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

Last updated: July 15, 2019
Sponsor: Coordinación de Investigación en Salud, Mexico
Overall Status: Active - Recruiting

Phase

3

Condition

Osteoarthritis

Knee Injuries

Treatment

N/A

Clinical Study ID

NCT04019782
R-2018-785-041
  • Ages 40-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 lupuserythematosus, 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; primaryosteochondromatosis; heritable disorders.

Study Design

Total Participants: 120
Study Start date:
August 01, 2019
Estimated Completion Date:
August 31, 2021

Study 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 months after treatment. Hypothesis to test is: If effectiveness of intra-articular collagen-PVP is not lower than hylan GF 20 treatment in knee osteoarthritis subjects, then, statistically significant difference would not exist in IKDC score mean increase among treatment groups, after six months.

Connect with a study center

  • Gabriel Horta Baas

    Merida, Yucatan 97000
    Mexico

    Active - Recruiting

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