Geniculate Artery Embolization for Knee Pain Secondary to Osteoarthritis (OA)
Completed · Not applicable · Has a placebo group
Conditions studied: Osteo Arthritis Knee
In brief
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 subjects enrolled over the age 40 with knee pain secondary to arthritis. Procedures (methods): 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. Clinical procedures and evaluations will consist of a preoperative screening assessment to determine if the potential study subject meets the inclusion and exclusion criteria, enrollment, surgical procedure for geniculate artery embolization, and follow-up visits at 24 hours, 2 weeks, 1, 3, 6, \& 12 months. An MRI may be performed after the 1-month visit.
Key facts
- Study ID
- NCT03362957
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 21
- Starts
- 2018-05-25
- Expected to finish
- 2020-04-24
- Last updated by the study team
- 2021-03-22
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- UNC Hospitals — Chapel Hill, North Carolina, United States
- Vascular Institute of Virginia — Woodbridge, Virginia, United States
Full record on ClinicalTrials.gov
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