Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Geniculate Artery Embolization
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Embolization
Eligibility Criteria
Inclusion Criteria:
- VAS score of at least 50 mm for knee pain
- Pain resistant to at least 3 months of conservative therapy (including medical therapy, physiotherapy, intra-articular cortisone or viscosupplement injection).
- Age > 40 years
- Radiographs demonstrating knee osteoarthritis on same side as pain
- Patient not a surgical candidate or declines surgical management
Exclusion Criteria:
- Radiographically severe knee osteoarthritis (Kellgren-Lawrence grade >2)
- Severe non-knee related lower limb pain with VAS > 50 mm.
- Local infection and inflammatory arthritis.
- Malignancy
- Previous knee surgery
- Bleeding risk - known hematologic disease increasing risk of bleeding, pre-procedure INR > 1.4, pre-procedure PTT > 40 seconds or pre-procedure platelets < 50,000/uL
- Known chronic renal failure or eGFR < 45
- ECOG grade > 2
- Patient weight > 300 lbs
- Patient unreliable for follow up
Sites / Locations
- Foothills HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Geniculate Artery Embolization arm
Arm Description
Outcomes
Primary Outcome Measures
Pain Reduction
To measure the proportion of patients achieving at least 50% pain reduction by the visual analogue pain score (VAS) after GAE for the treatment of pain due to knee osteoarthritis
Secondary Outcome Measures
Procedure related complications
To measure the incidence of minor and major procedure related adverse events
Pain Reduction
To measure the proportion of patients achieving at least 50% pain reduction by the visual analogue pain score (VAS) after GAE for the treatment of pain due to knee osteoarthritis
Pain, stiffness and physical function
To measure the average improvement in the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after GAE
Pain medication required
5. To measure proportion of patients achieving reduction in pain medication required, both in number and dose after GAE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05386797
Brief Title
Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis
Official Title
Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Osteoarthritis (OA) is a highly prevalent degenerative joint disease that contributes to chronic pain and disability in approximately 10% of people over the age of 55. With 25% of Canadians expected to be aged 55 or older by 2036, an increasing number of Canadians will be impacted by knee OA. In affected individuals the risk of medical co-morbidities is increased which can lead to adverse cardiovascular outcomes, depression, and poorer quality of life. Current conservative therapy includes oral analgesia, lifestyle modification, corticosteroid injection, and viscosupplementation. These current conservative measures have variable responses. In patients who would prefer to avoid surgery or are not surgical candidates safe and consistently effective treatment options are lacking.
Geniculate artery embolization (GAE) is a minimally invasive alternative with low risk of complications that has shown promise in exploratory studies. GAE provides benefit by disrupting angiogenesis in the knee which can contribute to chronic inflammation of the affected joint, and helps prevent the growth of new sensory nerve fibers which can reduce the pain associated with osteoarthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Embolization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Geniculate Artery Embolization arm
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Geniculate Artery Embolization
Intervention Description
The GAE procedure involves the use of an embolization agent to block blood flow to specific areas of the knee. Under sedo-analgesia, access to the target vessels is gained through the femoral or radial artery. GAE is performed with angiography to visualize blood vessels to assess the affected knee joint and ensure successful treatment.
Primary Outcome Measure Information:
Title
Pain Reduction
Description
To measure the proportion of patients achieving at least 50% pain reduction by the visual analogue pain score (VAS) after GAE for the treatment of pain due to knee osteoarthritis
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Procedure related complications
Description
To measure the incidence of minor and major procedure related adverse events
Time Frame
30 days
Title
Pain Reduction
Description
To measure the proportion of patients achieving at least 50% pain reduction by the visual analogue pain score (VAS) after GAE for the treatment of pain due to knee osteoarthritis
Time Frame
1 month and 6 months
Title
Pain, stiffness and physical function
Description
To measure the average improvement in the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after GAE
Time Frame
1, 3 and 6 months
Title
Pain medication required
Description
5. To measure proportion of patients achieving reduction in pain medication required, both in number and dose after GAE
Time Frame
1, 3, and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
VAS score of at least 50 mm for knee pain
Pain resistant to at least 3 months of conservative therapy (including medical therapy, physiotherapy, intra-articular cortisone or viscosupplement injection).
Age > 40 years
Radiographs demonstrating knee osteoarthritis on same side as pain
Patient not a surgical candidate or declines surgical management
Exclusion Criteria:
Radiographically severe knee osteoarthritis (Kellgren-Lawrence grade >2)
Severe non-knee related lower limb pain with VAS > 50 mm.
Local infection and inflammatory arthritis.
Malignancy
Previous knee surgery
Bleeding risk - known hematologic disease increasing risk of bleeding, pre-procedure INR > 1.4, pre-procedure PTT > 40 seconds or pre-procedure platelets < 50,000/uL
Known chronic renal failure or eGFR < 45
ECOG grade > 2
Patient weight > 300 lbs
Patient unreliable for follow up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Wong, MD
Phone
403-944-1132
Email
wongjk@ucalgary.ca
Facility Information:
Facility Name
Foothills Hospital
City
Calgary
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Wong, MD
12. IPD Sharing Statement
Learn more about this trial
Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis
We'll reach out to this number within 24 hrs