Genicular Artery Embolization to Reduce Pain Associated With Unilateral Mild to Moderate Osteoarthritis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Knee Osteoarthritis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Patients who meet study eligibility will undergo the novel Genicular artery embolization procedure by a licensed Interventional Radiologist at the University of Chicago Medical Center.Masking: None (Open Label)Primary Purpose: Device Feasibility
Participation Requirements
- Age
- Between 40 years and 80 years
- Gender
- Both males and females
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 unila...
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.
Tracking Information
- NCT #
- NCT04592562
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Osmanuddin Ahmed, MD University of Chicago
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