Collagen-PVP vs Hylan G-F 20 in the Treatment of Knee Osteoarthritis

• Status: Unknown status
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

Summary

Articular cartilage degradation is the main characteristic of osteoarthritis (OA), involving enzymatic and inflammatory mechanisms that change it into a chronic disease. Since articular cartilage shows limited regenerative ability, several intra-articular drugs have been developed in order to decrease inflammation and provide a better clinical outcome to the patient.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Coordinación de Investigación en Salud, Mexico
• Treatments: Hyaluronic Acid; Hylan; Povidone

Criteria

Inclusion Criteria:

• Aged between 40 and 80 years old

• Osteoarthritis in the knee rated II or III (Kellgren-Lawrence Grading Scale).

• Pain intensity (MOS Pain Severity Scale) greater than 40.

• Subject able to understand, co-operative and reliable.

• Written informed consent.

Exclusion Criteria:

• Acute arthritis in the knee.

• Ongoing anticoagulant therapy.

• Skin infection at the injection site.

• Systemic or intraarticular (target knee) corticosteroids in the past 3 months.

• Viscosupplementation (target knee) in the past year

• Arthroscopy/osteotomy/surgery in the past 5 months (target knee).

• Any surgery scheduled in the next 6 months

• Concomitant rheumatic disease (rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, fibromyalgia).

• Severe varus/valgus deformity (>15°).

• Frontal deformity greater than 20 degrees

• History of allergy or hypersensitivity to hyaluronic acid or avian proteins

• History/present evidence of: metabolic joint diseases; crystal arthropaties; ochronosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis; heritable disorders.