Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
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
Conditions
Interventions
microparticles
inert microparticles
embolization
Injection of inert microparticles in neovessels using a microcatheter
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