Geniculate Artery Embolization for Osteoarthritis
Launched by UNIVERSITY OF MINNESOTA · Jun 29, 2020
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a procedure called geniculate artery embolization, which is being tested as a new treatment for people with mild to moderate knee osteoarthritis (OA). The goal is to see if this procedure can help relieve pain and slow down the progression of OA compared to standard treatments, which usually include physical therapy and anti-inflammatory medications. In this study, 20 participants will be divided into two groups: one group will receive the embolization procedure along with their usual treatments, while the other group will receive only the standard medical care.
To be eligible for this trial, participants need to be experiencing knee pain from osteoarthritis for at least three months and must not be candidates for knee surgery. They should also be willing to undergo an MRI and attend follow-up appointments for a year. If you think you or someone you know might qualify, this trial is currently recruiting participants. This study aims to provide important information about the safety and effectiveness of this new treatment option for knee OA.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Between 40 - 70 years of age.
- • Unilaterally dominant symptomatic OA (bilateral radiographic OA will not exclude).
- • Symptomatically refractory of at least 3 months of medical and/or rehabilitation measures (anti-inflammatory drugs, and/or physical therapy, and/or strength conditioning, and/or intra-articular injections of the affected knee in the last 3 months).
- • Kellgren-Lawrence grade 1, 2, or 3 on radiograph of the knee
- • Willing to comply with the protocol requirements and willing to undergo non- contrast MRI during screening and at 12 months.
- • Willing to comply with regular follow up during the 12 month follow-up period.
- • Not a current candidate for partial or total knee arthroplasty.
- • WOMAC Score \>=6 in at least 2 categories.
- Exclusion Criteria:
- • BMI \>35 kg/m2
- • Advanced peripheral arterial disease (resting ABI \<= 0.9).
- • Known significant peripheral arterial disease precluding common femoral catheterization
- • Have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
- • Diabetics with hemoglobin A1C of \>9%
- • Previous lower extremity embolization
- • Uncontrolled emotional disorders per patient medical history
- • Chronic pain syndrome or currently under a pain contract.
- • Anatomic variants involving the lower extremities which would increase the risk of non-target embolization
- • Renal insufficiency based on an estimated GFR\<45 ml/min who are not already on hemodialysis.
- • Abnormal INR (\>1.5)
- • Platelet count \<50x109/L.
- • Currently receiving medications for anticoagulation which cannot safely be held for the procedure and for 7 days post-procedure.
- • Known severe allergy to iodine which cannot be adequately pre-medicated
- • Pregnant or intend to become pregnant within 6 months of the procedure
- • Contraindication to drugs used for moderate sedation during interventional procedures, including Midazolam and Fentanyl
- • Life expectancy \<60 months
- • Currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial
- • Contraindications to medical and physical rehabilitative treatments of OA.
- • Advanced atherosclerosis.
- • Current or previous lower extremity fistula.
- • Rheumatoid arthritis or seronegative arthropathies.
- • WOMAC Pain Scale \< 6
- • Steroid injection in the affected joint within 3 months of screening. I- n investigator assessment, patient is not a candidate for study participation
About University Of Minnesota
The University of Minnesota is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on interdisciplinary collaboration, the university leverages its extensive resources and expertise to conduct cutting-edge studies aimed at improving patient outcomes and addressing critical health challenges. Its robust clinical trial program emphasizes ethical standards, patient safety, and scientific rigor, contributing to the development of novel therapies and interventions that enhance medical practice and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Minneapolis, Minnesota, United States
Patients applied
Trial Officials
Reza Talaie, MD
Principal Investigator
University of Minnesota
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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