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

University of Chicago5 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

the Terumo Hydropearl® microspheres deviceDEVICE

Genicular artery embolization (GAE) is a new, minimally invasive investigational not yet approved therapy. In previous studies, this procedure has provided pain relief in patients with mild to moderate OA in the short to midterm. We will be utilizing the Terumo Hydropearl® microspheres particle beads during the GAE procedures. The procedure will take place utilizing fluoroscopic and ultrasound guidance. Following catheterization of the femoral artery, angiography of the affected limb will be performed to define the genicular arterial anatomy. Genicular arteries demonstrating abnormal vascularity and corresponding to the site of the patient's pain will be catheterized and embolized using microspheres. Prior to and after embolization, parametric imaging will be performed utilizing proprietary software to quantify changes in blood flow to the target area The intended use of the Terumo Hydropearl® microspheres device is to embolize the geniculate artery branch.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Chicago Hospital

Chicago, Illinois, United States

Outcomes

Primary Outcomes

WOMAC Scale

The reduction of Bilateral or unilateral knee pain and dysfunction associated with mild to moderate osteoarthritis at 12 months as measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score

Time frame: 12 Months

KOOS Scale

The reduction of Bilateral or unilateral knee pain and dysfunction associated with mild to moderate osteoarthritis at 12 months as measured by the Knee Injury and Osteoarthritis Outcome (KOOS) score

Time frame: 12 Months

Oswestry Disability Index

The reduction of Bilateral or unilateral knee pain and dysfunction associated with mild to moderate osteoarthritis at 12 months as measured by the Oswestry Disability Index

Time frame: 12 Months

Secondary Outcomes

WOMAC for Knee Pain and Dysfunction

To assess reduction in knee pain and dysfunction at 3, 6, and 9-months for subjects undergoing the GAE procedure using the WOMAC scale

Time frame: 12 Months

KOOS for Knee Pain and Dysfunction

To assess reduction in knee pain and dysfunction at 3, 6, and 9-months for subjects undergoing the GAE procedure using the KOOS scale

Time frame: 12 Months

Oswestry Disability Index for Knee Pain and Dysfunction

To assess reduction in knee pain and dysfunction at 3, 6, and 9-months for subjects undergoing the GAE procedure using the Oswestry Disability Index

Time frame: 12 Months

VAS for Pain

To report the outcomes of Visual Analog Score (VAS) for pain at 0, 3, 6, 9, and 12 months post.

Data from ClinicalTrials.gov

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