Bayer OA Knee Pain Pilot

Description

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

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Study Overview

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Study Details

Study overview

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.

Transcatheter Geniculate Arterial Embolization: Treatment and Monitoring of Response

Bayer OA Knee Pain Pilot

Condition
Osteoarthritis, Knee
Intervention / Treatment

-

Contacts and Locations

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

25 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medical University of South Carolina,

Andre Uflacker, MD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

2024-11