Comparison of Effectiveness Between PL and PRP on Knee Osteoarthritis: a Prospective,Randomized,Placebo-controlled Trial
NCT ID: NCT03734900
Last Updated: 2021-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2018-05-15
2022-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Saline injection
Sodium Chloride injection into the study knee joint every 4 weeks for a total of 3 injections
Saline injection
5ml Placebo infusion of 0.9% Sodium Chloride
PRP injection
PRP injection into the study knee joint every 4 weeks for a total of 3 injections
PRP injection
Device: "Aeon" Acti-PRP
5ml autologous platelet rich plasma 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.
PL injection
Device: "Aeon" Acti-PRP
5ml autologous platelet lysate injection
Interventions
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Saline injection
5ml Placebo infusion of 0.9% Sodium Chloride
PRP injection
Device: "Aeon" Acti-PRP
5ml autologous platelet rich plasma injection
PL injection
Device: "Aeon" Acti-PRP
5ml autologous platelet lysate injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
80 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Wu Chueh-Hung, MD, CIPS
Role: STUDY_DIRECTOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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201803124RIPD
Identifier Type: -
Identifier Source: org_study_id
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