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Pediatric ACL: Understanding Treatment Options
Sponsor: Boston Children's Hospital
Summary
Pediatric ACL: Understanding Treatment Outcomes (PLUTO) is a multi-center, prospective cohort study. Specific aims of PLUTO are to evaluate the safety and comparative effectiveness of non-operative treatment, as well as four operative treatments including (1) transphyseal ACL reconstruction (2) partial transphyseal ACL reconstruction, (3) physeal-sparing epiphyseal ACL reconstruction using the Anderson technique, and (4) physeal-sparing ACL reconstruction using the Micheli/Kocher technique in prepubescent and pubescent skeletally immature patients.
Official title: Pediatric ACL: Understanding Treatment Options (PLUTO)
Key Details
Gender
All
Age Range
5 Years - 18 Years
Study Type
OBSERVATIONAL
Enrollment
765
Start Date
2016-09
Completion Date
2030-12
Last Updated
2025-05-13
Healthy Volunteers
Yes
Interventions
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).
Locations (10)
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