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RecruitingNCT05386797Updated Dec 19, 2023

Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis

An interventional study of Geniculate Artery Embolization in Knee Osteoarthritis, sponsored by University of Calgary. Recruiting at 1 site in Canada. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-19.

Sponsored by University of Calgary · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Embolization
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 50 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Geniculate Artery Embolization arm

    Procedure: Geniculate Artery Embolization

Interventions

  • ProcedureGeniculate 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

Secondary outcomes

  1. Procedure related complications

    To measure the incidence of minor and major procedure related adverse events

    Time frame: 30 days

  2. 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

    Time frame: 1 month and 6 months

  3. Pain, stiffness and physical function

    To measure the average improvement in the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after GAE

    Time frame: 1, 3 and 6 months

  4. Pain medication required

    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

07

Study locations

1 of 1 sites recruiting
  • Foothills Hospital
    Calgary, Canada
    • Jason Wong, MD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05386797
Lead sponsor
University of Calgary
Responsible party
Sponsor
First posted
May 23, 2022
Start date
Jan 1, 2023
Primary completion
Jun 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Dec 19, 2023

Study contacts

Jason Wong, MD
Contact
wongjk@ucalgary.ca
403-944-1132

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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