Clinical Outcomes of ACL Reconstruction Augmented by an Injectable Osteoconductive/Osteoinductive Compound
NCT ID: NCT04993339
Last Updated: 2021-09-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
26 participants
INTERVENTIONAL
2016-10-24
2020-02-20
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
SINGLE
Study Groups
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Standard Surgery
Participants in this group undergoing standard of care reparative surgery will not receive additional intervention
No interventions assigned to this group
Standard Surgery with OOC
Participants in this group undergoing standard of care reparative surgery will receive OOC as an additional intervention
OOC
The OOC will be mixed with autologous 5cc of platelet rich plasma (PRP), and then injected using a syringe into both tibia and femoral tunnels
Interventions
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OOC
The OOC will be mixed with autologous 5cc of platelet rich plasma (PRP), and then injected using a syringe into both tibia and femoral tunnels
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
18 Years
ALL
No
Sponsors
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Arthrex, Inc.
INDUSTRY
University of Miami
OTHER
Responsible Party
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Francesco Travascio
Associate Professor
Principal Investigators
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Francesco Travascio
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Coral Gables, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20150981
Identifier Type: -
Identifier Source: org_study_id
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