Knee OsteoarthritisNCT05386797
Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis
A study testing Geniculate Artery Embolization in people with Knee Osteoarthritis, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Geniculate Artery Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Known chronic renal failure or eGFR < 45
- ECOG grade > 2
- Patient weight > 300 lbs
- Patient unreliable for follow up
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Geniculate Artery Embolization
- Keywords
- Embolization
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geniculate Artery EmbolizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Geniculate Artery Embolization arm | Experimental | Not described Receives: Procedure: Geniculate Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (4)
Procedure related complications
To measure the incidence of minor and major procedure related adverse events
Measured: 30 days
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
Measured: 1 month and 6 months
Pain, stiffness and physical function
To measure the average improvement in the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after GAE
Measured: 1, 3 and 6 months
Pain medication required
- To measure proportion of patients achieving reduction in pain medication required, both in number and dose after GAE
Measured: 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Jan 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386797
- Sponsor's protocol ID
- REB21-0641
- Status last verified
- Dec 2023
- First submitted
- 18 May 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05386797
- Acronym / sponsor ID
- REB21-0641
- Conditions
- Knee Osteoarthritis
- Keywords
- Embolization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geniculate Artery Embolization arm | Experimental | Procedure: Geniculate Artery Embolization |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geniculate Artery EmbolizationThe 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. | Procedure or surgery | Geniculate Artery Embolization arm |
Primary outcome
Pain Reduction
Time frame: 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
4 secondary outcomes
Procedure related complications
Time frame: 30 days
Pain Reduction
Time frame: 1 month and 6 months
Pain, stiffness and physical function
Time frame: 1, 3 and 6 months
Pain medication required
Time frame: 1, 3, and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geniculate Artery Embolization in people with Knee Osteoarthritis, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason Wong, MD (403-944-1132, wongjk@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Reduction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.