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

Phase 4

• Conditions: Osteoarthritis (OA) of the Knee
• Interventions: Other: Saline injection; Biological: PL injection; Biological: PRP injection

• Registration Number: NCT03734900
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

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 Timeline

• Study Start: 2018-05-15
• Study First Submitted: 2018-10-25
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-08
• Status Verified: 2021-07
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-20
• Primary Completion: 2022-05-14
• Study Completion: 2022-05-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline injection	Saline injection	Sodium Chloride injection into the study knee joint every 4 weeks for a total of 3 injections
PL injection	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.
PRP injection	PRP injection	PRP injection into the study knee joint every 4 weeks for a total of 3 injections

Primary Outcome Measures

Name	Time	Method
Pain score of the patient	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 Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan