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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03734900
Collaborator
(none)
150
Enrollment
1
Location
3
Arms
48
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Saline injection
  • Biological: PRP injection
  • Biological: PL injection
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Comparison of Effectiveness Between Platelet Lysate and Platelet-rich Plasma on Knee Osteoarthritis: a Prospective, Randomized, Placebo-controlled Trial
Actual Study Start Date :
May 15, 2018
Anticipated Primary Completion Date :
May 14, 2022
Anticipated Study Completion Date :
May 14, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Knee functional score [up to 24 weeks after surgery]

    Using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  2. X-ray [up to 24 weeks after surgery]

    Knee X-ray image

  3. Ultrasonic image [up to 24 weeks after surgery]

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

  4. adverse events [up to 24 weeks after surgery]

    adverse events in clinical trial

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan 100

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT03734900
Other Study ID Numbers:
  • 201803124RIPD
First Posted:
Nov 8, 2018
Last Update Posted:
Sep 20, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee

Study Results

No Results Posted as of Sep 20, 2021