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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WITHDRAWN
NA
INTERVENTIONAL
2025-04-01
2026-09-26
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
DOUBLE
Study Groups
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Internal Brace
Patients will undergo ACL Reconstruction (ACLR) with an internal brace. At 6 months post-operation patients will fill out clinical outcome surveys. At the routine 1 year postoperative visit, all patients will fill out clinical outcome surveys and undergo MRI evaluation of the knee.
Arthrex Internal Brace
The Arthrex Internal Brace method for ACL reconstruction consists of suture tape used to reinforce the ACL during surgery. This suture tape is secured in place with bioabsorbable anchors that gradually degrade within the body over time.
ACL Reconstruction
All patients will undergo ACL reconstruction (ACLR) with or without an internal brace.
Standard ACLR
Patients will undergo ACLR without an internal brace. At 6 months post-operation patients will fill out clinical outcome surveys. At the routine 1 year postoperative visit, all patients will fill out clinical outcome surveys and undergo MRI evaluation of the knee.
ACL Reconstruction
All patients will undergo ACL reconstruction (ACLR) with or without an internal brace.
Interventions
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Arthrex Internal Brace
The Arthrex Internal Brace method for ACL reconstruction consists of suture tape used to reinforce the ACL during surgery. This suture tape is secured in place with bioabsorbable anchors that gradually degrade within the body over time.
ACL Reconstruction
All patients will undergo ACL reconstruction (ACLR) with or without an internal brace.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of blood-borne diseases including HIV, HBV, HCV, HTLV, and syphilis.
18 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Guillem Gonzalez-Lomas, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Other Identifiers
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23-01182
Identifier Type: -
Identifier Source: org_study_id
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