RECRUITING

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

Conditions

Knee Osteoarthritis Knee Osteoarthritis (Knee OA)Knee Osteoarthritis (OA)knee pain knee replacement alternative knee arthritis

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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

The goal of this study is to create a prospective registry (\<100 patients) to show the effectiveness of the genicular artery embolization procedure overtime in reducing bilateral or unilateral osteoarthritic knee pain as measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.

Official Title

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

Quick Facts

Study Start:2023-10-01

Study Completion:2028-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06781463

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients aged \>=18 * Bilateral or unilateral knee pain attributed to knee osteoarthritis (KOA). For bilateral KOA patients, the more severe knee will be permitted inclusion to the registry * Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale * Knee pain \>6 months refractory to conservative medical management (Nonsteroidal anti-inflammatory drugs, acetaminophen, etc.) * Not eligible for surgical knee replacement or patient's personal preference to undergo Genicular Artery Embolization (GAE) for reasons such as minimally invasiveness of GAE	* Active malignancy * Active infection of the affected knee * Platelets \<50,000/uL, INR \>2.0 (unless on anticoagulation that can be reversed or performing radial/pedal access without reversal) * Corticosteroid injection of the affected knee within 3 months of enrollment * Rheumatoid arthritis or other seronegative arthropathy * Previous surgery (excluding arthroscopy) of the affected knee * Grade 4 per Kellgren-Lawrence Grading Scale of the affected knee * Pregnancy or expected pregnancy * Glomerular Filtration Rate (GFR) \<30 * Anaphylactic reaction to iodinated contrast * Moderate to severe pain in other lower limb joints * Body weight \>400 lbs. (prohibiting safe angiography) * Peripheral arterial disease of the treated extremity (Rutherford Grade 2 or greater)

Inclusion Criteria

Exclusion Criteria

* Patients aged \>=18
* Bilateral or unilateral knee pain attributed to knee osteoarthritis (KOA). For bilateral KOA patients, the more severe knee will be permitted inclusion to the registry
* Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale
* Knee pain \>6 months refractory to conservative medical management (Nonsteroidal anti-inflammatory drugs, acetaminophen, etc.)
* Not eligible for surgical knee replacement or patient's personal preference to undergo Genicular Artery Embolization (GAE) for reasons such as minimally invasiveness of GAE

* Active malignancy
* Active infection of the affected knee
* Platelets \<50,000/uL, INR \>2.0 (unless on anticoagulation that can be reversed or performing radial/pedal access without reversal)
* Corticosteroid injection of the affected knee within 3 months of enrollment
* Rheumatoid arthritis or other seronegative arthropathy
* Previous surgery (excluding arthroscopy) of the affected knee
* Grade 4 per Kellgren-Lawrence Grading Scale of the affected knee
* Pregnancy or expected pregnancy
* Glomerular Filtration Rate (GFR) \<30
* Anaphylactic reaction to iodinated contrast
* Moderate to severe pain in other lower limb joints
* Body weight \>400 lbs. (prohibiting safe angiography)
* Peripheral arterial disease of the treated extremity (Rutherford Grade 2 or greater)

Contacts and Locations

Study Contact

Jordan A Olsen, Bachelor of Science

CONTACT

2184612112

jordan.olsen@bsd.uchicago.edu

Osmannudin Ahmed, Doctor of Medicine

CONTACT

847-812-4513

OAhmed@bsd.uchicago.edu

Study Locations (Sites)

University of Chicago Duchossois Center for Advanced Medicine

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

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 Date2023-10-01

Study Completion Date2028-10-01

Study Record Updates

Study Start Date2023-10-01

Study Completion Date2028-10-01

Terms related to this study

Keywords Provided by Researchers

knee pain
knee replacement alternative
knee arthritis

Additional Relevant MeSH Terms

Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Knee Osteoarthritis (OA)