Autologous Plasma Rich in Growth Factors (PRGF) Treating the Symptomatic Knee OA
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|ClinicalTrials.gov Identifier: NCT00782197|
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : October 4, 2010
|Condition or disease||Intervention/treatment||Phase|
|Joint Disease||Device: PRGF Intraarticular injection Device: Hyaluronic Acid Intraarticular injection||Phase 4|
Several studies have shown the positive effects of the autologous "Preparation Rich in Growth Factors" (PRGF) in different clinical situations involving connective tissues and also in OA synovial cells. PRGF is a biological delivery system of a complex mixture of bioactive proteins essential to natural repair including anabolic factors for cartilage such as transforming growth factor-β1 (TGF-β1), platelet-derived growth factor (PDGF) and insulin-like growth factor (IGF-I). The potential of PRGF to enhance the limited capacity of cartilage to repair itself encouraged the idea of treating degenerative joint conditions with this autologous preparation.
The present study was undertaken to assess the efficacy and safety of the intra-articular injection of PRGF and to obtain useful information about the clinical effects. Since pain is the most pressing problem facing people with OA, a significant improvement in pain would indicate the potential of the proposed treatment. We will also evaluate functionality and quality of life. In addition we will examine changes in novel serum and synovial fluid biomarkers and their correlation with MRI-based parameters in a subgroup of patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy and Safety of the Infiltration of Autologous Plasma Rich in Growth Factors (PRGF) in the Symptomatic Treatment of Knee Osteoarthritis|
|Study Start Date :||January 2008|
Device: PRGF Intraarticular injection
Three consecutive PRGF injections each one week apart.
Active Comparator: 2
Device: Hyaluronic Acid Intraarticular injection
Three consecutive Hyaluronic acid (EUFLEXXA) injections, each one week apart.
- Improvement in Womac pain subscore and visual analogue score from baseline and changes in Lequesne's algofunctional index. [ Time Frame: 6 months ]
- Improvement of joint function (change in Womac OA index total score and function and stiffness subscores.) [ Time Frame: 6 months ]
- Changes in Quality of life (SF-12 questionnaire). [ Time Frame: 6 months ]
- Changes in Degree of joint mobility.(determined by goniometer). [ Time Frame: 6 months ]
- Complications and/or adverse effects. [ Time Frame: 6 months ]
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): NCT00782197
|UCA (Unidad de Cirugía Artroscopica Mikel Sanchez.) Clinica USP La Esperanza.|
|Vitoria, Alava, Spain|
|San Sebastian, Gipuzkoa, Spain|
|San Sebastian, Gipuzkoa, Spain|
|Principal Investigator:||Mikel Sanchez||UCA (Unidad de Cirugía Artroscópica Mikel Sanchez). USP Clínica la Esperanza. C/LA Esperanza 3, 01002 Vitoria (Alava)SPAIN.|
|Study Director:||Jaime Usabiaga||Hospital Donostia|
|Study Director:||Javier Albillos||Policlinica Gipuzkoa|