Osteo Arthritis KneeGAEKONCT03835988
Geniculate Artery Embolization for Knee Osteoarthritis
A study testing Geniculate Artery Embolization in people with Osteo Arthritis Knee, run by University of Calgary at 1 site in Canada.
Trial summary
A prospective cohort study to study the effectiveness and safety profile of geniculate artery embolization for the treatment of symptomatic knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Geniculate Artery Embolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2019to 31 Dec 2021
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe knee pain (visual analog scale (VAS) > 50 mm), and
- Pain refractory for at least 3 months of conservative therapies (anti-inflammatory drugs, physical therapy, muscle strengthening or intra-articular injections), and
- Kellgren-Lawrence grade 1, 2 or 3 on knee radiograph, and
- MRI features of active synovitis (Synovial thickening and/or enhancement on MRI using pre-gadolinium sagittal T2-weighted/proton-density sequences and post-gadolinium T1 weighted imaging, respectively), and
- Willing, able and mentally competent to provide written informed consent (to ensure that all study subjects demonstrate an understanding of the risks of the procedure and participate in the informed consent), and
- Not eligible for surgical arthroplasty within 1 year of estimated procedure date
Who cannot join
- Major surgery within the past six weeks (excluding arthroscopic/meniscal interventions), or
- Ipsilateral knee intra-articular injection in the last 3 months, or
- Pregnant or attempting to become pregnant during study period, or
- Current local infection, or
- Life expectancy less than 6 months, or
- Known advanced atherosclerosis, or
Show all 16Show fewer
- Rheumatoid or seronegative arthropathies, or
- Infectious arthritis, or
- Prior knee surgery (excluding arthroscopic/meniscal interventions), or
- Uncorrectable coagulopathy including international normalized ratio (INR) > 1.5 or platelets < 50,000, or
- Iodinated contrast allergy resulting in anaphylaxis, or
- Inability to lay supine on an angiographic table >500 lbs due to table weight limits, or
- Renal dysfunction as defined as glomerular filtration rate < 30 mL/min/1.73m2 obtained within the past 30 days, or
- Patients with documented noncompliance with previous medical care, or
- Patients with certain psychiatric disorders such as schizophrenia, borderline personality disorder, uncontrolled depression, or mental/cognitive impairment that limits the individual's ability to understand the proposed therapy, or
- Absence of synovitis on MRI
Trial locations and contacts
1 site in 1 country.
About this study
A prospective cohort study to study the effectiveness and safety profile of geniculate artery embolization for the treatment of symptomatic knee osteoarthritis.
Read the detailed description
Purpose: The investigators aim to determine whether geniculate artery embolization is a safe treatment for symptomatic knee osteoarthritis and confirm published reports of sustained post-procedural pain relief, improved physical function and investigate potential improvements in joint function quantitatively through imaging and targeted assessments.
Participants:Twenty patients with moderate to severe knee pain, pain refractory for 3 months of conservative therapies, imaging features of symptomatic osteoarthritis and ineligible for arthroplasty for 1 year.
Procedures (methods): Patients will undergo a brief clinical evaluation to verify eligibility through inclusion and exclusion criteria in addition to a comprehensive joint pain treatment history will be recorded including active analgesic and anti-inflammatory use. A pre-procedural MRI will be completed to assess the extent of their osteoarthritis, signs of active synovitis and vascular anatomy of the knee. Evaluations post geniculate artery embolization will occur at 24 hours, 1, 6 and 12 months to assess for changes in knee pain and joint function and monitor adverse events. An MRI will be performed at the 6 month visit to detect changes in synovitis and exclude complications.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Geniculate Artery Embolization
- Keywords
- Embolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geniculate Artery EmbolizationDevice
Also called Embozene Embolic Particles, Embosphere Embolic Particles
Embolization is a procedure completed by an Interventional Radiologist in which abnormal blood vessels are blocked for treatment purposes. In the case of geniculate artery embolization, abnormal blood vessels which supply your knee joint are blocked in an effort to reduce inflammation and subsequently and reduce pain and improve joint function.
| Study group | Role | What they receive |
|---|---|---|
| Geniculate Artery Embolization | Experimental | Patients undergoing geniculate artery embolization. Patients will be assessed and followed post-procedurally to detect changes in knee pain and function. Medication use, adverse events and performance based tests of physical function will also be recorded. A pre-procedural MRI will be compared to a 6 month post-procedure MRI to assess for changes in synovitis and assess for complications. Receives: Device: Geniculate Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Pain (mm): visual analog scale
Severity of pain as assessed by visual analog scale. The visual analog scale is a 100 mm horizontal line with 0 mm correlating with "No Pain" and 100 mm with "Worst Possible Pain". Accompanying the verbal description is an illustrative guide correlating values to facial expressions. Patients mark their responses with a single vertical line. Results will be recorded prior to the procedure and afterwards at each follow-up visit to measure for changes in knee pain.
