Pediatric ACL: Understanding Treatment Options
PLUTO
1 other identifier
observational
765
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2016
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2016
CompletedFirst Posted
Study publicly available on registry
May 16, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
May 13, 2025
May 1, 2025
13.7 years
May 11, 2016
May 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Knee functional outcome at 2 years post-ACL reconstruction (Pedi-IKDC)
To compare outcomes associated with four surgical techniques performed to treat complete intrasubstance ACL tears in pre- and early pubescent children: (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.
2 years
Secondary Outcomes (4)
Health-related quality of life (Pediatric Quality of Life Inventory (PedsQL)
2 years
Graft failure (MRI, Lachman, Pivot-Shift)
2 years
Activity level (P-FABS and Physical Activity Questionnaire)
2 years
Growth disturbance (angular deformity, leg length discrepancy per clinical exam and radiographs)
2 years
Other Outcomes (5)
Re-injury or instability requiring ACL reconstruction
2 years
Knee function (Pedi-IKDC)
2 years
Health-related quality of life (PedsQL)
2 years
- +2 more other outcomes
Study Arms (5)
Non Operative: Rehabilitation, Bracing, Activity Restriction
Operative: Transphyseal
Operative: Partial Transphyseal
Operative: Physeal sparing by Anderson Technique
Operative: Physeal sparing by Micheli/Kocher Technique
Interventions
The non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions.
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.
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.
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).
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
The pool of patients for this study will be patients seen in outpatient and sports medicine clinics at each clinical center. The minimum accrual target for this study is 360 surgical patients and 45 non-operative patients
You may qualify if:
- Diagnosis of complete intrasubstance ACL tear
- Skeletally Immature (by knee radiographs)
You may not qualify if:
- Prior ACL surgery on the ipsilateral knee
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Children's Hospitallead
- Children's Hospital of Philadelphiacollaborator
- Children's Hospital Medical Center, Cincinnaticollaborator
- Rady Children's Hospital, San Diegocollaborator
- Washington University School of Medicinecollaborator
- Children's Healthcare of Atlantacollaborator
- The Cleveland Cliniccollaborator
- Tennessee Orthopedic Alliancecollaborator
- Hospital for Special Surgery, New Yorkcollaborator
- Stanford Universitycollaborator
Study Sites (10)
Stanford University Medical Center
Palo Alto, California, 94304, United States
Rady Children's Hospital
San Diego, California, 92123, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Washington University at St. Louis
St Louis, Missouri, 63130, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45229, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Tennessee Orthopaedic Alliance
Nashville, Tennessee, 37205, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mininder S Kocher, MD, MPH
Boston Children's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 11, 2016
First Posted
May 16, 2016
Study Start
September 1, 2016
Primary Completion (Estimated)
May 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
May 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share