Knee Osteoarthritis
Conditions
Keywords
Knee osteoarthritis, Platelet-rich plasma, Pain's treatment
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALPlatelet rich plasma
Three intraarticular injections of platelet-rich plasma, one each fifteen days
DRUGHyaluronic acid
Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1% solution, administered by intraarticular injections (three doses, one each fifteen days)
Sponsors
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Arthritis in the knee rated I, II, or III (Kellgren-Lawrence Grading Scale) * VAS greater than 5 * Between 40and 80 years of age
Exclusion criteria
* Level IV arthritis of the knee * Either surgery, corticoid infiltration, or viscosupplementation in the knee in the previous three months * Frontal deformity greater than 10 degrees * Ipsilateral pathology of the knee or ankle * Range of motion or flexibility of the knee less than 90 degrees * Deficit of knee extension greater than 15 degrees * Anticoagulation treatment, antiplatelet treatment * Hepatopathy * Hematological neoplastic pathology * Active infection * Fibromyalgia * Chronic fatigue syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline Visual Analogue Scale (VAS) value | Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline Knee and Osteoarthritis Outcome System (KOOS) scale value | Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration | 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 |
| Effects on quality of life | Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration | EUROQOL (European Quality of Life) for the evaluation of function and quality of life |
| All reported adverse events | Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration | — |
Outcome results
None listed