Knee Osteoarthritis Clinical Trial
Official title:
Symptomatic Efficacy of Microparticle Arterial Embolization in Knee Osteoarthritis Resistant to Medical Treatment: Randomized Prospective Study Versus Placebo
The aim of this double-blind, randomized, single-center prospective study (patient and evaluator) is to evaluate the efficacy of arterial occlusion (embolization) of neovessels by microparticle versus placebo on pain in disabling knee osteoarthritis at 12 months.
Rational: in the normal state, the articular cartilage is devoid of vessels and innervation.
In osteoarthritic cartilage, neovascularization is observed and is accompanied by a sensitive
neoinnervation. The development of these neovessels also contributes to the structural damage
of cartilage by achieving a real "perforation"of the cartilage. Studies designate
neovascularization as a target for new therapeutic. In two non-comparative open-label
studies, a Japanese team has shown that endovascular occlusion of these neovessels in
patients with knee osteoarthritis significantly reduced the patient pain without any
complication.
The aim of this double-blind, randomized, single-center prospective study (patient and
evaluator) is to evaluate the efficacy of arterial occlusion (embolization) of neovessels by
microparticle versus placebo on pain in disabling knee osteoarthritis at 12 months.
The main objective is to evaluate the effectiveness of embolization on the pain of patients
with disabling osteoarthritis by double-blind comparison of two groups: the first control
group will include patients who will benefit from arteriography and an injection of saline in
their neovessels, the second group called treatment will consist of patients whose neovessels
will be occluded by inert microparticles of 75 µm. The pain will be evaluated in both groups
before and 12 months after embolisation. The objective is to show that the pain is
significantly less important in the group of patients whose neovessels have been occluded
with microparticles in comparison to the control group.
Secondary objectives are to evaluate the effectiveness of neovascular embolization on pain at
1, 6, 24 and 36 months; knee stiffness, physical activity, quality of life, at 1, 6, 12, 24
and 36 months; the structural course of knee osteoarthritis at 12, 24 and 36 months; the use
of arthroplasty at 24 and 36 months.
Study Population: Patients aged 40 to 80 years with knee osteoarthritis with a visual
analogue scale (VAS) score greater than or equal to 50 mm for at least 3 months optimal
medical treatment, whose radiological stage of osteoarthritis according to Kellgren and
Lawence is 2 or 3 and does not have a knee prosthesis surgical indication.
Primary endpoint: modification of the pain item of the self-administered Knee injury and
Osteoarthritis Outcome Score (KOOS) collected in the 15 days preceding the procedure and at
12 months.
Secondary evaluation criteria are KOOS, EQ-5D (Quality of Life Scale) in the 15 days
preceding the procedure and then at 1, 6, 24 and 36 months; knee radiographs, number of
patients who had 12, 24 and 36 months of joint replacement surgery; knee MRI at 12 months;
the use of analgesics and anti-inflammatories; adverse events.
Expected benefits: confirm the results of the non-randomized studies that showed a clear
decrease in pain related to knee osteoarthritis after occlusion of neovessels, allowing the
reduction of antalgic drug consumption, improving the quality of life of patients of this
pathology, delay the need for prosthetic surgery.
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