Efficacy of OSTENIL PLUS (Hyaluronic Acid) Versus SYNVISC-ONE in Patients With Tibiofemoral Osteoarthritis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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) |
Device: OSTENIL PLUS
Injection into the joint cavity of the most painful knee
|
| Active Comparator: 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) |
Device: SYNVISC-ONE
Injection into the joint cavity of the most painful knee
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- WOMAC C [Day 0 to Day 180]
Function subscore (section C) 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
- 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)
Other Outcome Measures
- Incidence of all adverse events [Day 0 to Day 180]
Recording of all adverse events and changes in concomitant treatments
- Incidence of local adverse reactions [Day 30]
Recording of adverse manifestations such as post-injection pain, inflammatory reaction, presence of hydrarthrosis, presence of acute pseudoseptic or septic arthritis
- Assessment of local treatment tolerability by the patient [Day 30]
5-point scale scale (1 = very good, 2 = good, 3= moderate, 4 = poor, 5 = very poor)
- Assessment of local treatment tolerability by the investigator [Day 30]
5-point scale scale (1 = very good, 2 = good, 3= moderate, 4 = poor, 5 = very poor)
- Assessment of overall treatment tolerability by the investigator [Day 30 to Day 180]
5-point scale (1 = very good; 2 = good; 3 = moderate; 4 = poor; 5 = very poor)
- Assessment of overall treatment tolerability by the patient [Day 30 to Day 180]
5-point scale (1 = very good; 2 = good; 3 = moderate; 4 = poor; 5 = very poor)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female aged 40-85 years;
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Primary knee osteoarthritis complying with the American College or Rheumatology criteria;
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Radiographically defined osteoarthritis: joint space narrowing and osteophyte in X-ray taken less than one year previously and modified Kellgren-Lawrence grade Ib-III;
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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;
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Pain present on at least 15 days in the month before inclusion;
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Failure or intolerance of first line analgesics and NSAIDs;
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With health insurance;
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Understanding and following the study instructions;
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Signed the informed consent.
Exclusion Criteria:
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Knee osteoarthritis that is not symptomatic or insufficiently symptomatic;
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Bilateral symptomatic knee osteoarthritis of the same severity on both sides;
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Post-traumatic secondary knee osteoarthritis;
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Knee osteoarthritis of radiographic grade I, Ia or IV;
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Exclusively patellofemoral osteoarthritis where the symptoms are principally of patellofemoral origin (Patellar syndrome);
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Symptomatic homolateral coxarthrosis;
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Varus or valgus deformation of the selected knee (deformation axis ≥15° in X-ray);
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Inflammatory rheumatism (rheumatoid arthritis, psoriatic rheumatism, articular chondrocalcinosis, gout, Paget's disease, ankylosing spondylitis, lupus, etc.);
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History of injury to the selected knee during the 6 months before inclusion;
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Venous or lymphatic stenosis of the lower limb;
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Femoral or sciatic nerve root pain of the lower limb to be tested;
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Tendinopathy (e.g. hip periarthritis);
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Treatment with intra-articular hyaluronic acid in the selected knee during the 6 months before inclusion;
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Intra-articular injection of corticosteroids in the selected knee during the 2 months before inclusion;
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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;
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Total knee replacement of the selected knee;
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Surgery of the other knee or of the hip or any other surgery scheduled during the period of the study;
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History of any surgical intervention, arthroscopy, osteotomy, etc. in the year before inclusion;
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Obesity: body mass index ≥30 kg/m2;
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History of autoimmune disease;
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Severe condition likely to interfere with the evaluation, such as neoplasia, malignant blood disease, kidney disease, liver disease or severe infection;
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Very marked hydrarthrosis (requiring puncture) at the time of inclusion;
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Wound or skin condition of the selected knee;
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Anticoagulant treatment with heparin or warfarin (platelet antiaggregants such as ASPIRIN ≤325 mg/d, ticlopidine or clopidogrel were allowed);
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Known hypersensitivity to hyaluronic acid and/or to avian proteins and/or paracetamol;
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Known hypersensitivity to mannitol;
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Participation in a clinical research study within the previous 3 months;
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Pregnancy, breast-feeding.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- TRB Chemedica
Investigators
- Study Chair: Renée Liliane Dreiser, Dr, APHP Bichat-Claude Bernard, Paris, France
- Study Chair: Bernard Avouac, Dr, APHP Henri Mondor, Creteil, France
- Principal Investigator: Thomas Bardin, Prof., APHP Lariboisière, Paris, France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OSTP-EUR-10-01
- 2011-A00258-33