Genicular Artery Embolization Vs Observation for Symptomatic Knee Osteoarthritis
- Conditions
- Knee OsteoarthritisDegenerative Joint Disease of Knee
- Interventions
- Device: Embozene MicroSpheres
- Registration Number
- NCT04682652
- Lead Sponsor
- University of California, Los Angeles
- Brief 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 During the trial, all subjects will also get MRIs and fluid withdrawn from their knee joints at various timepoints in order to precisely figure out how the procedure works on a closer (microscopic) level.
- Detailed Description
This is a single-center, prospective, open-label 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 the clinical response defined by 50% or greater reduction in WOMAC between the treatment and observation arms with a significance level (alpha) of 0.050 using a two-sided two-proportions using Fisher's exact test. With 100 symptomatic knee osteoarthritis subjects, the power of study is approximately 85% where we assume a target response rate of 67.5% for the experimental arm and 31% for the observational arm with up to 20% drop-out rate prior to 6 months. 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, and will be counseled on conservative management with a referral or prescription for physical therapy. Follow-up visits will be at 1 month (± 2 weeks), 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 WOMAC, KOOS5, visual analog scale (VAS) pain score, undergo a directed physical examination, and report any new adverse events (AEs). At 6 and 24 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 1 month (± 2 weeks), 3 months (± 2 weeks), 6 months (± 2 weeks), 12 months (± 2 weeks), and 24 months (± 2 weeks) post-GAE. For the purposes of data analyses, the follow-up evaluations for crossover subjects will match those of the initial GAE subjects. For example, if a subject in the observation arm undergoes GAE crossover at 6 months, that will be considered the treatment visit, and then subject will undergo evaluation at 1, 3, 6, 12, and 24 months after GAE.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description GAE Treatment Embozene MicroSpheres 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.
- Primary Outcome Measures
Name Time Method Changes in clinical response 6 months The primary evaluation is the change in clinical response, measured by The Western Ontario and McMaster Universities Arthritis Index (WOMAC). The primary endpoint is percentage of subjects achieving at least a 50% reduction in WOMAC at 6 months with an intent-to-treat analysis.
- Secondary Outcome Measures
Name Time Method Change in inflammatory biomarkers 6-24 months • To assess changes in inflammatory markers in patients undergoing GAE versus observation at 0, 6 and 24 months. This will be a per-protocol exploratory analysis.
Degree of progression of osteoarthritis 24 months • To assess the degree of progression of osteoarthritis via changes in knee radiograph at 0 and 24 months in patients undergoing GAE versus observation. This will be a per-protocol exploratory analysis.
Correlation of baseline characteristics with clinical response 1-24 months • To assess how differences in baseline clinical, imaging, and biochemical characteristics correlate with clinical response. This will be a per-protocol exploratory analysis.
Safety assessment 24 months Assess safety via tabulation of adverse events
Pain medication use 24 months To assess change in pain medication use after GAE versus observation.
Short term clinical outcomes 1 and 3 months • Compare clinical success rates (defined as at least 50% reduction in WOMAC) between GAE and observation at 1 and 3 months. This will be a intent-to-treat analysis.
Decrease in pain 1-24 months • Compare median decrease in pain (measured by VAS: visual analog scale) between GAE and observation at various timepoints: 1 month, 3 months, 6 months, 12 months, 24 months. This will be a per-protocol analysis.
Change in quality of life 1-24 months • Compare median improvement in health-related quality of life (measured by KOOS5) between GAE and observation at various timepoints: 1 month, 3 months, 6 months, 12 months, 24 months. This will be a per-protocol analysis.
Change in MRI 6-24 months • To assess changes in imaging (MRI) in patients undergoing GAE versus observation, at 0, 6, and 24 months. This will be a per-protocol exploratory analysis.
Degree of change in clinical outcomes via WOMAC 1-24 months • Compare median decrease in WOMAC (measured by percentage) between GAE and observation at various timepoints: 1 month, 3 months, 6 months, 12 months, 24 months. This will be a per-protocol analysis.
Clinic outcomes at multiple timepoints 1-24 months • Compare clinical success rates (defined as at least 50% reduction in WOMAC) between GAE and observation at various timepoints: 1 months, 3 months, 6 months, 12 months, 24 months. This will be a per-protocol analysis.
Trial Locations
- Locations (1)
UCLA Santa Monica Hospital
🇺🇸Santa Monica, California, United States