Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05386797
• Other study ID #: REB21-0641
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: University of Calgary
• Contact: Jason Wong, MD
• Phone: 403-944-1132
• Email: wongjk[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Canada	Foothills Hospital	Calgary

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Procedure related complications	To measure the incidence of minor and major procedure related adverse events	30 days
Secondary	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
Secondary	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
Secondary	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