Osteoarthritis, KneeNCT04113681
Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.
A study testing Geniculate Artery Embolization in people with Osteoarthritis, Knee, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
Geniculate Artery Embolization (GAE) has recently been described and studied as a palliative treatment for osteoarthrosis-related knee pain in patients un-eligible for surgical intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Geniculate Artery Embolization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 14 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Moderate to severe knee pain (visual analog scale (VAS) > 70 mm)
- Pain refractory to at least 6 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections)
- Localized pain on physical examination
- Kellgren-Lawrence (KL) Score on knee X-Ray
- Patients 50 years old and over : grade 1, 2, 3 or 4
- 18-50 years old: KL grade 3 or 4
Who cannot join
- Current local infection
- Life expectancy less than 6 months
- Known advanced atherosclerosis
- Rheumatoid or infectious arthritis
- Prior knee surgery
- Uncorrectable coagulopathy including international normalized ratio (INR) > 1.5 or platelets < 50,000
Show all 10Show fewer
- Iodine allergy
- Renal dysfunction as defined by GFR < 60ml/min obtained within the past 30 days.
- Diabetic patient
- Previous embolization of the geniculate arteries during the last year
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CIUSSS de l'Est-de-l'Île-de-Montréal, Installation Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Alexandre Cengarle-Samak, MD, 514-252-3400, alexandre.cengarle-samak@umontreal.ca
Pascal Andre Vendittoli, MD, 514-252-3400, pa.vendittoli@me.com
About this study
Geniculate Artery Embolization (GAE) has recently been described and studied as a palliative treatment for osteoarthrosis-related knee pain in patients un-eligible for surgical intervention. This treatment is based on the hypothesis that hypervascularization and associated increased nerve proliferation are possible sources of chronic pain following the morphological changes of osteoarthrosis. A large animal model has shown digital subtraction arteriography to be well correlated to both the histological findings of synovial inflammation and synovial contrast enhancement on magnetic resonance imaging. This embolization technique has also been applied to other regions of the musculoskeletal system including the elbow and the shoulder.
Read the detailed description
Primary Objective Confirm the efficacy and the effectiveness of geniculate artery embolization for pain control in knee osteoarthrosis.
Secondary Objective Evaluate the effectiveness of geniculate artery embolization for pain control in specific population: young patients between 18 and 50 years old with advanced osteoarthritis (KL grade 3 or 4) for whom an orthopedic surgeon has deemed a total knee arthroplasty is not an appropriate therapy, and whom have failed conservative management for at least 6 months.
Investigators propose a prospective pilot study on 40 patients with osteoarthrosis.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Geniculate Artery Embolization
- Keywords
- Embolization, Osteoarthritis, Knee, Geniculate Artery
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geniculate Artery EmbolizationProcedure or surgery
- Conscious sedation : midazolam and fentanyl
- Local anesthesia : Lidocaine 2% subcutaneous
- Retrograde or anterograde common femoral artery access - 4Fr introducer
- Sub-therapeutic anticoagulation (heparin 2000 IU IA)
- Lower extremity arteriography
- Selective and supra-selective catheterization of geniculate arteries supplying painful region of the knee
- If abnormal arterial blushes are demonstrated selective and supra-selective embolization will be performed with Embozene microspheres (100 microns to 200 microns) - cold saline or ice-packs sac to be applied to overlying skin if significant cutaneous arteries are demonstrated at angiography.
- Angiographic end-points: embolization of abnormal blush while preserving the parent vessel
- Arteriotomy closure (manual compression or closure device)
| Study group | Role | What they receive |
|---|---|---|
| Geniculate Artery Embolization Arm | Experimental | Single-arm prospective study of geniculate artery embolization for symptomatic knee osteoarthritis Receives: Procedure: Geniculate Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain control VAS
The pain intensity is assessed using VAS (horizontal line 100 mm in length). Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain".
- Expected mean VAS pre treatment: 7
- Expected mean VAS at 1, 3, 6 and 12 months: 3-4 (50% reduction)
Measured: 12 months
Secondary outcomes (2)
Function
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subcategories of pain (5 items), stiffness (2 items), and physical function (17 items). Individuals select the level of difficulty they have performing various tasks using a 5 points Likert scale (0=None, 1=Slightly, 3=Very, 4=Extremely). Results are scored with a total maximum score of 96. A higher score indicates more difficulty in each of the categories.
- Expected mean WOMAC score pre treatment: 50
- Expected mean WOMAC score at 1, 3, 6 and 12 months: 25 (50% reduction).
Measured: 12 months
Radiological examinations
- Knee x-ray examinations
- Knee MRI (if a complication is suspected clinically)
- Sustained response expected to be less likely with increased KL grade
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start14 Feb 2019
- Primary completion1 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, 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
- Model description
- Patients will be stratified into two groups: * Group 1: Patients between 18-50 years old with KL grade 3-4 * Group 2: Patients age 50 years old and over with KL grade 1-4
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Cengarle-Samak, Maisonneuve-Rosemont Hospital
- Investigators
- Alexandre Cengarle-Samak, MD, Principal investigator, CIUSSS de l'Est-de-l'Ile-de-Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113681
- Sponsor's protocol ID
- Geniculate embolization.
