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

The University of Chicago

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Device: the Terumo Hydropearl® microspheres device

Study type: Interventional

Funder types: Other

Identifiers

NCT04592562

IRB20-0868

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

GAE Arm

Experimental group

Description:

Patients who meet study eligibility will be scheduled to undergo the Genicular Artery Embolization procedure and will subsequent be followed for 12 months after their procedure.

Treatment:

Device: the Terumo Hydropearl® microspheres device