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

Phase 4RecruitingNCT03734900

National Taiwan University Hospital150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Osteoarthritis (OA) of the Knee

Interventions

Saline injectionOTHER

5ml Placebo infusion of 0.9% Sodium Chloride

PRP injectionBIOLOGICAL

Device: "Aeon" Acti-PRP 5ml autologous platelet rich plasma injection

PL injectionBIOLOGICAL

Device: "Aeon" Acti-PRP 5ml autologous platelet lysate injection

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

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