Intraarticular Leukocyte-rich and Leukocyte-poor PRP for Osteoarthritis of the Knee

Study Overview
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Brief Summary
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To compare the efficacy of intraarticular knee injection between leukocyte-rich and leukocyte-poor platelet-rich plasma in knee osteoarthritis treatment

Detailed Description
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Participants were randomized into 3 groups (leukocyte-rich platelet-rich plasma (LR-PRP), leukocyte-poor platelet-rich plasma (LP-PRP), and Corticosteroid (CS)). The primary outcome of this study is The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and was measured pre-treatment and post-treatment at follow-up at 1, 3, and 6 months

Official Title
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Comparison Efficacy of Intraarticular Knee Injection in Knee Osteoarthritis With Leukocyte-rich and Leukocyte-poor Platelet-rich Plasma

Conditions
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Osteo Arthritis Knee

Intervention / Treatment
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* Drug: Leukocyte-rich platelet-rich plasma
* Drug: Leukocyte-poor platelet-rich plasma
* Drug: Corticosteroid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 50 years old, Plain radiographs knee AP shows Kellgren-Lawrence classification 1-4, Refuse the use of NSAIDs for 2 weeks. Exclusion Criteria: 1) Previous intra-articular injection therapy in the past 6 months; 2) Previously treated with intra-knee PRP injection; 3) History of knee arthritis from other causes such as rheumatoid arthritis, pseudogout or infectious joints 4) History of blood disorder including anemia and thrombocytopenia (Hb < 12 g/dl, plt < 150,000/ml ) 5) History of surgery on the aforementioned knee 6) Obvious knee deformity (valgus > 15, varus > 20, flexion ROM < 90 , extension lag > 20) 7) Pregnancy and lactation

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 99 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leukocyte-rich platelet-rich plasma<br>Leukocyte-rich PRP: Centrifuge at 300 G for 5 min, separate the plasma and buffy coat layers, and then centrifuge at 700 G for 17 min with calcium chloride at the ratio of 1:5 to PRP by volume. | Drug: Leukocyte-poor platelet-rich plasma<br>* Intra-articular knee injection<br>* Other names: LPPRP;Drug: Corticosteroid<br>* Intra-articular knee injection<br>* Other names: CS;|
| Experimental: Leukocyte-poor platelet-rich plasma<br>Leukocyte-poor PRP: Centrifuge at 123 G for 15 min, separate the plasma and buffy coat layers, and then centrifuge at 448 G for 10 min. Calcium chloride was added 1:5 to PRP by volume. | Drug: Leukocyte-rich platelet-rich plasma<br>* Intra-articular knee injection<br>* Other names: LRPRP;Drug: Corticosteroid<br>* Intra-articular knee injection<br>* Other names: CS;|
| Experimental: Corticosteroid<br>Corticosteroid: 1 ml of triamcinolone acetonide (40mg/ml) mixed with 0.9% NaCl to a total volume of 4 ml. | Drug: Leukocyte-rich platelet-rich plasma<br>* Intra-articular knee injection<br>* Other names: LRPRP;Drug: Leukocyte-poor platelet-rich plasma<br>* Intra-articular knee injection<br>* Other names: LPPRP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | a self-administered questionnaire consisting of 24 items divided into 3 subscales Pain (5 items) Stiffness (2 items) Physical Function (17 items) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain | total of 10 score | 6 months | 
| the time up and go test | unit: second | 6 months | 
| 30-second chair stand test | unit second | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OA knee, PRP, Leukocyte concentration, Osteoarthritis Knee