Bayer OA Knee Pain Pilot

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Osteoarthritis, Knee

Treatments: Procedure: geniculate artery embolization; Diagnostic Test: dynamic contrast enhanced MRI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05349682

00113621

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 25 to 90 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

GAE and MRI treatment arm

Experimental group

Description:

GAE is geniculate artery embolization.

Treatment:

Diagnostic Test: dynamic contrast enhanced MRI

Procedure: geniculate artery embolization