Effect Of Plasma Rich In Growth Factors In Knee Osteoarthritis

NCT02039531 | Completed Phase 3

• 1 other identifier: PI 05/2011
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

Knee; osteoarthritis; plasma rich in growth factors; platelet rich plasma; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• Effectiveness after 6 months of treatment with PRGF with an improvement in the reference tests of more than 15% compared to treatment with hyaluronic acid.

  Measured by WOMAC and Lequesne reference scales score for osteoarthritis of the knee.

  6 months

Secondary Outcomes (3)

• Effectiveness of the treatment with PRGF compared to treatment with hyaluronic acid after 12 months of follow-up.

  12 months

• Effectiveness of the two-cycles-treatment-based with PRGF in the second phase compared to one-cycle-treatment-based in the first phase after 12 months of the second phase

  12 months of follow-up in the second phase

• Blood platelet quantification and its correlation with the effect

  12 months (main stage) and 12 months (extension stage)

Study Arms (2)

Plasma rich in growth factors (PRGF)

EXPERIMENTAL

Patients in this group will receive one cycle of three intra-articular injections of PRGF every 15 days. Procedure for the application of the treatment: 1\. Study Group or PRGF group * Blood sample : * Taken minimum after 4 hours of fasting and drinking only water in order to maintain low levels of glucose. * 20 cc of peripheral blood will be taken by sterile systems with Sodium Citrate buffer to avoid hemolysis. * Spinning of the sample: * 8 minutes at 1800 rpm . * getting the blood fraction containing the PRGF * activation of PRGF with 50 ul of 10% CaCl2 per ml of plasma. * the application of PRGF should not exceed 90 minutes after the blood sample extraction in order to avoid risk of contamination.

Biological: Plasma rich in growth factors

Hyaluronic acid (Durolane®)

ACTIVE COMPARATOR

Patients in this group will receive a single intra-articular injection at visit 1.

Drug: Hyaluronic Acid

Interventions

Plasma rich in growth factors BIOLOGICAL

Plasma rich in growth factors (PRGF)

Hyaluronic Acid DRUG

Also known as: Durolane

Hyaluronic acid (Durolane®)

Eligibility Criteria

• Age: 55 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias: lead
• Funds for independent clinical research by the spanish ministry of health: collaborator

Study Sites (1)

Hospital Universitario Principe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Intercellular Signaling Peptides and Proteins; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Victor Vaquerizo, MD,PhD

  Hospital Universitario Principe de Asturias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2013
• First Posted: January 17, 2014
• Study Start: August 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: January 1, 2015
• Last Updated: May 5, 2015

Record last verified: 2015-05

Locations

ES (1)