Genicular Artery Embolization Versus Observation for the Treatment of Symptomatic Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT04682652|
Recruitment Status : Not yet recruiting
First Posted : December 24, 2020
Last Update Posted : November 1, 2021
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 During the trial, all subjects will also get MRIs and fluid withdrawn from their knee joints at various timepoints in order to precisely figure out how the procedure works on a closer (microscopic) level.
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis Degenerative Joint Disease of Knee||Device: Embozene MicroSpheres||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||A total of 100 subjects will be enrolled in the double-arm study, subjects will be randomized to GAE or observation in a 2:1 ratio (67 assigned to GAE, 33 assigned to observational). Subjects in the observation group will have the option to crossover to the GAE treatment arm after they've completed their 6-month follow-up time point. Subjects who crossover to treatment arm will undergo the GAE procedure and undergo all subsequent follow-up visits (3 month, 6 month, 12 month, 24 month).|
|Masking:||None (Open Label)|
|Official Title:||GRAVITY: Genicular Artery Embolization Versus Observation for the Treatment of Symptomatic Knee Osteoarthritis: a Randomized Controlled Trial|
|Estimated Study Start Date :||June 1, 2022|
|Estimated Primary Completion Date :||June 1, 2026|
|Estimated Study Completion Date :||June 1, 2027|
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.
Device: Embozene MicroSpheres
Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.
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.
- Changes in the clinical response [ Time Frame: 24 months ]The Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QoL) (4 questions). On this scale, 100% indicates no problems and 0% indicates extreme problems
- Changes in baseline MOAKS [ Time Frame: 24 months ]The MRI Osteoarthritis Knee Score (MOAKS) score is a semi-quantitative whole joint morphologic assessment of knee joint tissues in 14 subregions. Assessments are based on presence of Bone Marrow Lesions within the subregional volume (scale of 0-3, where none=0 and >66%=3), articular cartilage loss (scale of 0-3, where none=0 and >75%=3), presence of osteophytes in 12 of the 14 regions (scale of 0-3, where none=0 and large=3), Hoffa's synovitis and synovitis-effusion (scale of 0-3, where normal=0 and capsular distention=3), meniscus extrusion grading (scale of 0-3, where <2mm=0and >5mm=3), meniscus morphologic features present (Y/N; signal, tear, maceration, cyst, hypertrophy): ligaments and tendons (scale of 0-1, where normal=0 and complete tear/abnormality=1), and periarticular features = present or not (Hunter et al, 2011 Osteoarthritis Cartilage, 19:990-1002).
- Tabulation of adverse events as a measure of safety. [ Time Frame: 24 months ]AE/SAE data will be collected at baseline, treatment, 3-month, 6-month, 12-month and 24-month follow-up visits for both the treatment group versus observational group.
- Change in chronic pain medication use [ Time Frame: 24 months ]Concomitant Pain Medications data will be collected from patient medical chart review.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04682652
|Contact: Stephanie Gilbert, BAemail@example.com|
|Contact: Saima Chaabane, PhD||310-794-8995||SChaabane@mednet.ucla.edu|
|United States, California|
|Santa Monica Hospital|
|Santa Monica, California, United States, 90404|
|Contact: Siddharth Padia, MD|
|Principal Investigator:||Siddharth Padia, MD||University of California, Los Angeles|