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Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.

NCT04113681 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-03-08

No results posted yet for this study

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

Interventions

PROCEDURE

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)

Sponsors & Collaborators

  • Maisonneuve-Rosemont Hospital

    lead OTHER

Principal Investigators

  • Alexandre Cengarle-Samak, MD · CIUSSS de l'Est-de-l'Ile-de-Montreal

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-14
Primary Completion
2021-06-01
Completion
2021-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04113681 on ClinicalTrials.gov