Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03734900

Comparison of Effectiveness Between PL and PRP 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location status: Recruiting

Location contact

Wu Chueh-hung, MD,CIPS

CONTACT

[email protected]

0223123456 ext. 66473

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline injection

Other

5ml Placebo infusion of 0.9% Sodium Chloride

PRP injection

Biological

Device: "Aeon" Acti-PRP

5ml autologous platelet rich plasma injection

PL injection

Biological

Device: "Aeon" Acti-PRP

5ml autologous platelet lysate injection

Primary outcomes

  1. Pain score of the patient

    Time frame: up to 24 weeks after surgery

    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

Secondary outcomes

  1. Knee functional score

    Time frame: up to 24 weeks after surgery

    Using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  2. X-ray

    Time frame: up to 24 weeks after surgery

    Knee X-ray image

  3. Ultrasonic image

    Time frame: up to 24 weeks after surgery

    Ultrasonic-between thickness of the medial and lateral sides of the femoral condyle

  4. adverse events

    Time frame: up to 24 weeks after surgery

    adverse events in clinical trial

Study contacts

Contact information is provided by the study sponsor or research team.

WU Chueh-Hung, MD, CIPS

CONTACT

[email protected]

0223123456 ext. 66473

Wang Tyng-Guey, MD

CONTACT

[email protected]

0223123456 ext. 67588

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Nov 8, 2018
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.