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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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12 December 2020 |
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Main ID: |
NCT02409719 |
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Date of registration:
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30/03/2015 |
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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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Home Rehabilitation in Patients After Primary Total Knee Arthroplasty
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Scientific title:
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Home Rehabilitation in Patients After Primary Total Knee Arthroplasty |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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76 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02409719 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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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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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age between 18 and 90 years
- Patients with Knee osteoarthritis (OA) grade 4 ( Kellgren-Lawrence based on
radiographic findings)
- Total Knee Arthroplasty (TKA) for primary OA
- Rapid rehabilitation desire
Exclusion Criteria:
- Age <18 and > 90 years
- Patients with Knee osteoarthritis grade 1-2 ( 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
- Drugs abuse history
- Physiatric disease
- Pregnant patients
- Patients with hemoglobin values < 11g/dl , platelets < 150,000/ µL
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
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Rehabilitation
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Intervention(s)
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Other: Schedule
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Other: Verbal Information and Booklet
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Primary Outcome(s)
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Total WOMAC Score
[Time Frame: up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)]
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Secondary Outcome(s)
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Visual Analog Scale (Measure of Pain Intensity)
[Time Frame: up to 12 months (O, 2, 4, 6 weeks, 3,6 and 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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