Bayer OA Knee Pain Pilot

Study Purpose

The objective of this study is to investigate if MRI can be used to evaluated effect of knee artery embolization for knee osteoarthritis. Participants be evaluated in clinic, obtain a knee MRI, undergo embolization of the symptomatic knee, and follow up in clinic at 1, 6, and 12 months after embolization. A second MRI is obtained 6 months after embolization. Participants will keep a record of their pain level and treatment and answer questionnaires at each visit. In addition, this study aims to determine the effects of knee artery embolization on the amount of opioid (pain reliever drugs) needed to manage osteoarthritis-associated pain and change in quality of life.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	25 Years - 90 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age 25 to 90. 2. Symptomatic osteoarthritis of one or both knees, with Kellgren-Lawrence grade 1-3 assessed by weight-bearing knee radiography, including post-traumatic osteoarthritis. 3. One or more months of non-surgical therapy for knee pain such as joint injections, oral NSAIDs, or opioid analgesia. 4. Subjects able to provide informed consent. As this is a study of pain, patients must be able to consent for themselves. 5. Patients without contraindication to MRI imaging with gadolinium-based contrast.

Exclusion Criteria:

1. Anaphylaxis to gadolinium or iodinated contrast media. 2. Impaired renal function with GFR <30ml/min. 3. Severe atherosclerotic disease of the lower extremity precluding percutaneous angiographic access to the involved geniculate artery(ies) 4. Active septic arthritis of the symptomatic knee within 2 months of screening. 5. Malignancy of the involved knee. 6. Rheumatoid Arthritis or Gout. 7. Prior knee surgery. 8. Hemarthrosis. 9. Females who are pregnant or plan to become pregnant during the study. All participants able to become pregnant will be administered a urine pregnancy test.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05349682
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Medical University of South Carolina
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Andre Uflacker, MD
Principal Investigator Affiliation	Medical University of South Carolina
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis, Knee

Arms & Interventions

Arms

Experimental: GAE and MRI treatment arm

GAE is geniculate artery embolization.

Interventions

Diagnostic Test: - dynamic contrast enhanced MRI

An MRI study of the knee will be done to check the degree of osteoarthritis and blood flow to the affected knee. This scan will take about 1-2 hour(s).

Procedure: - geniculate artery embolization

The physician will perform a diagnostic angiography, where they will take pictures of vessels near the knee that will be treated. Once the artery to be treated is identified, the doctor will guide a thin wire called a microwire, and a plastic tube called a microcatheter to the targeted artery, and more pictures of vessels at the knee will be taken. This picture will be used to see if there are any abnormal vessels at the knee, such as abnormal blood flow, abnormal vessel connections (between the veins and arteries), or new blood vessel growth. Once the targeted artery at the knee is confirmed, the doctor will inject enough particle embolic (Embozene) to slow or stop the blood flow in the geniculate artery. Once all vessels are treated, a final angiogram (pictures of blood vessels) will be performed to ensure that the blood flow has slowed.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Medical University of South Carolina, Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Site Contact

Samuel Bidwell

[email protected]

843-792-2305

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