Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: Geniculate Artery Embolization

• Registration Number: NCT05386797
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-23
• Study Start: 2023-01-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-19
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Geniculate Artery Embolization arm	Geniculate Artery Embolization	-

Primary Outcome Measures

Name	Time	Method
Pain Reduction	3 months	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

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

Trial Locations

Locations (1)

Foothills Hospital; 🇨🇦 Calgary, Canada