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The purpose of this study is to evaluate the efficacy and safety of PRGF infiltrations in the treatment of knee osteoarthritis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | PRGF |
|
| 2 | Active Comparator | Hyaluronic Acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRGF Intraarticular injection | Device | Three consecutive PRGF injections each one week apart. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Womac pain subscore and visual analogue score from baseline and changes in Lequesne's algofunctional index. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of joint function (change in Womac OA index total score and function and stiffness subscores.) | 6 months | |
| Changes in Quality of life (SF-12 questionnaire). | 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mikel Sanchez | UCA (Unidad de CirugÃa Artroscópica Mikel Sanchez). USP ClÃnica la Esperanza. C/LA Esperanza 3, 01002 Vitoria (Alava)SPAIN. | Principal Investigator |
| Jaime Usabiaga | Hospital Donostia | Study Director |
| Javier Albillos | Policlinica Gipuzkoa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCA (Unidad de CirugÃa Artroscopica Mikel Sanchez.) Clinica USP La Esperanza. | Vitoria-Gasteiz | Alava | Spain | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
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| Hyaluronic Acid Intraarticular injection |
| Device |
Three consecutive Hyaluronic acid (EUFLEXXA) injections, each one week apart. |
|
| Changes in Degree of joint mobility.(determined by goniometer). |
| 6 months |
| Complications and/or adverse effects. | 6 months |
| Hospital Donostia. |
| Donostia / San Sebastian |
| Gipuzkoa |
| Spain |
| Policlinica Gipuzkoa | Donostia / San Sebastian | Gipuzkoa | Spain |