Safety and Efficacy of Viscosupplementation of Hyaluronic Acid With Addition of Lecithin in Patients With Mild or Moderate Osteoarthrosis of the Knee Joint.

Launched by BIOVICO SP. Z O.O. · May 23, 2024

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Eligibility criteria

• Inclusion Criteria:
• • Age between 38 and 70 years,
• • OA diagnosed by the American College of Rheumatology (ACR) criteria,
• • OA diagnosed by radiographic imaging (grade II - III according to the Kellgren-Lawrence scale),
• • Pain in the knee joint for at least 3 months,
• • Screening pain intensity in the target knee measured on VAS scale was required to be 4 for symptomatic knee and 2 for the contralateral knee.
• Exclusion Criteria:
• • Previous injections of hyaluronic acid or platelet-rich plasma within 6 months or corticosteroid injections within 3 months before the enrollment,
• • Present joint infection,
• • Previous knee arthroscopy up to 1 year prior to examination,
• • Peripheral inflammatory and autoimmune diseases that progress with joint involvement (rheumatoid arthritis, spondyloarthropathies, systemic lupus erythematosus etc.),
• • Total arthroplasty and osteotomy,
• • Ankylosis of the study joint,
• • Dermatitis or dermatological disease at the intended injection site,
• • Known hypersensitivity to the components of the preparation,
• • Coexistence of the degenerative changes in other limb joints (hip, foot),
• • Cancer,
• • Oral corticosteroid therapy,
• • Use of medicines that affect blood clotting (heparins, oral anticoagulants, thrombolytic drugs),
• • Pregnancy or breast-feeding.
• • History of injury to the knee, a broken bone or dislocation of a joint, other musculoskeletal diseases that affect the study joint, neoplastic disease.
• • Participation in other clinical trials.