NCT05386797

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

1.4 years

First QC Date

May 18, 2022

Last Update Submit

December 18, 2023

Conditions

Knee Osteoarthritis

Keywords

Embolization

Outcome Measures

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

    3 months

Secondary Outcomes (4)

  • Procedure related complications

    30 days

  • Pain Reduction

    1 month and 6 months

  • Pain, stiffness and physical function

    1, 3 and 6 months

  • Pain medication required

    1, 3, and 6 months

Study Arms (1)

Geniculate Artery Embolization arm

EXPERIMENTAL
Procedure: Geniculate Artery Embolization

Interventions

Geniculate Artery EmbolizationPROCEDURE

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.

Geniculate Artery Embolization arm

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Hospital

Calgary, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Jason Wong, MD

CONTACT

403-944-1132wongjk@ucalgary.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 23, 2022

Study Start

January 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

December 19, 2023

Record last verified: 2023-12

Locations

CA(1)