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

National Taiwan University

Status and phase: Unknown; Phase 4

Conditions: Osteoarthritis (OA) of the Knee

Treatments: Biological: PRP injection; Other: Saline injection; Biological: PL injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03734900

201803124RIPD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

Saline injection

Placebo Comparator group

Description:

Sodium Chloride injection into the study knee joint every 4 weeks for a total of 3 injections

Treatment:

Other: Saline injection

PRP injection

Experimental group

Description:

PRP injection into the study knee joint every 4 weeks for a total of 3 injections

Treatment:

Biological: PRP injection

PL injection

Experimental group

Description:

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.

Treatment:

Biological: PL injection