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RecruitingNCT03734900Updated Sep 21, 2026

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

A Phase 4 interventional study of Saline injection and PRP injection in Osteoarthritis (OA) of the Knee, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by National Taiwan University Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled May 2018, registered Oct 2018).
  • Started May 2018; still recruiting 8 years 4 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteoarthritis (OA) of the Knee

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03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 150 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
150 participants (estimated)

Study arms

  • Placebo comparator
    Saline injection

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

    Other: Saline injection

  • Experimental
    PRP injection

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

    Biological: PRP 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

Interventions

  • OtherSaline injection

    5ml Placebo infusion of 0.9% Sodium Chloride

  • BiologicalPRP injection

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

  • BiologicalPL injection

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 24 weeks after surgery

Secondary outcomes

  1. Knee functional score

    Using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: up to 24 weeks after surgery

  2. X-ray

    Knee X-ray image

    Time frame: up to 24 weeks after surgery

  3. Ultrasonic image

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

    Time frame: up to 24 weeks after surgery

  4. adverse events

    adverse events in clinical trial

    Time frame: up to 24 weeks after surgery

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03734900
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Nov 8, 2018
Start date
May 15, 2018
Primary completion
May 14, 2027 (estimated)
Completion
May 14, 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

WU Chueh-Hung, MD, CIPS
Contact
nojred@gmail.com
0223123456 ext. 66473
Wang Tyng-Guey, MD
Contact
tgw@ntu.edu.tw
0223123456 ext. 67588
Wu Chueh-Hung, MD, CIPS
study director · National Taiwan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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