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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 During the trial, all subjects will also get MRIs and fluid withdrawn from their knee joints at various timepoints in order to precisely figure out how the procedure works on a closer (microscopic) level.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 79
Healthy Volunteers: f
View:

⁃ Subjects must meet all of the following inclusion criteria in order to be eligible for this study:

• Provided informed consent

• Age ≥ 40 years and less than 80 years

• Ineligibility for or refusal of surgical management

• Moderate-severe knee pain as determined by visual analog scale \> 5 out of 10

• Osteoarthritis based on X-ray. Kellgren-Lawrence score \> 2 based on radiograph completed within 3 months of procedure date.

• Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection/ hyaluronic acid joint injection) for at least 3 months

• Able to comply with all treatments and protocol follow-up visits

Locations
United States
California
UCLA Santa Monica Hospital
RECRUITING
Santa Monica
Contact Information
Primary
Aniket Joglekar, BA
ajoglekar@mednet.ucla.edu
310-948-8026
Backup
Saima Chaabane, PhD
SChaabane@mednet.ucla.edu
424-465-4482
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 100
Treatments
Experimental: GAE Treatment
Subjects will be treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the subject's pain.
No_intervention: Observational
Subjects randomized to the observational group will not undergo the experimental GAE Treatment.~PI will offer subjects enrolled into the observational group to crossover to the experimental GAE Treatment group after they have completed their 6-month follow-up assessments.
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles
Collaborators: Varian Medical Systems

This content was sourced from clinicaltrials.gov