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Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis

NCT ID: NCT05386797

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-06-30

Brief Summary

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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

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Conditions

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Knee Osteoarthritis

Keywords

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Embolization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Geniculate Artery Embolization arm

Group Type EXPERIMENTAL

Geniculate Artery Embolization

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Foothills Hospital

Calgary, , Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jason Wong, MD

Role: CONTACT

Phone: 403-944-1132

Email: [email protected]

Facility Contacts

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Jason Wong, MD

Role: primary

Other Identifiers

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REB21-0641

Identifier Type: -

Identifier Source: org_study_id