Efficacy of Microparticle Geniculate Artery Embolization in Total Knee Prosthesis Patients
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 med
| Condition(s) | Knee Pain Chronic, Knee Pain Swelling |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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. * Allerg |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Lead sponsor | Societe Francaise de Rhumatologie |
| Locations | Créteil, France; Dijon, France; Grenoble, France; Lomme, France; Lomme, France; Marseille, France (+5 more sites) |
| Start date | 2025-03-10 |
| NCT ID | NCT06466330 |
| Official listing | https://clinicaltrials.gov/study/NCT06466330 |