ACL Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation
NCT ID: NCT04550299
Last Updated: 2020-09-16
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
NA
112 participants
INTERVENTIONAL
2013-02-26
2023-12-01
Brief Summary
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Detailed Description
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This is a single-center prospective randomized clinical trial with 112 patients diagnosed with anterior cruciate ligament rupture randomly allocated in four groups: single bundle with autologous bioabsorbable implant; single bundle with intrafix implant; double bundle with autologous bioabsorbable implant; double bundle with intrafix implant.
Primary outcome is graft ligamentization assessed in MRI images at 4-6 months
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
single bundle technique with the use of bioabsorbable implants
Surgical technique combined with a specific choice of the material for the ligament reconstruction
The surgical procedure is done as standard of care. The intervention is to randomize the participant into the study arms, which none of those has been proved yet to be a superior choice
Group B
single bundle technique with the use of Bio-Intrafix
Surgical technique combined with a specific choice of the material for the ligament reconstruction
The surgical procedure is done as standard of care. The intervention is to randomize the participant into the study arms, which none of those has been proved yet to be a superior choice
Group C
double bundle technique with the use of bioabsorbable implants
Surgical technique combined with a specific choice of the material for the ligament reconstruction
The surgical procedure is done as standard of care. The intervention is to randomize the participant into the study arms, which none of those has been proved yet to be a superior choice
Group D
double bundle technique with the use of Bio-Intrafix
Surgical technique combined with a specific choice of the material for the ligament reconstruction
The surgical procedure is done as standard of care. The intervention is to randomize the participant into the study arms, which none of those has been proved yet to be a superior choice
Interventions
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Surgical technique combined with a specific choice of the material for the ligament reconstruction
The surgical procedure is done as standard of care. The intervention is to randomize the participant into the study arms, which none of those has been proved yet to be a superior choice
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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Johnson & Johnson
INDUSTRY
Vita Care
OTHER
Responsible Party
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Principal Investigators
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Wagner Castropil
Role: PRINCIPAL_INVESTIGATOR
Instituto Vita
Locations
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Instituto Vita
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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022
Identifier Type: -
Identifier Source: org_study_id
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