- Status last verified
- Mar 2021
- First submitted
- 1 Oct 2019
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Baardewijk LJ, Hoogeveen YL, van der Geest ICM, Schultze Kool LJ. Embolization of the Geniculate Arteries Is an Effective Treatment of Recurrent Hemarthrosis Following Total Knee Arthroplasty That Can Be Safely Repeated. J Arthroplasty. 2018 Apr;33(4):1177-1180.e1. doi: 10.1016/j.arth.2017.11.002. Epub 2017 Nov 24.
PubMed 29224993Bagla S, Rholl KS, van Breda A, Sterling KM, van Breda A. Geniculate artery embolization in the management of spontaneous recurrent hemarthrosis of the knee: case series. J Vasc Interv Radiol. 2013 Mar;24(3):439-42. doi: 10.1016/j.jvir.2012.11.011.
PubMed 23433418Okuno Y, Korchi AM, Shinjo T, Kato S, Kaneko T. Midterm Clinical Outcomes and MR Imaging Changes after Transcatheter Arterial Embolization as a Treatment for Mild to Moderate Radiographic Knee Osteoarthritis Resistant to Conservative Treatment. J Vasc Interv Radiol. 2017 Jul;28(7):995-1002. doi: 10.1016/j.jvir.2017.02.033. Epub 2017 Mar 30.
PubMed 28365171Okuno Y, Korchi AM, Shinjo T, Kato S. Transcatheter arterial embolization as a treatment for medial knee pain in patients with mild to moderate osteoarthritis. Cardiovasc Intervent Radiol. 2015 Apr;38(2):336-43. doi: 10.1007/s00270-014-0944-8. Epub 2014 Jul 4.
PubMed 24993956Iwamoto W, Okuno Y, Matsumura N, Kaneko T, Ikegami H. Transcatheter arterial embolization of abnormal vessels as a treatment for lateral epicondylitis refractory to conservative treatment: a pilot study with a 2-year follow-up. J Shoulder Elbow Surg. 2017 Aug;26(8):1335-1341. doi: 10.1016/j.jse.2017.03.026.
PubMed 28734535Okuno Y, Iwamoto W, Matsumura N, Oguro S, Yasumoto T, Kaneko T, Ikegami H. Clinical Outcomes of Transcatheter Arterial Embolization for Adhesive Capsulitis Resistant to Conservative Treatment. J Vasc Interv Radiol. 2017 Feb;28(2):161-167.e1. doi: 10.1016/j.jvir.2016.09.028. Epub 2016 Dec 19.
PubMed 28007330Okuno Y, Oguro S, Iwamoto W, Miyamoto T, Ikegami H, Matsumura N. Short-term results of transcatheter arterial embolization for abnormal neovessels in patients with adhesive capsulitis: a pilot study. J Shoulder Elbow Surg. 2014 Sep;23(9):e199-206. doi: 10.1016/j.jse.2013.12.014. Epub 2014 Mar 4.
PubMed 24618195
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.
- ClinicalTrials.gov ID
- NCT04113681
- Acronym / sponsor ID
- Geniculate embolization.
- Conditions
- Osteoarthritis, Knee
- Keywords
- Embolization, Osteoarthritis, Knee, Geniculate Artery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Oct 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.
Geniculate Artery Embolization (GAE) has recently been described and studied as a palliative treatment for osteoarthrosis-related knee pain in patients un-eligible for surgical intervention. This treatment is based on the hypothesis that hypervascularization and associated increased nerve proliferation are possible sources of chronic pain following the morphological changes of osteoarthrosis. A large animal model has shown digital subtraction arteriography to be well correlated to both the histological findings of synovial inflammation and synovial contrast enhancement on magnetic resonance imaging. This embolization technique has also been applied to other regions of the musculoskeletal system including the elbow and the shoulder.
Detailed description
Primary Objective Confirm the efficacy and the effectiveness of geniculate artery embolization for pain control in knee osteoarthrosis.
Secondary Objective Evaluate the effectiveness of geniculate artery embolization for pain control in specific population: young patients between 18 and 50 years old with advanced osteoarthritis (KL grade 3 or 4) for whom an orthopedic surgeon has deemed a total knee arthroplasty is not an appropriate therapy, and whom have failed conservative management for at least 6 months.
