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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001303-36 | EudraCT Number |
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Platelet-rich plasma (PRP), due to its high content of cytokines, bioactive proteins and platelet growth factors, may contribute to diminish the pain of arthritic knee. It was also recently recognized a regenerative cell potential improving the concentration of hyaluronic acid and stabilizing angiogenesis in arthritic knees
This study therefore seeks to assess the analgesic power of PRP in osteoarthritic knees intraarticularly infiltrated, and which patients would benefit most from treatment, eliminating false expectations in the rest.
This is the first clinical trial developed following the report of the Spanish Competent Authority on May 23, 2013, considering the PRP as a medicinal product for human use and establishing minimum guarantees required of the product and the process of manufacturing. It has been conducted from the perspective of both the trauma and the specialized treatment of chronic pain anesthesiologist, and manufacturing the PRP on the premises of a Regional Centre for Transfusions, all belonging to the Public Health System and therefore without commercial interests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet rich plasma | Experimental | Three intraarticular injection, one each fifteen days |
|
| Hyaluronic acid | Active Comparator | Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1 % solution, administered by intraarticular injection (3 doses, one each fifteen days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet rich plasma | Biological | Three intraarticular injections of platelet-rich plasma, one each fifteen days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline Visual Analogue Scale (VAS) value | The main objective of this study is to determine the clinical value of intraarticular injections of platelet-rich plasma (PRP) in the reduction of perceived pain in patients with osteoarthritic knees | Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline Knee and Osteoarthritis Outcome System (KOOS) scale value | KOOS is an instrument to assess the patient's opinion about their knee and associated problems. It includes 5 subscales which measure respectively the pain, symptoms, activities of daily living, sporting activity and quality of life | Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elvira Montañez Heredia, MD, PhD | Hospital Universitario Virgen de la Victoria. Málaga | Principal Investigator |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Hyaluronic acid | Drug | Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1% solution, administered by intraarticular injections (three doses, one each fifteen days) |
|
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| Effects on quality of life | EUROQOL (European Quality of Life) for the evaluation of function and quality of life | Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration |
| All reported adverse events | Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration |
| D012216 |
| Rheumatic Diseases |