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
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.
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
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
- 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.
- 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
- 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
- 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.
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
|Hospital Universitario Principe de Asturias|
|Alcala de Henares, Madrid, Spain, 28805|
|Principal Investigator:||Victor Vaquerizo, MD,PhD||Hospital Universitario Principe de Asturias|