Platelet-rich Plasma Intra-articular Knee Injections for Knee Osteoarthritis

Study Overview
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Brief Summary
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The benefit of using platelet rich plasma (PRP) in cartilage injuries, and specifically in degenerative ones, has not been assessed yet. Current studies on the PRP healing or repairing effect on knee cartilage degenerative injuries are not conclusive to establish a standard of behavior, although PRP has shown to improve joint functionality and reduce pain. Hypothesis: PRP intra-articular injections in osteoarthritic knees reduces pain and leads to a more effective and lasting functional recovering than corticosteroid intra-articular injections.

Official Title
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A Prospective, Randomized, Double-blinded, Clinical Trial, Comparing Platelet-rich Plasma Intra-articular Knee Injections Versus Corticosteroid Intra-articular Knee Injections for Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Biological: platelet-rich plasma
* Drug: Corticosteroid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Degenerative osteoarthritis of the knee confirmed radiologically Degenerative osteoarthritis of the knee replacement candidate Walking ability in patients with or without external support Baseline in pain VAS greater than 60 Exclusion Criteria: Neoplastic disease Immunosuppressive States Patients who received intra-articular injections of steroids, anesthetic and / or hyaluronic acid in the last 3 months. Patients who have undergone arthroscopic surgery on the last 3 months Patients with involvement of bone metabolism except osteoporosis (Paget's disease, renal osteodystrophy, osteomalacia) Fibromyalgia or chronic fatigue syndrome Liver disease Deficit coagulation (blood dyscrasia) Thrombocytopenia Anticoagulant treatment

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: platelet-rich plasma intra-articular knee injections<br>a single intra-articular injection of PRP in knee osteoarthritis | Biological: platelet-rich plasma<br>* a single intra-articular injection<br>|
| Active Comparator: Corticosteroid intra-articular knee injections<br>a betamethasone and bupivacaine intra-articular injection | Drug: Corticosteroid<br>* A single betamethasone and bupivacaine intra-articular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The value of the visual analogue scale pain (VAS) | The difference between the baseline and the value of the scale one month after treatment | one month after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the value of pain visual analog scale according to |  | 4 weeks, 3 and 6 months after treatment | 
| the functional level of the knee KOOS |  | 4 weeks, 3 and 6 months after treatment | 
| All reported adverse events |  | 4 weeks, 3 and 6 months after treatment | 
| Scale of the SF36 quality of life |  | 4 weeks, 3 and 6 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis, comparing platelet-rich plasma, intra-articular knee injections