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

Osteoarthritis (OA) of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03734900
• Other study ID #: 201803124RIPD
• Status: Recruiting
• Phase: Phase 4
• Start date: May 15, 2018
• Est. completion date: May 14, 2022

Study information

• Verified date: July 2021
• Source: National Taiwan University Hospital
• Contact: WU Chueh-Hung, MD, CIPS
• Phone: 0223123456
• Email: nojred[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 14, 2022
• Est. primary completion date: May 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis (OA) of the Knee
• Osteoarthritis, Knee

Intervention

Other:
• Saline injection
5ml Placebo infusion of 0.9% Sodium Chloride

Biological:
• PRP injection
Device: "Aeon" Acti-PRP 5ml autologous platelet rich plasma injection
• PL injection
Device: "Aeon" Acti-PRP 5ml autologous platelet lysate injection

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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