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Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Geniculate Artery Embolization
Sponsored by
Maisonneuve-Rosemont Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Embolization, Osteoarthritis, Knee, Geniculate Artery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CIUSSS de l'Est-de-l'Île-de-Montréal, Installation Hopital Maisonneuve-RosemontRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Geniculate Artery Embolization Arm

Arm Description

Single-arm prospective study of geniculate artery embolization for symptomatic knee osteoarthritis

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).
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

Full Information

First Posted
October 1, 2019
Last Updated
March 5, 2021
Sponsor
Maisonneuve-Rosemont Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04113681
Brief Title
Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.
Official Title
Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maisonneuve-Rosemont Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Embolization, Osteoarthritis, Knee, Geniculate Artery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Geniculate Artery Embolization Arm
Arm Type
Experimental
Arm Description
Single-arm prospective study of geniculate artery embolization for symptomatic knee osteoarthritis
Intervention Type
Procedure
Intervention Name(s)
Geniculate Artery Embolization
Intervention Description
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)
Primary Outcome Measure Information:
Title
Pain control VAS
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Function
Description
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).
Time Frame
12 months
Title
Radiological examinations
Description
Knee x-ray examinations Knee MRI (if a complication is suspected clinically) Sustained response expected to be less likely with increased KL grade
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Cengarle-Samak, MD
Phone
514-252-3400
Email
alexandre.cengarle-samak@umontreal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Pascal Andre Vendittoli, MD
Phone
514-252-3400
Email
pa.vendittoli@me.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Cengarle-Samak, MD
Organizational Affiliation
CIUSSS de l'Est-de-l'Ile-de-Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
CIUSSS de l'Est-de-l'Île-de-Montréal, Installation Hopital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Cengarle-Samak, MD
Phone
514-252-3400
Email
alexandre.cengarle-samak@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Pascal Andre Vendittoli, MD
Phone
514-252-3400
Email
pa.vendittoli@me.com
First Name & Middle Initial & Last Name & Degree
Alexandre Cengarle-Samak, MD
First Name & Middle Initial & Last Name & Degree
Pascal Andre Vendittoli, MD
First Name & Middle Initial & Last Name & Degree
Véronique Caty, MD
First Name & Middle Initial & Last Name & Degree
Michel-Pierre Dufresne, MD
First Name & Middle Initial & Last Name & Degree
Michel Dubé, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29224993
Citation
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.
Results Reference
background
PubMed Identifier
23433418
Citation
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.
Results Reference
background
PubMed Identifier
28365171
Citation
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.
Results Reference
background
PubMed Identifier
24993956
Citation
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.
Results Reference
background
PubMed Identifier
28734535
Citation
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.
Results Reference
background
PubMed Identifier
28007330
Citation
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.
Results Reference
background
PubMed Identifier
24618195
Citation
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.
Results Reference
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Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.

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