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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50-80
SponsorNational Taiwan University Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Saline injection

    Other intervention

    5ml Placebo infusion of 0.9% Sodium Chloride

  • PRP injection

    Biological/Vaccine

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

  • PL injection

    Biological/Vaccine

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

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Saline injectionPlacebo comparator 1 intervention
Group B: PRP injectionExperimental treatment 1 intervention
Group C: PL injectionExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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