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RECRUITING
NCT06859164
PHASE2

Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis

Sponsor: University of Chicago

View on ClinicalTrials.gov

Summary

Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. Additionally, this study aims to determine the magnitude of difference in pain response between GAE and sham to adequately power a larger, more definitive randomized sham-controlled trial (RCT). The influence of psychosocial and psychocognitive factors, changes in analgesic use, and conditions of knee joint cartilage and effusion will similarly be explored to determine their impacts on perceived pain response to GAE.

Official title: Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-05-01

Completion Date

2026-11-30

Last Updated

2025-05-15

Healthy Volunteers

No

Interventions

PROCEDURE

Genicular Artery Embolization

Embolization of genicular arteries that demonstrate neoangiogenesis or blush on angiogram.

DEVICE

Lipiodol

3:1 emulsion of Lipiodol to Optiray

PROCEDURE

Simple angiogram

Simple angiogram of the genicular arteries

Locations (1)

University of Chicago

Chicago, Illinois, United States