Status:
COMPLETED
Geniculate Artery Embolization for Treatment of Osteoarthritis
Lead Sponsor:
NYU Langone Health
Conditions:
Osteoarthritis
Eligibility:
All Genders
30-80 years
Phase:
NA
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 radiogra...
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04379700
Start Date
December 1 2020
End Date
March 12 2025
Last Update
June 18 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10013