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RECRUITING
NCT06466330
NA

Efficacy of Microparticle Geniculate Artery Embolization in Total Knee Prosthesis Patients With Pain Resistant to Medical Treatment. A Prospective Randomized Controlled Trial

Sponsor: Societe Francaise de Rhumatologie

View on ClinicalTrials.gov

Summary

The goal of this clinical investigation is to evaluate the effectiveness on pain of arterial occlusion (embolization) of neovessels by microparticle in a double-blind sham controlled randomised trial in patients with persistent pain on a total knee prosthesis (TKP), inserted for gonarthrosis, despite well-conducted medical treatment. The study patient population will consist of up to 112 subjects with knee pain for at least 3 months that is resistant to conservative treatment measures. Subjects will be treated with knee embolisation or saline in the sham arm. The efficacy of embolization will be judged on the basis of the following criteria: improvement in pain, mobility, use of pain medication, adverse effects of embolization and duration of improvement. After verification of eligibility criteria, patients with painful total knee prosthesis will be randomized to either the embolization group or the control group. Embolization will be performed using microparticles (Embozene® Microspheres 100 microns from Varian), for the treatment group. For the "sham " group, only diagnostic arteriography will be performed without injection of microparticles. Subjects will be followed up at 1, 3, 6 and 12 months.

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2025-03-10

Completion Date

2027-02-28

Last Updated

2025-05-30

Healthy Volunteers

No

Interventions

DEVICE

microparticles

inert microparticles

PROCEDURE

embolization

Injection of inert microparticles in neovessels using a microcatheter

PROCEDURE

sham embolization

injection of saline solution

Locations (11)

Centre Hospitalier Henri Mondor

Créteil, France

Centre Hospitalier Dijon

Dijon, France

Centre Hospitalier Universitaire de Grenoble

Grenoble, France

Centre Hospitalier Saint-Philibert

Lomme, France

Hôpital Saint Philibert

Lomme, France

CHU Marseille

Marseille, France

Centre Hospitalier Universitaire de Nice

Nice, France

Centre Hospitalier de Nîmes

Nîmes, France

Hôpital Lariboisière

Paris, France

Hôpital Saint-Antoine

Paris, France

Hospices Civils de Strasbourg

Strasbourg, France