The main objective of the study was to demonstrate the non-inferiority of the efficacy of a single intra-articular injection of OSTENIL PLUS compared to that of a single intra-articular injection of the reference product SYNVISC-ONE in the treatment of symptomatic tibiofemoral osteoarthritis. The primary endpoint was the change in mean score on the WOMAC pain scales from D0 to D180.
After a period of washout-out for NSAIDs, the patients received a single intra-articular injection of OSTENIL PLUS or of SYNVISC-ONE in the most painful knee. The study involved a preselection visit at D-7 and five further visits: at D0 (baseline, evaluation before intra-articular injection), at D2 ± 2 days (injection), at D30 ± 15 days, at D90 ± 15 days and C5 at D180 ± 15 days. To enrol the patients as quickly as possible, 129 sites, i.e. general medical or rheumatology practices, were open. After verifying the inclusion and exclusion criteria, the evaluating investigators assigned a randomisation number based on the chronological order of inclusion of patients at their site. The patient was then sent to the injecting investigator so that he/she could give the injection of the product corresponding to the randomisation number.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
290
Injection into the joint cavity of the most painful knee
Injection into the joint cavity of the most painful knee
Change in WOMAC A
Change from baseline in the pain subscore (section A) of the WOMAC score
Time frame: Day 0 to Day 180
Lequesne algofunctional index
Index assessing the severity of osteoarthritis
Time frame: Day 0 to Day 180
WOMAC B
Stiffness subscore (section B) of the WOMAC score
Time frame: Day 0 to Day 180
WOMAC C
Function subscore (section C) of the WOMAC score
Time frame: Day 0 to Day 180
Patient's overall status score in relation to his/her knee osteoarthritis
Visual analogue scale assessed by the patient
Time frame: Day 0 to Day 180
Assessment of overall treatment efficacy by the patient
5-point scale (1 = very good; 2 = good; 3 = moderate; 4 = poor; 5 = very poor)
Time frame: Day 30 to Day 180
Assessment of overall treatment efficacy by the investigator
5-point scale (1 = very good; 2 = good; 3 = moderate; 4 = poor; 5 = very poor)
Time frame: Day 30 to Day 180
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