Efficacy of Microparticle Geniculate Artery Embolization in Total Knee Prosthesis Patients With Pain Resistant to Medical Treatment. A Prospective Randomized Controlled Trial
NCT Number: NCT06466330
Acronym: EPROGE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knee Pain Chronic|Knee Pain Swelling
Interventions: DEVICE: microparticles|PROCEDURE: embolization|PROCEDURE: sham embolization
Sponsor: Societe Francaise de Rhumatologie
Collaborators: Centre Hospitalier Universitaire de Nice|Euraxi Pharma
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 112
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09-15
Completion Date: 2026-09-30
Locations: Centre Hospitalier Henri Mondor, Créteil, France|Centre Hospitalier Dijon, Dijon, France|Centre Hospitalier Universitaire de Grenoble, Grenoble, France|CHU Marseille, Marseille, France|Centre Hospitalier Universitaire de Nice, Nice, France|Hôpital Lariboisière, Paris, France|Hôpital Saint-Antoine, Paris, France|Hospices Civils de Strasbourg, Strasbourg, France

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.

Primary Outcome Measures: 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 Outcome Measures: 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., 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, 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., From before intervention to 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., 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, 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., From before intervention to Month 12|Analgesic and anti-inflammatory drugs consumption throughout the the patient's follow-up period, This consumption will be evaluated by the number of days with anti-inflammatory drugs and the number of days with analgesics during the follow-up from Month 0 to Month 6. This information will be collected by the patient in a notebook provided specifically for this purpose. Patients will simply be asked to record the days on which they took anti-inflammatory drugs and analgesics in relation to their knee pain., From before intervention to Month 12|Incidence of Serious Adverse Events (safety) throughout the study, Adverse events will be recorded throughout the sudy. Safety will be assessed by incidence of Serious Adverse Events., From consent signature to Month12|Medico-economic impact assessed by the incremental cost-effectiveness ratio throughout the study, The medico-economic impact is assessed by the incremental cost-effectiveness ratio in terms of cost per patient with at least a 50% reduction in the KOOS 12 pain score throughout the study., From before intervention to Month 12|Medico-economic impact assessed by the incremental cost-utility ratio throughout the study, The medico-economic impact is assessed by the incremental cost-utility ratio in terms of cost per quality-adjusted life year (QALY) gained. The EQ-5D-5L (EuroQol questionnaire 5-Dimensions-5 Levels) comprises a descriptive system and a visual analog scale (VAS). The descriptive system comprises 5 items representing 5 dimensions (mobility, autonomy, daily activities, pain/grief and anxiety/depression) with five levels of health status (no problems, mild problems, moderate problems, severe problems and extreme problems/incapacity). For each of the 5 dimensions, the patient's response is converted into a number between 1 and 5. The 5 numbers obtained are then combined to produce a five-digit score describing the patient's state of health, which is then converted into a utility value (For France : utility value of between -0.53 (health worse than death) and 1 (best possible health). The VAS records the respondent's self-assessed state of health (scale 0 to 100), From before intervention to Month 12