Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: Geniculate Artery Embolization

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandre Cengarle-Samak, MD; Phone Number: 514-252-3400; Email: alexandre.cengarle-samak@umontreal.ca
• Study Contact Backup: Name: Pascal Andre Vendittoli, MD; Phone Number: 514-252-3400; Email: pa.vendittoli@me.com

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1T 2M4
      • Recruiting
      • CIUSSS de l'Est-de-l'Île-de-Montréal, Installation Hopital Maisonneuve-Rosemont
      • Contact: Alexandre Cengarle-Samak, MD; Phone Number: 514-252-3400; Email: alexandre.cengarle-samak@umontreal.ca
      • Contact: Pascal Andre Vendittoli, MD; Phone Number: 514-252-3400; Email: pa.vendittoli@me.com
      • Principal Investigator: Alexandre Cengarle-Samak, MD
      • Sub-Investigator: Pascal Andre Vendittoli, MD
      • Sub-Investigator: Véronique Caty, MD
      • Sub-Investigator: Michel-Pierre Dufresne, MD
      • Sub-Investigator: Michel Dubé, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Geniculate Artery Embolization Arm; Single-arm prospective study of geniculate artery embolization for symptomatic knee osteoarthritis

Procedure: Geniculate Artery Embolization; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	12 months

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital
• Investigators: Principal Investigator: Alexandre Cengarle-Samak, MD, CIUSSS de l'Est-de-l'Île-de-Montréal

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Embolization, Osteoarthritis, Knee, Geniculate Artery
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Geniculate embolization.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No