Clinical trial NCT06134817: Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty
Official title: Prospective Pilot Study on Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Pain
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 resistant to conservative management for at least 9 months after total knee arthroplasty (TKA). Eligible participants will receive geniculate artery embolization (GAE) using Embozene™ Color-Advanced Microspheres. Patients will be followed up for a total of 24 months after GAE.


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)

Primary outcomes:
measure: Change in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Score from Baseline to Month 6
timeFrame: Baseline, Month 6 Post-GAE Procedure
Secondary outcomes:
measure: KOOS Symptoms Score
timeFrame: Month 3 Post-GAE Procedure
measure: KOOS Symptoms Score
timeFrame: Month 6 Post-GAE Procedure
measure: KOOS Symptoms Score
timeFrame: Month 12 Post-GAE Procedure
measure: KOOS Symptoms Score
timeFrame: Month 24 Post-GAE Procedure
measure: Knee Pain Measured via Visual Analogue Scale (VAS)
timeFrame: Month 3 Post-GAE Procedure
measure: Knee Pain Measured via VAS
timeFrame: Month 6 Post-GAE Procedure
measure: Knee Pain Measured via VAS
timeFrame: Month 12 Post-GAE Procedure
measure: Knee Pain Measured via VAS
timeFrame: Month 24 Post-GAE Procedure
measure: Quality of Life Measured via EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score
timeFrame: Month 3 Post-GAE Procedure
measure: Quality of Life Measured via EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score
timeFrame: Month 6 Post-GAE Procedure
measure: Quality of Life Measured via EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score
timeFrame: Month 12 Post-GAE Procedure
measure: Quality of Life Measured via EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score
timeFrame: Month 24 Post-GAE Procedure
measure: Incidence of Synovitis
timeFrame: Month 6 Post-GAE Procedure
measure: Incidence of Synovitis
timeFrame: Month 24 Post-GAE Procedure
measure: Incidence of Successful Selective Catheterization of Target Genicular Artery
timeFrame: Up to Month 24 Post-GAE Procedure
measure: Incidence of Successful Embolization from at least One Feeding Artery of the Knee Joint
timeFrame: Up to Month 24 Post-GAE Procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Bedros Taslakian, MD
role: PRINCIPAL_INVESTIGATOR
References: