Embolization treatment for knee pain after knee replacement surgery

Prospective Pilot Study on Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty

This study is testing a new treatment to see if it can help people who still have knee pain after knee replacement surgery feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 30 Years to 85 Years
• Sex: All
• Sponsor: NYU Langone Health (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06134817 on ClinicalTrials.gov

What this trial studies

This pilot trial evaluates the safety and efficacy of geniculate artery embolization (GAE) using Embozene™ Color-Advanced Microspheres in patients experiencing persistent knee pain for at least 9 months following total knee arthroplasty (TKA). It is a single-arm, single-center study with no placebo group, focusing on individuals whose knee pain has not improved with conservative treatments. Participants will be monitored for 24 months post-procedure to assess outcomes related to pain relief and functional improvement.

Who should consider this trial

Good fit: Ideal candidates are individuals with moderate to severe knee pain that has not responded to conservative management for at least 9 months after TKA.

Not a fit: Patients with active infections, malignancies, or certain autoimmune conditions, as well as those with recent knee surgeries or specific renal issues, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant pain relief and improved quality of life for patients suffering from chronic knee pain after knee replacement surgery.

How similar studies have performed: While this approach is relatively novel, similar studies exploring embolization techniques for pain management have shown promising results.

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)

Where this trial is running

New York, New York

• NYU Langone Health — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Bedros Taslakian, MD — NYU Langone Health
• Study coordinator: Bedros Taslakian, MD

Conditions Knee Pain