Genicular artery embolization for treating knee pain from osteoarthritis
GRAVITY: Genicular Artery Embolization Versus Observation for the Treatment of Symptomatic Knee Osteoarthritis: a Randomized Controlled Trial
This study is testing if a new procedure called genicular artery embolization can help people with knee pain from osteoarthritis feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 40 Years to 79 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Santa Monica, California) |
| Trial ID | NCT04682652 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of genicular artery embolization (GAE) in alleviating knee pain caused by osteoarthritis. The procedure involves infusing microscopic spheres into the genicular artery to reduce blood flow and inflammation in the knee joint. Participants will be randomly assigned to receive either the GAE treatment or be placed under observation for comparison. The study will track outcomes over a 24-month period, assessing pain reduction and other clinical responses. A total of 100 subjects will be enrolled, with eligibility determined through a screening process.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 to 80 with moderate to severe knee pain from osteoarthritis who have not responded to conservative treatments.
Not a fit: Patients with mild knee pain or those who are eligible for surgical management may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce knee pain and improve quality of life for patients suffering from osteoarthritis.
How similar studies have performed: Previous trials at UCLA have shown promising results for this procedure, indicating potential effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 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 Exclusion Criteria 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 * OA on knee radiograph resulting in greater than 20 degree varus or valgus angulation * Moderate loss of kidney function, define as estimated glomerular filtration rate of less than 45 mL/min. * Significant arterial atherosclerosis that would limit selective angiography * History of fibromyalgia, autoimmune, or inflammatory disorder * History of any lumbar spine surgery, spine injections, or radicular pain in the extremity believed to originate from the spine * Allergy to iodinated contrast agents * Active Infection or malignancy * Recent (within 12 months) or active cigarette use * Prior total or partial knee replacement in the subject knee * Active pregnancy * Uncorrectable bleeding diasthesis
Where this trial is running
Santa Monica, California
- UCLA Santa Monica Hospital — Santa Monica, California, United States (Recruiting)
Study contacts
- Principal investigator: Siddharth A Padia, MD — University of California, Los Angeles
- Study coordinator: Aniket Joglekar, BA
- Email: ajoglekar@mednet.ucla.edu
- Phone: 310-948-8026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.