Randomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain

N/ARecruitingNCT06872567

North American Science Associates Ltd.126 enrolled

Overview

Multi-center, prospective, randomized trial of GAE using Nexsphere-F against steroid injection

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Knee Osteoarthritis (Knee OA)

Interventions

genicular artery embolizationDEVICE

genicular artery embolization

Corticosteroid InjectionDRUG

Corticosteroid Injection

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has localized knee pain * Must be an appropriate candidate for arterial vascular access procedure Exclusion Criteria: * Known sensitivity or allergy to implant materials * Unable or unwilling to comply with study requirements

Locations (1)

University of Virginia

Charlottesville, Virginia, United States

RECRUITING

Outcomes

Primary Outcomes

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Changes in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scale ranges from 0 to 96 with higher scores equating to greater pain, stiffness and difficulty with activities of daily living.

Time frame: 6 and 12-month post treatment

Serious Adverse Events (SAE)

Time frame: Treatment, 1,3,6,9 and 12-month post treatment

Secondary Outcomes

WOMAC total score

Time frame: 9 month post treatment

Central Contacts

Ziv J Haskal, MD

CONTACT

16463691570 haskalembo@gmail.com

Data from ClinicalTrials.gov

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