Effect Of Plasma Rich In Growth Factors In Knee Osteoarthritis

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

HYPOTHESIS:

The application of plasma rich in growth factors (PRGF) will improve the quality of life and functional capacity of patients diagnosed with knee osteoarthritis, providing better functional results than conventional treatment with viscosupplementation.

OPERATING ASSUMPTIONS

Following the initial administration of three doses of PRGF interspersed every 15 days, applied via intraarticular, patients will present an improvement in functional test (WOMAC and Lequesne scales) of 15% or more after 6 and 12 months compared to the control group with patients treated with hyaluronic acid.

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

Details

• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
• Collaborator: Funds for independent clinical research by the spanish ministry of health
• Treatments: Hyaluronic Acid; Mitogens

Criteria

Inclusion Criteria:

• Age above 55.

• Moderate to severe symptoms according to the WOMAC pain score of more than 6 months of evolution.

• Grade II - III knee osteoarthritis radiographic criteria for the classification of Kellgren and Lawrence.

• BMI Index below 35 which is considered Morbid Obesity according to WHO.

• Absence of treatments for osteoarthritis in the last 6 months.

Exclusion Criteria:

• Patients who have previously received medical treatment through viscosupplementation in the last 6 months.

• Patients who have allergies to some of the components of DUROLANE ® either hyaluronic acid itself or any of its excipients.

• Patients with severe angular changes and joint instability.

• Patients on anticoagulants or antiplatelet treatment that may not temporarily reversed for infiltrations.

• Polyarticular disease

• Infectious Diseases

• Tumor processes on treatment or medical care.

• Immunosuppressive therapy or immunosuppressive processes.

• Inability to understand the health questionnaires and / or adequately complete.