Intraarticular Injections of Platelet-rich Plasma in Pain's Treatment of the Osteoarthritic Knee

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intraarticular Injections of Platelet-rich Plasma in Pain's Treatment of the Osteoarthritic Knee

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Biological: Platelet rich plasma
* Drug: Hyaluronic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet rich plasma<br>Three intraarticular injection, one each fifteen days | Biological: Platelet rich plasma<br>* Three intraarticular injections of platelet-rich plasma, one each fifteen days<br>* Other names: PRP, Platelet Concentrate;|
| Active Comparator: Hyaluronic acid<br>Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1 % solution, administered by intraarticular injection (3 doses, one each fifteen days) | Drug: Hyaluronic acid<br>* Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1% solution, administered by intraarticular injections (three doses, one each fifteen days)<br>* Other names: Adant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee osteoarthritis, Platelet-rich plasma, Pain's treatment