Measured: 1 year
Patient function (arbitrary units)
Knee injury and Osteoarthritis Outcome Score (KOOS) will be used to measure joint function. This is a questionnaire in which questions regarding pain, other symptoms, function in activities of daily living, function in sport and recreation and knee-related quality of life are answered to calculate subscale scores. Each subscale (symptoms, activities of daily living, sport and recreation, quality of life) is scored from 0 to 100 with 0 representing extreme symptoms and 100 indicating no symptoms). The questionnaire will be completed at follow-up evaluations to measure change in each subscale from baseline (prior to intervention). Investigators will analyze scores to determine if patient's subjective joint function changes.
Measured: 1 year
Secondary outcomes (3)
Medication use (arbitrary units)
Change in number or dosage of osteoarthritis medical therapy including oral, topical medications and joint injections will be recorded. Number will be defined as total number of medications used for knee osteoarthritis. Dosage will be defined as the frequency of administration multiplied by the dose of each administration (i.e. 200 mg, 3 times daily will be scored as 600 mg daily). Values will be recorded at each follow-up visit to measure change from baseline and summarized with simple statistics (i.e. percentage of patients with a decrease in medication use).
Measured: 1 year
Physical function (arbitrary units)
Change in physical function performance will be assessed with a 30 second chair stand test.
Measured: 1 year
Synovitis (arbitrary units)
A semiquantifiable synovitis scoring scale on contrast enhanced MRI will be used to assess change in synovitis as proposed by Guermazi et al. in 2011. Synovial thickness will be scored semiquantifiably from grade 0 to 2 at 11 anatomical locations. Grading is calculate by meausrement of maximal synovial thickness with 2 mm or less scored as grade 0, 2-4 mm as grade 1 and > 4 mm as grade 2. Grading at each location are summed to compute a total synovitis score with a minimum score of 0 representing no synovitis and a maximal score of 22 representing severe synovitis. Investigators will compare scores calculated at a 6 month contrast enhanced MRI to those obtained prior to intervention to assess for changes in synovitis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start1 Mar 2019
- Primary completion1 Apr 2021
- Study completion31 Dec 2021 (estimated)
Why it stopped: Covid department protocol prevented patient recruitment and affected funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ani Mirakhur, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835988
- Sponsor's protocol ID
- REB19-0007
- Acronym
- GAEKO
- Status last verified
- Apr 2021
- First submitted
- 31 Jan 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.
PubMed 14613558Guermazi A, Roemer FW, Hayashi D, Crema MD, Niu J, Zhang Y, Marra MD, Katur A, Lynch JA, El-Khoury GY, Baker K, Hughes LB, Nevitt MC, Felson DT. Assessment of synovitis with contrast-enhanced MRI using a whole-joint semiquantitative scoring system in people with, or at high risk of, knee osteoarthritis: the MOST study. Ann Rheum Dis. 2011 May;70(5):805-11. doi: 10.1136/ard.2010.139618. Epub 2010 Dec 27.
PubMed 21187293
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geniculate Artery Embolization for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03835988
- Acronym / sponsor ID
- GAEKO / REB19-0007
- Conditions
- Osteo Arthritis Knee
- Keywords
- Embolization
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid department protocol prevented patient recruitment and affected funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Feb 2019 (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.
A prospective cohort study to study the effectiveness and safety profile of geniculate artery embolization for the treatment of symptomatic knee osteoarthritis.
Detailed description
Purpose: The investigators aim to determine whether geniculate artery embolization is a safe treatment for symptomatic knee osteoarthritis and confirm published reports of sustained post-procedural pain relief, improved physical function and investigate potential improvements in joint function quantitatively through imaging and targeted assessments.
Participants:Twenty patients with moderate to severe knee pain, pain refractory for 3 months of conservative therapies, imaging features of symptomatic osteoarthritis and ineligible for arthroplasty for 1 year.
