Randomized Trial of Microparticle Geniculate Artery Embolization to Reduce Pain in Patients Aged 40 to 80 With Painful Total Knee Replacement Resistant to Medical Treatment

What this Trial Is About

This research aims to evaluate the effectiveness of arterial embolization using microparticles to reduce persistent pain in patients who have a total knee prosthesis due to gonarthrosis but continue to experience pain despite well-managed medical treatment. The trial includes up to 112 patients aged 40 to 80 years with knee pain lasting at least 3 months that is resistant to conservative treatments. The study compares the pain relief effects of embolization versus a sham procedure. Participants will be randomly assigned to one of two groups the treatment group receiving embolization with inert microparticles injected into abnormal blood vessels in the knee via angiography, and the control group undergoing only diagnostic arteriography with injection of saline. The embolization procedure uses microspheres of 100 microns delivered through a microcatheter inserted via the femoral artery. Follow-up visits are scheduled at 1, 3, 6, and 12 months after the procedure to monitor outcomes. During the study, participants will have their pain assessed using the Knee injury and Osteoarthritis Outcome Score 12 KOOS-12 pain item at baseline and at 3 months, which is the primary outcome measure. Additional evaluations include pain scores, symptoms, knee function, physical activity, quality of life, medication use, adverse effects, and economic impact over a 12-month period. Safety and treatment effects will be closely monitored throughout, with the total duration of participation lasting up to one year.

Efficacy of Microparticle Geniculate Artery Embolization in Total Knee Prosthesis Patients With Pain Resistant to Medical Treatment. A Prospective Randomized Controlled Trial