Efficacy Study of Intra-articular Hyaluronic Acid in the Knee Osteoarthritis

Study Overview
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Brief Summary
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The purpose of this study is to prove the non-inferiority of the intra-articular injection of hyaluronic acid (Sinovial®) in the symptomatic treatment of knee OA in comparison to Synvisc®.

Official Title
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Efficacy Evaluation of Intra-articular Hyaluronic Acid (Sinovial®) vs Synvisc® in the Treatment of Symptomatic Knee Osteoarthritis. A Double-blind, Controlled, Randomised, Parallel-group Non-inferiority Study

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Sinovial® (syringe containing sodium hyaluronate solution)
* Device: Synvisc® ( syringe containing Hylan G-F 20 solution)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 40 and 80 years Primary knee OA of the medial or lateral femoro-tibial compartment Symptoms for at least 3 months Diagnosis according to ACR criteria Kellgren & Lawrence radiological grade 2-3 Patients who failed to respond sufficiently (not responders) to analgesics and/or NSAIDs taken regularly or responders intolerant to the regular use of analgesics and/or NSAIDs. Mean WOMAC pain subscore at the target knee >= 40 mm and < 80 mm on a VAS at baseline after wash-out from analgesics/NSAIDs· If bilateral knee OA: definition of the most symptomatic joint at screening based on patient's evaluation and Investigator's clinical judgment and mean WOMAC pain subscore at baseline in the contra-lateral knee < 30 mm Written informed consent Subject able to understand, co-operative and reliable Exclusion Criteria: BMI >= 32 kg/m2 Secondary (post-traumatic) knee OA Predominantly patello-femoral pain/syndrome No remaining joint space width Symptomatic hip OA or other interfering health condition Severe varus/valgus deformity (>15°) History/present evidence of (target knee): inflammatory, infective or metabolic joint diseases; recurrent clinical chondrocalcinosis; crystal arthropaties; osteo-articular pathologies differing from arthrosis; articular fracture; ochronosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis; heritable disorders; collagen gene mutations. Concomitant rheumatic disease Significant injury to the target knee in the last 6 months Previous joint replacement/arthroplasty (target knee) Arthroscopy/osteotomy/surgery in the past 1 year (target knee) Any surgery scheduled in the next 6 months Venous or lymphatic stasis in the relevant limb Skin infection/disease/trauma at the injection site Systemic or i.a. (target knee) corticosteroids in the past 3 months I.a. corticosteroids (non-target joint) in the past 4 weeks Viscosupplementation (target knee) in the past year Recently started (in the last 3 months) physical therapy (target knee) Recently (in the last 3 months) started therapy or change in dosage of SYSADOAs Ongoing anticoagulant therapy Chronic or recurrent use of NSAIDs/analgesics/narcotics because of diseases different from OA of the target knee History of allergy or hypersensitivity to hyaluronic acid or paracetamol or avian proteins Participation in a clinical study in the last 3 months Pregnant or lactating women, and women of childbearing potential not willing to use adequate contraception Patients unable to stay in the study for 6 months, non-cooperating, not able to understand

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sinovial<br>3 intra-articular injections of Sinovial® | Device: Sinovial® (syringe containing sodium hyaluronate solution)<br>* 2 mL 0.8% sodium hyaluronate (16 mg) solution. 3 intra-articular injections once-a-week.<br>* Other names: Sinovial®: Class III medical device(CE mark n° 0499);|
| Active Comparator: Sinvisc<br> | Device: Synvisc® ( syringe containing Hylan G-F 20 solution)<br>* 2 mL 0.8% Hylan G-F 20 (16 mg) solution. 3 intra-articular injections once-a-week.<br>* Other names: Synvisc®: class III medical device (CE mark n° 0088);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in WOMAC pain subscore from baseline |  | to week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in WOMAC OA Index total score and pain, function and stiffness subscores;Change in Lequesne's algofunctional index; Change in global pain (visit assessment); Change in global status by the patient;Change in global status by the Investigator;SPID% |  | 26 weeks |