Summary

Eligibility
for people ages 40-80 (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Siddharth Padia, MD (ucla)

Description

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 During the trial, all subjects will also get MRIs and fluid withdrawn from their knee joints at various timepoints in order to precisely figure out how the procedure works on a closer (microscopic) level.

Official Title

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

Details

This is a single-center, prospective, randomized trial to compare outcomes of GAE versus observation, and to identify biomarkers and imaging endpoints that change in response to GAE. Subjects will be considered enrolled in the study once they have provided informed consent and have been determined to meet all eligibility criteria. A total of 100 subjects will be enrolled in the double-arm study and will be followed for 24 months. The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, subjects will then be randomized to GAE or observation in a 2:1 ratio. Group sample sizes of 67 and 33 achieve approximately 85% power to reject the null hypothesis of no difference in KOOS between groups when the population mean difference is 9.7 (50 from observation and 40.3 from GAE arm) with a standard deviation for both groups of 15 and with a significance level (alpha) of 0.050 using a two-sided two-sample equal-variance t-test. All study subjects will undergo the initial procedures, consisting of a history and physical exam, dynamic contrast-enhanced knee MRI, blood serum and joint aspiration with biochemical analysis. For the treatment arm, subjects will undergo GAE with Embozene microspheres (100 micron) (Varian Medical Systems). Observation group will not receive the GAE procedure at baseline. Follow-up visits will be at 3 months (± 2 weeks), 6 months (± 2 weeks), 12 months (± 2 weeks), and 24 months (± 2 weeks) post-procedure. At these visits, subjects will complete the KOOS score, visual analog scale (VAS) pain score, undergo a directed physical examination, and report any new adverse events (AEs). At 6 months of follow-up, all subjects will also undergo dynamic contrast-enhanced knee MRI, and serum and joint aspiration with biochemical analysis. At 6 months, subjects in the observation group will have the option to crossover to the GAE treatment arm. Subjects in the crossover group will then undergo GAE, with follow up at 3 months (± 2 weeks), 6 months (± 2 weeks), 12 months (± 2 weeks), and 24 months (± 2 weeks) post-GAE.

Keywords

Knee Osteoarthritis Degenerative Joint Disease of Knee Microspheres Artery Embolization Chronic Pain Embozene Osteoarthritis Osteoarthritis, Knee Joint Diseases Embozene MicroSpheres

Eligibility

You can join if…

Open to people ages 40-80

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
  • Presence of moderate knee joint effusion (based on physical exam or radiograph)

You CAN'T join if...

Subjects that meet any of the following exclusion criteria will not be eligible for this study:

  • Mild knee pain as determined by visual analog scale < 5 out of 10
  • Chronic renal insufficiency (serum creatinine >2 mg/dL)
  • Significant arterial atherosclerosis that would limit selective angiography
  • Allergy to iodinated contrast agents
  • Active Infection or malignancy
  • Recent (within 12 months) or active cigarette use
  • Prior total knee replacement in the subject knee
  • Active pregnancy
  • Uncorrectable bleeding diasthesis

Location

  • Santa Monica Hospital
    Santa Monica California 90404 United States

Lead Scientist at University of California Health

  • Siddharth Padia, MD (ucla)
    HS Clinical Professor, Radiological Sciences. Authored (or co-authored) 68 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT04682652
Study Type
Interventional
Last Updated