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

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

The main objective of this prospective, open-label clinical trial is to assess the effectiveness and safety of intra-articular liposomal gel therapy for knee OA symptoms.

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.