthritis Outcome Score (KOOS) was developed as an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).
Time Frame
Baseline, 1 month, 3 month and 12 month follow up visits
Title
Change in Quality of life
Description
The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable.
Time Frame
Baseline, 1 month, 3 month and 12 month follow up visits
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
30-80 years of age of any gender;
Kellgren-Lawrence Grade 2, 3, or 4 (in select subjects who have no bony deformity) knee OA on most recent knee radiograph obtained within 6 months of screening visit;
Knee pain resistant to conservative treatment for at least 3 months (anti- inflammatory drugs, acetaminophen, physical therapy, muscle strengthening, or intra- articular injection of hyaluronic acid and/or steroids);
Moderate to severe knee pain: pain VAS ≥ 40 mm with 0 representing 'no pain' and 100 'the worst pain imaginable. If both knees meet inclusion criteria, the one with a higher VAS score will be chosen for the study (i.e., target knee).
Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaire is validated in English.
Exclusion Criteria:
Active systemic or local knee infection;
Active malignancy;
Life expectancy less than 12 months;
Prior ipsilateral knee surgery (within 3 years of baseline visit), arthroscopic surgery (within 6 months of baseline), total or partial knee replacement regardless of timing;
Ipsilateral knee intra-articular injection in the last 3 months;
Rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus;
Pregnant during the study period;
Renal dysfunction as defined by serum creatinine >1.6 dl/mg or eGFR <60 on blood tests obtained within 30 days of procedure;
Body weight greater than 200 Kg;
Uncorrectable coagulopathy (platelet count < 50,000, international normalized ratio >1.5 within 30 days of procedure;
Known history of contrast allergy resulting in anaphylaxis;
Known significant arterial atherosclerosis that would limit selective angiography and/or lower extremity symptoms thought to be secondary to arterial vascular disease (eg claudication, ischemic rest pain);
Post-traumatic knee (if trauma occurred within 12 months of baseline or was associated with fractures);
Known avascular necrosis in the target knee;
Contraindications to MRI such as such as claustrophobia, metallic fragment/implants, pacemaker.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bedros Taslakian, MD
Phone
212-263-5898
Email
bedros.taslakian@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Danibel Ramos
Phone
212-263-0245
Email
Danibel.Ramos@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bedros Taslakian, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bedros Taslakian
Phone
212-263-5898
Email
bedros.taslakian@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Reshma Gadde
Email
Resma.Gadde@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Bedros Taslakian, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This is a small scale, single-site research study for NYU
Learn more about this trial
Geniculate Artery Embolization for Treatment of Osteoarthritis
We'll reach out to this number within 24 hrs