The purpose of this study is to assess whether a single injection hyaluronic acid (HA) product is not inferior to a 3 injection HA product at 24 weeks (6 months), in terms of effectiveness in reducing pain when walking in patients suffering from symptomatic tibiofemoral osteoarthritis of the knee.
non-inferiority study of two HA products commercially availalble
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
290
DUROLANE Hyaluronic acid 20mg/ml
HYALGAN Hyaluronic acid 10mg/ml
Cabinet Médical
Argeles, France
Centre Hospitalier de Belfort-Montbeliard
Belfort, France
Cabinet Médical
Billère, France
Patients assessment of WOMAC A1 pain when walking
Time frame: 24 weeks
Patients assessment of WOMAC A pain
Time frame: 24 weeks
Patients assessment of WOMAC C function
Time frame: 24 weeks
Patient global assessment
Time frame: 24 weeks
OMERACT-OARSI responder rate
Time frame: 24 weeks
Patient Acceptable Symptom State (PASS)
Time frame: 24 weeks
Minimal Clinically Important Improvement (MCII)
Time frame: 24 weeks
Adverse events observed or spontaneously reported by patients for each treatment
Time frame: 24 weeks
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Hopital de Meulan-les-Mureaux
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