efficacy of ostenil plus (hyaluronic acid) versus synvisc-one in patients with tibiofemoral osteoarthritis

Conditions: Knee Osteoarthritis

Summary: 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.

Eligibility criteria:
inclusion criteria: * male or female aged 40-85 years; * primary knee osteoarthritis complying with the american college or rheumatology criteria; * radiographically defined osteoarthritis: joint space narrowing and osteophyte in x-ray taken less than one year previously and modified kellgren-lawrence grade ib-iii; * symptoms on one side only, with a mean womac a of ≥40 mm. if knee osteoarthritis is bilateral, a difference for that score between the contralateral knee and the selected knee should be of at least 20 mm; * pain present on at least 15 days in the month before inclusion; * failure or intolerance of first line analgesics and nsaids; * with health insurance; * understanding and following the study instructions; * signed the informed consent. exclusion criteria: * knee osteoarthritis that is not symptomatic or insufficiently symptomatic; * bilateral symptomatic knee osteoarthritis of the same severity on both sides; * post-traumatic secondary knee osteoarthritis; * knee osteoarthritis of radiographic grade i, ia or iv; * exclusively patellofemoral osteoarthritis where the symptoms are principally of patellofemoral origin (patellar syndrome); * symptomatic homolateral coxarthrosis; * varus or valgus deformation of the selected knee (deformation axis ≥15° in x-ray); * inflammatory rheumatism (rheumatoid arthritis, psoriatic rheumatism, articular chondrocalcinosis, gout, paget's disease, ankylosing spondylitis, lupus, etc.); * history of injury to the selected knee during the 6 months before inclusion; * venous or lymphatic stenosis of the lower limb; * femoral or sciatic nerve root pain of the lower limb to be tested; * tendinopathy (e.g. hip periarthritis); * treatment with intra-articular hyaluronic acid in the selected knee during the 6 months before inclusion; * intra-articular injection of corticosteroids in the selected knee during the 2 months before inclusion; * treatment with symptomatic slow-acting drugs for osteoarthritis and/or dietary supplements for osteoarthritis (chondroitin sulphate, diacerein, avocado and soybean unsaponifiables, oxaceprol, copper granions, glucosamine) which had been started less than 3 months previously or whose dose had been changed during the last 3 months before inclusion; * total knee replacement of the selected knee; * surgery of the other knee or of the hip or any other surgery scheduled during the period of the study; * history of any surgical intervention, arthroscopy, osteotomy, etc. in the year before inclusion; * obesity: body mass index ≥30 kg/m2; * history of autoimmune disease; * severe condition likely to interfere with the evaluation, such as neoplasia, malignant blood disease, kidney disease, liver disease or severe infection; * very marked hydrarthrosis (requiring puncture) at the time of inclusion; * wound or skin condition of the selected knee; * anticoagulant treatment with heparin or warfarin (platelet antiaggregants such as aspirin ≤325 mg/d, ticlopidine or clopidogrel were allowed); * known hypersensitivity to hyaluronic acid and/or to avian proteins and/or paracetamol; * known hypersensitivity to mannitol; * participation in a clinical research study within the previous 3 months; * pregnancy, breast-feeding.