Efficacy of OSTENIL PLUS (Hyaluronic Acid) Versus SYNVISC-ONE in Patients With Tibiofemoral Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Interventions
- Device: OSTENIL PLUSDevice: SYNVISC-ONE
- Registration Number
- NCT03203408
- Lead Sponsor
- TRB Chemedica
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 290
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OSTENIL PLUS OSTENIL PLUS A single intra-articular injection of sodium hyaluronate 40 mg/2.0 ml at Day 2, i.e. 2 days post Baseline (Day 0 = Week 0) SYNVISC-ONE SYNVISC-ONE A single intra-articular injection of hylan G-F 20 48 mg/6 ml at Day 2, i.e. 2 days post Baseline (Day 0 = Week 0)
- Primary Outcome Measures
Name Time Method Change in WOMAC A Day 0 to Day 180 Change from baseline in the pain subscore (section A) of the WOMAC score
- Secondary Outcome Measures
Name Time Method Lequesne algofunctional index Day 0 to Day 180 Index assessing the severity of osteoarthritis
WOMAC B Day 0 to Day 180 Stiffness subscore (section B) of the WOMAC score
Patient's overall status score in relation to his/her knee osteoarthritis Day 0 to Day 180 Visual analogue scale assessed by the patient
WOMAC C Day 0 to Day 180 Function subscore (section C) of the WOMAC score
Assessment of overall treatment efficacy by the patient Day 30 to Day 180 5-point scale (1 = very good; 2 = good; 3 = moderate; 4 = poor; 5 = very poor)
Assessment of overall treatment efficacy by the investigator Day 30 to Day 180 5-point scale (1 = very good; 2 = good; 3 = moderate; 4 = poor; 5 = very poor)