CLINICAL TRIAL / NCT04592562

Genicular Artery Embolization to Reduce Pain Associated With Unilateral Mild to Moderate Osteoarthritis

Interventional
OPEN TO ACCRUAL
NCT04592562

Eligibility Details Visit Clinicaltrials.gov

Genicular Artery Embolization to Reduce Pain Associated With Unilateral Mild to Moderate Osteoarthritis: A Pilot Study to Assess Feasibility

The goal of this study is to perform a feasibility study to show the effectiveness of the genicular artery embolization procedure in reducing bilateral or unilateral osteoarthritic knee pain at 12 months as measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score, Knee Injury and Osteoarthritis Outcome (KOOS) score, and Oswestry Disability Index.

Detailed Description

This is a single-center, pilot study to assess the feasibility of a study show the effectiveness of the genicular artery embolization (GAE) in reducing arthritic pain and dysfunction associated with mild to moderate Bilateral or unilateral osteoarthritis of the knee. Patients with bilateral or unilateral Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale, will be offered enrollment to the study. Following a screening questionnaire, these patients will then be enrolled in this study. Baseline MRI will be obtained prior to the GAE procedure. Follow up intervals will include 3, 6, 9, and 12 months with the primary objective measured by a clinician as the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score, Knee Injury and Osteoarthritis Outcome (KOOS) score, and Oswestry Disability Index at the 12-month follow up visit. Patients will also undergo 1 year follow up MRI to be interpreted by a diagnostic radiologist with subspecialty training in musculoskeletal radiology. This radiologist will compare the treated knee to the baseline screening according to the WORMS classification (Whole Organ Magnetic Resonance Scoring) to assess for radiologic changes of osteoarthritis and any adverse effects.

Eligibility Details

Gender
All

Age Group
40 Years to 80 Years

Accepting Healthy Volunteers
No

Inclusion Criteria: We intend to include patients who meet the following criteria in the study: 1. Patients aged 40-80 2. Bilateral or Unilateral knee pain attributed to osteoarthritis 3. Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale 4. Knee pain \>6 months refractory to conservative medical management (NSAIDs, paracetamol, intra-articular injections, physiotherapy/exercise, weight loss, etc.) Exclusion Criteria: * We plan to exclude patients who meet any of the following criteria: 1. Active malignancy 2. Active infection of the affected knee 3. Platelets \<50,000 4. INR \>1.8 (unless on anticoagulation that can be reversed) 5. Corticosteroid injection of the affected knee within 3 months 6. Rheumatoid arthritis or other seronegative arthropathy 7. Previous surgery (excluding arthroscopy) of the affected knee 8. Grade 4 per Kellgren-Lawrence Grading Scale of the affected knee 9. Pregnancy or expected pregnancy 10. GFR \<30 11. Anaphylactic reaction to iodinated contrast 12. Moderate to severe pain in other lower limb joints 13. Body weight \>400 lbs. (Procedure table weight limit) 14. BMI \>50 15. Patients at high risk for contrast nephropathy