Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis Patients

Study Overview
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Brief Summary
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Knee osteoarthritis is the most common type of osteoarthritis in the lower extremity and constitutes 23% of all arthritis cases, about 13% of females and 10% of males aged above 60 years have symptomatic knee OA. Intra-articular corticosteroids (IACs) are a frequently-used treatment regimen for pain relief from symptomatic knee OA as it inhibits inflammation and reduces prostaglandin synthesis. Platelet-rich plasma (PRP) is an autologous blood product containing a high percentage of various growth factors (GFs), such as fibroblast growth factor, epidermal growth factor, vascular endothelial growth factor, transforming growth factor-β and platelet-derived growth factor. The aim of this study is to compare effect of intra-articular injection of platelet rich plasma versus corticosteroid in treatment of primary knee osteoarthritis.

Official Title
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Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis

Conditions
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Osteoarthritis Knee, Corticosteroid, Platelet Rich Plasma

Intervention / Treatment
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* Drug: Corticosteroid
* Other: Platelet Rich Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 40-70 years of age suffering from knee OA with Kellgren Lawrence grade II or III on standing antero-posterior and lateral knee radiographs. Patients diagnosed according to ACR classification criteria. Exclusion Criteria: Systemic diseases as Patients having diabetes mellitus,Cardiovascular diseases or coagulopathies. Those receiving treatment with anticoagulant , anti_platelet medications or systemic corticosteroid 10 days before injection or recent use of NSAIDs. Pregnant and breast feeding females. Patients have hemoglobin values <10 g/dl or platelet values<150,000/ml.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OA group injected by corticosteroid<br>Group l include 50 patients who will be injected with one intra_articular injection of 2 ml of methylprednisolone acetate 40 mg/ml mixed with 2ml of lidocaine | Drug: Corticosteroid<br>* The injection will be given at a site near the superolateral pole of patella in the suprapatellar pouch under aseptic conditions and the patient will be advised to take one day of rest after injection and apply ice to the area if there are any signs of inflammation.<br>|
| Active Comparator: OA group injected by Platelet Rich Plasma<br>Group lI include 50 patients who will be injected with a single 5 ml intra_articular injection of PRP prepared in our hospital | Other: Platelet Rich Plasma<br>* PRP preparation :- 20 ml of venous blood will be drawn from the antecubital vein using an 18G needle to avoid traumatizing platelets and will be collected in a sterile tube containing 2 ml of Sodium Citrate anticoagulant. Approximately 2 ml of whole blood will be separated for a complete blood count.The blood with anticoagulant will centrifuged at 4000 rpm for 6-10 minutes to separate erythrocytes and then at 4000 rpm for 6-10 min to concentrate platelets.The final product was 4-5 ml of PRP containing leukocytes with platelet concentration of 3-5 times the average normal value.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of knee pain, stiffness and physical function prior knee injection | Assessment through the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. The final score for the WOMAC was determined by adding the aggregate scores for pain, stiffness, and function. Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status. | Assessment will be done just before injection | 
| Assessment of knee pain, stiffness and physical function 2 weeks after injection | Assessment through WOMAC score | 2 weeks after injection | 
| Assessment of knee pain, stiffness and physical function 6 weeks after injection | Assessment through WOMAC score | 6 weeks after injection | 
| Assessment of knee pain, stiffness and physical function 12 weeks after injection | Assessment through WOMAC score | 12 weeks after injection |