Status:
RECRUITING
Bayer OA Knee Pain Pilot
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Bayer
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
25-90 years
Phase:
NA
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, underg...
Eligibility Criteria
Inclusion
- Age 25 to 90
- Symptomatic osteoarthritis of one or both knees, with Kellgren-Lawrence grade 1-3 assessed by weight-bearing knee radiography, including post-traumatic osteoarthritis
- One or more months of non-surgical therapy for knee pain such as joint injections, oral NSAIDs, or opioid analgesia
- Subjects able to provide informed consent. As this is a study of pain, patients must be able to consent for themselves.
- Patients without contraindication to MRI imaging with gadolinium-based contrast.
Exclusion
- Anaphylaxis to gadolinium or iodinated contrast media
- Impaired renal function with GFR \<30ml/min
- Severe atherosclerotic disease of the lower extremity precluding percutaneous angiographic access to the involved geniculate artery(ies)
- Active septic arthritis of the symptomatic knee within 2 months of screening
- Malignancy of the involved knee
- Rheumatoid Arthritis or Gout
- Prior knee surgery
- Hemarthrosis
- 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.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05349682
Start Date
October 1 2022
End Date
June 1 2026
Last Update
April 18 2025
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425