Recruiting

Geniculate Artery Embolization

Sponsor:

Maisonneuve-Rosemont Hospital

Code:

NCT04113681

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Geniculate Artery Embolization

Study Details

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

Study ID

NCT04113681

Start date

Feb 14, 2019

Status verified date

Mar, 2021

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Jun 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Geniculate Artery Embolization Arm

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

Interventions

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)

Primary outcome measure

  • Pain control VAS [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Alexandre Cengarle-Samak, MD

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

Pascal Andre Vendittoli, MD

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

Locations

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

Recruiting

Montréal, Quebec, Canada, H1T 2M4

Contacts

Alexandre Cengarle-Samak, MD

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

Pascal Andre Vendittoli, MD

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

Principal Investigator:

Alexandre Cengarle-Samak, MD

More Information

Sponsor

Maisonneuve-Rosemont Hospital

Last update posted

Mar 8, 2021

Last verified

Mar, 2021

Keywords

  • Embolization, Osteoarthritis, Knee, Geniculate Artery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maisonneuve-Rosemont Hospital on 2021-03-08.