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

NCT06466330 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2025-05-30

No results posted yet for this study

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.

Conditions

  • Knee Pain Chronic
  • Knee Pain Swelling

Interventions

DEVICE

microparticles

inert microparticles

PROCEDURE

embolization

Injection of inert microparticles in neovessels using a microcatheter

PROCEDURE

sham embolization

injection of saline solution

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    collaborator OTHER

  • Euraxi Pharma

    collaborator INDUSTRY

  • Societe Francaise de Rhumatologie

    lead OTHER

Principal Investigators

  • Christian Roux, Pr, MD · Centre Hospitalier Universitaire de Nice

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2026-02-28
Completion
2027-02-28

Countries

  • France

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 NCT06466330 on ClinicalTrials.gov