Geniculate Artery Embolization for Treatment of Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Feasibility and Safety of Geniculate Artery Embolization for Treatment of Mild to Moderate Knee Osteoarthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04379700
• Other study ID #: 19-00370
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 2025

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: June 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 30-80 years of age of any gender;

2. 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;

3. 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);

4. 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).

5. Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaire is validated in English.

Exclusion Criteria:

1. Active systemic or local knee infection;

2. Active malignancy;

3. Life expectancy less than 12 months;

4. 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;

5. Ipsilateral knee intra-articular injection in the last 3 months;

6. Rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus;

7. Pregnant during the study period;

8. Renal dysfunction as defined by serum creatinine >1.6 dl/mg or eGFR <60 on blood tests obtained within 30 days of procedure;

9. Body weight greater than 200 Kg;

10. Uncorrectable coagulopathy (platelet count < 50,000, international normalized ratio >1.5 within 30 days of procedure;

11. Known history of contrast allergy resulting in anaphylaxis;

12. 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);

13. Post-traumatic knee (if trauma occurred within 12 months of baseline or was associated with fractures);

14. Known avascular necrosis in the target knee;

15. Contraindications to MRI such as such as claustrophobia, metallic fragment/implants, pacemaker.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Transcatheter arterial embolization
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.

Device:
• Embozene™ Microspheres
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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 1 month, 3 month and 12 month follow up visits
Secondary	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".	Baseline, 1 month, 3 month and 12 month follow up visits
Secondary	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).	Baseline, 1 month, 3 month and 12 month follow up visits
Secondary	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).	Baseline, 1 month, 3 month and 12 month follow up visits
Secondary	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.	Baseline, 1 month, 3 month and 12 month follow up visits