Efficacy of Microparticle Geniculate Artery Embolization in Total Knee Prosthesis Patients With Pain Resistant to Medical Treatment. A Prospective Randomized Controlled Trial
embolization: Injection of inert microparticles in neovessels using a microcatheter
sham embolization: injection of saline solution
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.
Eligibility
Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Evolution of the pain assessed by Pain item of the Knee injury and Osteoarthritis Outcome Score 12 (KOOS 12) at 3 months — before intervention and at month 3 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.
Trial sites (11)
Facility
City
Region
Status
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
More Societe Francaise de Rhumatologie trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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