Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty

Launched by NYU LANGONE HEALTH · Nov 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called geniculate artery embolization (GAE) for patients who have ongoing knee pain after having total knee replacement surgery, known as total knee arthroplasty (TKA). The trial aims to see if this treatment can help people who have been experiencing moderate to severe knee pain for at least 9 months, despite trying other treatments that didn't work. The participants in this study will receive the GAE treatment and will be monitored for 24 months to assess how well it works and if it is safe.

To participate in the trial, individuals must have knee pain that hasn’t improved with standard treatments and must be willing to provide consent and complete questionnaires in English. Key factors that would exclude someone from joining include active infections, certain serious health conditions, recent knee surgeries, or other specific knee problems. Overall, this study offers a potential new option for those struggling with persistent knee pain after knee replacement surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)