Investigating knee artery embolization for osteoarthritis pain relief
Transcatheter Geniculate Arterial Embolization: Treatment and Monitoring of Response
NA · Medical University of South Carolina · NCT05349682
This study is testing if a procedure called knee artery embolization can help relieve pain and improve the quality of life for people with knee osteoarthritis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 25 Years to 90 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina (other) |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05349682 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of knee artery embolization in treating knee osteoarthritis by using MRI to assess changes in pain and quality of life. Participants will undergo an initial MRI, followed by the embolization procedure, and will be monitored through follow-up visits at 1, 6, and 12 months. A second MRI will be conducted at the 6-month mark to further evaluate the treatment's impact. Participants will also track their pain levels and complete questionnaires throughout the study.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 25 to 90 with symptomatic osteoarthritis of one or both knees who have not found relief from non-surgical therapies.
Not a fit: Patients with severe renal impairment, certain types of arthritis, or those who have had prior knee surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, less invasive treatment option for managing knee osteoarthritis pain.
How similar studies have performed: While the use of embolization for knee pain is a novel approach, similar studies have shown promise in other areas of pain management.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Andre Uflacker, MD — Medical University of South Carolina
- Study coordinator: Samuel Bidwell
- Email: bidwells@musc.edu
- Phone: 843-792-2305
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteoarthritis, Knee