The Efficacy and Safety of Intraarticular Sodium Hyaluronate (Hyalgan) After Proximal Tibial Osteotomy in Treatment of Knee Osteoarthritis Patients

Launched by TRB CHEMEDICA · Dec 27, 2010

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients between 35 and 65 years with primary knee OA with malalignment
• • 2. Mild to moderate OA of grade II or III severity on the Kellgren-Lawrence scale with require treatment by osteotomy
• • 3. Malalignment is not exceed 15 degree (+,-)
• • 4. Pain on walking (15 m) ≥ 40 mm.
• • 5. Range of motion \> 90 degree
• • 6. Evidence of adequate contraceptive methods in women of childbearing age
• Exclusion Criteria:
• • 1. Previous surgery on affected knee
• • 2. Previous intraarticular intervention within the last 3 months (eg. Steroid, anaesthetic, Sodium hyaluronate)
• • 3. Oral SYSADOA treatment (chondroitin, glucosamine, diacerein) within 2 months prior to study start
• • 4. Known or suspected infection of the affected joint
• • 5. Painful knee condition due to another cause than chondral lesions, such as Sudeck's atrophy, intraarticular neoplasm, pigmented villonodular synovitis, chondromatosis
• • 6. Poor general health or other conditions which would make regular hospital attendance difficult
• • 7. Ascertained hypersensitivity to any component used in the study (eg. Hyaluronic acid, diclofenac, morphine, omeprazole and paracetamol)
• • 8. Hypersensitivity to avian protein
• • 9. Ongoing or previous participation in a clinical study within the last 3 months