TERMINATED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-24

Study Completion:2025-02-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06134817

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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)

Inclusion Criteria

Exclusion 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.

* 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)

Contacts and Locations

Principal Investigator

Bedros Taslakian, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

NYU Langone Health

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Bedros Taslakian, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-24

Study Completion Date2025-02-12

Study Record Updates

Study Start Date2024-05-24

Study Completion Date2025-02-12

Terms related to this study

Additional Relevant MeSH Terms

Knee Pain