The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction
NCT ID: NCT04533880
Last Updated: 2024-08-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2020-08-31
2023-07-07
Brief Summary
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The purpose of the proposed study is to evaluate the effect bone-void filler on anterior knee pain following ACL reconstruction BPTB autograft.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
The control group will receive autologous bone obtained from the BTBPB graft harvest
Autologous bone graft
Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
Autologous Bone + DBM
Autologous bone plus demineralized bone matrix
DBM
Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)
Autologous bone graft
Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
Autologous Bone + Calcium Phosphate Cement
Autologous bone plus calcium phosphate cement
Calcium phosphate cement
Quickset, Arthrex, Naples, FL
Autologous bone graft
Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
Interventions
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DBM
Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)
Calcium phosphate cement
Quickset, Arthrex, Naples, FL
Autologous bone graft
Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
Eligibility Criteria
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Inclusion Criteria
* Skeletally mature (as defined by closed growth plates on plain radiograph)
* At least 18 years of age
* Willing and able to provide consent
Exclusion Criteria
* skeletally immature (as defined by open physis on plain radiograph)
* pregnant
* less than 18 years of age
* previous ACL repair or reconstruction
* unable to speak english or perform informed consent
* multiligamentous knee injury (two or more ligaments requiring surgical attention)
* varus or valgus malalignment greater than 3 degrees
18 Years
ALL
Yes
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Eric Strauss, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Orthopedic Hospital
New York, New York, 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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20-00081
Identifier Type: -
Identifier Source: org_study_id
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