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Effect Of Plasma Rich In Growth Factors In Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02039531
Recruitment Status : Completed
First Posted : January 17, 2014
Last Update Posted : May 5, 2015
Sponsor:
Collaborator:
Funds for independent clinical research by the spanish ministry of health
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias

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.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: Plasma rich in growth factors Drug: Hyaluronic Acid Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: THE APPLICATION OF PLASMA RICH IN GROWTH FACTORS FOR KNEE OSTEOARTHRITIS IMPROVES THE QUALITY OF LIFE AND FUNCTIONAL CAPACITY COMPARED WITH CONVENCIONAL TREATMENT WITH VISCOSUPLEMENTATION
Study Start Date : August 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Plasma rich in growth factors (PRGF)

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
Active Comparator: Hyaluronic acid (Durolane®)
Patients in this group will receive a single intra-articular injection at visit 1.
Drug: Hyaluronic Acid
Other Name: Durolane




Primary Outcome Measures :
  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. [ Time Frame: 6 months ]
    Measured by WOMAC and Lequesne reference scales score for osteoarthritis of the knee.


Secondary Outcome Measures :
  1. Effectiveness of the treatment with PRGF compared to treatment with hyaluronic acid after 12 months of follow-up. [ Time Frame: 12 months ]
    Measured by the reference tests WOMAC and Lequesne

  2. 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 [ Time Frame: 12 months of follow-up in the second phase ]
    Measured by the reference scales WOMAC and Lequesne scores

  3. Blood platelet quantification and its correlation with the effect [ Time Frame: 12 months (main stage) and 12 months (extension stage) ]
    To quantify PDGF platelet concentration in patients treated with PRGF and its correlation with the intraarticular effect regarding a single treatment cycle and the two cycles treatment.



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Ages Eligible for Study:   55 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039531


Locations
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Spain
Hospital Universitario Principe de Asturias
Alcala de Henares, Madrid, Spain, 28805
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
Funds for independent clinical research by the spanish ministry of health
Investigators
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Principal Investigator: Victor Vaquerizo, MD,PhD Hospital Universitario Principe de Asturias

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Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias
ClinicalTrials.gov Identifier: NCT02039531     History of Changes
Other Study ID Numbers: PI 05/2011
First Posted: January 17, 2014    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015

Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias:
Knee
osteoarthritis
plasma rich in growth factors
platelet rich plasma
hyaluronic acid

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Mitogens
Hyaluronic Acid
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents