Genicular Artery Embolization to Reduce Pain Associated With Unilateral Mild to Moderate Osteoarthritis: A Pilot Study to Assess Feasibility
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Chicago
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- WOMAC Scale
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •We intend to include patients who meet the following criteria in the study:
- •Patients aged 40-80
- •Bilateral or Unilateral knee pain attributed to osteoarthritis
- •Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale
- •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:
- •Active malignancy
- •Active infection of the affected knee
- •Platelets <50,000
- •INR >1.8 (unless on anticoagulation that can be reversed)
- •Corticosteroid injection of the affected knee within 3 months
- •Rheumatoid arthritis or other seronegative arthropathy
- •Previous surgery (excluding arthroscopy) of the affected knee
- •Grade 4 per Kellgren-Lawrence Grading Scale of the affected knee
- •Pregnancy or expected pregnancy
- •Anaphylactic reaction to iodinated contrast
- •Moderate to severe pain in other lower limb joints
- •Body weight >400 lbs. (Procedure table weight limit)
- •Patients at high risk for contrast nephropathy
Arms & Interventions
GAE Arm
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.
Intervention: the Terumo Hydropearl® microspheres device (Device)
Outcomes
Primary Outcomes
WOMAC Scale
Time Frame: 12 Months
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
KOOS Scale
Time Frame: 12 Months
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
Oswestry Disability Index
Time Frame: 12 Months
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
Secondary Outcomes
- WOMAC for Knee Pain and Dysfunction(12 Months)
- KOOS for Knee Pain and Dysfunction(12 Months)
- Oswestry Disability Index for Knee Pain and Dysfunction(12 Months)
- Six-Minute Walk Test for Functional Improvement(12 months)
- Thirty-Second Chair Test for Performance(12 Months)
- VAS for Pain(12 Months)
- Opiate Usage(12 Months)