- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04379700
Geniculate Artery Embolization for Treatment of Osteoarthritis
October 2, 2023 updated by: NYU Langone Health
Feasibility and Safety of Geniculate Artery Embolization for Treatment of Mild to Moderate Knee Osteoarthritis
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bedros Taslakian, MD
- Phone Number: 212-263-5898
- Email: bedros.taslakian@nyulangone.org
Study Contact Backup
- Name: Danibel Ramos
- Phone Number: 212-263-0245
- Email: Danibel.Ramos@nyulangone.org
Study Locations
-
-
New York
-
New York, New York, United States, 10013
- Recruiting
- NYU Langone Health
-
Contact:
- Bedros Taslakian
- Phone Number: 212-263-5898
- Email: bedros.taslakian@nyulangone.org
-
Contact:
- Reshma Gadde
- Email: Resma.Gadde@nyulangone.org
-
Principal Investigator:
- Bedros Taslakian, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Embolization Group
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Knee pain using Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) score
Time Frame: Baseline, 1 month, 3 month and 12 month follow up visits
|
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.
|
Baseline, 1 month, 3 month and 12 month follow up visits
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Knee pain using the Visual Analogue Scale (VAS) scale
Time Frame: Baseline, 1 month, 3 month and 12 month follow up visits
|
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".
|
Baseline, 1 month, 3 month and 12 month follow up visits
|
Change in Knee Stiffness
Time Frame: Baseline, 1 month, 3 month and 12 month follow up visits
|
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).
|
Baseline, 1 month, 3 month and 12 month follow up visits
|
Change in Physical Functioning
Time Frame: Baseline, 1 month, 3 month and 12 month follow up visits
|
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).
|
Baseline, 1 month, 3 month and 12 month follow up visits
|
Change in Quality of life
Time Frame: Baseline, 1 month, 3 month and 12 month follow up visits
|
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.
|
Baseline, 1 month, 3 month and 12 month follow up visits
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bedros Taslakian, MD, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
May 6, 2020
First Submitted That Met QC Criteria
May 6, 2020
First Posted (Actual)
May 7, 2020
Study Record Updates
Last Update Posted (Actual)
October 3, 2023
Last Update Submitted That Met QC Criteria
October 2, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-00370
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
This is a small scale, single-site research study for NYU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis
-
Sanford HealthActive, not recruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder Osteoarthritis | Ankle Osteoarthritis | Wrist OsteoarthritisUnited States
-
University of EdinburghHospital for Special Surgery, New YorkRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited Kingdom
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
Hospital for Special Surgery, New YorkRoyal Infirmary of EdinburghRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited States, United Kingdom
-
Ottawa Hospital Research InstituteNot yet recruitingKnee Osteoarthritis | Hip Osteoarthritis
-
University Hospital, LilleCompleted
-
Massachusetts General HospitalNewton-Wellesley Hospital; The New England Baptist HospitalCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
Clinical Trials on Transcatheter arterial embolization
-
Next Biomedical Co., Ltd.RecruitingOsteoarthritisKorea, Republic of
-
Rigshospitalet, DenmarkCompleted
-
Next Biomedical Co., Ltd.RecruitingOsteoarthritisKorea, Republic of
-
Peking University People's HospitalNot yet recruitingPelvic Tumor | Embolization
-
Odense University HospitalCompleted
-
Huazhong University of Science and TechnologyCompletedHepatocellular Carcinoma | Hepatic Impairment | Rupture, Spontaneous | Rupture Liver
-
Hospital Authority, Hong KongSchering-PloughUnknown
-
Assistance Publique Hopitaux De MarseilleRecruitingMusculoskeletal InflammatoryFrance
-
Antonios LikourezosWithdrawnBenign Prostatic HyperplasiaUnited States
-
Fundación para la Investigación del Hospital Clínico...CompletedEsophageal Anastomotic Leak | Tissue Pressure of OxygenSpain