Geniculate Artery Embolization for Treatment of Osteoarthritis

NYU Langone Health

Status: Active, not recruiting

Conditions: Osteoarthritis

Treatments: Device: Embozene™ Microspheres; Procedure: Transcatheter arterial embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT04379700

19-00370

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Embolization Group

Experimental group

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.

Treatment:

Procedure: Transcatheter arterial embolization

Device: Embozene™ Microspheres