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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis (OA) of the Knee
• Intervention / Treatment: Other: Saline injection; Biological: PRP injection; Biological: PL injection

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: WU Chueh-Hung, MD, CIPS; Phone Number: 66473 0223123456; Email: nojred@gmail.com
• Study Contact Backup: Name: Wang Tyng-Guey, MD; Phone Number: 67588 0223123456; Email: tgw@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Wu Chueh-hung, MD,CIPS; Phone Number: 66473 0223123456; Email: nojred@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Saline injection; Sodium Chloride injection into the study knee joint every 4 weeks for a total of 3 injections	Other: Saline injection; 5ml Placebo infusion of 0.9% Sodium Chloride
EXPERIMENTAL: PRP injection; PRP injection into the study knee joint every 4 weeks for a total of 3 injections	Biological: PRP injection; Device: "Aeon" Acti-PRP 5ml autologous platelet rich plasma injection
EXPERIMENTAL: PL injection; 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; Device: "Aeon" Acti-PRP 5ml autologous platelet lysate injection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Director: Wu Chueh-Hung, MD, CIPS, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2018
• Primary Completion (ANTICIPATED): May 14, 2022
• Study Completion (ANTICIPATED): May 14, 2022

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (ACTUAL): November 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 201803124RIPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No