RECRUITING

Genicular Artery Embolization Vs Observation for Symptomatic Knee Osteoarthritis

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 purpose of this clinical trial is to determine whether genicular artery embolization (GAE) is an effective way to treat knee pain from osteoarthritis. Pain from arthritis is often due to underlying inflammation in the joint. The inflammation is associated with increased abnormal blood flow going to the specific area of pain. If the investigator can reduce the blood flow, the inflammation can be reduced and the pain can be controlled. The GAE procedure is an experimental procedure to decrease the blood flow (embolize) to the specific region of the knee that is causing the pain. This will be done by infusing microscopic spheres into the specific blood vessel (genicular artery) supplying the area of pain in the knee. This is done through a procedure which is called an angiogram, which is done entirely through a pinhole at the creased of the thigh, using twilight (conscious) sedation. The investigators have already completed an initial trial at UCLA, and shown that this procedure is safe and effective. The purpose of this new trial is to compare outcomes of people undergoing the GAE procedure to those who do not undergo the procedure. A total of 100 patients will be enrolled, and 2/3 of the patients will be randomly selected to undergo the GAE procedure. 1/3 will not undergo the procedure. This is known as a randomized trial. During the trial, all subjects will also get MRIs and fluid withdrawn from their knee joints at various timepoints in order to precisely figure out how the procedure works on a closer (microscopic) level.

Official Title

GRAVITY: Genicular Artery Embolization Versus Observation for the Treatment of Symptomatic Knee Osteoarthritis: a Randomized Controlled Trial

Quick Facts

Study Start:2023-08-01
Study Completion:2027-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04682652

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:40 Years to 79 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Aniket Joglekar, BA
CONTACT
310-948-8026
ajoglekar@mednet.ucla.edu
Saima Chaabane, PhD
CONTACT
424-465-4482
SChaabane@mednet.ucla.edu

Principal Investigator

Siddharth A Padia, MD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

UCLA Santa Monica Hospital
Santa Monica, California, 90404
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Siddharth A Padia, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

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 Date2023-08-01
Study Completion Date2027-10-01

Study Record Updates

Study Start Date2023-08-01
Study Completion Date2027-10-01

Terms related to this study

Keywords Provided by Researchers

  • Microspheres
  • Artery Embolization
  • Knee Osteoarthritis
  • Chronic Pain
  • Embozene

Additional Relevant MeSH Terms

  • Knee Osteoarthritis
  • Degenerative Joint Disease of Knee