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Purpose

Patients will be asked to take part in this research study because they have mild-to-moderate knee osteoarthritis (OA) and were referred clinically for a procedure called Genicular Artery Embolization (GAE). Osteoarthritis is the most common form of arthritis. It occurs when the protective cartilage that cushions the ends of the bones wears down over time. The symptoms of OA include pain or aching, stiffness, decreased range of motion, and swelling. The purpose of this study is to evaluate the safety and effectiveness of GAE for the treatment of knee pain attributed to OA. Research participants will be in this research study for about 3 years. The study includes a screening visit, GAE procedure, and six follow-up visits. At the screening visit, a review of their medical history, demographics, and medications will be collected; physical examination will be completed; knee x-ray will be done; and two questionnaires on your knee pain will be administered. The GAE procedure will involve receiving sedation or medication to help them relax, lidocaine injected under the skin in the area of the body where catheters will be inserted into one of your arteries and then using x-ray, a catheter will be directed to the arteries supplying the lining of the knee. Then tiny microspheres will be injected into the artery to decrease the blood supply to this knee joint tissue. The follow-up visits up to 12 months will include a focused physical examination of the treated knee, documentation of medications, and two questionnaires will be administered. The follow-up visits at year 2 and 3 will include documentation of medications and any new treatments for OA as well as completion of two questionnaires. Follow-up visits maybe conducted in clinic or remotely.

Conditions

Eligibility

Eligible Ages
Between 40 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 40-80 years - Mild-to-moderate knee OA as determined by radiographs demonstrating Kellgren- Lawrence grade 2-3 - Self-reported pain of at least 5/10 VAS questionnaire - Failure of conservative therapy, such as pain medications, for at least 3 months - Patient must understand and sign the informed consent - Patient can comply with the proposed follow-up schedule - Patient can follow the post-operative management

Exclusion Criteria

  • History of rheumatoid arthritis - Renal insufficiency precluding angiography (GFR < 50 mL/min) - Irreversible coagulopathy - Previous knee arthroplasty on the intended knee - Existing knee joint infection - Kellgren-Lawrence grade 1 or 4 - Severe atherosclerosis as manifest by claudication and/or diminished peripheral pulses - Life expectancy < 6 months - Infectious arthritis - Allergy to iodinated contrast resulting in anaphylaxis - Pregnant or interested in becoming pregnant three months from the date of the GAE procedure - Involved in litigation or worker's compensation claims

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
GAE Procedure 		All participants will undergo a procedure called Genicular Artery Embolization (GAE) that will be done to try to reduce the pain in their knees.
  • Device: Embosphere Microspheres
    Genicular Artery Embolization is performed by either inserting a small catheter into the artery of the upper thigh or an artery at the wrist, and with the use of x-ray, the catheter is guided to the arteries supplying the lining of the knee. Tiny particles are then injected through the catheter into these arteries, reducing the blood supply. These small particles are considered a medical device called Embosphere Microspheres. These microspheres are approved by the Food and Drug Administration (FDA) in the United States to treat hypervascular tumors; in the prostate arteries to relieve symptoms related to benign prostate hyperplasia; and to address arteriovenous malformations. The use of Embosphere Microspheres in this study is considered experimental as it has not been approved by the FDA to reduce pain associated with knee OA.

Recruiting Locations

Northwestern University
Chicago, Illinois 60611
Contact:
Robert Lewandowski, MD
312-695-9121
r-lewandowski@northwestern.edu

More Details

Status
Recruiting
Sponsor
Northwestern University

Study Contact

Robert Lewandowski, MD
312-695-9121
r-lewandowki@northwestern.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.