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NCT05349682 | RECRUITING | Osteoarthritis, Knee

Bayer OA Knee Pain Pilot
Sponsor:

Medical University of South Carolina

Information provided by (Responsible Party):

Antony Gayed

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.

Condition or disease

Osteoarthritis, Knee

Intervention/treatment

dynamic contrast enhanced MRI

geniculate artery embolization

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 12 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Transcatheter Geniculate Arterial Embolization: Treatment and Monitoring of Response
Actual Study Start Date : 2022-10-01
Estimated Primary Completion Date : 2024-10
Estimated Study Completion Date : 2024-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 25 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Bayer OA Knee Pain Pilot

Location Details

NCT05349682

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How to Participate

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Locations

RECRUITING

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425