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

NCT06466330 | Recruiting DMC

• 1 other identifier: EPROGE
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 11

Brief 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

Keywords

total hip replacement; pain

Outcome Measures

Primary Outcomes (1)

• Evolution of the pain assessed by Pain item of the Knee injury and Osteoarthritis Outcome Score 12 (KOOS 12) at 3 months

  The effectiveness of embolization will be determined by pain assessment using the pain item of the Knee injury and Osteoarthritis Outcome Score 12 (KOOS 12) self-questionnaire (score 0-100). The evolution of this pain score between M0 and M3 will be calculated. KOOS 12 is a self-administered questionnaire that measures patients' perceptions of their knee health, symptoms and functionality. The KOOS-12 comprises 4 items relating to pain, 4 items relating to function (activities of daily living, sport and recreation) and 4 items relating to quality of life.

  before intervention and at month 3

Secondary Outcomes (8)

• Evolution of pain throughout the patient's follow-up period assessed by KOOS 12 pain score

  From before intervention to Month 12.

• Progression of patient's symptoms and functional limitations throughout the patient's follow-up period assessed by global KOOS score

  From before intervention to Month 12.

• Evolution of pain throughout the patient's follow-up period assessed by VAS (Visual Analog Score)

  From before intervention to Month 12.

• Evolution of Quality of Life throughout the patient's follow-up period, assessed by the AMIQUAL (Arthrose des Membres Inférieurs et QUAlité de vie) Score

  From before intervention to Month 12

• Analgesic and anti-inflammatory drugs consumption throughout the the patient's follow-up period

  From before intervention to Month 12

Study Arms (2)

Embolization

EXPERIMENTAL

The genicular artery embolisation procedure identifies abnormal blood vessels in the knee via angiography. Through groin access and puncture of the femoral artery through a microcatheter, microspheres (Embozene) will be injected into this area.

Device: microparticles; Procedure: embolization

Placebo

SHAM COMPARATOR

In the control (sham) arm patients will undergo angiography but there will be injection of saline.

Procedure: sham embolization

Interventions

microparticles DEVICE

inert microparticles

Embolization

embolization PROCEDURE

Injection of inert microparticles in neovessels using a microcatheter

Embolization

sham embolization PROCEDURE

injection of saline solution

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman aged between 40 and 80 years with a TKR for more than one year.
• TKR pain with a VAS ≥ 40 mm having progressed for at least 3 months despite the initiation of a well-conducted medical treatment including stage I and II analgesics and NSAIDs in the absence of contraindication.
• Investigations within 6 months to rule out malposition, loosening and sepsis (conventional X-rays, bone scan, knee CT scan and biological work-up for inflammatory syndrome).
• No revision surgery envisaged.
• Echodoppler hyperemia over the painful area of the knee.
• Subjects affiliated to social security.
• Signed consent to the study.

You may not qualify if:

• Local infection of the TKR or systemic infection.
• Algoneurodystrophy.
• Prosthesis loosening.
• Neuropathic pain.
• Allergy to contrast media.
• Fibromyalgia.
• Chronic or acute renal failure (clearance \< 30 ml/mn).
• Hemostasis disorders (platelet count \< 50,000/mm3 or patient activated partial thromboplastin time (aPTT)/control aPTT\>1.2 or prothrombin ratio \< 50%).
• Operative indication for removal of the prosthesis retained
• Patient with severe obliterative arteriopathy of the lower limbs (Leriche et Fontaine stage 3).
• Lidocaine contraindication: known hypersensitivity to lidocaine hydrochloride, amide-bonded local anesthetics or any of the excipients; patients with recurrent porphyria.
• Vulnerable persons (minors, patients under guardianship or curatorship, deprived of liberty, under court protection, etc.).
• Pregnant patients: for patients of childbearing age, a pregnancy test will be performed during the screening visit.

Sponsors & Collaborators

• Societe Francaise de Rhumatologie: lead
• Centre Hospitalier Universitaire de Nice: collaborator
• Euraxi Pharma: collaborator

Study Sites (11)

Centre Hospitalier Henri Mondor

Créteil, France

NOT YET RECRUITING

Centre Hospitalier Dijon

Dijon, France

RECRUITING

Centre Hospitalier Universitaire de Grenoble

Grenoble, France

RECRUITING

Centre Hospitalier Saint-Philibert

Lomme, France

NOT YET RECRUITING

Hôpital Saint Philibert

Lomme, France

NOT YET RECRUITING

CHU Marseille

Marseille, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Nice

Nice, France

RECRUITING

Centre Hospitalier de Nîmes

Nîmes, France

NOT YET RECRUITING

Hôpital Lariboisière

Paris, France

NOT YET RECRUITING

Hôpital Saint-Antoine

Paris, France

NOT YET RECRUITING

Hospices Civils de Strasbourg

Strasbourg, France

NOT YET RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Study Officials

• Christian Roux, Pr, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascale Thevenot

CONTACT

+33(0)1.42.50.00.18; recherche@rhumatologie.asso.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the interventional radiologist cannot be blinded, given the procedure (embolization with microparticles) . This means that the patient and the principal investigator at each center involved in the clinical evaluation of the patient will be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 20, 2024
• Study Start: March 10, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

FR (11)