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.
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.
Local infection of the TKR or systemic infection.
Algoneurodystrophy.
Prosthesis loosening.
Neuropathic pain.
Parallel
microparticles
Deviceinert microparticles
embolization
Procedure/SurgeryInjection of inert microparticles in neovessels using a microcatheter
sham embolization
Procedure/Surgeryinjection of saline solution
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.
Evolution of pain throughout the patient's follow-up period assessed by KOOS 12 pain score
The evolution of pain will be measured here by the KOOS 12 pain score, as in the main objective. The KOOS 12 pain score will be collected at Month 0, Month 1, Month 3, Month 6 and Month 12.
Progression of patient's symptoms and functional limitations throughout the patient's follow-up period assessed by global KOOS score
The patient's symptoms and functional limitations will be assessed using the global KOOS 12 score (score from 0 to 100). The global KOOS 12 score will be collected at Month 0, Month 1, Month 3, Month 6 and Month 12.
Evolution of pain throughout the patient's follow-up period assessed by VAS (Visual Analog Score)
Pain will be measured using a VAS (Visual Analog Scale). The VAS will be graduated from 0 to 100 mm, with 0 = no pain and 100 = maximum pain perceived in the 48 hours preceding the consultation, as recommended by the OARSI in osteoarthritis on pain assessment.The pain VAS will be collected at Month 0, Month 1, Month 3, Month 6 and 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
Quality of life (QoL) will be measured using the AMIQUAL score. This score is a quality-of-life instrument specific to hip and knee osteoarthritis, capable of capturing patients' perception of their disease.It comprises 5 domains: physical activity (19 items), mental health (14 items), social support (4 items), social functioning (3 items) and pain (3 items), plus 3 items relating to family, sexuality and work. Each item is scored from 1-10, with lower scores reflecting better quality of life. QoL will be collected during patient follow-up at Month 0, Month 3 and Month 12.
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Societe Francaise de Rhumatologie
Lead sponsor
Centre Hospitalier Universitaire de Nice
Collaborator
Euraxi Pharma
Collaborator
