Status:
RECRUITING
Geniculate Artery Embolization for Osteoarthritis
Lead Sponsor:
University of Minnesota
Conditions:
Osteo Arthritis Knee
Arthritis
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
The need for exploration of more definitive and cost effective non-arthroplasty treatments of osteoarthritis (OA) has been demonstrated by the orthopedic and health economic research. Embolotherapy o...
Detailed Description
This is a single center, two-arm, open label, pilot study to assess feasibility and safety and obtain a preliminary estimate of efficacy of geniculate artery embolization in reducing pain compared to ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04456569
Start Date
February 1 2022
End Date
February 1 2026
Last Update
June 29 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455