Efficacy of OSTENIL PLUS (Hyaluronic Acid) Versus SYNVISC-ONE in Patients With Tibiofemoral Osteoarthritis

This is an interventional treatment trial for Knee Osteoarthritis Read More

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.