Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.
NCT ID: NCT04113681
Last Updated: 2021-03-08
Study Results
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Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2019-02-14
2021-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
* 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
TREATMENT
NONE
Study Groups
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Geniculate Artery Embolization Arm
Single-arm prospective study of geniculate artery embolization for symptomatic knee osteoarthritis
Geniculate Artery Embolization
1. 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)
Interventions
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Geniculate Artery Embolization
1. 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)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Maisonneuve-Rosemont Hospital
OTHER
Responsible Party
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Alexandre Cengarle-Samak
Interventional radiologist
Principal Investigators
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Alexandre Cengarle-Samak, MD
Role: PRINCIPAL_INVESTIGATOR
CIUSSS de l'Est-de-l'Ile-de-Montreal
Locations
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CIUSSS de l'Est-de-l'Île-de-Montréal, Installation Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Bagla 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.
Okuno 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.
Okuno 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.
Iwamoto 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.
Okuno 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.
Okuno 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.
Other Identifiers
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Geniculate embolization.
Identifier Type: -
Identifier Source: org_study_id
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