Actively Recruiting
Efficacy of Microparticle Geniculate Artery Embolization in Total Knee Prosthesis Patients With Pain Resistant to Medical Treatment. A Prospective Randomized Controlled Trial
Led by Societe Francaise de Rhumatologie · Updated on 2025-05-30
112
Participants Needed
11
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Societe Francaise de Rhumatologie
Lead Sponsor
C
Centre Hospitalier Universitaire de Nice
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Efficacy of Microparticle Geniculate Artery Embolization in Total Knee Prosthesis Patients With Pain Resistant to Medical Treatment. A Prospective Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 40 to 80 years with a total knee replacement for more than one year
- Knee pain with a visual analog scale (VAS) score of 40 mm or higher lasting at least 3 months despite proper medical treatment including analgesics and NSAIDs
- Recent imaging and tests within 6 months ruling out prosthesis malposition, loosening, or infection
- No planned revision surgery
- Evidence of increased blood flow (hyperemia) over the painful knee area by echodoppler
- Affiliated with social security
- Signed informed consent to participate in the study
You will not qualify if you...
- Local or systemic infection related to the knee prosthesis
- Algoneurodystrophy
- Prosthesis loosening
- Neuropathic pain
- Allergy to contrast media
- Fibromyalgia
- Chronic or acute kidney failure with clearance less than 30 ml/min
- Blood clotting disorders (platelet count less than 50,000/mm3 or abnormal coagulation tests)
- Planned surgery to remove the prosthesis
- Severe peripheral artery disease of the lower limbs (stage 3 Leriche and Fontaine)
- Contraindication to lidocaine or related local anesthetics
- Vulnerable persons such as minors, those under guardianship, deprived of liberty, or under court protection
- Pregnant women; pregnancy test required for women of childbearing age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants undergo angiography with either injection of inert microparticles to occlude abnormal knee blood vessels or a saline injection as a sham procedure.
1 visit (in-person)
Duration - 12 months
Participants are followed for 12 months to assess pain, function, quality of life, medication use, safety, and economic impact after the procedure.
Follow-up visits at 3, 6, and 12 months
Trial Site Locations
Total: 11 locations
1
Centre Hospitalier Henri Mondor
Créteil, France
Not Yet Recruiting
2
Centre Hospitalier Dijon
Dijon, France
Actively Recruiting
3
Centre Hospitalier Universitaire de Grenoble
Grenoble, France
Actively Recruiting
4
Centre Hospitalier Saint-Philibert
Lomme, France
Not Yet Recruiting
5
Hôpital Saint Philibert
Lomme, France
Not Yet Recruiting
6
CHU Marseille
Marseille, France
Not Yet Recruiting
7
Centre Hospitalier Universitaire de Nice
Nice, France
Actively Recruiting
8
Centre Hospitalier de Nîmes
Nîmes, France
Not Yet Recruiting
9
Hôpital Lariboisière
Paris, France
Not Yet Recruiting
10
Hôpital Saint-Antoine
Paris, France
Not Yet Recruiting
11
Hospices Civils de Strasbourg
Strasbourg, France
Not Yet Recruiting
Research Team
P
Pascale Thevenot
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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