Status:
UNKNOWN
Collagen-PVP vs Hylan G-F 20 in the Treatment of Knee Osteoarthritis
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Conditions:
Knee Osteoarthritis
Gonarthrosis
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief 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 show...
Detailed Description
This study aims to compare effectiveness of the treatment with intra-articular administration of collagen-PVP versus hylan GF 20, using the International Knee Documentation Committee (IKDC) score, 6 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04019782
Start Date
August 1 2019
End Date
August 31 2021
Last Update
July 17 2019
Active Locations (1)
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1
Gabriel Horta Baas
Mérida, Yucatán, Mexico, 97000