Status:
COMPLETED
Geniculate Artery Embolization for Knee Pain Secondary to Osteoarthritis (OA)
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Medtronic
Conditions:
Osteo Arthritis Knee
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
Purpose: To evaluate embolization as a treatment for OA related knee pain versus placebo to demonstrate the actual effect of embolization on pain and disability. Participants: There will be 21 subjec...
Detailed Description
This will be a single-blinded randomized-controlled study of GAE versus placebo in a small population with knee pain secondary to arthritis to determine safety and efficacy. After Institutional Review...
Eligibility Criteria
Inclusion
- Moderate to severe knee pain (visual analog scale (VAS) \> 50 mm), and Pain refractory to at least 3 months\* of conservative therapies (anti- inflammatory drugs, or physical therapy, or muscle strengthening, or intra- articular injections), and Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee.
Exclusion
- Current local infection, or Life expectancy less than 6 months, or Known advanced atherosclerosis, or Rheumatoid or infectious arthritis, or Prior knee surgery, or Uncorrectable coagulopathy including international normalized ratio (INR) \> 2.5 or platelets \< 30,000, or Iodine allergy resulting in anaphylaxis, or Renal dysfunction as defined by serum creatinine \>1.6 dl/mg or estimated glomerular filtration rate (eGFR) \<60 obtained within the past 30 days.
Key Trial Info
Start Date :
May 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03362957
Start Date
May 25 2018
End Date
April 24 2020
Last Update
March 22 2021
Active Locations (2)
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1
UNC Hospitals
Chapel Hill, North Carolina, United States, 27599
2
Vascular Institute of Virginia
Woodbridge, Virginia, United States, 22193