Comparison of Effectiveness Between PL and PRP on Knee Osteoarthritis: a Prospective,Randomized,Placebo-controlled Trial

Study Overview
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Brief Summary
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This study will focus on grade I to III knee osteoarthritis by randomized controlled trials which comparing the effectiveness between placebo, autologous platelet rich plasma and autologous platelet lysate injections.

Detailed Description
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The current methods for treating knee osteoarthritis include delaying the disease progression and joint replacement surgery. The usual treatment methods are mostly temporary, such as taking drug and hyaluronic acid injection. Therefore, finding the safe and effective methods will greatly reduce medical resource, medical expenses and surgery cost, etc., and restore the patient's quality of life. Platelet lysate is the product of complete activation from autologous platelet. It contains rich growth factors and cytokines such as PDGF, TGF-β, VEGF, EGF and IGF, etc. It can support cell growth and doesn't have any white blood cells in it. It is superior to the platelet rich plasma because of reducing the overall inflammatory response and pain of the patient during treatment.

Official Title
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Comparison of Effectiveness Between Platelet Lysate and Platelet-rich Plasma on Knee Osteoarthritis: a Prospective, Randomized, Placebo-controlled Trial

Conditions
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Osteoarthritis (OA) of the Knee

Intervention / Treatment
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* Other: Saline injection
* Biological: PRP injection
* Biological: PL injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 to 80 years old Study Subjects must be willing to sign Informed Consent to participate in the study In the past month, at least seven consecutive days in the squat, standing, walking or going up and down the stairs, the most serious degree of visual analogy of the knee pain (Visual Analogue Scale) is greater than or equal to 40 (the most pain is 100, not painful is 0) Morning joint stiffness is less than 30 minutes X-ray：Grade 1-3 radiographic OA as defined by the K-L classification Exclusion Criteria: Knee instability The knee joint is obviously deformed (> 5 degree valgus or varus deviation on X-ray) Clinical diagnosed as Pes tendinitis, Chondromalacia Taking NSAIDs or steroids (including oral and injection) within one week Using anticoagulant drugs for a long time Platelet count is less than 150,000 / UL, or coagulation disorders, prothrombin time (PT value) is less than 11 seconds or greater than 16 seconds Leukemia, sepsis, platelet dysfunction or other blood related diseases tumors, infections or the trauma before the same site Pregnancy

Ages Eligible for Study
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Minimum Age: 50 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 |
| --- | --- |
| Placebo Comparator: Saline injection<br>Sodium Chloride injection into the study knee joint every 4 weeks for a total of 3 injections | Other: Saline injection<br>* 5ml Placebo infusion of 0.9% Sodium Chloride<br>|
| Experimental: PRP injection<br>PRP injection into the study knee joint every 4 weeks for a total of 3 injections | Biological: PRP injection<br>* Device: Aeon Acti-PRP 5ml autologous platelet rich plasma injection<br>|
| Experimental: PL injection<br>PL injection into the study knee joint every 4 weeks for a total of 3 injections Platelet lysate is the product of nature activation from autologous platelet. | Biological: PL injection<br>* Device: Aeon Acti-PRP 5ml autologous platelet lysate injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score of the patient | Using Visual Analog Score (from 0 to 10, 0 indicate no pain and 10 indicate maximal pain) to evaluate pain of surgical wound of the patient | up to 24 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee functional score | Using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | up to 24 weeks after surgery | 
| X-ray | Knee X-ray image | up to 24 weeks after surgery | 
| Ultrasonic image | Ultrasonic-between thickness of the medial and lateral sides of the femoral condyle | up to 24 weeks after surgery | 
| adverse events | adverse events in clinical trial | up to 24 weeks after surgery |