Procedures (methods): Patients will undergo a brief clinical evaluation to verify eligibility through inclusion and exclusion criteria in addition to a comprehensive joint pain treatment history will be recorded including active analgesic and anti-inflammatory use. A pre-procedural MRI will be completed to assess the extent of their osteoarthritis, signs of active synovitis and vascular anatomy of the knee. Evaluations post geniculate artery embolization will occur at 24 hours, 1, 6 and 12 months to assess for changes in knee pain and joint function and monitor adverse events. An MRI will be performed at the 6 month visit to detect changes in synovitis and exclude complications.
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 | Experimental | Device: Geniculate Artery EmbolizationPatients undergoing geniculate artery embolization. Patients will be assessed and followed post-procedurally to detect changes in knee pain and function. Medication use, adverse events and performance based tests of physical function will also be recorded. A pre-procedural MRI will be compared to a 6 month post-procedure MRI to assess for changes in synovitis and assess for complications. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Moderate to severe knee pain (visual analog scale (VAS) > 50 mm), and
- Pain refractory for at least 3 months of conservative therapies (anti-inflammatory drugs, physical therapy, muscle strengthening or intra-articular injections), and
- Kellgren-Lawrence grade 1, 2 or 3 on knee radiograph, and
- MRI features of active synovitis (Synovial thickening and/or enhancement on MRI using pre-gadolinium sagittal T2-weighted/proton-density sequences and post-gadolinium T1 weighted imaging, respectively), and
- Willing, able and mentally competent to provide written informed consent (to ensure that all study subjects demonstrate an understanding of the risks of the procedure and participate in the informed consent), and
Key exclusion criteria (16 listed)
- Major surgery within the past six weeks (excluding arthroscopic/meniscal interventions), or
- Ipsilateral knee intra-articular injection in the last 3 months, or
- Pregnant or attempting to become pregnant during study period, or
- Current local infection, or
- Life expectancy less than 6 months, or
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 EmbolizationAlso: Embozene Embolic Particles, Embosphere Embolic ParticlesEmbolization is a procedure completed by an Interventional Radiologist in which abnormal blood vessels are blocked for treatment purposes. In the case of geniculate artery embolization, abnormal blood vessels which supply your knee joint are blocked in an effort to reduce inflammation and subsequently and reduce pain and improve joint function. | Device | Geniculate Artery Embolization |
Primary outcome
Patient Pain (mm): visual analog scale
Time frame: 1 year
Severity of pain as assessed by visual analog scale. The visual analog scale is a 100 mm horizontal line with 0 mm correlating with "No Pain" and 100 mm with "Worst Possible Pain". Accompanying the verbal description is an illustrative guide correlating values to facial expressions. Patients mark their responses with a single vertical line. Results will be recorded prior to the procedure and afterwards at each follow-up visit to measure for changes in knee pain.
Patient function (arbitrary units)
Time frame: 1 year
Knee injury and Osteoarthritis Outcome Score (KOOS) will be used to measure joint function. This is a questionnaire in which questions regarding pain, other symptoms, function in activities of daily living, function in sport and recreation and knee-related quality of life are answered to calculate subscale scores. Each subscale (symptoms, activities of daily living, sport and recreation, quality of life) is scored from 0 to 100 with 0 representing extreme symptoms and 100 indicating no symptoms). The questionnaire will be completed at follow-up evaluations to measure change in each subscale from baseline (prior to intervention). Investigators will analyze scores to determine if patient's subjective joint function changes.
3 secondary outcomes
Medication use (arbitrary units)
Time frame: 1 year
Physical function (arbitrary units)
Time frame: 1 year
Synovitis (arbitrary units)
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 14613558Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.
- Background: PubMed 21187293Guermazi A, Roemer FW, Hayashi D, Crema MD, Niu J, Zhang Y, Marra MD, Katur A, Lynch JA, El-Khoury GY, Baker K, Hughes LB, Nevitt MC, Felson DT. Assessment of synovitis with contrast-enhanced MRI using a whole-joint semiquantitative scoring system in people with, or at high risk of, knee osteoarthritis: the MOST study. Ann Rheum Dis. 2011 May;70(5):805-11. doi: 10.1136/ard.2010.139618. Epub 2010 Dec 27.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteo Arthritis Knee, 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 6 inclusion and 16 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: withdrawn, as of the sponsor's last update on 28 Apr 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Pain (mm): visual analog scale (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03835988, which also lists 2 linked publications.
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 28 Apr 2021.