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

Primary Purpose

Osteoarthritis (OA) of the Knee

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Saline injection
PRP injection
PL injection
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis (OA) of the Knee

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Saline injection

PRP injection

PL injection

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Knee functional score
Using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
X-ray
Knee X-ray image
Ultrasonic image
Ultrasonic-between thickness of the medial and lateral sides of the femoral condyle
adverse events
adverse events in clinical trial

Full Information

First Posted
October 25, 2018
Last Updated
September 16, 2021
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03734900
Brief Title
Comparison of Effectiveness Between PL and PRP on Knee Osteoarthritis: a Prospective,Randomized,Placebo-controlled Trial
Official Title
Comparison of Effectiveness Between Platelet Lysate and Platelet-rich Plasma on Knee Osteoarthritis: a Prospective, Randomized, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
May 14, 2022 (Anticipated)
Study Completion Date
May 14, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis (OA) of the Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saline injection
Arm Type
Placebo Comparator
Arm Description
Sodium Chloride injection into the study knee joint every 4 weeks for a total of 3 injections
Arm Title
PRP injection
Arm Type
Experimental
Arm Description
PRP injection into the study knee joint every 4 weeks for a total of 3 injections
Arm Title
PL injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Saline injection
Intervention Description
5ml Placebo infusion of 0.9% Sodium Chloride
Intervention Type
Biological
Intervention Name(s)
PRP injection
Intervention Description
Device: "Aeon" Acti-PRP 5ml autologous platelet rich plasma injection
Intervention Type
Biological
Intervention Name(s)
PL injection
Intervention Description
Device: "Aeon" Acti-PRP 5ml autologous platelet lysate injection
Primary Outcome Measure Information:
Title
Pain score of the patient
Description
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 Outcome Measure Information:
Title
Knee functional score
Description
Using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame
up to 24 weeks after surgery
Title
X-ray
Description
Knee X-ray image
Time Frame
up to 24 weeks after surgery
Title
Ultrasonic image
Description
Ultrasonic-between thickness of the medial and lateral sides of the femoral condyle
Time Frame
up to 24 weeks after surgery
Title
adverse events
Description
adverse events in clinical trial
Time Frame
up to 24 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
WU Chueh-Hung, MD, CIPS
Phone
0223123456
Ext
66473
Email
nojred@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Tyng-Guey, MD
Phone
0223123456
Ext
67588
Email
tgw@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wu Chueh-Hung, MD, CIPS
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu Chueh-hung, MD,CIPS
Phone
0223123456
Ext
66473
Email
nojred@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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