Osteoarthritis, Knee
Conditions
Brief summary
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®.
Interventions
DEVICESinovial® (syringe containing sodium hyaluronate solution)
2 mL 0.8% sodium hyaluronate (16 mg) solution. 3 intra-articular injections once-a-week.
DEVICESynvisc® ( syringe containing Hylan G-F 20 solution)
2 mL 0.8% Hylan G-F 20 (16 mg) solution. 3 intra-articular injections once-a-week.
Sponsors
IBSA Institut Biochimique SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in WOMAC pain subscore from baseline | to week 26 |
Secondary
| Measure | 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 |
Countries
Czechia, France, Germany, Italy, Slovakia, Switzerland
Outcome results
None listed