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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ACTIVE_NOT_RECRUITING
765 participants
OBSERVATIONAL
2016-09-30
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Non Operative: Rehabilitation, Bracing, Activity Restriction
Non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions
The non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions.
Operative: Transphyseal
Surgical technique: Transphyseal reconstruction
Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include standardized surgical techniques for transphyseal reconstruction with soft tissue graft and metaphyseal fixation.
Operative: Partial Transphyseal
Surgical technique: Partial transphyseal reconstruction
Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include partial transphyseal reconstruction (tibial transphyseal and femoral epiphyseal) with soft tissue graft.
Operative: Physeal sparing by Anderson Technique
Surgical technique: Physeal sparing reconstruction by the Anderson method
Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include standardized surgical techniques for physeal sparing epiphyseal reconstruction with soft tissue graft (Anderson technique).
Operative: Physeal sparing by Micheli/Kocher Technique
Surgical technique: Physeal sparing reconstruction by the Micheli/Kocher method
Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include physeal-sparing with Iliotibial band combined extra-articular and intra-articular reconstructions (Micheli/Kocher Technique).
Interventions
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Non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions
The non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions.
Surgical technique: Transphyseal reconstruction
Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include standardized surgical techniques for transphyseal reconstruction with soft tissue graft and metaphyseal fixation.
Surgical technique: Partial transphyseal reconstruction
Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include partial transphyseal reconstruction (tibial transphyseal and femoral epiphyseal) with soft tissue graft.
Surgical technique: Physeal sparing reconstruction by the Anderson method
Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include standardized surgical techniques for physeal sparing epiphyseal reconstruction with soft tissue graft (Anderson technique).
Surgical technique: Physeal sparing reconstruction by the Micheli/Kocher method
Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include physeal-sparing with Iliotibial band combined extra-articular and intra-articular reconstructions (Micheli/Kocher Technique).
Eligibility Criteria
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Inclusion Criteria
* Skeletally Immature (by knee radiographs)
Exclusion Criteria
* Congenital ACL deficiency
* Multiple ligament reconstruction required
* Other significant comorbidities including syndromic conditions, neuromuscular disorders or developmental delay
* If scheduling of the ACL surgery is impacted by the skeletal maturity of the patient
* Simultaneous bilateral ACL tears
5 Years
18 Years
ALL
Yes
Sponsors
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Children's Hospital of Philadelphia
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Rady Children's Hospital, San Diego
OTHER
Washington University School of Medicine
OTHER
Children's Healthcare of Atlanta
OTHER
The Cleveland Clinic
OTHER
Tennessee Orthopedic Alliance
OTHER
Hospital for Special Surgery, New York
OTHER
Stanford University
OTHER
Boston Children's Hospital
OTHER
Responsible Party
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Mininder Kocher
Principal Investigator
Principal Investigators
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Mininder S Kocher, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Stanford University Medical Center
Palo Alto, California, United States
Rady Children's Hospital
San Diego, California, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Washington University at St. Louis
St Louis, Missouri, United States
Hospital for Special Surgery
New York, New York, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Tennessee Orthopaedic Alliance
Nashville, Tennessee, United States
Countries
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Other Identifiers
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IRB-P00017850
Identifier Type: -
Identifier Source: org_study_id
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