Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Geniculate Artery Embolization

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jason Wong, MD; Phone Number: 403-944-1132; Email: wongjk@ucalgary.ca

Study Locations

• Canada
  • Calgary, Canada
    • Recruiting
    • Foothills Hospital
    • Contact: Jason Wong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. VAS score of at least 50 mm for knee pain
2. Pain resistant to at least 3 months of conservative therapy (including medical therapy, physiotherapy, intra-articular cortisone or viscosupplement injection).
3. Age > 40 years
4. Radiographs demonstrating knee osteoarthritis on same side as pain
5. Patient not a surgical candidate or declines surgical management

Exclusion Criteria:

1. Radiographically severe knee osteoarthritis (Kellgren-Lawrence grade >2)
2. Severe non-knee related lower limb pain with VAS > 50 mm.
3. Local infection and inflammatory arthritis.
4. Malignancy
5. Previous knee surgery
6. 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
7. Known chronic renal failure or eGFR < 45
8. ECOG grade > 2
9. Patient weight > 300 lbs
10. Patient unreliable for follow up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Geniculate Artery Embolization arm	Procedure: Geniculate Artery Embolization; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure related complications	To measure the incidence of minor and major procedure related adverse events	30 days
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	1 month and 6 months
Pain, stiffness and physical function	To measure the average improvement in the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after GAE	1, 3 and 6 months
Pain medication required	5. To measure proportion of patients achieving reduction in pain medication required, both in number and dose after GAE	1, 3, and 6 months

Collaborators and Investigators

• Sponsor: University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Embolization
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: REB21-0641

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No