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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 March 2015 |
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Main ID: |
NCT02370420 |
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Date of registration:
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27/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Intra-Articular Injections of Platelet-Rich Plasma in Knee Osteoarthritis: Unique Application Versus Triple Application
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Scientific title:
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Intra-Articular Injections of Platelet-Rich Plasma in Knee Osteoarthritis: Unique Application Versus Triple Application |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02370420 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Felix Vilchez, MD, PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad Autonoma de Nuevo Leon |
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Name:
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Felix Vilchez, MD, PHD |
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Address:
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Telephone:
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Email:
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fvc78@hotmail.com |
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Affiliation:
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Name:
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VIlchez Cavazos, Dr. med. |
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Address:
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Telephone:
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Email:
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fvc78@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age between 18 and 90 years
- Patients with no previous treatment
- Patients with Knee osteoarthritis grade 1-2 ( Kellgren-Lawrence based on radiographic
findings)
Exclusion Criteria:
- Age <18 and > 90 years
- Patients with Knee osteoarthritis grade 3-4 ( Kellgren-Lawrence based on radiographic
findings)
- Patients with asociated Rheumatic syndromes
- Patients with anticoagulant therapy
- Patients with hepatic problems, Diabetes Mellitus, Coagulopathy, hearth conditions,
immunodepressed, or infections
- Pregnant patients
- Patients with prosthetic or orthotic.
- Patients with hemoglobin values < 11g/dl , platelets < 150,000/uL
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
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Intervention(s)
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Behavioral: rehabilitation exercises
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Biological: Platelet-Rich Plasma
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Primary Outcome(s)
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therapeutic effect measured with WOMAC scale.
[Time Frame: Baseline,3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months]
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Secondary Outcome(s)
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therapeutic effect measured with Visual Analog Scale
[Time Frame: Baseline,3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months]
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therapeutic effect measured with SF-12 scale.
[Time Frame: Baseline,3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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