Actively Recruiting

Age: 18Years +
All Genders
ID06781463

Creation of a Prospective Data Collecting Registry for Genicular Artery Embolization for Arthritis (GAE)

Led by University of Chicago · Updated on 2026-05-13

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Knee osteoarthritis (KOA) is a common and disabling condition characterized by pain, stiffness, and loss of joint function, affecting over 15 million people in the US. This research aims to create a prospective registry of fewer than 100 patients to evaluate the effectiveness of genicular artery embolization (GAE) in reducing knee pain over time, measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. The study is observational and sponsored by the University of Chicago. GAE is a minimally invasive procedure that uses live X-ray guidance to block blood flow in specific arteries around the knee believed to contribute to inflammation and pain. All enrolled patients will undergo GAE and be followed for one year after their procedure to observe changes. The study also plans to use MRI scans as an imaging biomarker to assess positive changes in the knee's condition after treatment. Participants will be monitored for one year from their procedure date, with regular assessments of knee pain using the WOMAC score and tracking of any adverse events related to GAE. The registry will collect data to better understand the procedure's effects and safety over a longer period and larger sample size, potentially informing a future controlled trial. The total participation time is one year per patient.

CONDITIONS

Brief Title

Creation of a Prospective Data Collecting Registry for Genicular Artery Embolization for Arthritis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 60;18 years
  • Have knee pain caused by knee osteoarthritis in one or both knees
  • Diagnosed with grade 1 to 3 osteoarthritis on standing weight-bearing knee X-rays
  • Have had knee pain for more than 6 months that did not improve with conservative medical treatment
  • Not eligible for knee replacement surgery or prefer to undergo genicular artery embolization instead
Not Eligible

You will not qualify if you...

  • Active cancer
  • Current infection in the affected knee
  • Low platelet count below 50,000/uL or high INR above 2.0 unless anticoagulation can be reversed
  • Received corticosteroid injection in the affected knee within the last 3 months
  • Rheumatoid arthritis or other similar joint diseases
  • Previous knee surgery except arthroscopy
  • Grade 4 osteoarthritis on the affected knee
  • Pregnant or expecting pregnancy
  • Poor kidney function with GFR less than 30
  • Severe allergic reaction to iodinated contrast
  • Moderate to severe pain in other lower limb joints
  • Body weight over 400 lbs preventing safe angiography
  • Peripheral arterial disease in the treated leg with Rutherford Grade 2 or higher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Long-term Monitoring

Duration - 1 year

Participants who undergo genicular artery embolization are observed for outcomes and safety over one year.

Regular follow-up visits over 1 year

Trial Site Locations

Total: 1 location

1

University of Chicago Duchossois Center for Advanced Medicine

Chicago, Illinois, United States, 60637

Actively Recruiting

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Research Team

T

Tiana Jackson

P

Patrick Tran, Doctor of Medicine

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010.

Theo Vos, Abraham D Flaxman, Mohsen Naghavi...

https://pubmed.ncbi.nlm.nih.gov/23245607