Bayer OA Knee Pain Pilot

NCT ID: NCT05349682

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2026-06-30

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GAE and MRI treatment arm

GAE is geniculate artery embolization.

Group Type: EXPERIMENTAL

dynamic contrast enhanced MRI

Intervention Type: DIAGNOSTIC_TEST

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).

geniculate artery embolization

Intervention Type: PROCEDURE

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.

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andre Uflacker, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Samuel Bidwell

Role: CONTACT

bidwells@musc.edu

843-792-2305

Facility Contacts

Samuel Bidwell

Role: primary

bidwells@musc.edu

843-792-2305

Andre Uflacker, MD

Role: backup

uflackera@musc.edu

843-876-3185

Other Identifiers

00113621

Identifier Type: -

Identifier Source: org_study_id