Status:
WITHDRAWN
Geniculate Artery Embolization for Knee Osteoarthritis
Lead Sponsor:
University of Calgary
Conditions:
Osteo Arthritis Knee
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
A prospective cohort study to study the effectiveness and safety profile of geniculate artery embolization for the treatment of symptomatic knee osteoarthritis.
Detailed Description
Purpose: The investigators aim to determine whether geniculate artery embolization is a safe treatment for symptomatic knee osteoarthritis and confirm published reports of sustained post-procedural pa...
Eligibility Criteria
Inclusion
- Moderate to severe knee pain (visual analog scale (VAS) \> 50 mm), and
- Pain refractory for at least 3 months of conservative therapies (anti-inflammatory drugs, physical therapy, muscle strengthening or intra-articular injections), and
- Kellgren-Lawrence grade 1, 2 or 3 on knee radiograph, and
- MRI features of active synovitis (Synovial thickening and/or enhancement on MRI using pre-gadolinium sagittal T2-weighted/proton-density sequences and post-gadolinium T1 weighted imaging, respectively), and
- Willing, able and mentally competent to provide written informed consent (to ensure that all study subjects demonstrate an understanding of the risks of the procedure and participate in the informed consent), and
- Not eligible for surgical arthroplasty within 1 year of estimated procedure date
Exclusion
- Major surgery within the past six weeks (excluding arthroscopic/meniscal interventions), or
- Ipsilateral knee intra-articular injection in the last 3 months, or
- Pregnant or attempting to become pregnant during study period, or
- Current local infection, or
- Life expectancy less than 6 months, or
- Known advanced atherosclerosis, or
- Rheumatoid or seronegative arthropathies, or
- Infectious arthritis, or
- Prior knee surgery (excluding arthroscopic/meniscal interventions), or
- Uncorrectable coagulopathy including international normalized ratio (INR) \> 1.5 or platelets \< 50,000, or
- Iodinated contrast allergy resulting in anaphylaxis, or
- Inability to lay supine on an angiographic table \>500 lbs due to table weight limits, or
- Renal dysfunction as defined as glomerular filtration rate \< 30 mL/min/1.73m2 obtained within the past 30 days, or
- Patients with documented noncompliance with previous medical care, or
- Patients with certain psychiatric disorders such as schizophrenia, borderline personality disorder, uncontrolled depression, or mental/cognitive impairment that limits the individual's ability to understand the proposed therapy, or
- Absence of synovitis on MRI
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03835988
Start Date
March 1 2019
End Date
December 31 2021
Last Update
April 28 2021
Active Locations (1)
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1
South Healthy Campus
Calgary, Alberta, Canada, T3M 1M4