Embolization of knee arteries for treating osteoarthritis

Geniculate Artery Embolization for Osteoarthritis: Pilot Study

This study is testing if blocking certain knee arteries can help people with mild to moderate osteoarthritis feel less pain compared to just standard treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 40 Years to 70 Years
• Sex: All
• Sponsor: University of Minnesota (other)
• Locations: 1 site (Minneapolis, Minnesota)
• Trial ID: NCT04456569 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the safety and efficacy of geniculate artery embolization in patients with mild to moderate knee osteoarthritis. It involves randomly assigning 20 participants into two groups: one receiving embolization along with standard care, and the other receiving only standard care. The study aims to gather preliminary data on pain reduction and other outcomes using established assessment scales and imaging techniques. The findings will help determine the feasibility of this innovative approach compared to traditional treatments.

Who should consider this trial

Good fit: Ideal candidates are individuals with unilateral symptomatic knee osteoarthritis who have not responded to conservative treatments for at least three months.

Not a fit: Patients who are currently candidates for knee arthroplasty or have severe osteoarthritis (Kellgren-Lawrence grade 4) may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a less invasive and more effective option for managing knee osteoarthritis pain.

How similar studies have performed: While embolotherapy for osteoarthritis is a promising approach, this specific method is novel and has not been extensively tested in prior studies.

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

Where this trial is running

Minneapolis, Minnesota

• University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)

Study contacts

• Principal investigator: Reza Talaie, MD — University of Minnesota
• Study coordinator: Research Coordinator

Conditions: Osteo Arthritis Knee, Arthritis, Osteoarthritis, Osteoarthritis, Knee, Embolotherapy