Status:
TERMINATED
Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty
Lead Sponsor:
NYU Langone Health
Conditions:
Knee Pain
Eligibility:
All Genders
30-85 years
Phase:
NA
Brief Summary
Single-arm, single-center, no sham or placebo, prospective pilot trial designed to evaluate the safety and efficacy of transcatheter arterial embolization in patients with persistent knee pain resista...
Eligibility Criteria
Inclusion
- Knee pain resistant to conservative treatment for at least 9 months post TKA performed for knee OA, and
- Moderate to severe knee pain: pain VAS ≥40 mm, and
- Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaires are validated in English.
Exclusion
- Active systemic or local knee infection or;
- Active malignancy or;
- Life expectancy less than 6 months or;
- Prior ipsilateral knee arthroscopic surgery or repeat TKA (within 9 months of screening) or;
- Ipsilateral knee intra-articular injection in the last 3 months or;
- Rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus or;
- Pregnant during the study period or;
- Renal dysfunction as defined by serum creatinine \>1.6 dl/mg or eGFR \<60 on blood tests obtained within 30 days of procedure or;
- Body weight greater than 200 Kg or;
- Known history of severe contrast allergy to iodinated contrast resulting in anaphylaxis or;
- 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) or;
- known avascular necrosis in the target knee or;
- Complications of TKA such as suspected or confirmed early loosening, ligamentous instability, reflex sympathetic dystrophy, polyethylene wear with or without particle disease (osteolysis), and large effusions (with or without hemarthrosis) or;
- Patient is enrolled in a different trial for treatment of knee pain post total knee arthroplasty (ipsilateral knee)
Key Trial Info
Start Date :
May 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2025
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT06134817
Start Date
May 24 2024
End Date
February 12 2025
Last Update
August 7 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016