Status:
COMPLETED
Symptomatic Efficacy of Microparticle Arterial Embolization in Knee Osteoarthritis Resistant to Medical Treatment
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
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...
Detailed Description
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 neoinnervatio...
Eligibility Criteria
Inclusion
- An effective contraceptive system for women of childbearing age, a pregnancy test will be offered to these women in the preoperative assessment.
- Obtaining the signature of the consent to participate in the study
- Kellgren-Lawrence (KL) grade 2-3 assessed by routine weight-bearing knee radiographs on the most affected knee in bilateral cases
- Pain with EVA ≥ 50 mm evolving for at least 3 months despite the start of a well-conducted medical treatment according to current recommendations including analgesics, NSAID, intra-articular injections, rehabilitation and weight loss
- No surgical indication retained
Exclusion
- Serious visceral failure
- Local infection
- Arthropathy secondary to chronic inflammatory rheumatism (rheumatoid arthritis, spondylarthritis) or microcrystalline rheumatism
- History of surgery on the studied knee, except arthroscopy for more than 6 months
- Gonarthrosis with KL score\> 3
- Osteonecrosis of one of the bones of the knee joint on the MRI
- Pregnant or lactating woman
- Allergy to contrast products
- Chronic or acute renal failure (clearance \<30 ml / min)
- Haemostasis disorders (blood platelet count \<50,000 / mm3 or patient ACT / control ACT\> 1,2 or PT \<50%)
- Operative indication of placement of a prosthesis
Key Trial Info
Start Date :
October 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03460665
Start Date
October 4 2018
End Date
January 29 2025
Last Update
February 24 2025
Active Locations (3)
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1
chu Bordeaux
Bordeaux, France
2
BREUIL
Nice, France, 06000
3
Chu de Nimes
Nîmes, France