Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.

NCT04113681 | Unknown

• 1 other identifier: Geniculate embolization.
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Embolization, Osteoarthritis, Knee, Geniculate Artery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Function

  12 months

• Radiological examinations

  12 months

Study Arms (1)

Geniculate Artery Embolization Arm

EXPERIMENTAL

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

Procedure: Geniculate Artery Embolization

Interventions

Geniculate Artery Embolization PROCEDURE

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)

Geniculate Artery Embolization Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years old: KL grade 3 or 4

You may not qualify if:

• 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

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

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

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Related Publications (7)

• 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.

  PMID: 29224993 BACKGROUND

• 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.

  PMID: 23433418 BACKGROUND

• 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.

  PMID: 28365171 BACKGROUND

• 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.

  PMID: 24993956 BACKGROUND

• 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.

  PMID: 28734535 BACKGROUND

• 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.

  PMID: 28007330 BACKGROUND

• 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.

  PMID: 24618195 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Alexandre Cengarle-Samak, MD

  CIUSSS de l'Est-de-l'Ile-de-Montreal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Cengarle-Samak, MD

CONTACT

514-252-3400; alexandre.cengarle-samak@umontreal.ca

Pascal Andre Vendittoli, MD

CONTACT

514-252-3400; pa.vendittoli@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional radiologist

Model Details: 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

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: February 14, 2019
• Primary Completion: June 1, 2021
• Study Completion: December 31, 2021
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)