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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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31 October 2022 |
Main ID: |
NCT03433170 |
Date of registration:
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27/01/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Quadrupled Semitendinosus Graft in Anterior Cruciate Ligament Reconstruction
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Scientific title:
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Quadrupled Semitendinosus Graft and Traditional Hamstrings Graft in Anterior Cruciate Ligament Reconstruction: Randomized Controlled Trial |
Date of first enrolment:
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January 20, 2018 |
Target sample size:
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42 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03433170 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Colombia
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Contacts
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Name:
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Juan P Martinez, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Fundacion Clinica Valle del Lili |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with anterior cruciate ligament injury that are candidates for surgical
reconstruction with hamstrings. They should be at least 16 years old.
Exclusion Criteria:
- Multiligament injuries. Re-ruptures of the ACL.
Age minimum:
15 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Anterior Cruciate Ligament Injury
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Intervention(s)
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Procedure: Quadrupled semitendinosus graft
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Procedure: ST-Gracilis graft
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Primary Outcome(s)
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Hamstrings Strength
[Time Frame: 6 months]
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Secondary Outcome(s)
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Anterior cruciate ligament rerupture
[Time Frame: 24 months]
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ACL laxity
[Time Frame: 24 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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