Investigators propose a prospective pilot study on 40 patients with osteoarthrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will be stratified into two groups: * Group 1: Patients between 18-50 years old with KL grade 3-4 * Group 2: Patients age 50 years old and over with KL grade 1-4
| Arm | Type | Receives |
|---|---|---|
| Geniculate Artery Embolization Arm | Experimental | Procedure: Geniculate Artery EmbolizationSingle-arm prospective study of geniculate artery embolization for symptomatic knee osteoarthritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years and older
- Moderate to severe knee pain (visual analog scale (VAS) > 70 mm)
- Pain refractory to at least 6 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections)
- Localized pain on physical examination
- Kellgren-Lawrence (KL) Score on knee X-Ray
Key exclusion criteria (10 listed)
- Current local infection
- Life expectancy less than 6 months
- Known advanced atherosclerosis
- Rheumatoid or infectious arthritis
- Prior 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 Embolization1. Conscious sedation : midazolam and fentanyl 2. Local anesthesia : Lidocaine 2% subcutaneous 3. Retrograde or anterograde common femoral artery access - 4Fr introducer 4. Sub-therapeutic anticoagulation (heparin 2000 IU IA) 5. Lower extremity arteriography 6. Selective and supra-selective catheterization of geniculate arteries supplying painful region of the knee 7. If abnormal arterial blushes are demonstrated selective and supra-selective embolization will be performed with Embozene microspheres (100 microns to 200 microns) - cold saline or ice-packs sac to be applied to overlying skin if significant cutaneous arteries are demonstrated at angiography. 8. Angiographic end-points: embolization of abnormal blush while preserving the parent vessel 9. Arteriotomy closure (manual compression or closure device) | Procedure or surgery | Geniculate Artery Embolization Arm |
Primary outcome
Pain control VAS
Time frame: 12 months
The pain intensity is assessed using VAS (horizontal line 100 mm in length). Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". * Expected mean VAS pre treatment: 7 * Expected mean VAS at 1, 3, 6 and 12 months: 3-4 (50% reduction)
2 secondary outcomes
Function
Time frame: 12 months
Radiological examinations
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Background: PubMed 29224993van Baardewijk LJ, Hoogeveen YL, van der Geest ICM, Schultze Kool LJ. Embolization of the Geniculate Arteries Is an Effective Treatment of Recurrent Hemarthrosis Following Total Knee Arthroplasty That Can Be Safely Repeated. J Arthroplasty. 2018 Apr;33(4):1177-1180.e1. doi: 10.1016/j.arth.2017.11.002. Epub 2017 Nov 24.
- Background: PubMed 23433418Bagla S, Rholl KS, van Breda A, Sterling KM, van Breda A. Geniculate artery embolization in the management of spontaneous recurrent hemarthrosis of the knee: case series. J Vasc Interv Radiol. 2013 Mar;24(3):439-42. doi: 10.1016/j.jvir.2012.11.011.
- Background: PubMed 28365171Okuno Y, Korchi AM, Shinjo T, Kato S, Kaneko T. Midterm Clinical Outcomes and MR Imaging Changes after Transcatheter Arterial Embolization as a Treatment for Mild to Moderate Radiographic Knee Osteoarthritis Resistant to Conservative Treatment. J Vasc Interv Radiol. 2017 Jul;28(7):995-1002. doi: 10.1016/j.jvir.2017.02.033. Epub 2017 Mar 30.
- Background: PubMed 24993956Okuno Y, Korchi AM, Shinjo T, Kato S. Transcatheter arterial embolization as a treatment for medial knee pain in patients with mild to moderate osteoarthritis. Cardiovasc Intervent Radiol. 2015 Apr;38(2):336-43. doi: 10.1007/s00270-014-0944-8. Epub 2014 Jul 4.
- Background: PubMed 28734535Iwamoto W, Okuno Y, Matsumura N, Kaneko T, Ikegami H. Transcatheter arterial embolization of abnormal vessels as a treatment for lateral epicondylitis refractory to conservative treatment: a pilot study with a 2-year follow-up. J Shoulder Elbow Surg. 2017 Aug;26(8):1335-1341. doi: 10.1016/j.jse.2017.03.026.
- Background: PubMed 28007330Okuno Y, Iwamoto W, Matsumura N, Oguro S, Yasumoto T, Kaneko T, Ikegami H. Clinical Outcomes of Transcatheter Arterial Embolization for Adhesive Capsulitis Resistant to Conservative Treatment. J Vasc Interv Radiol. 2017 Feb;28(2):161-167.e1. doi: 10.1016/j.jvir.2016.09.028. Epub 2016 Dec 19.
- Background: PubMed 24618195Okuno Y, Oguro S, Iwamoto W, Miyamoto T, Ikegami H, Matsumura N. Short-term results of transcatheter arterial embolization for abnormal neovessels in patients with adhesive capsulitis: a pilot study. J Shoulder Elbow Surg. 2014 Sep;23(9):e199-206. doi: 10.1016/j.jse.2013.12.014. Epub 2014 Mar 4.
- 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.
Alexandre Cengarle-Samak, MD principal investigator
CIUSSS de l'Est-de-l'Ile-de-Montreal
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 Osteoarthritis, Knee, run by Maisonneuve-Rosemont Hospital 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 7 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 8 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Cengarle-Samak, MD (514-252-3400, alexandre.cengarle-samak@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain control VAS (time frame: 12 months). 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 NCT04113681, which also lists 7 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 8 Mar 2021.