Efficacy of Microparticle Geniculate Artery Embolization in Total Knee Prosthesis Patients With Pain Resistant to Medical Treatment. A Prospective Randomized Controlled Trial
Societe Francaise de Rhumatologie
112 participants
Mar 10, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria13
- 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.
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Interventions
inert microparticles
Injection of inert microparticles in neovessels using a microcatheter
injection of saline solution
Locations(11)
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NCT06466330